March
FDA Goes on the Road to Promote Orphan Drug Development
Posted: 11 March 2010
In an effort to encourage the development of drugs for rare diseases, the US Food and Drug Administration (FDA) has begun a series of workshops outside the Washington area to provide regulatory advice for potential drug sponsors. The first such workshop was recently held in California and another is planned for August at the University of Minnesota. The agency may even hold one in Europe. While the Orphan Drug Act gives companies incentives to create therapies for those diseases that affect fewer than 200,000 patients in the US, treatments exist for only a small fraction of the approximately 7,000 such conditions. Companies want to have a reasonable expectation of making a profit before they begin the expensive development process. The workshops help give potential sponsors feedback on issues that could delay or derail applications.
German Health Minister to Propose Drug Price Controls
Posted: 11 March 2010
In a move to save on healthcare costs, German Health Minister Philipp Roesler intends to compel brand-name drugmakers to negotiate lower prices directly with insurers, according to a German magazine report. The proposed plan would impose a price ceiling on drug companies if they fail to negotiate and is intended to save two billion euros annually. Germany, along with the UK, has been one of Europe's last free upfront drug pricing markets, allowing companies a large measure of control over setting new drug prices.
Report Cites Lack of Comparative Effectiveness Studies
Posted: 11 March 2010
While much has been made of the notion of comparing the effectiveness and cost value of various medical treatments, there currently is little such research being conducted, according to a report this week in the Journal of the American Medical Association. Researchers looked at 328 drug studies published in major medical journals. They found most such research being done at academic institutions or by other noncommercial enterprises. The researchers found most research simply tested whether one drug is better than another and did not compare the drugs to alternative treatments. Less than 20% examined safety and just 2% included an analysis of cost effectiveness.
Expiring Patents Will Slow Pharma Market Growth in Belgium
Posted: 11 March 2010
The expiring patents of a number of brand-name drugs will slow growth in Belgium’s pharmaceutical market to about 0.46% per year through 2014, according to a new forecast. This is down from 3.4% average annual increases between 2004 and 2009. This is bad news for the branded drug industry in Belgium, a market with high per-capita drug spending. Last year the Belgian drug market was worth 4.59 billion euros and will be worth 4.75 billion euros in 2010, falling to 4.57 billion euros in 2013 as medicines continue to lose patent protection, says the report. Sales are predicted to climb upward again beginning in 2014, with growth forecast for biologic drugs and personalized medicines.
FDA to Increase Criminal Prosecutions
Posted: 4 March 2010
The US Food and Drug Administration (FDA) plans to increase criminal prosecutions of pharmaceutical and food industry executives, according to FDA Commissioner Margaret Hamburg. The statement came in a letter to Sen. Chuck Grassley (R-IA), saying an internal committee has recommended that FDA "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool." The agency has the authority to prosecute corporate executives for criminal actions within their companies under a provision called "strict liability,” but the provision has not been used much in recent years.
Campaign Seeks to Limit Risk From CT Scans
Posted: 4 March 2010
A nationwide push is underway in the US to lower radiation exposure from CT scans, amid growing concern about increased cancer risks associated with the high-powered imaging technology. Studies show that a third or more of scans may be unnecessary and in scans that are medically appropriate, radiation doses could be dramatically reduced without hurting the quality of the images. The Society for Pediatric Radiology is sponsoring an “Image Gently” campaign to promote use of the smallest amount of radiation possible during an imaging study. The group also is urging radiologists to take other precautions, including covering areas of the body such as reproductive organs, and to consider alternative tests such as ultrasound.
DTC Drug Ad Spending Up 2%
Posted: 4 March 2010
Drugmakers’ spending on consumer advertising last year rose 1.9% to $4.5 billion from 2008, according to the latest Nielsen data. Spending on the two largest categories was mostly unchanged, with television up just 0.6% and advertising spending in national magazines down 0.6%. Broadcast television spending fell nearly 6%, while spending on cable networks continues to increase significantly. A Nielsen executive cited longer advertisements due to pressure from the US Food and Drug Administration to present more balanced risk/benefit information as one reason for the increase. Newspaper advertising spending was up 11% to $162 million and radio spending more than doubled to $46 million. Spending on Spanish-language cable networks was up 409% to $4 million and Spanish-language broadcast television spending increased 294% to $29 million. Internet advertising rose 31%to $117 million.
Concerns Grow Over Metal Hip Implants
Posted: 4 March 2010
The type of hip implants known as “metal on metal” implants have raised concern that they are causing severe tissue and bone damage in some patients, and some orthopedic surgeons have ceased using them altogether. In some cases, the devices can quickly begin to wear, generating high volumes of metallic debris that is absorbed into a patient’s body. The devices, whose ball-and-socket joints are made from metals like cobalt and chromium, were thought to be more durable than previous types of implants and became widely used in recent years. The studies conducted thus far have been limited, but estimate that 1–3%of implant patients could be affected by the problem, meaning thousands in the US alone.
February
Generics Review Time Up, User Fees Could Help
Posted: 25 February 2010
The US Food and Drug Administration (FDA) is taking much longer to approve new generic drugs today compared to five years ago and FDA Commissioner Margaret Hamburg believes user fees for generic drugs can help. Five years ago, FDA’s average time to approve a new generic was 16.3 months, but by last year, such approvals took an average of 26.7 months. The delays have been caused by a growing backlog of applications and limited staff to review them. Hamburg said last week that the agency’s generic drugs department was underfunded and that collecting user fees from generic drug sponsors could help alleviate the situation.
EMA Seeks Closer Ties With Health Tech Assessors
Posted: 25 February 2010
As part of the European Medicines Agency's five-year strategy document, the "Road Map to 2015," the agency is seeking closer ties with national-level health technology assessment (HTA) bodies, including the UK’s National Institute for health and Clinical Excellence (NICE). The agency recently launched a series of workshops with European HTA bodies to discus how to involve them earlier in the drug development process. European regulators are concerned about the confusion that could result from the appearance of having two parallel systems with slightly different requirements: one focused on clinical risks and benefits, and the other on relative effectiveness and cost benefits.
510(k) Approval Process for Devices Scrutinized
Posted: 25 February 2010
The US Food and Drug Administration (FDA) held a daylong public hearing last week to collect input to strengthen the 510(k) premarket notification process for review of medical devices. Most medical devices are approved in the US through 510(k), but the process has been under increasing scrutiny from both outside and within FDA. The program is often called a "fast-track" program because it relies on previous approvals of similar devices. Critics charge that this approach isn’t rigorous enough. Others fear that changes to the system might create a burdensome process that could stifle the innovation often driven by small start-up companies.
NIH, FDA Announce Plan to Speed Innovative Treatments
Posted: 25 February 2010
The US Food and Drug Administration (FDA) and the National Institutes of Health (NIH) announced a new partnership intended to help speed up the process of bringing innovative medical therapies to patients. According to FDA, the initiative involves the interrelated scientific disciplines of translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality. The agencies will establish a Joint NIH-FDA Leadership Council to coordinate the efforts, and to help ensure that regulatory considerations are taken into account in biomedical research planning and the latest science is integrated into the regulatory review process. NIH and FDA will also make $6.75 million available over the next three years to help fund regulatory science research.
Biopharma Companies in Listening Mode on Social Media
Posted: 18 February 2010
While most of the technology business world has embraced social media strategies, biotechnology companies remain in more of a listening mode. Biotechs and other life sciences companies naturally have been slow to take a proactive role because of the highly regulated world in which they do business. Anything that may be perceived as promotional in nature risks inviting scrutiny from regulatory agencies such as the US Food and Drug Administration (FDA). As was seen last March, FDA sent out a rash of warning letters to a group of large drugmakers in a single day because the companies’ Google search ads did not include information about drug risks.
Patents Still an Obstacle to Brand Name Drugmakers in India
Posted: 18 February 2010
Drugmakers have had their eyes on India as a prospective growth market for some time but the Indian patent system remains a stumbling block. India’s growing healthcare spending, a relatively inexpensive pool of skilled labor and many potential local partners have attracted a lot of investment from many large pharmacuetical companies. However, patents are still much harder to come by there, compared with other markets. Just last week, the Delhi High Court refused to block approval of a copycat version of a brand name cancer drug. This is only the latest example of a top-selling drug being denied patent protection or, in some cases, enforcement. Drugmakers want greater protections, but Indian officials say their system is fair.
Counterfeit Drugs a Serious Problem in Middle East
Posted: 18 February 2010
Sale and distribution of counterfeit drugs remains a widespread and dangerous problem in the Middle East. A recent seizure of fake drugs in Syria provides some inkling of the scale of this problem. The haul netted millions of dollars worth of phony breast cancer, leukemia and other medicines, along with tens of thousands of anticoagulant pills that purported to treat heart attacks and other diseases, and at least 65 people were detained. Distributors not only sold the fakes to private pharmacies but also to public heathcare systems, particularly in Iraq.
FDA Releases Quarterly List of Safety Investigations
Posted: 18 February 2010
The US Food and Drug Administration (FDA) released its quarterly list of drug safety probes to inform the public about early investigations of potential side effects that have been reported. The lists released this week covered issues identified between April 2009 and September 2009. More than two dozen drugs were listed. Investigations are probing reports of hearing loss, hypothermia, neurological disorders and other adverse events that may be connected to marketed medicines. Being on the list "does not mean that FDA has identified a causal relationship between the drug and the listed risk," according to the agency.
EU’s Centralized OTC Switch Faster but Limited
Posted: 12 February 2010
Makers of over-the-counter (OTC) drugs have welcomed Europe’s new centralized procedure for switching prescription drugs to OTC, but the new process also has drawn attention to the problems of existing national processes. National switches comprise the majority of OTC approvals in Europe, and will likely do so until the EU opens restrictions on which drugs can use the new centralized switch process, so most switches must occur via national approval processes, which can take years to complete.
Philippines to Reveal Next Round of Drug Price Cuts
Posted: 12 February 2010
A second round of voluntary price cuts to popular drugs marketed in the Philippines will be announced next week, according to that nation’s health secretary. The government had asked drugmakers to voluntarily reduce prices on a number of their top-selling and most expensive medicines to avoid government-imposed cuts. Price reduction proposals were due to the government by 22 January and the Pharmaceutical and Healthcare Association of the Philippines confirmed that its member companies had complied with the request, but also has called on the government to find a “more sustainable” approach to ensuring Filipinos’ access to medicines and health care.
US Government to Create Horizon Scanning System
Posted: 12 February 2010
The Agency for Health Care Research and Quality (AHRQ) will use some of the $1.1 billion in federal stimulus money set aside for comparative effectiveness research to create a "horizon scanning system" for the agency and has requested bids to create a the system. The goal of the project will be to "provide AHRQ with a systematic process to identify and monitor healthcare technologies that are likely to have a high clinical, system and cost impact in the US." Some are concerned about the federal government monitoring what is in the pipeline and possibly discouraging innovation, but AHRQ’s director has said the intention is not to impede, but rather to encourage development effective innovative healthcare treatments.
EU Proposes Excipient GMPs
Posted: 12 February 2010
The EU’s Committee on the Environment, Public Health and Food Safety has proposed good manufacturing practice (GMP) requirements for excipients as part of an anti-counterfeiting directive. While the European Fine Chemicals Group (EFCG) supports the measure, according to a spokesperson, saying that “patient safety is paramount” and excipient quality is an important aspect of ensuring this, the group has called for a “deeper analysis” of the situation. Some excipients are already appropriately regulated, according to EFCG, and consequently GMP legislation covering all products would be overly broad and burdensome. EFCG proposes singling out only those excipients that are not already covered by existing rules.
EU-India Free Trade Talks Criticized
Posted: 4 February 2010
Free trade talks between the EU and India resumed last week in Mumbai, but critics in India have complained about a lack of transparency and rumored proposed pharmaceutical patent terms. The text of the draft agreement has not been published and some are decrying the lack of consultation with India’s national parliament and state governments. While no details of the draft’s intellectual property protection terms have been made public, sources say EU representatives are calling for India to accept 20-year patent extensions, a five-year increase over current levels, and extensive data exclusivity provisions.
FDA Moves Authority for Radiology Devices to OIVD
Posted: 4 February 2010
The US Food and Drug Administration (FDA) has moved its Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in an effort to effect more cohesive policies on diagnostic device review. Issues under the purview of the radiological branch, which oversees diagnostic imaging equipment and other radiation-emitting devices, had been the subject of public disagreements within the Office of Device Evaluation (ODE). OIVD Director Alberto Gutierrez commented that the agency had seen discrepancies emerge between how OIVD was regulating diagnostics compared with other divisions within ODE, but an agency spokesperson stressed that the move was meant to address regulatory concerns, not personal tensions.
Obama Proposes Generic User Fees
Posted: 4 February 2010
The Obama administration is asking Congress to pass legislation allowing the US Food and Drug Administration (FDA) to collect user fees from generic drugmakers, as it does from sponsors of innovator medicines. The money would be used to speed review times and reduce the current backlog of applications, according to the proposed budget documents. Generic drugmakers have been supportive of such user fees as long as they are coupled with improvements in the FDA review process. Some of the money collected could be put toward creating a regulatory approval pathway for biosimilars.
EC Issues Medical Device Report
Posted: 4 February 2010
A report from the European Commission's Exploratory Process on the Future of Medical Devices was published last week identifying challenges facing the medical devices industry. The Exploratory Process was coordinated by DG Enterprise and brought together European medical device stakeholders.
January
DTC Ads More Muted Due to Stricter FDA Enforcement
Posted: 28 January 2010
Direct-to-consumer ads for prescription medicines in the US have grown increasingly serious in tone due to stricter enforcement of regulatory guidelines by the US Food and Drug Administration (FDA), according to industry analysts. Consumers may have noticed, for example, decreasing use of sexual innuendo used in ads for erectile dysfunction treatments, and more attention paid to side effect warnings. When Margaret Hamburg was confirmed FDA commissioner last year, she promised more aggressive enforcement of existing ad guidelines. The agency issued almost double the number of warning letters to drugmakers in 2009, compared with the previous year.
Drug, Device Recalls Up Sharply in UK
Posted: 28 January 2010
The number of product recalls and alerts affecting drugs and medical devices in the UK nearly quadrupled between 2004 and 2008, according to a new study. The report from Blueview Group cites manufacturing errors as the most common reason. Recalls and alerts climbed to 94 from just 22 during the four-year period, with nearly two-thirds attributed to manufacturing defects. The study found 12% of pharmaceutical recalls were caused by labeling and packaging problems and 9% due to compromised sterility.
US Orphan Drug Numbers More Than Doubled
Posted: 28 January 2010
The number of orphan drug designations in the US more than doubled in the last decade, growing from 208 during 2000-02 to 425 in 2006-08, according to a new study. The Orphan Drug Act was passed in 1983 to promote the development of products for rare diseases or conditions affecting fewer than 200,000 people. Since then, more than 2,000 products have been designated as orphan drugs, and the US Food and Drug Administration (FDA) has granted market approval to 350 drugs and biologics, according to the study conducted by the Tufts Center for the Study of Drug Development. The report also found that, during the 2000s, orphan products comprised 22% of all new molecular entities and 31% of all significant biologics receiving US marketing approval.
Electronic Submissions to CDRH on the Rise
Posted: 28 January 2010
Electronic submissions to the US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) significantly increased from 2008 to 2009. The number of electronically filed device submissions climbed from 4,619 to 21,296 last year, according to FDA statistics cited in a recent post on a regulatory consulting company’s blog. These numbers provide strong evidence of the acceptance of electronic submissions and suggest they could grow further after a final ruling is issued on the agency’s draft guidance on electronic medical device reporting.
FDA Names Shuren Permanent CDRH Chief
Posted: 21 January 2010
The US Food and Drug Administration (FDA) named Dr. Jeffrey Shuren the permanent director of the agency’s Center for Devices and Radiological Health (CDRH), which has been criticized in recent years from both outside and within FDA itself for a flawed approvals process. Shuren had been serving as the acting head of CDRH since Daniel Schultz resigned as director in August of last year. FDA Commissioner Margaret Hamburg has said she intends to correct the center’s problems and had already begun doing so prior to Shuren’s appointment. According to documents posted on the FDA website, CDRH priorities for 2010 include strengthening product reviews and increasing transparency about decision making.
Smart Pill Technology Could Open New Possibilities
Posted: 21 January 2010
So-called “smart pills” that can transmit patient health data to external receivers may represent a promising new technology for drugmakers and healthcare providers. Such devices could be used to monitor patients’ reactions to various medications or whether they are following the prescribed dosage regimen. Various studies have estimated that one-third to one-half of prescription drugs are not taken as prescribed, costing an estimated $100 billion a year in the US alone. And with healthcare product makers under increasing pressure to demonstrate the effectiveness of treatments in practice as well as in theory, smart pills could provide needed evidence. However, the technology is not without its critics, as some are concerned about protecting the privacy of patients who may use such a device.
New EU Health Chief Calls for Action on Patient Drug Info
Posted: 21 January 2010
The EU’s new, incoming health commissioner intends to push to break the deadlock on last year’s proposal to allow prescription drugmakers to provide drug information directly to patients. John Dalli, the commissioner-designate for Health and Consumer Policy told the European Parliament’s Committee on the Environment, Public Health and Food Safety last week that the current draft directive needs to be reassessed to “bring more patient’s perspective in the proposal,” and that there may need to be a “harder demarcation between industry and advertising,” but also declared his general support for patients’ right to accurate information on prescription medicines.
UK May Allow Early Drug Access; Funding Uncertain
Posted: 21 January 2010
A new proposal in the UK could grant some groups of patients early access to certain new medicines prior to their formal approval. However, the government has no plans in place to provide funding for such drugs. The proposed scheme would allow patients without treatment options to receive drugs in development that could potentially prolong their lives, similar to the US Food and Drug Administration’s Treatment IND regulation, which permits the use of an investigational drug among some patients, provided the drug is for a serious or life-threatening disease and there is at least preliminary evidence of efficacy. Most countries, including the UK, have compassionate use programs permitting patients to obtain investigational drugs on an individual basis, but only a few, including the US, France and Sweden, have programs to allow early access to cohorts of patients.
Philippines Asks Drugmakers for More Price Cuts
Posted: 21 January 2010
After seeking and getting price cuts for a number of essential medicines last summer, the government of The Philippines is asking drugmakers for a second round of price reductions. While pharmaceutical companies are being asked to voluntarily reduce prices on select medicines up to 50%, the government is prepared to impose reductions as it did last summer for five essential medicines. Prices for an additional 16 medicines were lowered voluntarily by drug companies at the time. Drugmakers had been given an initial compliance deadline of 14 January for this round of cuts, which has now been extended to 22 January.
FDA Launches First Phase of Transparency Initiative
Posted: 14 January 2010
This week, the US Food and Drug Administration (FDA) launched its new "FDA Basics" area of the agency's website as the first step in its new transparency initiative. FDA Basics is intended to help the public more fully understand how the agency works and includes information about FDA's organizational structure, regulated products, regulatory processes, answers to frequently asked questions and video interviews with agency personnel. During the next phases of the initiative, FDA plans to focus on making information about agency activities more "transparent, useful, and understandable in a manner that's compatible with our goal of protecting confidential information," said Joshua Sharfstein, principal deputy commissioner of food and drugs.
EU Investigates Pay-for-Delay Deals; Ban Proposed in US
Posted: 14 January 2010
So-called "pay-for-delay" deals to delay competition from generic drugs are being further investigated by the European Commission (EC) while a group of US officials have proposed an explicit ban of the practice. EC antitrust investigators report they have asked unnamed pharmaceutical companies for details of patent settlement deals as part of an ongoing pharmaceutical competition inquiry. At the same time, a group of legislators from the US House of Representatives and the Federal Trade Commission chairman are calling for a provision in the pending healthcare reform legislation that would prevent brand-name drugmakers from directly or indirectly paying generic makers to delay cheaper generic alternatives. The House version of the bill already includes such a ban while the Senate version does not.
EU is Slow to Move on Direct-to-Patient Drug Info
Posted: 14 January 2010
Last year, the EU proposed a package of legislation, including a provision that would allow drugmakers to distribute nonpromotional information about prescription medicines directly to patients, but has yet to act on it. The goal of such a change would be to provide greater access to information on existing medications without legalizing the type of direct-to-consumer advertising that is allowed in the US. However, the EU appears to be moving slowly as the draft proposal is stalled and is likely to be amended, with the soonest action not likely until May of this year.
US Medical Research Funding Down, Say Report
Posted: 14 January 2010
Public and private funding for US biological and medical research has slowed and resources from one major federal source shrank when inflation is taken into account, researchers reported this week. The team from the University of Rochester Medical Center said its findings suggest a more cautious future for medical research, and one in which new scientists may shy away from more innovative and risky projects that could deliver potential breakthroughs, in favor of safer endeavors. According to the report, industry sources invested the most in biomedical research, accounting for 58% of all 2007 spending, and the US National Institutes of Health (NIH) was the second-largest source, accounting for 27%, but NIH funding fell by 2% in real terms.
FDA Drug Approvals Up in '09; NDAs Need Improvement
Posted: 7 January 2010
The US Food and Drug Administration (FDA) approved one more new drug last year than it did the year before—25 in 2009, compared with 24 in 2008. While this is not a big increase, it is the second year in a row of higher approval totals. With Office of New Drugs Director John Jenkins revoking late last year the permission he had previously granted his staff to miss user fee deadlines, innovator drug sponsors are looking forward to favorable new drug review conditions heading into 2010. However, Jenkins recently advised sponsors that they need to submit better applications. Speaking before a group of biopharma executives last month, he told the audience that in his view, too many new drug applications are filed before they are complete to meet sponsors' internal goals.
FDA Developing Tougher Standards for Devices
Posted: 7 January 2010
In the wake of criticism about the way the US Food and Drug Administration (FDA) handles the approval of medical devices, the agency is developing guidelines that will set tougher scientific approval standards. The new standards will set the bar higher for data from tests on humans that device makers must submit when seeking approval. FDA's acting director of the Center for Devices and Radiological Health told The New York Times that the agency most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, he added.
Drugmakers Accused of Promoting "False Pandemic"
Posted: 7 January 2010
The Parliamentary Assembly of the Council of Europe plans to convene this month for an emergency debate and inquiry into alleged influence exerted by drugmakers on the World Health Organization's (WHO) global H1N1 flu campaign. Critics charge that drugmakers influenced WHO scientists, encouraging a "false pandemic" in an effort to promote unnecessary flu drug and vaccine sales. In France, President Nicolas Sarkozy, is at the center of a political controversy after health authorities admitted they had a huge oversupply of vaccines for the H1N1 virus and were trying to sell them to other countries. Pharmaceutical manufacturers face the prospect of significantly lower flu vaccine sales than forecast as a growing number of governments seek to renegotiate purchases of unused stocks.
UK Clinical Trials Decline Sharply in 2009
Posted: 7 January 2010
The latest figures from the UK's Department of Health show a sharp decline in the number of clinical trials conducted in that country. The number of mid- and late-stage and postapproval clinical trials fell from 728 in 2008 to 470 in 2009, the lowest of the past decade. Early-stage trials fell to 210, the lowest in five years. Despite government efforts to encourage UK-based trials, bureaucracy, low recruitment rates and the slow uptake of new drugs are being blamed for pharmaceutical companies' moves to conduct more research in other countries in Europe and North America, as well as increasingly in low-cost, developing nations. The UK's share of global clinical trials fell from 6% in 2002 to 2% in 2007.
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