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FDA and EMA to Begin Joint Inspections
Posted: 15 December 2011
Following a successful pilot program, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will begin sharing the work of inspecting pharmaceutical manufacturing facilities in their respective regions. The initiative will start in January and will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate, duplicate inspections. FDA and EMA officials say it will allow the agencies to work more efficiently and shift needed resources to other regions.
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Bill Would Require Increased Monitoring of Implants
Posted: 15 December 2011
New legislation introduced in the US Senate this week would compel manufacturers of certain medical implants to more closely monitor their products after they have been approved and are on the market. The proposal is an attempt to address mounting problems that have been reported in metal artificial hips and other implants, which do not require human testing for clearance under FDA’s 510(k) process. While the bipartisan bill would not require additional premarket testing, it would give the US Food and Drug Administration (FDA) additional authority to force device makers to track and report the performance of such implants.
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France May Toughen Regulations After Mediator
Posted: 15 December 2011
French lawmakers are looking to toughen drug regulations in the wake of the scandal over handling of the diabetes pill Mediator, linked to as many as 2,000 deaths over 33 years. Public trust in France’s drug regulator, known as AFSSAPS, has taken a big hit over allegations that officials ignored decades-old warning signs about the drug and that the agency failed to address conflicts of interest that may have played a role in the failure to quickly address Mediator’s risks. Lawmakers now aim to put an end to such conflicts of interest and bring more accountability for reporting them, possibly making the failure to do so a criminal offense, as is the case in the US.
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Manufacturers Get Extension on Reporting Payments to Docs
Posted: 15 December 2011
This week, the US Centers for Medicare and Medicaid Services (CMS) released its draft regulations covering the procedures for manufacturers of healthcare products to report payments to doctors and disclose that information to the public. The new reporting requirement was enacted under the Physician Payment Sunshine Act, part of last year’s healthcare reform legislation, and was initially supposed to come into force 1 January 2012. However, the draft regulation was delayed, giving companies until the final rule is published sometime in 2012 before they must start reporting payments. The act requires manufacturers of drugs, devices or biologics covered by Medicare, Medicaid or the Children’s Health Insurance Program to report all physician payments above $10 and to pay penalties for failure to meet that obligation.
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HHS Overrules FDA on Morning-after Pill
Posted: 8 December 2011
In an unprecedented move, US Health and Human Services (HHS) Secretary Kathleen Sebelius overruled a decision by the US Food and Drug Administration (FDA) to allow over-the-counter sales of the “morning-after” contraceptive pill to women younger than 17. While FDA Commissioner Margaret Hamburg issued a statement outlining why the agency had found the Plan B One-Step pill safe to sell over the counter, Sebelius issued her own statement contending the data “do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.” The pill is currently available without a prescription for women 17 and older.
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China Unveils Plan to Improve Drug Safety
Posted: 8 December 2011
China’s State Council this week approved a five-year plan to bolster the country’s drug safety standards. "Our country's pharmaceutical companies are experiencing various problems such as the lack of an integrated credit system, inadequate supervision and a weak technical foundation. Medicinal safety is in a high-risk stage," according to an official statement released after the State Council executive meeting. Under the plan, there will be quick revision of the laws and regulations governing standards for medicines and biological products to bring them in line with other key global regulatory agencies, stepped up action to combat counterfeiting, strengthening of enforcement powers and improved monitoring of adverse events and postmarket surveillance. The plan also calls for China to take the lead in setting global standards for traditional Chinese medicine.
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Healthcare Executives Held Liable for Wrongdoing
Posted: 8 December 2011
In some recent high-profile cases, federal prosecutors have revived the doctrine under US law that holds corporate executives responsible for company wrongdoing, even if their knowledge of the misdeeds cannot be established. Known as the "responsible corporate officer" or Park doctrine, prosecutors do not have to prove an executive knew of violations, only that the executive was in a position of responsibility to prevent them. While the doctrine has been little used for decades, a number of healthcare company executives have recently been convicted without proof they were aware of unlawful activity, and face sentences including prison time and long-term bans on doing business with the federal government.
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US Supreme Court Hears Diagnostic Patent Case
Posted: 8 December 2011
This week, the US Supreme Court heard arguments concerning whether observed correlations between drug dosages and medical treatment can be patent protected. The case’s outcome could affect the future of companion diagnostics and personalized medicine. The patent in question is held by Prometheus Laboratories and covers a method to find the correct dosage of a drug to treat gastrointestinal disorders based on metabolite levels in patients’ blood. Prometheus claims the Mayo Clinic violated its patent in developing a similar test. The Mayo Clinic is questioning the validity of a patent based on scientific observations.
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EU Extends Patent Protection for Multi-disease Drugs
Posted: 1 December 2011
The Court of Justice of the European Union (CJEU), the EU’s highest court, issued a ruling last week that extended patent protection for drugs and vaccines that are used in to treat multiple diseases. The ruling provides greater clarity on how to interpret EU rules on supplementary protection certificates (SPCs) and has been welcomed by the pharmaceutical industry. Representatives of the European Federation of Pharmaceutical Industries and Associations and the Association of the British Pharmaceutical Industry said the decision will help stimulate further research and development.
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Uncertainty Remains for Companion Drug/Diagnostic Pathway
Posted: 1 December 2011
Recent approvals by the US Food and Drug Administration (FDA) of companion diagnostics for use in oncology bode well for the future of coordinated drug/diagnostic development, however, questions remain. While FDA has done a lot to work with sponsors to help coordinate the separate processes for reviewing companion drugs and diagnostics in a timely manner, the very existence of separate FDA review authorities that must be coordinated and the inherent complexity of this process, along with the shorter regulatory pathway for diagnostics in Europe and elsewhere, continue to make sponsors and their investors think hard about where to pursue clinical trials and product development.
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FDA Enforcement Actions Continue to Rise
Posted: 1 December 2011
In the latest in a series of reports of increased enforcement actions by the US Food and Drug Administration (FDA), the blog FDAzilla is reporting that it expects the number of Form 483s issued by the agency to top 10,000 for the second year in a row. FDAzilla reports: “Through November 2, 2011, the FDA has issued 9,052 483s, approximately 215 more 483s than the same time period in 2010, roughly a 2.4% increase. Extrapolating for the rest of the year, we expect the FDA to issue roughly 10,690 483s for 2011.” Early last month, it was reported that FDA’s pharma Warning Letters and product recalls are also on the rise.
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Health Canada Follows FDA on Avastin
Posted: 1 December 2011
Following closely on the heels of a decision by the US Food and Drug Administration (FDA) to remove the breast cancer indication for Avastin, Health Canada is taking the same action. Canadian officials conducted their own review of Avastin evidence, but took into account reviews by FDA and the European Medicines Agency. Like FDA, they determined that the potential harm of using the drug to treat metastatic breast cancer outweighed its potential benefits.
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Senator’s Plan Would Expand FDA Accelerated Approval Program
Posted: 17 November 2011
A plan in the works from Sen. Kay Hagan of North Carolina, working closely with the Biotechnology Industry Organization, would expand the US Food and Drug Administration (FDA) accelerated approval program for drugs for unmet needs. The proposed plan would define a pathway for drugmakers to gain marketing approval for a drug that addresses an unmet medical need, supported by only Phase II clinical data. FDA already has the authority to grant such approval on a case-by-case basis, but uses it infrequently. The proposal would clearly lay out the rules and criteria drugmakers would need to meet.
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China Steps Up Enforcement Against Drug Counterfeiting
Posted: 17 November 2011
China this week took significant steps against the country’s counterfeit drug producers, establishing a new national office of intellectual property rights infringement and counterfeiting, and seizing the equivalent of $315 million (US) worth of fake drugs and packaging. The counterfeit drug seizures occurred in nationwide raids and was the second major enforcement action in recent weeks. As China has come under increasing global scrutiny as a source of counterfeit drugs, the Chinese government has felt increasing pressure to act in order to bolster international confidence in Chinese drugs and active pharmaceutical ingredients.
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Shuren Defends CDRH, Vows to Work With Device Makers
Posted: 17 November 2011
Appearing before a US Senate Committee this week, Jeffrey Shuren, director of the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), acknowledged shortcomings within CDRH due to personnel turnover and other factors, but defended the center’s process for medical device review. Fielding a number of tough questions from committee members about lengthy review times, he also put some of the blame on device makers for poor submissions, but promised to do more to rectify that. "We do need to work with industry ... on ensuring we're getting quality submissions," he said. "We're working on criteria for when we would not accept an application."
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FDA Safety Warnings Inadequate, Says Report
Posted: 17 November 2011
A new report published in the Archives of Internal Medicine contends the US Food and Drug Administration’s (FDA) safety-alert system is falling short. FDA’s process for monitoring its adverse-events database and publicizing early findings that could signal potential safety risks has resulted in some drug-label changes, but without adequate advice about their significance or what patients and healthcare providers should do in response, say the article’s authors. "The FDA should consider changing the statements ... to better reflect the significance of potential safety signals," they say.
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Obama Orders FDA to Address Drug Shortages
Posted: 3 November 2011
President Obama issued an executive order this week directing the US Food and Drug Administration (FDA) to take specific actions to prevent and reduce future drug shortages. Under the order, FDA will require drugmakers to provide advance notice of manufacturing problems likely to lead to shortages, and the agency will expedite review of new drug suppliers, manufacturing sites and manufacturing changes in cases where expedited review will help avoid or mitigate shortages. Under the order, FDA will also be required to report suspected stockpiling or price gouging of scarce drugs to the Department of Justice. Generic drugmakers have pledged to work closely with FDA to address the shortage problem.
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MHRA Seeks Input on Consolidation of Drug Laws
Posted: 3 November 2011
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a formal public consultation on the consolidation of UK medicines legislation. MHRA’s goal is to simplify existing laws regulating medicines in the UK, and the agency has invited stakeholders and the public to provide input. The initiative seeks to replace around 200 legal statutes and much of the Medicines Act of 1968. “It will amalgamate 40 years of outdated and fragmented legislation, reducing it by around two thirds, making it clearer and easier to understand as well as ensuring that medicines regulation is supported by a modern and straightforward legal framework,” said MHRA Chief Executive, Sir Kent Woods,
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FDA Reports 35 Drugs Approved in FY 2011
Posted: 3 November 2011
The US Food and Drug Administration (FDA) reported having approved 35 new medicines over the past 12 months, the second-highest number of approvals in the past decade and topped only by the agency’s 37 approvals in 2009. The report comes as Congress is considering reauthorization of the Prescription Drug User Fee Act, due next year. “Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” said FDA Commissioner Margaret Hamburg in a statement. FDA noted some of the approved drugs it deemed important medical advances, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.
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India to Expand Drug Price Controls
Posted: 3 November 2011
The Indian government announced plans to set price controls for at least 400 essential drugs, about 60% of the country’s domestic pharmaceuticals market. This represents a substantial increase from the 34 medicines—around 20–30% of the market—currently under government price control. The proposal would also change the way prices of controlled products are regulated, switching from a system where prices are based upon market share to one that would set a price ceiling based on the weighted average price of the top three brands. The move would likely force dramatic price cuts on most imported brands subject to the price controls.
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PDUFA Re-auth May Bring More Communication, Predictability
Posted: 27 October 2011
As the US Food and Drug Administration (FDA) gets closer to making its final recommendations on changes to the Prescription Drug User Fee Act (PDUFA) before the US Congress considers the re-authorization of the law required next year, one revision being proposed is increased communication between the agency and product sponsors. Current proposed recommendations would commit FDA to specific review timelines and require agency representatives to meet with sponsors three times at specific points during the process. Product sponsors and their regulatory staffs have been calling on FDA for a more predictable process, and these scheduled meetings are expected to help keep applicants better clued in to FDA’s thinking as it develops during the review period.
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FTC Renews Call for Pay-for-delay Ban
Posted: 27 October 2011
As the US Congressional bipartisan “super committee” charged with identifying areas for cutting the federal budget nears its deadline, the Federal Trade Commission (FTC) released a report showing that a ban on pay-for-delay settlements would save $2.67 billion over 10 years. FTC Chairman Jon Leibowitz has been a vocal critic of the deals between brand-name drugmakers and generic manufacturers that delay market entry for generic drugs. "Fortunately, Congress has the opportunity to fix this problem through the Joint Select Committee on Deficit Reduction—and save the government and American taxpayers billions of dollars," said Leibowitz.
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FDA Invests $2 Million in Regulatory Science Centers
Posted: 27 October 2011
The US Food and Drug Administration (FDA) will invest $2 million to create two Centers of Excellence in Regulatory Science and Innovation, intended to help the agency improve and modernize its oversight of healthcare product industries that are rapidly developing new, innovative technologies. The grant will fund centers at the University of Maryland and Georgetown University. According to FDA, they will be tasked with assisting federal regulators in "driving innovation in medical product development as well as in advancing laboratory, population, behavioral and manufacturing sciences."
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Drugmakers Share Info to Fight Tropical Diseases
Posted: 27 October 2011
Eight drugmakers agreed to share patented information through a UN-administered consortium aimed at speeding development of medicines and therapies to fight tropical diseases. The World Intellectual Property Organization (WIPO) launched the consortium this week as a way to boost research on treatments for diseases that may not otherwise be developed because the commercial potential for the treatments is limited. WIPO's director general said that by joining the initiative, “companies and researchers commit to making selected intellectual property assets available under royalty-free licenses to qualified researchers anywhere in the world for research and development on neglected tropical diseases, malaria and tuberculosis.” Participants include AstraZeneca , GlaxoSmithKline, Novartis and Pfizer.
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EU Ruling Restricts Stem Cell Patents
Posted: 20 October 2011
The European Court of Justice this week issued a ruling prohibiting patents for stem cell work involving the destruction of human embryos. The decision is seen as critical setback for stem cell research in Europe and a blow to the progress of research to find treatments for a range of diseases. While the ruling allows patents on processes that use human embryos “for therapeutic or diagnostic purposes that are applied to the human embryo and are useful to it,” many in the European scientific community believe it will drive research to other countries.
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FDA Proposes Lower Risk Class for External Pacemakers
Posted: 20 October 2011
The US Food and Drug Administration (FDA) has issued a draft guidance proposing lowering the risk classification for external pacemaker pulse generators from Class III to Class II. The change would remove such devices from the list of 22 remaining Class III medical devices on the market prior to the Medical Device Amendments Act of 1976 that continue to be reviewed under the 510(k) program rather than Premarket Approval.
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Drugmaker, Patient Group Collaborate on New CF Drug
Posted: 20 October 2011
Vertex Pharmaceuticals this week submitted its new cystic fibrosis (CF) drug, Kalydeco, to the US Food and Drug Administration (FDA), seeking expedited review. The drug is designed to treat a rare form of CF affecting just 4% of the approximately 30,000 CF patients in the US, who have a mutation of a gene known as G551D. It was developed as a result of a unique collaboration between Vertex and the Cystic Fibrosis Foundation, and will be the subject of a special closing session at 2011 RAPS: The Regulatory Convergence. Panelists from CFF and Vertex, and other regulatory experts will discuss the implications for drug development, personalized medicine and increasing involvement of patient groups.
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Drug Shortages May Worsen, Says FDA
Posted: 20 October 2011
US Food and Drug Administration (FDA) officials expect drug shortages to worsen over the next few months to years despite the fact that the causes are well-known, including manufacturing problems, scarcity of ingredients, stricter FDA enforcement, industry consolidation and the thin margins for generic drugs. Peter Lurie, a senior FDA adviser, cites "multiple factors and it's very difficult to identify which one is most important." However, no one seems to have an explanation for why the shortages are escalating.
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EU to Set Strict Limits on Rx Info to Patients
Posted: 13 October 2011
Under proposed rules released this week, the European Commission (EC) will set strict limits on information drugmakers are allowed to provide directly to patients about prescription medicines. The current ban on direct-to-consumer advertising would remain in place under the proposal and additional restrictions would be enacted. The proposed rules would amend a 2008 EC proposal that was criticized as too permissive. The new rules would allow prescription drug information only in specific places such as on drug packaging, labels and instructions, but not in third-party publications and elsewhere as drugmakers had hoped.
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FDA, CMS Launch Parallel Innovative Device Review Pilot
Posted: 13 October 2011
The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have launched a pilot parallel review program for innovative medical devices. Under the program, reviewers from FDA’s Center for Devices and Radiological Health (CDRH) and CMS will simultaneously review devices for both FDA approval and Medicare coverage. FDA and CMS officials anticipate parallel review will increase efficiency and help facilitate the development of innovative new products. “The pilot program will help the FDA and CMS streamline the parallel review process so that it works efficiently for expedient patient access to safe and effective medical devices,” said CDRH Director Jeffrey Shuren.
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FDA to Issue Three Biosimilars Guidances in 2011
Posted: 13 October 2011
The US Food and Drug Administration (FDA) will release three separate guidance documents on biosimilars "before the end of the year," said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, according to a report from BioCentury. Woodcock announced the plans during remarks before a recent conference on rare diseases and orphan products. She did not go into specifics about what the documents will address, but an FDA spokesperson promised they will "cover the most pressing scientific issues facing a manufacturer as they contemplate developing a biosimilars program."
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Google Backs Genomics Data Start-up, Will Host Data in Cloud
Posted: 13 October 2011
DNAnexus, a genomics data management start-up company, has secured Google Ventures as one of its big backers in a $15 million second round of financing, and will allow Google to provide web access to genomics data. The deal will result in a web-based interface for searching and accessing data in the public Sequence Read Archive (SRA) database. Google Cloud Storage will host this central repository for the massive amounts of genomics data, giving investigators access to information that could impact innovative personalized treatments. The move could mean a major role for Google in the rapidly developing area of genomics data.
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FDA Emphasizes Support for Innovation in New Report
Posted: 6 October 2011
US Food and Drug Administration (FDA) Commissioner Margaret Hamburg unveiled the agency’s blueprint for fostering biomedical innovation to help speed medical advances to patients. FDA has come under fire from many in industry and other critics for processes that are too slow and unpredictable, which they say are forcing many developers of innovative new healthcare products to seek approval from regulators in other parts of the world first. The agency also faces pressure from Congress to help the US maintain its status as a world leader in the pharmaceutical, medical device and biotech industries. The report, entitled Driving Biomedical Innovation: Initiatives for Improving Products for Patients, was released in conjunction with Hamburg’s appearance at the 3rd annual Washington Ideas Forum, where she talked about some of the programs and ideas outlined in the report, including the need to be more responsive to small business.
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EMA Invites Feedback on Proposed Biosimilars Guidelines
Posted: 6 October 2011
The European Medicines Agency (EMA) this week published a concept paper on its proposed revisions to the agency’s guideline on biosimilars and is seeking public comment. EMA will accept comments until 31 December 2011, and the final revised guideline is expected to be published in 2012. The EU’s regulatory framework for biosimilars is more advanced than those of many of its global counterparts, such as the US Food and Drug Administration, which is currently in the process of crafting the regulatory pathway for biosimilars.
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CDRH to Create External Scientific Expert Advisory Network
Posted: 6 October 2011
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has announced plans to create an outside network of scientific experts to advise agency staff on device approvals. In addition, CDRH has simultaneously launched a 12-week pilot of the network that will run through 30 December 2011 and is soliciting public comment. The experts “would provide staff with rapid access to specific specialized knowledge about emerging technology, as well as other topics,” according to a statement from FDA, but would not provide opinions or advice, allowing agency reviewers to draw their own conclusions. The program is part of FDA’s efforts to improve its 510(k) review process.
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FDA Unveils Transparency Plan, Researchers Want All Clinical Data
Posted: 6 October 2011
Increasing transparency has become a high priority for regulatory agencies around the globe, and this week, the US Food and Drug Administration (FDA) released a transparency plan outline that includes eight proposals for further consideration. The broad proposals focus on improving the quality of, and access to, FDA’s compliance and enforcement data. In a separate development, two clinical researchers are leading the call for all clinical data from drug trials and device studies to be disclosed, regardless of whether the research was a success or not. They argue such disclosure would improve research and allow more efficient use of resources. The FDA plan does not directly address clinical data.
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Coalition Calls for Overhaul of EU Clinical Trials Directive
Posted: 29 September 2011
A coalition of 16 European academic and industry groups is calling for major changes to the EU’s Clinical Trials Directive, saying it hinders medical research in the Community. The group, which includes the Association of the British Pharmaceutical Industry, the Academy of Medical Sciences and several cancer research organizations, says the directive is interpreted differently by different Member States, adding unnecessary complexity to the conduct of multinational trials. In a joint statement to the European Commission and members of the European Parliament, the coalition outlined specific revisions to streamline the process and boost efficiencies.
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FDA Targets Unapproved Drugs for Enforcement Action
Posted: 29 September 2011
The US Food and Drug Administration (FDA) has released a new guidance, Marketed Unapproved Drugs—Compliance Policy Guide, that outlines the agency’s risk-based enforcement priorities for drugs marketed without proper regulatory approval. The guidance updates the previous version from June 2006. The agency notes that since it lacks the resources to take immediate action against all illegally marketed products, it must give higher priority to enforcement against unapproved products in certain high-risk categories, such as drugs that pose serious safety risks, those that lack evidence of effectiveness, reformulated drugs and drugs promoted through deceptive or fraudulent advertising practices.
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Despite Acrimony, Device Makers, FDA Work on User Fees
Posted: 29 September 2011
Medical device makers have expressed doubts about the US Food and Drug Administration’s (FDA) desire to increase user fees to help improve the device review process, but talks on the fees between industry and the agency continue with the hope of reaching an agreement. "I'm not a big believer that you throw money or people at a problem; you address the problem," James Mazzo, senior vice president of Abbott Medical Optics and chairman of the Advanced Medical Technology Association (AdvaMed) said earlier this week. In remarks a few days later at AdvaMed’s conference, Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health admitted fault on FDA’s part but continued to argue his case for more resources. AdvaMed president Stephen Ubl reported that both sides were "making progress" on reaching a user fee agreement.
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Is Open-access R&D the Future of Drug Development?
Posted: 29 September 2011
Two new members—Eli Lilly Canada and Pfizer Inc—have joined the Structural Genomics Consortium, and new funding was announced this week for the open-access research project. Members of the consortium forego early-stage patents, focusing on collaborative research up to Phase I trials with the intention of extending the cooperation into Phase II. If the approach proves successful, it could pave the way for a new standard in drug research and help speed the development of innovative lifesaving medicines, while saving drug sponsors time and money.
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Obama Proposal Would Limit Biologics Exclusivity Period
Posted: 22 September 2011
A new proposal tied to President Obama’s deficit reduction plan released this week would reduce the market exclusivity period for brand-name biologic drugs to seven years, from the 12-year period passed as part of last year’s US healthcare reform bill. The White House had pushed for the seven-year period initially, but ultimately, the healthcare law incorporated the 12 years favored by industry. According to Obama administration estimates, the shorter period would save the federal government $3.5 billion over 10 years by increasing competition. Industry has argued that the shorter exclusivity period will create a disincentive for innovation and is expected to strongly oppose the President’s proposal.
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Five EU Members Sign Agreement to Safeguard Biological Info
Posted: 22 September 2011
Five EU Member States and the European Molecular Biology Laboratory have signed a memorandum of understanding to create an infrastructure to manage and safeguard biological information. The goal of the initiative, known as European Life-science Infrastructure for Biological Information, or ELIXIR, is to ensure open access to information about genes, proteins, complex networks and other important biological information in support of life science research. The five countries involved are Denmark, Finland, the Netherlands, Sweden and the UK, with other countries expected to join in the future.
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DDMAC Becomes Office of Prescription Drug Promotion
Posted: 22 September 2011
Reorganization at the US Food and Drug Administration (FDA) has led to the former Division of Drug Marketing, Advertising and Communications (DDMAC) being reorganized and upgraded to a new office, the Office of Prescription Drug Promotion (OPDP). OPDP will include two divisions, one overseeing promotions aimed at healthcare professionals and one for direct-to-consumer promotions. Under the reorganization, the new office will have more authority and resources than DDMAC. “This reorganization will leverage OPDP’s resources and processes to provide for the highly effective oversight of prescription drug promotion,” said Center for Drug Evaluation and Research (CDER) Director Janet Woodcock in an email to FDA staff.
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Drug Supply Chain Safety Key to PDUFA Reauthorization
Posted: 22 September 2011
Last week’s US Senate hearing on securing the pharmaceutical supply chain put drug safety in the spotlight and illuminated a significant challenge for the pending Prescription Drug User Fee Act (PDUFA) reauthorization: how to address safety concerns while also alleviating critical drug shortages. The US Food and Drug Administration (FDA) wants more authority to police drugs and drug products entering the US from around the world, but must also take steps to address drug shortages, which Deputy Commissioner for Global Regulatory Operations and Policy Deborah Autor called a “complex economic problem.” Autor argued that track-and-trace technology would help FDA address resulting public health risks and respond accordingly and that the agency needs authority to mandate track-and-trace useage.
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FDA Asks for Increased Powers Over Global Drug Supply Chain
Posted: 15 September 2011
In testimony before a Senate committee this week, a top US Food and Drug Administration (FDA) official made the agency’s case for increased powers to police drugs entering the US from abroad. “The FDA needs the ability to refuse import of products from facilities that have delayed or denied regulatory inspections,” FDA Deputy Commissioner for Global Regulatory Operations Deborah Autor told committee members. Under current rules, FDA must show reason to believe an imported product has been adulterated or otherwise fails to meet FDA standards. Without additional powers, Autor warned another Heparin-like crisis is inevitable.
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Most Clinical Trial Protocols Changed During Trial
Posted: 15 September 2011
According to a new study, almost 60% of clinical trial protocols for new drugs are amended during the trial, but one-third of those changes could have been avoided. This is according to a new study from the Tufts Center for the Study of Drug Development (CSDD) released this week. Tufts researchers found that completed protocols across all clinical trials incur an average of 2.3 amendments, with each requiring an average of 6.9 changes to the protocol, leading to significant unplanned expense and delay. “Although amendments to protocols of clinical trials are sometimes necessary to optimize study results and ensure patient safety and ethical treatment, study sponsors can minimize the number of protocols through better initial study design and improved recruitment of study volunteers,” said Ken Getz, Tufts CSDD senior research fellow and assistant professor at Tufts, who led the study.
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Swedish Regulator Calls for Green Pharma Manufacturing Standards
Posted: 15 September 2011
Sweden's Medical Products Agency (MPA) recently issued a report calling for tougher environmental standards for pharmaceutical production within the EU. The report addresses concerns over the environmental impact of pharmaceutical production in low-cost countries, such as India and China. “Today a considerable share of pharmaceutical manufacturing and production of raw materials and semi-products takes place in low-cost countries, and many large companies plan to locate even more of their production there. In the first decade of the 21st century, Swedish research findings have revealed emissions from the manufacturing of pharmaceuticals in India on a scale that can seriously impact the health of humans and animals, as well as the environment,” according to an MPA statement.
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Indianapolis Ready to Host 2011 RAPS
Posted: 15 September 2011
A report this week in the Indianapolis Business Journal on 2011 RAPS: The Regulatory Convergence coming to the city called the conference “[t]he top event for regulatory professionals in the health care industry ,” and proclaimed it “the latest shot in the arm for the state’s regulatory affairs industry.” The annual RAPS conference is expected to draw thousands of regulatory professionals representing companies involved in pharmaceuticals, biotechnology and medical devices, and from regulatory agencies, including the US Food and Drug Administration, European Medicines Agency, Korea Food and Drug Administration and China’s State Food and Drug Administration. Representatives from regulatory agencies in Canada, India, Japan, New Zealand, Saudi Arabia, Singapore and The Netherlands also plan to attend. The event is set for 22–26 October at the Indianapolis Convention Center.
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Drugmakers, FDA Agree to New User Fee Deal
Posted: 8 September 2011
The US Food and Drug Administration (FDA) has reached a deal with pharmaceutical industry representatives that will give the agency an additional two months to review new drugs and raise user fees by 6%. The agreement comes after months of closed-door negotiations aimed at smoothing the way for reauthorization of the Prescription Drug User Fee Act (PDUFA), which is set to expire in October 2012. FDA has published a draft letter summarizing its performance goals and procedures related to the law’s reauthorization. Similar talks between the agency and medical device industry continue.
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Report: EMA Should Compare New Drugs to Best Available
Posted: 8 September 2011
New drugs applying for approval in Europe should be tested against the best available comparable medicine, not against a placebo, as is the current European Medicines Agency (EMA) requirement, says a new report. EMA requires only that new drugs be compared to a placebo, except in cases where it is deemed unethical. According to the report from researchers at the London School of Economics and the European Observatory, “This does not allow patients, clinicians, and other healthcare decision makers to determine whether a new drug is superior, equivalent, or inferior to its existing alternatives. This can result in the widespread use of potentially less efficacious and unsafe drugs." Changing the rule would boost efficiency and result in better, safer medicines reaching patients faster, researchers argue.
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FDA Guidance Promotes Remote Clinical Trial Monitoring
Posted: 8 September 2011
A new guidance from the US Food and Drug Administration (FDA) on risk-based approaches to monitoring clinical trials delineates how drugmakers and clinical research organizations should oversee the conduct of clinical studies, including the use of remote monitoring. While trial sponsors have been free to determine how best to monitor clinical studies conducted in disparate locations throughout the world and advances in data gathering have made remote monitoring methods more feasible, sponsors have traditionally seen site visits as more desirable by FDA. This new guidance makes the case that this is not necessarily true, and encourages the use of remote monitoring when appropriate, based on factors including the study’s complexity.
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FDA Introduces Medical Device Review Staff Training
Posted: 8 September 2011
The US Food and Drug Administration (FDA) has introduced a new training program for staff reviewing Premarket Applications at the agency’s Center for Devices and Radiological Health (CDRH). The Reviewer Certification Program, which began as a pilot in April 2010 with participants from CDRH’s Division of Anesthesia, General Hospital, and Infection Control and Dental Devices, launches this month and will be required for all new device reviewers. The program includes up to 18 months of training to sharpen staff skills and knowledge in areas such as biomedical engineering and healthcare. "This investment will improve the quality of submission review and make the process more consistent and predictable," said CDRH Director Jeffrey Shuren.
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Authorized Generics Good for Consumers, Says FTC Report
Posted: 1 September 2011
The Federal Trade Commission (FTC) issued its long-awaited final report on “authorized generic” drugs this week, concluding that consumers benefit from these drugs, despite the objections of many generic drugmakers. To provide an incentive for generic drugmakers to challenge brand-name drug patents and bring cheaper generic versions to market sooner, the first generic to successfully challenge an existing brand-name patent gets six months of market exclusivity without competition from other generics. However, the maker of the original drug is allowed to market its own so-called authorized generic during that six months. Many generic manufacturers have agued that this is anticompetitive and both hampers their incentive to challenge patents and hurts consumers. FTC disagrees, but acknowledges that the practice creates an opening for “pay-for-delay” deals where the original drugmaker strikes a deal with a generic company to keep a generic version off the market, which FTC does contend is anticompetitive.
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India to Hold Drugmakers Responsible for Clinical Trial Deaths
Posted: 1 September 2011
India’s health ministry has proposed a new rule that would require drugmakers to compensate victims in cases where death or injury was caused by a clinical trial. The proposal would also place the burden of proving that a clinical trial did not cause death or injury on the drugmaker. This comes in the wake of media reports of 671 deaths during clinical trials in 2010. “Under the proposed rule, it would be the responsibility of the trial sponsor on behalf of the pharma company to prove before the ethics committee that the injury or death is not on account of clinical trial within 30 days of receiving the report of the injury or death from investigator, failing which the sponsor shall be liable to pay the compensation within 60 days or as decided by the ethics committee,” according to a health ministry official.
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Consumer Group to FDA: Change Generic Labeling Rules
Posted: 1 September 2011
The consumer group Public Citizen is asking the US Food and Drug Administration (FDA) to allow generic drugmakers to update their product labeling with warnings about newly discovered risks associated with their drugs. Currently, FDA prohibits generics companies from updating labeling, even if they learn about a potential risk of a drug that is not covered in its labeling. Brand-name drugmakers, on the other hand, can update label warnings before getting FDA approval. Generic drugmakers must match drugs’ labeling to their brand-name equivalents. “Drug safety would benefit if generic manufacturers—who already have access to real-world information about adverse events—could use FDA procedures currently in place for brand-name manufacturers to revise labeling to warn of risks,” said Dr. Sidney Wolfe, director of Public Citizen Health Research Group in a press release. “Filling this regulatory gap would help to protect patients.”
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Canada Unveils Patient-centered Research Initiative
Posted: 1 September 2011
The Canadian government recently unveiled its new “patient-oriented research strategy” intended to create a unified clinical research infrastructure and to strengthen organizational, regulatory and financial support for clinical studies conducted in Canada. “By putting patients first, we are making sure that research will have a greater impact on treatment and services provided in clinics, hospitals and doctors’ offices throughout Canada,” said Canada’s Minister of Health Leona Aglukkaq. “Better integration of research evidence and clinical practices means improved health outcomes and a better health-care system in Canada.” The strategy is summarized in paper from the President’s Advisory Board under the leadership of the Canadian Institutes of Health Research (CIHR).
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FDA Unveils Details of Regulatory Science Plan
Posted: 25 August 2011
Last week, The US Food and Drug Administration (FDA) unveiled its plan for advancing regulatory science, identifying eight priority areas on which the agency will focus. The “Strategic Plan for Regulatory Science,” builds on FDA’s report, “Advancing Regulatory Science for Public Health,” released last year. “As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy," said FDA Commissioner Margaret Hamburg. The priority areas identified in the plan include supporting innovations in personalized medicine and manufacturing, improved data sharing and facilitating development of medical countermeasures to protect against threats to public health. Senator Michael Bennet (D-CO) reacted to the plan, asking FDA to go further by simplifying its review process and making it more transparent and industry-friendly.
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Study: Most Medical Journal Ads Not FDA-compliant
Posted: 25 August 2011
A recent study by researchers at Mount Sinai School of Medicine published in the journal PLoS One, from the Public Library of Science found that most pharmaceutical advertisements in biomedical journals fail to comply with US Food and Drug Administration (FDA) guidelines. The researchers looked at 192 ads and judged that only 18% were FDA-compliant. More than half (57.8%) failed to quantify serious risks such as death, according to the report. The findings may have implications for FDA’s "Bad Ad" program. "The limited resources of the FDA's Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry's multi-billion dollar marketing budget," said Dr. Deborah Korenstein, the study’s lead author.
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Drugmakers Must Adhere to New EMA eCTD Validation Criteria
Posted: 25 August 2011
Drugmakers must adhere to the European Medicines Agency’s (EMA) new validation criteria for electronic common technical document (eCTD) submissions beginning 1 September. EMA has agreed to the new criteria (version 3.1) with regulatory authorities in EU Member States, and has advised sponsors to become familiar with it. Applications that do not adhere to the new requirements will lead to a negative technical validation, according to an EMA press release.
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Drug Shortages Continue to Cause Concern
Posted: 25 August 2011
The number of drugs that are unavailable or in short supply has tripled since 2010, according to the US Food and Drug Administration (FDA). Most of the drugs are generic injectables, including cancer medications and anesthetics. "FDA has been monitoring shortages for the last six years, and in 2010 we saw a large spike in shortages, which was a large jump from the year before," according to Valerie Jensen, associate director of the Drug Shortage Program at FDA's Center for Drug Evaluation and Research. “Several different factors are contributing to the current shortage of sterile injectables and other drugs. Some firms decided to discontinue making their products for business reasons, others had problems with their raw materials suppliers, some had quality and manufacturing problems, and some were hit with an increased demand.” But some are blaming FDA, in part, for the shortages. "FDA enforcement actions that delay or deter the production of certain products have also had an impact," said a spokesman for the Generic Pharmaceutical Association.
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User Fee Deal Would Finance Foreign Inspections by FDA
Posted: 18 August 2011
A deal to collect user fees from generic drugmakers that would finance expanded US Food and Drug Administration (FDA) inspections of drug manufacturing facilities around the world is likely to pass Congress, according to reports. Under the deal, brokered in part by the president of Mylan, a large West Virginia-based generic drug company, generic makers would pay fees of $299 million annually to support FDA inspections of foreign manufacturing facilities every two years, the same frequency required for domestic plants. More than 80% of active pharmaceutical ingredients for drugs sold in the US are made elsewhere but, to this point, FDA has only been able to inspect a small fraction of foreign facilities.
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Drugmakers Face Decisions as Facebook Opens Comments
Posted: 18 August 2011
This week, as Facebook opened some pharmaceutical industry pages to allow public commenting, drugmakers have been forced to consider the potential consequences of comments or shut down some Facebook pages. Facebook’s reversal of a policy that exempted drugmakers’ pages from a requirement to allow comments took effect Monday. Under the new policy, corporate pages or those devoted to a specific disease or patient group are now open to comments, while those pages for specific prescription drugs are still allowed to disable commenting. While the rules of engagement pertaining to social media from the US Food and Drug Administration and other regulators are still unclear, drugmakers fear that regulators could see comments on adverse events, off-label uses or other inappropriate statements as violations. Some drugmakers’ pages have already been deleted.
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FDA Issues Guidances to Clarify Device Approvals Process
Posted: 18 August 2011
The US Food and Drug Administration (FDA) this week release two draft guidance documents it hopes will help clarify its requirements for companies seeking FDA approval of medical devices. One document outlines the agency's process for making benefit-risk determinations in assessing devices’ premarket applications. "As medical devices grow increasingly complex, many factors impact our benefit-risk determinations, especially for PMA devices. This guidance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision," said Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health. The other guidance provides details on the requirements for a clinical trial in support of Premarket Application submissions for Class III devices. Both drafts are open for public comment for 90 days.
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India to Require Barcodes on Drug Packaging
Posted: 18 August 2011
India will require drugmakers to implement a barcoding system to track drugs to and identify counterfeits, beginning in October, despite concerns from some smaller companies about their ability to comply with the new requirements. Drugs Controller General (DCGI) of India Surinder Singh acknowledged their concern and promised they would be given time to comply, but also stressed the importance of implementing the barcode system to bolster consumer confidence in Indian-made drugs as the nation competes for an increasing share of the global pharmaceutical market. "These technologies have already been introduced by the countries like Malaysia, China and to some extent Turkey," said Singh.
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Venture Capitalists Criticize FDA Review Process
Posted: 11 August 2011
Many venture capitalists have reacted strongly to US Food and Drug Administration (FDA) Commissioner Margaret Hamburg’s recent op-ed piece in The Wall Street Journal contending that the agency’s cautious approach to drug and device approvals actually helps spur economic growth by increasing consumer confidence. FDA critics argue that many innovative medical start-up companies have been forced out of business or moved overseas because of what they say is a slow and unclear approval process. In a letter to the editor of The Wall Street Journal, entitled “The FDA Isn't as Innovative as It Likes to Think It Is,” Skyline Ventures’ John Freund writes "Those of us on the front lines, who see innovative healthcare companies from the inside in a way the FDA does not, see the negative impacts of the FDA's approval process first hand on a daily basis."
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FDA Provides Insight on Biosimilar Standards
Posted: 11 August 2011
US Food and Drug Administration (FDA) officials provided insight into agency thinking on biosimilars approval standards in a New England Journal of Medicine article published last week. The article, entitled "Developing the Nation's Biosimilar's Program," gives an update on FDA's progress toward implementing a biosimilar approval pathway as part of the Biologics Price Competition and Innovation Act. The article shows that FDA has considered issues raised during its November 2010 public hearing on biosimilars. On one key point, interchangeability, the FDA authors maintain the first standard biosimilar sponsors will have to meet will be biosimilarity, but they regard interchangeability as a second, higher standard. A separate, recent report suggests that US payers may require even more clinical data than FDA for reimbursement.
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EU Issues New Stability Testing Rules
Posted: 11 August 2011
The EU has issued new draft guidelines on stability testing required to support a variation to a Marketing Authorization. Under the new rules, additional data must be submitted to accompany major, Type II variations, such as a change in batch size or switching suppliers. The draft document is posted on the European Medicines Agency (EMA) website.
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Critics Voice Concern Over Conflict of Interest Rules
Posted: 11 August 2011
Critics, including watchdog and physician groups, have expressed grave concern over a US Food and Drug Administration (FDA) proposal to relax conflict-of-interest rules governing advisory panels. FDA officials, including Commissioner Margaret Hamburg, have complained conflict-of-interest rules have hampered the agency’s ability to find qualified experts, but groups such as the Project on Government Oversight (POGO) say they are needed. “These rules do create an additional hurdle, but that is exactly the point,” wrote POGO’s Danielle Brian in a letter to the commissioner. “We want expert advice that is as free as possible from the influence of industry.”
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IOM Report Calls for 510(k) System to be Scrapped
Posted: 4 August 2011
Late last week, the Institute of Medicine (IOM) released a report criticizing the US Food and Drug Administration’s (FDA’s) 510(k) clearance process for medical devices and called for the development of a completely new framework. "The 510(k) process cannot achieve its stated goals—to promote innovation and make safe, effective devices available to patients in a timely manner—because they are fundamentally at odds with the statutes that govern how FDA must implement the process,” said David Challoner, chairman of the IOM committee that created the report. FDA officials disagree. "I don't think we should eliminate [the 510(k)] process in its entirety. It does have a role, it needs some fine-tuning," Jeffrey Shuren, head of FDA’s Center for Devices and Radiological Health, told a town hall audience in Minnesota this week. FDA intends to gather further public comment on the report through October.
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International Pilots Successful, FDA-EMA Collaboration to Continue
Posted: 4 August 2011
A pair of pilot programs fostering increased cooperation among health regulators in the US, EU and Australia have been declared successes, paving the way for further international collaboration. The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Australia's Therapeutic Goods Administration worked together on a pilot to jointly inspect active pharmaceutical ingredient (API) manufacturers, while a second pilot between FDA and EMA focused on Good Clinical Practice. FDA and EMA have already announced plans to continue their collaboration. "It is imperative that FDA work closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone," said Deborah Autor, FDA deputy commissioner for global regulatory operations and policy.
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US Lawmakers Likely to Relax FDA AdComm Conflict Rules
Posted: 4 August 2011
Following complaints from US Food and Drug Administration (FDA) officials, US lawmakers appear likely to relax conflict-of-interest rules for experts serving on FDA advisory committees reviewing new drugs and devices. FDA officials, including Commissioner Margaret Hamburg, have said publicly the rules intended to guard against undue influence on FDA decisions have impeded the agency’s ability to find qualified experts. Relaxation of the current rules may be included as part of the pending reauthorization of the Prescription Drug User Fee Act. The issue was raised during a recent US House committee hearing on the reauthorization. A Reuters report quoted a congressional staff member familiar with the matter, saying "Based on today's hearing and the comments from Senators[Al] Franken [D-MN) and [Mike] Enzi [R-WY], I think there is a good chance that this issue could end up in the final FDA user fee bill."
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India, EU Reach Agreement on Generic Drugs Dispute
Posted: 4 August 2011
India and the EU have reached an interim deal to prevent seizures of Indian generic drugs in transit through the EU. "Finally, EU has come around and we have agreed on an interim settlement... which means EU will not make any detention within its territory of pharmaceutical products coming from India. We will wait for the final settlement but we have not lost our right to agitate on the matter again," said Rajiv Kher, additional secretary in India’s commerce department. Indian officials brought a case to the World Trade Organization, arguing that the EU has been unlawfully seizing shipments of generic drugs in transit from India to developing countries because of unfounded suspicions of intellectual property rights violations. According to the agreement, Indian drugs will now be allowed to pass through EU countries and guidelines will be issued to all 27 EU Member States to that effect. In addition, new regulations on the matter are to be introduced in the European Parliament.
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FDA Clarifies Rules on Changes to 510(k)-cleared Devices
Posted: 28 July 2011
The US Food and Drug Administration (FDA) released draft guidance this week clarifying what types of changes to a previously-cleared medical device require a new premarket submission, and which changes do not warrant a new submission. According to FDA, changes to device features, such as labeling, manufacturing and materials, require a new 510(k) submission. "We are making the regulatory process for medical devices less challenging by better describing our expectations," said Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health. In related news, the results of a year-long investigation into FDA's medical device review process by the Institute of Medicine is due at the end of the week.
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Europe to Review DTC Communications Ban
Posted: 28 July 2011
The EU ban on drugmakers communicating directly with patients is set to be reviewed by the European Commission as it plans to draft new rules. The new rules are intended to make regulations more uniform across the EU. “The European Commission will revise the proposals to clarify and harmonize the rules in what companies can and can’t say to patients,” said Peter Arlett, head of the European Medicines Agency’s drug safety unit. Whether restrictions will be lifted is not certain, but it seems unlikely that the new regulations would allow the type of direct-to-consumer drug advertising allowed in the US.
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FDA Slow to Review Generics, May Tighten Standards
Posted: 28 July 2011
Despite the US Food and Drug Administration’s (FDA’s) abbreviated approval process for generic drugs, review takes three times as long as for new drugs because of the volume of applications and overtaxed FDA resources. According to Keith Webber, acting director of FDA’s Office of Generic Drugs, the agency office has been getting about 850 applications a year—about 10 times the number of new drug applications. “We do prioritize the review of applications where there is no generic yet on the market,” Webber said. In a separate measure, FDA is considering even stricter standards for bioequivalency on drugs known as "critical dose drugs" or "narrow therapeutic index" drugs.
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CDER Seeks to Improve Regulatory Science
Posted: 28 July 2011
The US Food and Drug Administration's (FDA’s) Center for Drug Evaluation and Research (CDER) released a report this week identifying seven research and science needs that it says will help develop its regulatory science efforts. The report focuses on improving in the areas of postmarket data and analysis; risk management strategies; regulatory communications to the public and other stakeholders; linking product quality, manufacturing and performance; developing predictive models of safety and efficacy; clinical trial design, analysis and conduct; and individualization of patient treatment.
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FDA Issues Draft Rules for Regulation of Mobile Apps
Posted: 21 July 2011
The growth of health-related mobile applications for smartphones and wireless tablets like the iPad has blurred the lines between these consumer devices and regulated medical devices, spurring the US Food and Drug Administration (FDA) this week to release its first guidelines for regulating mobile apps. FDA has identified the types of apps it deems fall under its purview—those doctors would likely use to diagnose or monitor a patient's medical condition. These include apps that affect how a currently regulated medical device performs or functions, and those that can turn a smartphone or tablet into a regulated device, such as a blood glucose meter. “We wanted to make sure that we are consistent in regulating medical devices so nothing has changed,” said Bakul Patel, an FDA policy adviser who helped create the guidelines. If “somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.”
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Report Calls on Australia’s TGA to Improve Transparency
Posted: 21 July 2011
An eight-month government panel investigation into Australia’s Therapeutic Goods Administration (TGA) concludes that the agency lacks transparency and calls on TGA to publish results of all its safety investigations, and improve its process for gathering adverse event reports. “The Panel considers that the TGA should adopt a pro-active stance to the many issues relating to therapeutic goods that are of concern to the public that it serves. It should move away from the conservative approach that has characterised its actions in the past and recognise that it has a duty to collaborate with stakeholders to create a culture in which the community has confidence in the therapeutic goods the TGA regulates.” The report notes the global trend toward greater government transparency and makes 21 specific recommendations to the agency. It is not clear how this report may impact the pending plan to create a joint Australia-New Zealand regulatory agency.
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FDA: Slower Device Review Due to Poor Submission Quality
Posted: 21 July 2011
While review times for 510(k) submissions at the US Food and Drug Administration (FDA) have increased more than 55% since 2005, agency officials say the slower review is due to poor quality submissions by device makers. FDA this week released an internal analysis of increasing review times, confirming industry claims that the time has gone up dramatically in the last five years. FDA’s analysis shows that the average decision time for a 510(k) submission increased from 90 days in 2005 to 140 days in 2009. According to the report, 83% of submissions had problems in at least one of the following areas: inadequate device description, discrepancies throughout submission, problems with indications for use, failure to follow or otherwise address current guidance document(s) or recognized standards, or missing performance testing and required clinical data for certain devices.
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Dearth of Diagnostics Slowing Growth of Personalized Med
Posted: 21 July 2011
A lack of a lack of clinically useful diagnostics is hindering the growth of personalized medicines, says a new study from the Tufts Center for the Study of Drug Development. This lack of evidence is leading payers in the US to be skeptical about the evidence linking diagnostic tests to health outcomes. “Scientifically, the process of biomarker discovery and validation in general, and parallel development of drugs and companion diagnostics in particular, has been slow. Additionally, regulatory and reimbursement issues have limited uptake in clinical practice, particularly with respect to companion diagnostics, but also for drugs lacking effective diagnostics,” said Joshua Cohen, PhD, senior research fellow at Tufts and author of the study.
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FDA Shakes Up Leadership, Hires New Deputy
Posted: 14 July 2011
The US Food and Drug Administration (FDA) has reorganized its top management structure and hired former Dartmouth Medical School Dean Stephen Spielberg as commissioner for medical products and tobacco, a new position. FDA Commissioner Margaret Hamburg informed agency staff in a letter on Wednesday afternoon. The move is intended to better regulate rapidly changing and increasingly complex products and industries. “The new organizational alignments more accurately reflect the agency's responsibilities, subject matter expertise and mandates in an ever more complex world, where products and services do not fit into a single category,” Hamburg wrote. In addition, Deborah Autor, currently director of the Office of Compliance within the Center for Drug Evaluation and Research, has been promoted to deputy commissioner for global regulatory operations and policy.
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FDA 2011 Drug Approvals on Pace to Top 2010
Posted: 14 July 2011
Thus far in 2011, the US Food and Drug Administration (FDA) has approved 20 new drugs, just one less than the 21 it approved for all of 2010. At this pace, the agency is likely to approve more new types of drugs this year than the previous few years. Testifying before the House Energy and Commerce Committee's health subcommittee, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, informed lawmakers of FDA drug approvals in response to concerns that FDA may be slowing down the pace of drug approvals due to increased safety concerns. Woodcock testified that FDA meets more than 90% of drug-review deadlines, first-cycle approvals are at a 20-year high and more than two-thirds of new drugs are approved within the six-to-10-month timeframes for New Drug Applications.
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EMA, FDA Seek Input on Development of Personalized Meds
Posted: 14 July 2011
In separate moves, regulators in the both the US and Europe have issued documents regarding the role of personalization in the development of new medicines and are seeking public comments. The US Food and Drug Administration (FDA) this week issued a draft guidance proposing that targeted drugs or therapies seeking FDA approval would have to be reviewed simultaneously with their companion diagnostic devices. The draft is open for comment through 12 September. Meanwhile, the European Medicines Agency (EMA) has issued a reflection paper on genomic markers in the development of new drugs. The paper examines the role DNA markers can play in predicting which patients respond to new medications and selecting patients for inclusion in clinical trials. The EMA paper is open for comment until 25 November.
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Drugmakers Seek Clarity on Off-label Promotion
Posted: 14 July 2011
Seven large pharmaceutical companies have filed a Citizen Petition with the US Food and Drug Administration (FDA) asking the agency to clarify its rules regarding communication about drugs’ off-label uses. Communications about medicines’ unapproved or “off-label” uses have long been a problem for drugmakers and have cost some companies hundreds of millions of dollars. Questions about unsolicited requests for information, the use of third-party clinical guidelines and what companies can say to payers about off-label uses for their products remain unresolved. “Unfortunately, the current state of regulatory guidance is not clear or comprehensive, or in some cases, even binding,” wrote lawyers representing Allergan, Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer and Sanofi. “That lack of clarity places manufacturers at risk of criminal and civil sanctions if they cannot correctly guess where the government would draw a line.”
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EMA Provides Guidance on Required Pharmacovigilance Info
Posted: 7 July 2011
The European Medicines Agency (EMA) has provided drugmakers with the specific electronic formats that will be required for information on all drugs authorized or registered in the EU beginning next year. The deadline for submission in the new formats is 2 July 2012. EMA issued both a legal notice including an overview of the main requirements and a detailed guidance document. In its press release on the subject, EMA called the release “the first milestone in the implementation of the new pharmacovigilance legislation.” Drugmakers will be required to submit original data in the new format and to maintain the information using the EudraVigilance Medicinal Product Report Message system.
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FDA Hopes Supplement Guidelines Will Clear Confusion
Posted: 7 July 2011
The US Food and Drug Administration (FDA) has issued a draft guidance document agency officials hope will clear up confusion over when supplement manufacturers need to notify FDA about new ingredients. Per a 1994 law, manufacturers must file a safety notification with FDA before marketing dietary ingredients that were not on the market when the law passed. However, in the 16 years since the law’s passage, FDA reports receiving only about 700 such notifications, while agency officials believe there are more than 55,000 dietary supplement products. Supplement makers say they have struggled to determine which products required a notice and what documentation was needed. FDA is seeking public comment on the draft through 3 October 2011
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Australia, New Zealand Revive Plan for Joint Regulator
Posted: 7 July 2011
Australia and New Zealand have revived their plans to create a joint agency to regulate medical products. The new agency would be known as the Australia New Zealand Therapeutic Products Agency (ANZTPA). “New Zealand’s regulatory arrangements for medicines and medical devices need to be updated, and this is a cost-effective and comprehensive way of achieving this,” said New Zealand Prime Minister John Key. The new agency is expected to take five years to create. (Editor’s note: readers may also be interested in the article “Update on Australian Regulatory Landscape” in the July issue of Regulatory Focus.)
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EU Issues Rules to Combat Counterfeit Drugs
Posted: 7 July 2011
This week, the EU has issued a new directive outlining regulations intended to help prevent counterfeit drugs from entering the legitimate supply chain. The new requirements include mandatory features on drugs’ outer packaging, strengthened requirements for inspection of the pharmaceutical ingredient manufacturers, and stepped-up enforcement of manufacturers’ and distributors’ obligation to report any suspicion of falsified medicines. The European Medicines Agency (EMA) issued a statement welcoming the rules, and said the agency would be working closely with the European Commission over the next 18 months to implement the legislation. The directive is scheduled to come into force later this month with full compliance by all Member States by January 2013.
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Drug R&D Spending on the Decline
Posted: 30 June 2011
The global pharmaceutical industry cut its research spending in 2010 to an estimated $68 billion (US), a 3% decrease. This reflects a growing disillusionment with poor returns on pharmaceutical R&D. According to a new report from Thomson Reuters’ R&D Factbook, the decline was accompanied by a drop in the number of new drug approvals, from 26 in 2009 to just 21 in 2010. The report notes that new Phase I clinical studies fell by 47%, while the number of Phase II studies dropped by more than half. In addition, 55 Phase III clinical studies were halted.
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31 Months to Get Drugs Onto Canadian Market
Posted: 30 June 2011
A new report says Canada’s federal and provincial governments now take 31 months, on average, to approve new prescription medicines. The report from the Fraser Institute says the federal regulatory, Health Canada, takes an average of nearly 16 months to approve new drugs, while the provincial governments typically spend another 15 months or more to decide whether the drugs will be eligible for reimbursement. Of the new drugs approved as safe and effective by Health Canada in 2004, only 23% had been approved for either full or partial reimbursement under provincial drug plans as of 9 June 2011, compared to 98% that had been covered by at least one private insurer. The report also notes that Health Canada took longer to approve new drugs during 2006-09 than the European Medicines Agency and, in five of the last six years studied (2004-09), performed worse than the US Food and Drug Administration.
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Senator Calls for Tighter FDA Oversight of Imported APIs
Posted: 30 June 2011
Senator Sherrod Brown (D-OH) is calling on the US Food and Drug Administration (FDA) to tighten oversight on US pharmaceutical companies that import the active pharmaceutical ingredients (APIs) from other countries. This follows a report that revealed more than 80% of APIs used in drugs sold in the US are imported. Senator Brown (D-OH) sent a letter to FDA Commissioner Margaret Hamburg this week. In it, among other things, he asked about the feasibility of charging fees when pharmaceutical companies move operations overseas to help pay for FDA inspections of those foreign facilities and suggested other fees to help pay for stepped-up oversight.
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India Attracting Investments, but Little Innovation
Posted: 30 June 2011
A report from The Boston Consulting Group found that despite signing research alliances with overseas companies, Indian biopharmaceutical companies continue to play a relatively small role in innovation. More than 70% of 40+ global biopharm executives interviewed for the report are satisfied with their R&D alliances in India, and three out of four expect these activities to increase. However, India currently accounts for only about 1% of overseas research investments by US biopharm companies, compared to Eastern Europe (8%) and Latin America (4%).
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FDA Acknowledges Problem Monitoring Imports
Posted: 23 June 2011
The US Food and Drug Administration (FDA) this week acknowledged the daunting challenge of monitoring the rapidly increasing number of imports of FDA-regulated products, and announced its plan to alter the agency’s approach to imports. “Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” said FDA Commissioner Margaret Hamburg, in a statement explaining why change is needed. As part of its plan, FDA plans to establish new partnerships with regulators in other countries and increase data-sharing initiatives with those agencies.
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Joint FDA/EMA Review Pilot Receives First Submission
Posted: 23 June 2011
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted the first application for parallel review under the two agencies’ joint pilot program to evaluate marketing authorization applications involving quality by design (QbD). The pilot was announced in March in an effort to maximize efficiencies among EMA, FDA and drug sponsors. The first application comes from Pfizer. According to an EMA statement, the two regulatory agencies “will communicate with and consult each other regularly during the evaluation process, resulting, if possible, in a common list of questions to the applicant and harmonised evaluation of the applicant's responses.”
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US Gets Cancer Drugs Before Europe, Says Study
Posted: 23 June 2011
Despite perceptions to the contrary, the US Food and Drug Administration (FDA) approved more new cancer drugs, and approved them faster, than the European Medicines Agency (EMA), getting the drugs to patients more quickly, according to a new study. Research published in Health Affairs shows that during 2003–10, FDA approved 32 new cancer drugs while EMA approved 26. The median time from marketing submission to approval for all 23 of the drugs approved by both agencies was 182 days for FDA, but 350 days for EMA. “To patients battling cancer, with no treatment options, access to new medicines five-and-a-half months sooner is a very important and potentially life-saving difference,” said Ellen Sigal, of the nonprofit advocacy group, Friends of Cancer Research.
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Coalition Seeks Social Media, Online Promo Guidelines
Posted: 23 June 2011
The lack of online and social media marketing guidance from the US Food and Drug Administration has prompted a group of drugmakers, marketers and Internet players to form a nonprofit coalition to help move toward consensus on standards. The Digital Health Coalition was created by Mark Bard, formerly of Manhattan Research, and includes representatives from Merck, Roche, AstraZeneca, Lilly, Sanofi, GlaxoSmithKline, Google, Epocrates, HealthCentral, and agencies Edelman and Digitas Health. “A lot of us have ideas about how the industry can evolve. Let's start that conversation,” said Bard, who recently spoke with Pharmalot’s Ed Silverman about the group’s goals and plans.
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US, EU Agree to Work Together on Drug R&D
Posted: 16 June 2011
Europe’s Innovative Medicines Initiative (IMI) and the US Critical Path Institute (C-Path) have signed a Memorandum of Understanding to further their shared mission of reshaping the drug development process to bring safer and more effective products to market more quickly. Both organizations bring together scientists from industry and academia, as well as representatives from patient organizations, small companies and regulatory agencies, in precompetitive public-private partnerships. With this agreement, IMI and C-Path will look for opportunities to leverage one another’s work, further accelerated progress and prevent duplication.
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FDA Releases Draft Nanotechnology Guidelines
Posted: 16 June 2011
The US Food and Drug Administration (FDA) has issued Draft Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology, establishing a framework for the regulation and oversight of this emerging science. Some nanotechnology experts have pushed for more explicit guidelines in the nanotechnology field to help spur innovation and commercialization. “With this guidance, we are not announcing a regulatory definition of nanotechnology,” said FDA Commissioner Margaret Hamburg, MD. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”
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Lawmakers Call for MDUFA Reauthorization to Spur Innovation
Posted: 16 June 2011
Two Republican senators are calling for the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA) as a catalyst for changes at the US Food and Drug Administration. In a letter addressed to the heads of life sciences industry organizations, Senators Richard Burr (R-NC) and Tom Coburn (R-OK) wrote that reauthorizing MDUFMA “provides an important opportunity to address the root causes of threats to our nation’s leadership in medical innovation.”
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ABPI Releases Guidance on Adverse Events and Social Media
Posted: 16 June 2011
The Association of the British Pharmaceutical Industry (ABPI) released Guidance Notes on the Management of Adverse Events and Product Complaints from Pharmaceutical Company Sponsored Websites this week. The guidance provides suggested best practices for monitoring and managing adverse events and product complaints from social media use of company-sponsored websites. It addresses ways pharmaceutical companies may learn of adverse events through social media, suggests that companies should declare their involvement and responsibility for the website, and recommends that company-owned sites provide access to “internal/external reporting based tools which allow users to report suspected adverse drug reactions.”
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FDA Office of Compliance Promoted to ‘Super Office’
Posted: 9 June 2011
The US Food and Drug Administration’s (FDA’s) Office of Compliance will be elevated to a “Super Office” within the agency’s Center for Drug Evaluation and Research (CDER). The move was reported to be under consideration a few months ago and has now been made official, according to an internal letter to staff from CDER Director Janet Woodcock. “Given CDER/OC’s expanding role, size, and importance in achieving the Agency’s mission of safeguarding the US drug supply, this structural transition makes a great deal of sense,” Woodcock wrote in the letter. “The reorganization will enable Compliance to align its scientific, technical, and legal capabilities with closely related program areas, leveraging our resources and maximizing its ability to achieve its public health mission.” The Office of Compliance will oversee subordinate offices, including four new offices.
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European Council Adopts Conclusions on Device Innovation
Posted: 9 June 2011
The Council of the European Union recently adopted conclusions resulting from a high-level meeting on innovation in the medical device sector held in March. The Council’s conclusions call upon Member States and the European Commission to promote the development of innovative devices to improve patient health and wellbeing throughout the EU. The Council also presented a list of considerations for commissioners to take into account in reviewing and recasting Europe’s Medical Devices Directives, including the importance of the EU’s continued role as a leader in international regulatory convergence and best regulatory practices.
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FDA Opposes Proposed ‘Hard Science’ Amendment
Posted: 9 June 2011
The US Food and Drug Administration (FDA) has taken a strong public stance against an amendment to proposed legislation that would limit the type of information the agency may use in making regulatory decisions. The amendment to an agriculture appropriations bill was offered by Rep. Denny Rehberg (R-MT) in what Rehberg said is an effort to block FDA from relying on “soft science.” If passed, the amendment would hinder FDA efforts to protect the public from unsafe drugs, tobacco, lead-filled candy and tainted blood, according to FDA documents. “FDA must sometimes act when there are credible risks, but before the weight of scientific evidence has been established,” agency officials wrote in an analysis of the amendment. “This amendment would require that consumers actually be harmed before FDA can take certain actions to protect the public health.”
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India Proposes Crackdown on Doctor Gifts
Posted: 9 June 2011
India’s Department of Pharmaceuticals has presented a draft code of marketing practices for the pharmaceutical industry that would, among other things, ban gifts from drugmakers to doctors. It also would require third parties working for drugmakers, including advertising agency personnel, consultants and others, to have a “good working knowledge” of the rules. The proposal follows on the heels of similar efforts in the US. However, the proposed rules are a bit more lenient regarding industry-sponsored continuing medical education, allowing some travel expenses, meals and refreshments, accommodations and registration fees for events held in India to be paid for by drugmakers.
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CBO Report Says DTC Ad Ban Could Be Bad for Consumers
Posted: 2 June 2011
A report from the US Congressional Budget Office (CBO) examining the potential impact of a two-year ban on direct-to-consumer (DTC) advertising for new drugs found the proposed ban would likely have little impact on prices and could be harmful to consumers. The CBO report, entitled Potential Effects of a Ban on Direct-to-Consumer Advertising of New Prescription Drugs, determined that such a DTC advertising moratorium would not have much of an effect on drug prices since brand-name drugs comprise such a small portion of the retail prescription drug market. The report also warned that a ban could prove harmful to patients, with fewer people seeking treatment as a result of being exposed to drug advertisements, and by creating a disincentive to innovation as it could make the marketing of novel, first-in-class drugs that typically receive heavy promotion less profitable.
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Proposal Would Compel Drugmakers to Warn FDA of Shortages
Posted: 2 June 2011
Growing public concern over drug shortages has led to proposed legislation that would require drugmakers to give the US Food and Drug Administration (FDA) advance warning of pending shortages. Supporters say the Preserving Access to Life-Saving Medications Act, which is currently under consideration by a Senate committee, would enable FDA to alert hospitals and healthcare providers in advance so they could make provisions. “It minimizes the pressure that is on pharmacists, doctors and other healthcare providers and increases manufacturer accountability,” said Sen. Charles Schumer (D-NY) this week, speaking at the University of Rochester Medical Center.
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EMA, Heads of Med. Agencies Release Transparency Guidance
Posted: 2 June 2011
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) of EU Member States have jointly released a draft guidance document on information transparency related to marketing authorization applications (MAAs). The document covers the types of information included in MAAs that can be released to the public, and that which is commercially confidential or protected personal data. Stakeholders and the public may submit comments on the draft document until 1 September.
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Device Maker Sues FDA Over Revoked 510(k) Clearance
Posted: 2 June 2011
A small medical device maker whose knee implant was cleared by the US Food and Drug Administration (FDA) only to have that clearance later revoked has filed suit against the agency. New Jersey-based ReGen Biologics filed the lawsuit this week in the US District Court for the District of Columbia, calling FDA's rescission of its original 510(k) clearance of the company’s Menaflex Collagen Meniscus Implant unlawful, arbitrary and capricious. FDA cleared the device in 2008, despite reported objections from FDA scientists. Officials reviewing the original decision later found that lobbying by four New Jersey congressmen and ex-FDA Commissioner Andrew von Eschenbach had influenced the agency’s decision to clear the device.
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510(k) Process Unpredictable, Europe Preferred for Device Approval
Posted: 26 May 2011
The unpredictability of the US Food and Drug Administration’s (FDA’s) 510(k) clearance process for medical devices is increasingly leading device makers, particularly smaller ones, to pursue approvals in Europe first, says a new report. The study conducted by researchers from Northwestern University and funded by the nonprofit Institute for Health Technology Studies (InHealth), surveyed more than 350 professionals engaged in medical device development. Speaking at the press conference announcing the study results, Dr. Jeffrey Shuren, head of the FDA's Center for Devices and Radiological Health, said that it “validates actions we are already taking” to improve the 510(k) system, but also pointed to “limitations” of the study, in that the survey’s 350 respondents represent less than 10% of the device industry.
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$285 Million in FDA Budget Cuts on the Table
Posted: 26 May 2011
A US House of Representatives subcommittee this week proposed cutting $285 million in funding for the US Food and Drug Administration (FDA), an 11.5% decrease. While FDA funding comes from industry-paid user fees as well as from Congress, the cuts would force the already heavily burdened FDA to assess its priorities and maximize efficiencies. Altogether, FDA’s total budget next year, including both fees and Congressional funding, would be $3.7 billion.
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FDA Issues Draft Guidance on Financial Disclosures
Posted: 26 May 2011
In the latest effort to oversee and minimize conflicts of interest among drugmakers and the clinical investigators involved in drug development, the US Food and Drug Administration (FDA) has issued draft guidance on financial disclosure rules for investigators. The guidance document is intended to update rules that have been in place for a decade. “During the intervening years, interest has grown in the public disclosure of industry financial arrangements with physicians,” according to the agency, and “FDA is striving to achieve a proper balance between transparency and the right to privacy of clinical investigators with respect to their financial arrangements as expressed in the agency’s protection of privacy regulation.
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Web Companies Implicated in Illegal Drug Ad Deals
Posted: 26 May 2011
Late last week, it was reported that online search and advertising giant Google had been repeatedly warned about questionable online drug sellers illegally advertising on its network and had set aside $500 million for a possible fine from the US Department of Justice. On the heels of that story, this week, it was reported that other large web companies such as Microsoft and Yahoo! may have engaged in the same practices. At issue are ads for online pharmacies outside the US promising to ship prescription drugs to US consumers without proof of prescription. The authenticity of the drugs is often in question and they may be shipped in unmarked packages designed to clear customs without raising suspicions.
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EU Doctors Call for Tougher Device Regulations
Posted: 19 May 2011
A group of doctors from the European Society of Cardiology (ESC) has raised concern over the EU’s oversight of medical devices and called for tougher standards. Writing in the European Heart Journal, the group, led by Alan Fraser of Cardiff University, wrote, “The regulatory system has not kept pace with technological advances and changing patterns of medical practice,” and criticized device makers for a practice they call “forum shopping” to take advantage of differing regulatory standards among EU Member States. The ESC doctors say the current regulatory system puts patients’ lives in jeopardy, and they call for an extensive overhaul that includes a single, coordinated system for device evaluation and approval in the EU.
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Pharma Spending to Decline as Generics Gain Market Share
Posted: 19 May 2011
Global pharmaceutical spending will reach almost $1.1 trillion (US) by 2015, according to a new report, but the growth of such spending will decline as brand-name drugs continue to lose market share to generics. The report from the IMS Institute for Healthcare Informatics predicts average annual spending growth slowing to between 3% and 6%, compared with 6.2% during the past five years. Spending on brand-name drugs in developed markets is expected to remain flat while their global market share continues to fall to 53%, compared with 64% in 2010 and 70% in 2005. “There are unprecedented dynamics at play, which are driving rapid shifts in the mix of spending by patients and payers between branded products and generics,” said Murray Aitken of IMS Health.
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A Call for Ethical Trial Standards as Part of Marketing Apps
Posted: 19 May 2011
This week, the European Medicines Agency (EMA) published its report covering the discussions and comments made on its draft reflection paper on ethical and Good Clinical Practice (GCP) aspects of clinical trials in countries outside the EU. The discussions took place during an international workshop of stakeholders from 43 countries in September of last year. A number of participants called for marketing applications to include more information related to clinical trial ethics and said that applications should be rejected if there are serious violations. “Serious non-compliance with ethical guidelines should have serious consequences. This should be made clear and a range of regulatory options established to enable proportionate action to be taken,” according to the EMA report.
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Rethinking Clinical Trials
Posted: 19 May 2011
The conventional process of developing a biopharmaceutical product includes taking it through randomized clinical trial (RCT) Phases 1 through 3, but there may be reasons to rethink how clinical trials are conducted and, perhaps, inject more flexibility into the process. The traditional clinical trial is entrenched because it is so effective in determining whether the given product has some effect, but it also has limitations, including its essentially binary nature, where the outcome is regarded as either passed or failed, according to Les Rose, a freelance clinical consultant and medical writer. “The real world is not like that,” observes Rose. “RCTs are not great at quantifying the effect size, and hence the treatment’s impact on normal clinical practice. For this reason, there has been much emphasis in recent years on ‘pragmatic’ trials which have less stringent selection criteria, and attempt to model the real world more realistically,” he writes.
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FDA Proposes User Fees for Biosimilars, Seeks Input
Posted: 12 May 2011
The US Food and Drug Administration (FDA) has promised to issue guidance on applications for biosimilar products this year and is seeking input on the agency’s proposed user-fee system for such applications. The move represents another step in FDA’s task of developing a regulatory pathway for biosimilars. The proposed user-fee system is similar to the one currently in place for brand-name pharmaceuticals under the Prescription Drug User Fee Act (PDUFA). FDA estimates the biosimilar product-development fee amount would be around $150,000. According to the notice published this week in the Federal Register, the user fee is necessary to support the increased review capacity needed. Comments must be submitted to FDA by 9 June 2011.
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Chile to Create New Drug Regulatory Agency
Posted: 12 May 2011
In a move supported by multinational drugmakers, the parliament of Chile will consider legislation to establish a new national medicines agency. Chile’s Health Minister has said he is sending the legislative proposal to parliament that would create the new Agencia Nacional de Medicamentos (Anamed). Anamed would assume regulatory responsibilities over drugs from the National Institute of Public Health. Drugmakers have criticized Chile’s regulatory system, citing ineffective patent enforcement and failure to adequately implement data protection as major areas of concern.
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FDA Pharmacogenomics Program Encourages Innovation
Posted: 12 May 2011
When the US Food and Drug Administration (FDA) created a pathway for voluntary submission of pharmacogenomic data, the program was initially greeted with skepticism by those who feared FDA would use the data to add more product restrictions. But there is evidence the program has been a success for FDA and that it has helped advance the use of pharmacogenomics in drug regulation, allowing the agency to better keep pace with industry innovations. FDA Center for Drug Evaluation and Research Director Janet Woodcock recently cited the program as an example of the importance of funding regulatory science at FDA and called it “wildly successful.” While the program is still fairly modest, it has helped make the pharmacogenomic data which are increasingly used in drug development a more common part of the product review process, as well.
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Counterfeit Drugs a Serious Global Problem
Posted: 12 May 2011
The production and distribution of counterfeit medicines is a growing problem around the world, say officials at the US Food and Drug Administration (FDA). “Globally, counterfeit drugs are a big concern,” said Ilisa Bernstein, a deputy director with FDA’s Center for Drug Evaluation and Research and an expert on counterfeit drugs during an report this week on CBS News’ The Early Show. According to the report, Internet sales are the most common channel for fake drugs, and FDA has recently identified nearly 300 websites the agency suspects of selling counterfeit drugs to consumers and ordered them to stop. FDA advises consumers to look for the Verified Internet Pharmacy Practice Sites (VIPPS) seal when shopping for drugs online and is working with drugmakers and pharmacies to develop a tracking system that will help verify legitimate medicines.
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FDA Issues Draft Guidance on Device Reprocessing
Posted: 5 May 2011
In an effort to reduce the risk of infection from reusable medical devices that have been improperly reprocessed, the US Food and Drug Administration(FDA) has released a draft guidance on proper reprocessing procedures and announced a public workshop on the subject to take place 8–9 June. FDA said in a statement that “the risk of acquiring an infection from a reprocessed device is relatively low and that the benefits of these important devices outweigh their risks.” As an example, the agency cited endoscopes, which are involved in 10 million medical procedures per year, and noted FDA had received 80 reports of inadequate reprocessing and 28 reports of infections related to endoscopes during the three-year period, 2007–10. The draft guidance is currently open for public comment. When final, it will replace a document from 1996.
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FTC Voices Concern Over Rise in Generics Settlement Deals
Posted: 5 May 2011
Branded drugmakers entered into an unprecedented number of so-called “pay-for-delay” deals with generic drugmakers last year, according to the US Federal Trade Commission (FTC). Such deals, in which the makers of a branded medicine pay generics companies to defer the introduction of lower-cost, generic versions, rose more than 60%, from 19 deals in Fiscal 2009 to 31 in 2010. FTC Chairman Jon Leibowitz, an outspoken critic of these types of agreements, said they “are outrageous, and they harm consumers,” and called for Congress or the courts to step in to stop them. “The increasing number of these deals is a win-win proposition for the pharmaceutical industry, but a lose-lose for everyone else,” said Leibowitz. Pharmaceutical industry representatives counter that the deals, which are legal, provide a way to cut legal costs and curtail lawsuits that could drag on for years, further delaying introduction of generics to the market.
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Increased Focus on Misuse of OTC Meds
Posted: 5 May 2011
Concern over misuse of over-the-counter (OTC) medications is on the rise and both regulators and drugmakers are taking steps to prevent misuse. Recent major OTC drug recalls have put a spotlight on risks associated with common medications available without a prescription, and studies show many consumers have limited knowledge of the OTC medicines they take. Only 41% of the respondents to one survey said they read the labels of their medications, and most could not name the active ingredients in several popular OTC drugs. For example, only 31% knew Tylenol contained acetaminophen. Regulators and manufacturers are giving OTC drugs a closer look and responding with some new standards and formulations. Just this week, the US Food and Drug Administration released new guidelines for liquid OTC medicines and drugmakers announced they would eliminate acetaminophen from OTC drugs for infants to limit risk of overdose.
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Regulatory Talent Highly Sought After by Biotechs
Posted: 5 May 2011
Regulatory and clinical jobs are among the most sought-after in the biotech world, say biotech staffing experts in comments published this week in FierceBiotech. “We're getting the most calls for experts in clinical development, medical affairs and regulatory affairs. That's the pathway where companies make and break their firms,” said one recruiter. In today’s regulatory climate, with biosimilars, increased focus on drug safety, and increased ambiguity over the regulatory requirements themselves, regulatory professionals who combine strategic thinking, regulatory knowledge and people skills are highly valued, the experts said. The comments are consistent with RAPS’ own research from its most recent Scope of Practice & Compensation Report for the Regulatory Profession, that shows regulatory professionals are increasingly called upon to weigh in on business and strategy. RAPS will soon publish the first in a series of special reports on regulatory talent management, based on additional analysis of the Scope of Practice data.
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FDA Partners With Industry to Improve Excipient Screening
Posted: 28 April 2011
The US Food and Drug Administration (FDA) has teamed with the makers of pharmaceutical excipients in an effort to speed up and improve its monitoring of the pharmaceutical supply chain. The agency is working with IPEC Americas, an industry group representing excipient manufacturers, to quickly identify and prevent counterfeit, contaminated or mislabeled substances from entering the supply chain. The partners will create a comprehensive library of excipient samples to be used as reference standards in screening pharmaceutical ingredients and finished medicines. FDA inspectors will use portable devices to examine substances and compare the results against the reference standards, and also to detect contaminants.
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FDA to Examine Influence of Drugmakers’ Websites
Posted: 28 April 2011
The US Food and Drug Administration (FDA) will conduct a series of studies to evaluate consumer reactions to prescription-drug websites. The three studies, officially announced in today's Federal Register, will ask participants to answer questions after viewing different versions of a website for a fictitious drug. The studies will “test different ways of presenting prescription drug risk and benefit information on branded drug Web sites” and will “complement qualitative research we plan to conduct on issues surrounding social media,” according to the notice. FDA will accept public comments on the plan until 27 June.
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International Consortium to Push for Rare Disease Treatments
Posted: 28 April 2011
An international consortium of patient advocacy groups, researchers, regulators and funders has set an ambitious goal of developing 200 new therapies for rare diseases by 2020. Currently, there are treatments for just 200 of the approximately 7,000 diseases affecting small patient populations and little financial incentive for drugmakers to develop new treatments without additional enticements. The International Rare Disease Research Consortium intendes to foster “unprecedented cooperation at the international level” to promote work on treatments to help those suffering such illnesses. The Group met recently to define the framework for its efforts and will meet again in October 2011
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Mass. Lawmakers Vote to Repeal Medical Industry Gift Ban
Posted: 28 April 2011
The Massachusetts House of Representatives voted 128–22 to repeal the state’s so-called “gift ban” that prohibited medical and pharmaceutical companies from giving certain gifts to doctors and required disclosure of some that were allowed. The law went into effect in 2008 and bans gifts including meals, event tickets and even promotional items such as pens, and it requires companies to report other types of gifts valued at more than $50 Supporters of the repeal contend the ban has been bad for business in the Commonwealth, saying it discouraged businesses considering expanding in Massachusetts and caused two medical conventions to decide against coming to the state. Even restaurant advocates said the law had a negative impact on their revenues from catering functions for healthcare product companies.
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Regulatory Risk Key Challenge for Drugmakers, Says PhRMA Chair
Posted: 21 April 2011
Last week, as US drugmakers gathered for the Pharmaceutical Research and Manufacturers of America (PhRMA) annual meeting, the organization’s chairman cited regulatory risk as the top issue facing the industry. Chairman Christopher Viehbacher, CEO of Sanofi-Aventis, told attendees that the science of medicine is rapidly advancing, but regulatory risk is hindering biopharmaceutical innovation in the US. “We need to have a regulatory process that can keep pace with that,” he said. “We need some predictability.” Viehbacher went on to stress the importance of the “three Ts”: transparency, truth and trust. Viehbacher’s remarks echoed themes discussed during RAPS’ recent Horizons conference, which will result in a series of RAPS reports on the role of regulatory in shaping the future of global health.
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FDA Issues Draft Guidance on Safety Labeling Changes
Posted: 21 April 2011
The US Food and Drug Administration (FDA) has published a new draft guidance on safety labeling changes. The Guidance, entitled, Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, covers the agency’s implementation plans for provisions added to the Food, Drug, and Cosmetic Act by the Food and Drug Administration Amendments Act of 2007. Section 505(o)(4) authorizes FDA to require labeling changes, if new safety information becomes available that agency officials judge should be included in a drug’s labeling, and establishes a timeframe within which such changes must be made.
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US Unveils Plan to Curb Painkiller Abuse, Opiods to Require REMS
Posted: 21 April 2011
As part of an Obama Administration, multi-agency plan to curb abuse of prescription drugs, the US Food and Drug Administration (FDA) will require the makers of opioid painkillers to implement Risk Evaluation and Mitigation Strategies (REMS). As part of the REMS, drugmakers will create and distribute educational materials to help train doctors on how to counsel patients on the risks and correct use of the drugs. The educational materials will require FDA approval before they can be implemented.
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EMA Holds First Pharmacovigilance Stakeholder Forum
Posted: 21 April 2011
Last week, the European Medicines Agency (EMA) held its first stakeholder forum on the implementation of the new EU pharmacovigilance legislation set to go into effect in July 2012. Forum participants included industry representatives, patient advocates, healthcare professionals and national medicines regulatory authorities. Additional stakeholder meetings are planned to take place this year and next. The next forum is scheduled for 17 June 2011. All presentations from the stakeholder forum are available on the EMA website. The new pharmacovigilance legislation, which amends existing legislation, was adopted last December.
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Scrutiny, Criticism Continue for FDA Device Review Process
Posted: 14 April 2011
A scathing report this week from the Government Accountability Office (GAO) renews the agency’s criticism of US Food and Drug Administration (FDA) oversight of medical devices. The report charges FDA failed to strengthen its approval and recall procedures, despite GAO recommendations made two years ago. Among the shortcomings cited by GAO are FDA’s failure to properly analyze recall data, and continuing gaps in the recall process itself that “may increase the risk that unsafe medical devices could remain on the market.” FDA’s oversight of medical devices was the subject of a pair of hearings on Capitol Hill this week, where GAO’s report and patient testimony cast a negative light on the agency’s effectiveness as a public watchdog. “The FDA has had over 20 years to solve these problems,” Sen. Herb Kohl (D-WI) told a Senate panel on Wednesday. “I believe the FDA needs to develop a more robust post-market surveillance program.”
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Indian Drugmakers Compete for Generics Market
Posted: 14 April 2011
With some $100 billion (US) worth of branded pharmaceuticals set to lose US patent protection over the next two years, Indian generic drugmakers are preparing to seize the opportunity, but face multiple challenges. Hurdles include fierce competition from rival generics companies, which already has resulted in a high-profile lawsuit by one firm to block a competitor from getting a head start on producing a generic form of Pfizer’s Lipitor. A strict stance from the US Food and Drug Administration (FDA) on manufacturing standards and processes has also hindered some Indian firms from marketing generics in the US. However, analysts estimate that Indian companies could add more than $2 billion in sales in the US market over the next five years, doubling their current revenue from the US.
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EMA Seeks Input on Alternatives to Animal Studies
Posted: 14 April 2011
The European Medicines Agency (EMA) has released a concept paper on the need to revise its position on the replacement of animal studies with alternative models and is seeking public input. The proposed new guideline would update the agency’s 1997 position paper on the subject. EMA said in a statement that it is considering the update because of a shift toward greater acceptance of in vitro methods by medicines regulators. The agency will accept comments through 17 June 2011.
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Docs Integral to Combating Off-label Marketing
Posted: 14 April 2011
A detailed analysis of whistleblower lawsuits over drugmakers’ off-label marketing finds the illegal practice difficult to control through regulatory means alone and suggests doctors and other healthcare professionals are key to stopping it. The research examined 41 lawsuits filed by 55 whistleblowers in fraud cases against 18 drugmakers that were settled or unsealed between January 2004 and October 2010. “Our findings suggest that no regulatory strategy will be complete and effective without physicians themselves serving as a bulwark against off-label promotion,” Aaron S. Kesselheim, MD, MPH, of Harvard, and colleagues wrote in the peer-reviewed medical journal PLoS Medicine.
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Adverse Event Reports Up Dramatically in Past Decade
Posted: 7 April 2011
Adverse drug reactions (ADRs) reported to the US Food and Drug Administration (FDA) have increased dramatically over the past decade, according to new research from the University of Maryland School of Pharmacy. The report examines FDA’s adverse events data since 1969 and found that 55% of all ADRs had been reported between 2000 and 2010. Lead researcher Sheila Weiss Smith cautioned that the reports do not accurately reflect the actual number of reactions as many go unreported, and also emphasized what she feels is the findings’ most important takeaway: the need for better quality reporting. Researchers found many reports lacked needed information, including one-third that failed to document the patient’s age, a critical piece of data. “Without ages, you have to throw out those reports,” said Weiss Smith.
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UK Drugmakers Get Informal Social Media Guidelines
Posted: 7 April 2011
The Prescription Medicines Code of Practice Authority (PMCPA), the body responsible for UK drugmakers’ self-imposed standards, has issued some informal guidelines on the use of digital communications, including social media. The move comes just after the US Food and Drug Administration’s announcement that it will again delay release of its promised guidance on social media promotion. However, the PMCPA guidelines are not new rules amending UK pharma’s self-regulatory Code of Practice for the Association of the British Pharmaceutical Industry (ABPI). Instead, PMCPA created a Q&A document clarifying how to use digital communications tools while adhering to existing regulations.
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IOM Seeks Device Makers’ Input on 510(k)
Posted: 7 April 2011
Now that the Institute of Medicine (IOM) has completed its review of the US Food and Drug Administration’s (FDA's) 510(k) clearance process, the review panel is looking to gather input on its findings from the medical device industry. The move may help assuage complaints that device makers have been under-represented in IOM’s review and FDA’s overall 510(k) reform process. “I would argue IOM recommendations shouldn’t have any bearing, because of a lack of expertise on the committee,” said Mark Leahey, president of the Medical Device Manufacturers Association. A vast majority of medical devices are cleared for market in the US through the 510(k) protocol.
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FDA Won’t Stop Pharmacists From Drug Compounding
Posted: 7 April 2011
Last week, the US Food and Drug Administration (FDA) announced that it would not take steps to prevent pharmacies from selling a compounded version of hydroxyprogesterone caproate, a drug to prevent preterm birth. The move was unusual as FDA generally does not allow compounded versions of commercially available medicines. The agency’s announcement comes in response to the uproar over cease-and-desist letters sent to pharmacies from KV Pharmaceutical, which had won FDA approval and seven years of exclusive rights under the Orphan Drug Act for a manufactured version of the drug that has been compounded in local pharmacies for years. After FDA approved KV’s version, the company initially set the price for its drug at $1,500 per injection ($30,000 for 20-week course), compared with $10–$20 per dose for the pharmacy version. The company later lowered the price to $690 per dose. FDA’s statement noted that it would not take enforcement action “unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards.”
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Biosimilars Market to Grow to $3.7 Billion by 2015
Posted: 31 March 2011
Worldwide sales of biosimilar medicines will grow from $243 million (US) in 2010 to $3.7 billion by 2015, according to a new study from market analysis firm Datamonitor. The report notes that there still are a number of obstacles to commercial success for biosimilar products despite the establishment of regulatory approval pathways in the US, EU and Japan. However, more than 30 innovative biologics worth $51 billion in sales are set to lose patent protection between 2011 and 2015, and biosimilars represent a “high-value proposition” as government and private payers seek increased value and savings on drug costs.
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FDA Issues Recommendations to Device Importers
Posted: 31 March 2011
The US Food and Drug Administration’s (FDA’s)Center for Devices and Radiological Health (CDRH) has issued recommendations to medical device importers to help improve the import entry review processes and ease entry of needed medical technology products into the US. Citing increasing concern over the number of imported devices lacking adequate data needed by FDA for timely admission into the country, CDRH Director of Compliance Steven Silverman issued a letter to industry last week. “Without the proper information, USFDA may initiate a manual review of each line of your entry, which may lead to delays in its release to the importer/consignee,” wrote Silverman.
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FDA Contemplating Drug Safety ‘Super Office’
Posted: 31 March 2011
The US Food and Drug Administration (FDA) is reportedly exploring the creation of a new position within its Center for Drug Evaluation and Research (CDER) that would oversee all of the agency’s multiple drug safety initiatives. It is not known whether the position is intended to oversee a new drug safety office or if FDA is simply looking to fill the vacant position of associate director of safety policy and communication. According to a story in The RPM Report, FDA’s goals for the proposed “super office” are to “elevate the visibility of CDER’s safety functions,” and “provide the CDER director with more support.”
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EU Herbal Medicine Ban to Face Legal Challenge
Posted: 31 March 2011
A ban on unregistered herbal medicines in the EU set to go into effect in May will face legal challenges from natural health advocates. Critics of the EU's Traditional Herbal Medicinal Products Directive, originally passed in 2004, say it will be difficult to implement the law fairly and that it could actually expose more people to fraudulent and possibly unsafe herbal remedies. "We plan to challenge the directive first of all in the High Court in London, on the grounds that it is disproportionate, non-transparent and discriminatory. We then hope to have the case referred to the European Court of Justice in Luxembourg,” said Dr. Robert Verkerk, executive and scientific director of the Alliance for Natural Health.
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Drug and Device Industries Assess Impact of Japan Quake
Posted: 24 March 2011
The devastation produced by the earthquake, tsunami and subsequent nuclear crisis in Japan has affected drug and medical device companies there along with just about every other aspect of Japanese life. As life sciences companies and regulators assess the damage and formulate next steps, companies are scrambling to determine the impact on their operations, including manufacturing, supply chains and ongoing clinical trials. Device makers are calling for increased resources to be devoted to getting medical technology companies up and running again to address the medical needs of the population, and regulators abroad are proceeding cautiously with regard to products imported from Japan.
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EMA Launches EU Clinical Trials Register
Posted: 24 March 2011
The European Medicines Agency (EMA) this week launched its EU Clinical Trials Register, an online database that gives the public access to information on interventional clinical trials for medicines authorized in the 27 EU Member States and Iceland, Liechtenstein and Norway. The register also allows the public to search for information on clinical trials authorized to be conducted outside the EU if they are part of a pediatric investigation plan. However, the register does not yet include summaries of clinical trial results.
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EMA Moves to Restrict Ex-Chief’s Consulting Activities
Posted: 24 March 2011
The European Medicines Agency (EMA) moved this week to place new restrictions on the business consulting activities of its former director, Thomas Lönngren. Lönngren’s industry consulting prompted criticism after he left the agency in December. While EMA’s statement formally approves its ex-chief’s consulting to date, saying there has been no misuse of confidential information or risk of undue influence on agency decisions, it also limits Lönngren’s activities for the next two years. Those limits include a prohibition on taking executive pharmaceutical industry positions, restrictions on providing advice on EMA-regulated products and limiting professional contact with EMA staff or committee members.
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Drugmakers Can Be Sued for Failure to Report Adverse Events
Posted: 24 March 2011
The US Supreme Court ruled this week that investors may sue drugmakers for securities fraud based on failure to disclose reports of adverse events, even if those events do not meet the standard of statistical significance. The case involves scattered reports that some users of the now-discontinued over-the-counter cold medicine Zicam lost their sense of smell. The company did not disclose what it called “anecdotal hearsay reports about alleged adverse health events,” but when media reports surfaced, the company’s stock price dropped and investors sued. All nine justices sided with the investors. “Given that medical professionals and regulators act on the basis of evidence of causation that is not statistically significant,” wrote Justice Sonia Sotomayor of behalf of the court, “it stands to reason that in certain cases reasonable investors would as well.”
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FDA, EMA to Conduct Parallel QbD Evaluations in Pilot
Posted: 17 March 2011
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have announced a new pilot program to conduct parallel evaluation of Quality by Design (QbD) data for new drug submissions. The three-year pilot to begin 1 April is intended to streamline the review process and help the two agencies further develop QbD concepts, according to Director of FDA’s Center for Drug Evaluation and Research, Janet Woodcock. “To fully implement QbD, we need to further harmonize the implementation of the guidelines, work collaboratively, and provide scientific, risk-based regulatory decisions in a timely manner,” said Woodcock.
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FDA’s Taylor Says Another Tainted Drug Crisis Inevitable
Posted: 17 March 2011
A senior US Food and Drug Administration (FDA) official this week said the agency cannot guarantee the safety of many medicines produced outside the US, and that another crisis involving tainted drugs “seems inevitable.” In public remarks, John Taylor, FDA's acting principal deputy commissioner, warned of another situation like the Heparin crisis of 2008 without more global collaboration among regulators. “Some of this work is already underway and has been for several years,” said Taylor. “But these efforts need to be taken to the next level,” he continued.
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Proposed Tougher Fraud Sentencing Could Impact Pharma Execs
Posted: 17 March 2011
The US Sentencing Commission recently proposed an amendment to fraud sentencing guidelines that would impose tougher punishments upon those convicted of “strict liability offenses” under the Food, Drug, and Cosmetic Act. If enacted, this change would mean pharmaceutical executives convicted of misdemeanor violations—even those they did not know about—could be sentenced at the same levels as felony violations.
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FDA to Issue Guidance for Mobile Medical Apps, Says Shuren
Posted: 17 March 2011
The US Food and Drug Administration (FDA) is planning to release guidance for mobile medical applications sometime this year, according to Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health. Shuren made the statement during a recent town hall meeting near Dallas. While FDA has already cleared some devices using mobile applications, the agency has yet to offer any official guidelines. Such guidance would allow developers to better assess how their products would be viewed by FDA; however, critics point out that the agency has not yet delivered its promised guidelines on social media promotion and question whether it will be able to issue mobile app guidelines more quickly.
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GHTF to Be Terminated
Posted: 3 March 2011
The 18-year-old Global Harmonization Task Force (GHTF), devoted to facilitating greater uniformity among national and regional medical device regulatory systems, will terminate its existence, according to a report in the Medical Technology Association of Australia’s PulseLine. At a recent meeting, regulators from GHTF’s founding member countries—US, EU, Japan, Canada and Australia—decided to terminate the task force, and have proposed replacing GHTF with a global regulator-only body in the future. Information on this development has yet to be posted on the public GHTF website.
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FDA Cracks Down on More Than 500 Unapproved Rx Drugs
Posted: 3 March 2011
The US Food and Drug Administration (FDA) this week took action against drugmakers manufacturing and marketing more than 500 unapproved prescription drugs used to treat colds, coughs and allergies. The affected products have never been evaluated by FDA for safety and effectiveness and cannot be legally marketed in the US but continue to be prescribed. Many of the unapproved drugs predate the 1962 federal law requiring drugs to undergo FDA review. “We don’t know what’s in them, whether they work properly or how they are made,” said Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research.
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Drugmakers Frustrated by India’s Slow Clinical Trial Approval Process
Posted: 3 March 2011
Large international pharmaceutical companies are becoming increasingly frustrated with lengthy delays in getting regulatory approval to conduct clinical trials in India. Drugmakers complain that their applications are getting stalled for months in the office of the Drugs Controller General of India (DCGI). In some cases, applications have been delayed for more than six months and drugmakers have been forced to cancel trials in India and pursue other sites. The number of global trials in India has been stable at about 250 approvals per year for the last three years, but drug company officials warn that this number could decline if approvals continue to be delayed inordinately.
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Too Few Women in Heart Device Studies, Says Report
Posted: 3 March 2011
Many heart devices are approved for use in the US despite a lack of data on safety and effectiveness for women and US Food and Drug Administration (FDA) requirements. According to research from the American Heart Association, two-thirds of participants in studies used to gain FDA approval for cardiac medical devices were men and more than a quarter of the trials did not disclose the gender of study participants. According to an FDA spokeswoman, the agency is aware the problem and FDA’s Center for Devices and Radiological Health is currently developing formal guidelines to be made available this year.
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Hamburg Says Biosimilar Rules Coming Soon, Backs Generic User Fees
Posted: 24 February 2011
US Food and Drug Administration (FDA) Commissioner Margaret Hamburg told a gathering of generic drugmakers last week that the agency will issue rules for reviewing biosimilar medicines “very soon,” and that she supports user fees to help speed up the review of generic drugs. US healthcare reform passed last year included a provision authorizing an approval process for biosimilars and FDA has been working to create that process. Hamburg said that different models have been discussed and the agency is close to being ready to formally implement its new process. She also expressed support for a user fee program for generic drug applications similar to the one that has been in place for New Drug Applications since 1992.
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Shuren Fires Back at Critics Who Say FDA Device Review Too Slow
Posted: 24 February 2011
During a recent hearing before US lawmakers, Jeffrey Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, responded to criticism of the agency’s review process for medical devices. While some have charged that FDA clears too many devices without thorough review, others have complained that the process is too slow, particularly compared with the equivalent process for devices marketed in Europe. “Just because a technology is available in another country doesn't mean it works or even that it's necessarily safe,” said Shuren, who placed blame on device companies for the declining quality of the applications submitted.
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India Plans Anti-counterfeiting Measures
Posted: 24 February 2011
The Drug Controller General of India (DCGI) is moving forward with ambitious plans to guard against counterfeit medicines in its drug supply chain. The Drug Consultative Committee has proposed that all drugs sold in India be required to carry a unique identifier (UID) bar code and a user-readable code that would allow consumers to verify a drug’s authenticity through text messaging. The move follows an earlier requirement for all drugs produced in India for export to carry bar codes by July 2011. However, some smaller Indian drugmakers oppose the requirement, fearing it will be too costly.
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FDA Review Process Hampers Innovation, Says Study
Posted: 24 February 2011
A new report charges that the US Food and Drug Administration's (FDA) review process for drugs and medical devices is “increasingly unpredictable” and negatively affecting innovation and investment in the healthcare product sector and damaging public health. The report from the California Healthcare Institute and The Boston Consulting Group points to review times that have increased 28% for drugs and 43% for devices compared with the 2003–07 period. “Reversing present regulatory trends is essential to sustaining the US biomedical industry as a vibrant source of technology jobs and encouraging future advances to improve public health,” say the report’s authors.
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Study Finds Most Recalled Devices Cleared Through 510(k) Process
Posted: 17 February 2011
A study published this week revealed that most medical devices recalled by the US Food and Drug Administration (FDA) between 2005 and 2009 were cleared through the 510(k) process and therefore not subject to premarket clinical testing. Of the 113 recalls during the time period, Only 21 (19%) had been approved through the more stringent premarket approval process. Eighty (71%) were cleared through the 510(k) process, and an additional 8 (7%) were exempt from any FDA regulation. “Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy,” wrote lead researchers Diana Zuckerman of the National Research Center for Women & Families and Steven Nissen of the Cleveland Clinic.
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FDA Drug Approval Success Rate Drops, Says Study
Posted: 17 February 2011
Sponsors trying to gain US Food and Drug Administration (FDA) approval for new medicines are only successful 10% of the time, about half the success rate previously reported, according to a new study. However, there were some differences among various categories of medicine, with biologic drugs twice as likely to gain FDA approval than traditional chemical drugs. The study from the Biotechnology Industry Organization and BioMedTracker covered 2004 through 2010, reviewing more than 4,000 drugs from companies large and small and both publicly traded and private.
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European Parliament Approves Bill to Stop Counterfeit Drugs
Posted: 17 February 2011
The European Parliament this week passed a new directive to protect patients from counterfeit medicines. The legislation paves the way for new safeguards, including extra safety features on drug packaging and new measures for Internet pharmacies, and it calls for more severe criminal penalties for those involved in producing the phony drugs. The European Commission is expected to issue guidelines. It is estimated that 1% of medicines sold legally in Europe are fake.
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FDA Relaxes Regulation of Medical Device Data Systems
Posted: 17 February 2011
The US Food and Drug Administration (FDA) has relaxed its regulations for medical device data systems, downgrading them from Class III to Class I devices, making them exempt from premarket review. FDA also took steps to carefully define such systems as “off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification.” Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, called the new rule “a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems.”
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FDA Proposes Plan to Speed Review of Innovative Devices
Posted: 10 February 2011
The US Food and Drug Administration (FDA) this week proposed a new “innovation pathway” initiative that would speed agency review of innovative medical devices. The initiative is one way FDA aims to help get revolutionary treatments to patients more quickly. Under the proposal, review time for such products would be cut roughly in half. “We must assure that our oversight doesn’t stifle innovation but rather encourages innovation, while maintaining a commitment to safety and effectiveness upon which Americans rely,’’ said Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health. FDA will hold a public meeting on the initiative in March and will accept comments through 11 April.
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India Seeks to Ease Export of Generic Drugs to Japan
Posted: 10 February 2011
India is seeking to ease rules for exporting generic drugs to Japan as part of ongoing economic trade negotiations. Japan, the world’s second largest drug market behind the US, opened doors for cheaper generic drugs in 2007 in an effort to cut rising healthcare costs for its aging population. But steep regulatory hurdles have made it difficult for foreign companies to make inroads into the Japanese market thus far. Indian drugmakers want to ease requirements, including allowing drug approval applications in English and a relaxation of mandatory trial requirements for every drug on the local population, as well as more transparency and a quicker approval process.
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‘Black Box’ Warnings Applied Inconsistently, Says Study
Posted: 10 February 2011
So-called “black box” safety warnings, the strongest tool the US Food and Drug Administration (FDA) has to communicate drug risks to consumers, are applied inconsistently according to a new study. Researchers examined 20 different drug classes covering a total of 176 medications and found inconsistencies in how the warnings were displayed in nine drug classes, with 15 specific warnings not uniformly evident on the labeling of all drugs within each specific class. “Our findings imply that the process of black box warning acquisition requires transparent and systematic rules, as well as clear justification for the presence of, or lack of evidence for, specific major risks for individual drugs,” said lead researcher, Orestis Panagiotou.
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FDA Approves First iPhone App
Posted: 10 February 2011
The US Food and Drug Administration (FDA) has approved a new mobile radiology application that will allow healthcare professionals to view medical images on an iPhone or iPad. It is the first FDA-approved diagnostic radiology application for mobile devices. The agency's decision appears to signal a step toward more direct regulation of mobile-based medical technology, a rapidly growing sector. More than 1,500 healthcare-related mobile apps are already available to both professionals and consumers.
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Anti-counterfeiting Measures Hinder Drug Access
Posted: 3 February 2011
According to Oxfam, the EU and US are using substandard medicines as an excuse to tighten intellectual property (IP) rules, boosting pharmaceutical industry profits while making it harder for the poor to access drugs. Fighting counterfeits by expanding IP does not address the public health threat of substandard and falsified drugs, claims the organization, arguing that such moves could limit access to generic medicines. Oxfam released its “Eye on the Ball” report Wednesday at the Sixth Global Congress on Combating Counterfeiting and Piracy.
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BHF Funds Research to “Mend Broken Hearts”
Posted: 3 February 2011
The British Heart Foundation (BHF) on Tuesday launched a £50 million ($80 million US) research project into the potential of stem cells to regenerate heart tissue. Scientists hope to have experimental drugs in development within the next decade that would enable certain kinds of cells in the heart the ability to regenerate tissue, repair damage and combat heart failure.
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2011 Bad, 2012 Worse for Patent Expirations
Posted: 3 February 2011
While the pharmaceutical industry may think 2011 will be bad for patent expirations, 2012 will be even worse according to a report from EvaluatePharma’s EP Vantage Unit. The groups analysis reveals a "staggering $33.2 billion of sales will be exposed to generics in 2012 in the USA alone, more than double this year’s figure, representing "a true annus horribilis." The report, which focuses on the US, also notes that the rate of erosion of branded sales "is set to remain incredibly high until 2015" and "the big picture is one of painful losses to sales and earnings, the scale of which the industry has never seen before".
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California Stem Cell Agency Creating Jobs
Posted: 3 February 2011
According to a report released recently by the California Institute for Regenerative Medicine (CIRM), the $1.1 billion from California taxpayers is generating 2,739 jobs annually. Most of the positions are new scientists, assistant and lab technicians and jobs linked to the construction of new research facilities. “This report demonstrates that we’ve delivered on the economic promise (of the funding program) today, even as we continue to see strong positive milestones on the research side progressing rapidly toward therapies,” said Robert Klein, chairman of CIRM’s governing board.
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FDA Issues Process Validation Guidance
Posted: 28 January 2011
This week, the US Food and Drug Administration (FDA) finally issued revised guidance on process validation, ending years of delay and anticipation. The guidance instructs drugmakers on how to verify and document the process used to make a drugs and biological products, including active pharmaceutical ingredients. The current guidance revises and replaces the 1987 guidance for industry entitled, Guideline on General Principles of Process Validation.
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Healthcare Payers, Biologic Developers Disagree on Exclusivity
Posted: 28 January 2011
The debate over just what type of exclusivity was promised to makers of new biologic drugs in last year’s US healthcare reform legislation is heating up. Developers of innovative biologic medicines contend the 12 years of exclusivity granted as part of the law refers to data exclusivity, preventing generic makers from accessing data on existing biologics until the end of the protected period. But generic drugmakers and payers wanting quicker access to cheaper medicines contend the exclusivity in question is market exclusivity, and potential makers of generic versions or “biosimilars” should have access to data long before the end of the 12-year period.
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Social Networking Could Help Drug R&D, Say Docs
Posted: 28 January 2011
Writing in The Boston Globe, two doctors have made an argument for harnessing the power of social media to aid in drug development. If drugmakers had a way to easily gather real-world data from prescribers and patients, they say, the result could be uncovering new uses for existing drugs, similar to the way Viagra resulted from side-effect reports from a cardiovascular trial. The two doctors, who work for a California biopharmaceutical company but wrote on their own behalf, suggest establishing a thoughtfully constructed open innovation platform built around existing medications, much in the same vein as Amazon reviews or Wikipedia.
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EMA to Encourage Development of Drugs for Unmet Needs
Posted: 28 January 2011
The European Medicines Agency (EMA) has published its final Road Map to 2015, which outlines the agency’s vision and priorities in further developing its role as the European regulatory agency for medicines and building on its previous road map initiative between 2005 and 2010. The new road map identifies three priority areas for future actions to strengthen the agency’s role in protecting and promoting human and animal health in the EU: addressing public-health needs, facilitating access to medicines and optimizing the safe and rational use of medicines. One way EMA plans to address public health needs is by encouraging new approaches to drug development and the development of medicines for areas of unmet medical need, including neglected and rare diseases.
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FDA Unveils 510(k) Plan
Posted: 20 January 2011
This week, the US Food and Drug Administration (FDA) unveiled its plan to update the 510(k) clearance process, the most common path to market for medical devices in the US. FDA’s plan outlines 25 actions the agency says it will take this year to improve the process, including streamlining the review of some low-risk devices and clarifying clinical data requirements. However, the agency will delay decisions on the most drastic and contentious proposals that would give it additional powers or impose new requirements on manufacturers. Safety advocates have argued in favor of increased FDA oversight while device makers have expressed concern about the possibility of increased review times and expense.
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EU Parliament Approves Cross-border Healthcare
Posted: 20 January 2011
The European Parliament has approved healthcare legislation that would make it easier for citizens of EU Member States to get medical treatment in a different Member State. The Cross-border Health Care Directive is expected to go into effect in 2013. According to a parliament report, “the aim is absolutely not to encourage cross-border healthcare as such, but to ensure its availability, safety and quality.”The legislation will benefit patients seeking advanced treatments unavailable to them in their country of residence, those living near national borders and those who may want to seek treatment near family living in another country.
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EU Taking Closer Look at Drug Patent Deals
Posted: 20 January 2011
In an effort to ensure there is no delay in cheaper generic drugs coming to market in the EU, the European Commission is subjecting drugmakers to increasing scrutiny, seeking additional information on patent settlement agreements made between originator and generic companies. The move is the latest in a series of EU actions to prevent anti-competitive practices in the pharmaceutical sector after a 2009 report on the subject and the potential harm to consumers.
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China Issues Medical Device Standards
Posted: 20 January 2011
China’s State Food and Drug Administration (SFDA) has announced 96 new industry standards for medical devices in China. Thirty-four of the standards are mandatory, while the remaining 62 are only recommended. The mandatory standards will go into effect on 1 June 2012.
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Report Calls for New UK Body to Simplify Regs, Speed Approvals
Posted: 13 January 2011
A new report from the UK’s Academy of Medical Sciences calls for the creation of a new central body to regulate all UK health research. The report’s authors say excessive bureaucracy is stifling clinical research. The proposal would combine seven ethics review groups into a single agency responsible for guidance and approvals. England’s health secretary has said the government would consider the recommendations.
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FDA Calls for Limits on Acetaminophen
Posted: 13 January 2011
The US Food and Drug Administration (FDA) is asking drugmakers to limit the amount of acetaminophen in all prescription combination products to no more than 325 milligrams per tablet or capsule. Drugmakers also will be required to update labels of such products to warn of the potential risk for severe liver injury. Over-the-counter products are not affected. The decision stops short of a June 2009 Advisory Committee recommendation to ban drugs that combine acetaminophen with narcotic painkillers.
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Drugmakers to Make ‘Aggressive Changes’ to R&D, Says Report
Posted: 13 January 2011
As more lucrative drugs go off patent and the development of new potential blockbuster drugs in the pipeline continues to slow, drug developers are “aggressively changing” their approach to research and development (R&D), according to a new study from the Tufts Center for the Study of Drug Development. To help improve R&D productivity, the report says developers should increasingly turn to translational science to help identify the right disease targets for new molecules. Report authors also predict that even as development activity continues to increase outside the US, companies will seek to reduce global logistical and regulatory complexity by decreasing the number of countries involved.
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EMA Publishes Paper on Active Controls, Seeks Input
Posted: 13 January 2011
The European Medicines Agency (EMA) has published a reflection paper on the need for active control in therapeutic areas where use of a placebo is deemed ethical and one or more established medicines are available. The reflection paper is open for public consultation until 31 March.
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Sharfstein Leaving FDA, Taylor to Serve as Acting Deputy
Posted: 6 January 2011
US Food and Drug Administration (FDA) Deputy Commissioner Joshua Sharfstein will leave the agency to take over as head of the Maryland Department of Health and Mental Hygiene. The news broke late Monday on the Internet and FDA made its official announcement Wednesday. Sharfstein has close ties to Maryland Governor Martin O’Malley and said that while he was not looking to leave FDA, when the offer came from the governor, “It was impossible to turn it down.” FDA Commissioner Margaret Hamburg has named John Taylor, the agency’s top lawyer, as acting deputy commissioner and speculation has already begun that he may fill that role on a permanent basis.
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Europe to Ban Hundreds of Herbal Treatments
Posted: 6 January 2011
A European ban on many traditional herbal medicines currently in use is set to go into effect beginning in May. Under the new law, most herbal products will require a license or prescription by a registered herbal practitioner. A small number of popular products for mild conditions will remain more widely available. The move comes in response to growing concern over adverse effects of such treatments but critics say the law is “discriminatory and disproportionate.”
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FDA New Drug Approvals Down in 2010
Posted: 6 January 2011
The US Food and Drug Administration (FDA) approved a total of 21 new drugs in 2010, a drop from 25 in 2009 and 24 in 2008, but higher than the mere 17 the agency approved in 2007, an historic low. Many industry observers believe the agency is taking a more cautious approach in its review process, resulting in few approvals. “Overall you have seen an increased conservatism from the FDA and an increased emphasis toward safety,” said one analyst.
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2011 Forecasts Mixed for Device Makers
Posted: 6 January 2011
While some medical device industry analysts and observers are concerned about increasing regulatory scrutiny and increasing pressure to reduce prices, others say 2011 is likely to be better than last year for device makers. One national survey of more venture capitalists indicated a growing enthusiasm for investment in the device sector, but some firms are expressing concern about the US Food and Drug Administration (FDA) taking longer to review and approve products.
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