December 2007

Counterfeit drug makers utilize free trade zones (posted 20 December 2007)
Anticounterfeiting experts say counterfeit drug makers are increasingly utilizing free trade zones in order to hide a drug’s place of origin or to make, market or relabel adulterated products.

“Free trade zones allow counterfeiters to evade the laws of the country because often times the regulations are lax in these zones,” Ilisa Bernstein, director of pharmacy affairs at US FDA told the New York Times, “This is where some of the Internet sellers work.”

Free trade zones are ideal way stations for goods being shipped around the world because they eliminate tariffs and quotas and lower bureaucratic requirements. The usual requirements for local ownership of companies are waived in areas like Dubai, in the United Arab Emirates, where three months ago a large cache of counterfeit drugs from a warehouse there unveiled a complex supply chain of fake drugs.

Nimo Ahmed, head of intelligence for a British drug regulatory agency, said the zones were set up to encourage legitimate trade. “They will process packages quicker, receive fees for them, and if everything is done legitimately it’s a win-win for everybody,” he said in the article. However, he also added, “counterfeiters are using it as a way to hide where their products are originally sourced.” Read the article

China, US FDA work out import safety agreement (posted 20 December 2007)
US FDA standards for regulated products will be increasingly enforced in the regulation of China’s drug manufacturing industry, as part of a memorandum of understanding signed 11 December in Beijing by US HHS, US FDA and China’s State Food and Drug Administration (SFDA). The MOU outlines a number of specific regulatory and information-sharing actions, according to PharmAsia News, and is based upon “a three-pronged strategy of registration, certification and verification.”

An email by FDA commissioner Andrew Von Eschenbach, obtained by PharmAsia News, describes this three-pronged strategy: “First, the Chinese manufacturers of the agreed-upon items have to register with the appropriate Chinese authorities…second, the agreements specify that AQSIQ (the Administration of Quality Supervision, Inspection and Quarantine) will certify that the food and feed covered by the agreement meet FDA’s standards.” And lastly, in addition to these and other public health protecting measures, “our Chinese counterparts have agreed to keep our agency informed of any problems or obstacles in the implementation of the agreements.”

According to Eschenbach, the MOU will “create an incremental, confidence-building system for enforcing compliance with US standards in regulated products before they leave China.” Read the article

FDAAA provisions require submission of additional information to FDA (posted 20 December 2007)
The addition of section 402(j) (42 U.S.C 282(j)) to Title VIII of the Food and Drug Amendments Act of 2007 (FDAAA) will require the submission of extra information, including expanded information on clinical trials and the results of clinical trials, to the clinical trials databank (ClinicalTrials.gov), says FDA.

According to an update on FDA’s website, one new FDAAA provision, 42 U.S.C 282(j)(5)(B) requires that a certification accompany human drug, biological, and device product submissions made to FDA. Other FDAAA provisions mentioned in the article include: “At the time of submission of an application under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the PHS Act (21 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements of section 402(j) of the PHS Act have been met. For the Center of Devices and Radiological Health, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, and premarket notifications (510(k)) require certification.”

Certifications must be submitted to FDA beginning no later than 26 December 2007. Read the article

Related resources:

• Learn more about FDAAA at Strategies for Prelaunch Success

Testing drug toxicity with stem cells (posted 20 December 2007)
Researchers are turning to human embryonic stem cells to come up with a better means of predicting the toxicity of potential pharmaceuticals. According to an article in Technology Review, the previous method of using lab rats was unreliable because, “often compounds that appear safe in the rodents prove to be toxic in human beings.”

By monitoring the behavior of embryonic stem cells exposed to a drug-candidate compound, and studying how potential drugs affect embryonic stem cells, researchers believe they can attain a more accurate prediction of a drug’s potential toxicity.

According to Gabriela Cezar, assistant professor of animal science at the University of Wisconsin-Madison, "Developmental disorders and birth defects start in utero during pregnancy, and we have no way to measure or look at mechanisms that could be participating in the onset of these diseases," says Cezar. "With human embryonic stem cells, we can recapitulate development of the human brain and measure concrete changes of chemicals to drugs like valproate." Read the article

FDA votes in favor of phenylephrine-based decongestants (posted 20 December 2007)
An FDA advisory panel recently voted 11-1 in favor of a certain type of over-the counter decongestant that uses the ingredient phenylephrine, despite opposition from pharmacists who question that ingredient’s effectiveness, especially at the currently approved dosage, says CNNMoney.com.

Certain companies used to sell over-the-counter (OTC) decongestants containing pseudoephedrine. However, because this compound is also used to make the illegal drug known as crystal methamphetamine, retailers have moved these products behind-the-counter. “Patients must now interact with pharmacists and show identification to buy pseudoephedrine products” says CNN. In order to continue selling decongestants over-the-counter, those companies reformulated their pills to contain phenylephrine.

Some researchers, however, believe that phenylephrine is an ineffective substitute for pseudoephedrine, and they have petitioned FDA to hold a meeting about this perceived ineffectiveness.

Analysts say the issue isn't likely to have a major impact on drug companies, which rely more financially on prescription drugs sales than on OTC drugs. Read the article

DC local government may regulate sales reps (posted 13 December 2007)
The local governing body in Washington, DC, has given initial approval to legislation to license pharmaceutical sales representatives there. The legislation would make Washington would become the first jurisdiction in the country to enact such a law.

The Safe Rx Act, given initial approval with a 7-6 vote of the DC Council, aims to create a pharmacy board to oversee a code of ethics and licensures for salespeople. According to The Washington Post, sales representatives in Washington “would have to be college graduates and would be prohibited from using titles that could lead doctors to think they are licensed to practice medicine, pharmacy, nursing or in other health fields.”

Representatives from the drug industry believe the move is unnecessary because it overlaps with federal laws. Additionally, many feel that if the bill makes it into law it would open the door for the passage of similar legislation by US states.

“In recent weeks, the District has become a battleground for those who have targeted the pharmaceutical industry in hopes of reining in drug prices and securing stronger local regulations,” The Washington Post reports.

The council must vote for final approval of the legislation on 8 January 2008. Read the article

Related resources:

• D.C. Effort to License Drug Sellers Advances

FDA, China import safety MOU almost final (posted 13 December 2007)
A memorandum of understanding (MOU) between US FDA and China on drug and medical device safety is expected to be finalized this week, but the agreement will not include plans to establish a permanent FDA office in China. US Health & Human Services (HHS) Secretary Mike Leavitt’s expects to make final the MOU during a trip to China, despite that MOU leaves unfulfilled his desire to establish a permanent FDA office in China.

According to PharmAsia News, discussions concerning such an office are “far from being concluded.” Members of the US House of Representatives have expressed interest in establishing FDA offices in China and India, and an FDA office could still be launched in China as soon as early 2008.

The exact components of the MOU are unknown. PharmAsia News reports, however, that “Leavitt said it will be ‘very similar in principle’ to the Action Plan for Import Safety that the Interagency Working Group for Import Safety released in November. Read the article

New stem cell technique cures mice of sickle cell (posted 13 December 2007)
Scientists have cured some mice of sickle cell anemia with the use of a recently developed technique for turning skin cells into stem cells. The research is “the first direct proof that the easily obtained cells can reverse an inherited, potentially fatal disease,” reports The Washington Post.

Induced pluripotent stem (iPS) cells are nearly identical to embryonic stem cells, and, because they do not use fertilized embryos, some scientists see them as way to bypass the embryo controversy currently surrounding stem cell debates.

However, according to The Washington Post, researchers also cautioned that the new approach will need to be changed before it can be tried on human patients, especially because “the technique depends on the use of gene-altered viruses that have the potential to trigger tumor growth.” Read the article

EMEA adopts pediatric class waiver list (posted 13 December 2007)
The European Medicines Agency (EMEA) adopted a pediatric class waiver list. The list, adopted on 3 December 2007, includes symptomatic conditions that qualify for class waivers from pediatric plans (PIPs) under the EU’s regulation on medicinal products for pediatric use (No. 1901/2006).

A company seeking approval for a new medicinal product or for a new indication, route of administration or pharmaceutical from of an existing patent-protected product, then that company must first submit a PIP detailing their strategy for developing the drug in all subsets of the pediatric population.

According to Pharma Times, “companies seeking approval either for a new medicinal product or for a new indication, route of administration or pharmaceutical form of an existing patent-protected product must submit a PIP detailing their strategy for developing the drug in all subsets of the paediatric population. The trade-off for meeting the requirements of an agreed PIP is a six-month extension to the product’s supplementary protection certificate.

“The list of symptomatic conditions – 17 in all – for which class waivers from a PIP are available includes a number of cancers (e.g., treatment of lung, breast or prostate carcinoma, hairy cell leukemia and multiple myeloma), as well as neurodegenerative diseases such as Alzheimer’s Disease and Parkinson’s Disease and age-related conditions such as macular degeneration or menopausal disorders.”

The waivers relate only to the treatment of these conditions and not to medicines for their prevention or diagnosis. Read the article

FDA offers Introduction to Improved FDA Prescription Drug Labeling (posted 13 December 2007)
FDA is now offering An Introduction to the Improved FDA Prescription Drug Labeling on its website to help users understand the revised prescription drug labeling imitative. Users of the FDA activity will learn descriptions of prescription drug labeling and related FDA requirements, the history of the drug labeling initiative, major content and format changes to prescription drug labeling, and related FDA electronic labeling initiatives. Read the article

EU and FDA simplify orphan status submissions (posted 6 December 2007)
The European Commission, European Medicines Agency (EMEA) and US FDA have adopted a common application form for sponsors seeking orphan designation of medicines in the EU and US, thus simplifying the process of obtaining orphan status for medicines intended for rare diseases.

Due to the smaller number of patients with rare diseases who will benefit from orphan medications, sponsors of these drugs often experience relatively low profit from sales, or even financial loss when the costs of research and development are taken into account, according to Medical News Today. The US and EU have each adopted regulation aimed at providing regulatory and financial incentives to sponsors who develop and market orphan medicinal products—the US 1983 Orphan Drug Act and the EU 1999 Regulation on Orphan Products.

To be eligible for these incentives, sponsors must currently submit separate applications for orphan designation to the EMEA and US FDA using different submission formats to satisfy the respective regulatory requirements. “These different formats have imposed an additional burden on sponsors,” reports Medical News Today, “Hence, the parties have agreed to harmonize the application form to simplify part of the orphan medicines designation process.” Read the article

FDA considers easing curbs on drug makers (posted 6 December 2007)
US FDA is considering whether pharmaceutical manufacturers should be allowed to provide doctors with medical journal studies on unapproved uses for drugs. According to The Washington Post, under a recent FDA draft guidance, drug and medical device manufacturers could “distribute unabridged reprints of peer-reviewed research from reputable medical journals as long as the articles were not written, edited or otherwise ‘significantly influenced’ by the manufacturers or people with financial ties to them.”

Rep. Henry A. Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, opposes the guidance, saying that it would: “open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs.”

Meanwhile, supporters believe that providing the articles to doctors could help them make better prescribing decisions. Diane Dorman, vice president for public policy at the National Organization for Rare Disorders, who supports the guidance, states in the article: "There are nearly 30 million people in the United States affected by almost 7,000 known rare diseases. Consequently, most of those disease states are treated off-label because there is no therapy specific for their disease. So getting that information to physicians, I would consider to be very, very important for the patient." Read the article

Companies prep for regulatory changes to supplements industry (posted 6 December 2007)
A recent report on regulatory changes in the dietary supplement industry indicates that supplement companies that have provided clinical research for their products will be at a significant advantage over those that have not. The report, The Dietary Supplements Market Outlook 2007, focuses on an overview of the recent regulatory climate change, particularly with the release of the final GMPs rule and AER regulations this year.

“Not only will these regulations hamper the flow of activity for those companies not prepared for the measures,” reports Nutraingredients “but they are also likely to bolster the success of those companies that are prepared and for whom the measures signify minimal change.”

The Good Manufacturing Practices (GMPs) rule, finalized in June, provides standards for inspectors to check for safety and legality in manufacturing. The Adverse Event Reporting (AER) regulations, which came out this year, require supplement manufacturers, packers and distributors to notify FDA of any serious adverse events reports. Read the article

FDA lacks resources for new demands, report indicates (posted 6 December 2007)
A new report indicates that demands placed on US FDA—stemming from advances in scientific discoveries, complex new products and the globalization of the health care products industry—have increased faster than increases to its resources. According to The Star-Ledger, FDA’s current lack of resources has “eroded its scientific base.”

"The result is that the scientific demands on the agency far exceed its capacity to respond. This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public,” the report states.

"What makes this report so extraordinary is the qualifications of the individuals who wrote it, the year-long process to put it together and the depth of analysis that supports its conclusion: FDA's mission is at risk for lack of support for its scientific capabilities," said Jane Henney, a former FDA commissioner. Read the article

Scientists use decoys to defeat superbugs (posted 6 December 2007)
British researchers have developed a new “decoy” method for attacking antibiotic-resistant bacteria that could eventually defeat superbugs like MRSA, according to a recent article in The Financial Times. Identifying segments of DNA that render the genes responsible for antibiotic resistance in bacteria inactive, researchers believe they can use this technology to develop new drugs against any bacterium within a couple of years.

“The DNA sequence acts as a decoy, disrupting gene expression and blocking resistance,” Michael McArthur, head of the John Innes research team, is quoted in the article. “We are putting genetic information directly into drugs.” The research team was successful in using this decoy approach to defeat resistance to vancomycin in laboratory experiments with Streptomycin bacteria.

Because the combination of an antibiotic with a decoy can be patented as a new drug, Financial Times reports that this new technology could “give fresh commercial life to existing antibiotics.” Read the article

November 2007

UK’s MHRA launches new plan to fight counterfeits (posted 29 November 2007)
Following a surge in the volume of counterfeit medicines distributed there, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new three-year action plan intended to confront the problem head on.

According to a recent DrugResearcher.com article, the UK has become a “key hub” for drug counterfeiters who manufacture fake drugs in locations such as China and India, but who “realize that the presence of a British stamp on their packages adds credibility to their operations.”

In response, MHRA has unveiled its first-ever dedicated anti-counterfeiting strategy. According to the article, “MHRA's three-year plan centers on continuous ‘threat assessment’ of the risk of counterfeit medicines and medical devices in the UK. With targeted market surveillance projects and international monitoring of counterfeiting activity, the agency hopes to be able to identify key areas or weaknesses in current legislation.” Read the article

Duke, FDA partner up to improve clinical trials (posted 29 November 2007)
Duke University Medical Center and US FDA are partnering to improve the clinical trials process in the US. The partnership will help FDA increase its efforts to inspect and track clinical trials.

According to The Wall Street Journal, a report from the inspector general of the Department of Health and Human Services was recently released, which estimated FDA inspects around 1% of clinical trials sites. It also says FDA struggles to track trials, and that its guidance and regulations do not reflect current clinical trials practices.

“We know it needs to be done differently than how it’s done now,” Robert Califf is quoted in the article. Califf is a cardiologist and vice chancellor for clinical research at Duke, and will chair the public-private partnership. According to the article, Califf says that a typical clinical outcomes trial costs around $500 million. Read the article

India to end pricing freedom for drug manufacturers (posted 29 November 2007)
India’s government is considering withdrawing the right of drug makers to set their own prices for innovative new medicines. The move follows a report from India’s National Prescription Pricing Authority.

According to an article in Pharma Times, “Market surveys by the Authority have found widespread abuse of the system, and local reports now say that multinational drugmakers have also been getting round this requirement by importing innovative new medicines rather than manufacturing them locally, as doing so would have allowed the authorities to check on the drug’s production costs.” Read the article

Nanotechnology presents both promise and risks (posted 29 November 2007)
Despite a dramatic in the number of products claiming to use nanotechnology, industry, regulators and governments still know little about the general safety of these materials.

According to a recent article in The Economist, “The unusual properties of tiny particles contain huge promise. But nobody knows how safe they are. And too few people are trying to find out.”

The article reports that, according to Lux Research, nanotechnology could help produce trillions of dollars of products by 2014, “ranging from face creams to computer chips and car panels.” The new technology could also contribute to making better batteries, generating green energy and producing clean research. The article points out, however, that “the necessary risk research” has yet to be performed, and it is unclear how “existing agencies can regulate a large, new, poorly understood area of risk.” Read the article

Congressional investigation called for illegal devices (posted 29 November 2007)
A member of the US Congress has called for an investigation into unproven “energy medicine” machines that are potentially dangerous and possibly illegal.

US Rep. Jay Inslee recently called for the congressional investigation into what the Seattle Times describes as “a collection of alternative therapies based on the belief that the body has energy fields that can be manipulated to improve health.” Inslee claims that some manufacturers have used these devices to misdiagnose diseases and divert critically ill people from life-saving care.

According to the same article, Seattle health officials have recently disclosed that “cases of illegal practice of medicine in Washington, especially by those using energy-medicine machines, have more than doubled since 2005.”

Assistant Secretary Laurie Jinkins told Seattle Times, "Unlicensed practice is growing very fast and it's become a big concern” and that the department has opened 573 investigations in the past two years. Nearly all of these investigations were the result of complaints from the public. Read the article

Russia’s clinical trials industry recovers from biologics ban (posted 21 November 2007)
Russia’s clinical trials industry shows signs of recovery following a significant downturn linked to an unexpected ban placed on biologic exports by the government there.
According to a recent article in DrugResearcher.com, new research published by the Russian contract research organization (CRO) Synergy Research Group which demonstrates a 2% increase in approvals to conduct new trials. This is a major improvement upon the 13% decrease in new trail approvals experienced in the second quarter.

A large portion of that decrease in the second quarter was seen as the result of a 25% fall in the number of international multi-center clinical trials being given the green light. Experts believe the second quarter’s decrease in international business is due primarily to the recent biologics ban.

“At the beginning of June, the Russian Federal Customs Service (FTS) without warning shut down the export from the country of all human medical biological materials, including blood and human tissue. The situation was eventually resolved, with things returning to as they were before the ban was implemented,” reports DrugResearcher.com. Read the article

Stem cell breakthrough may bypass embryo controversy (posted 21 November 2007)
A recent breakthrough in stem cell research could bypass the embryo controversy currently surrounding stem cell debates by creating primate embryonic stem cells that do use fertilized embryos. According to a recent In-Pharmatechnologist article, the new technique uses a modification of a previous technique known as somatic cell nuclear transfer (SCNT) to combine the genetic material from a masque monkey's skin cell with an egg to create stem cells that have identical nuclear DNA to the donor cell. SCNT has already been used to successfully create embryonic stem cells from mice. However, previous attempts to use the technique to create primate embryonic stem cell lines have failed.

According to Dr Shoukhrat Mitalipov, PhD, director of the OHSU-based research team and lead author of the study, the team's success lies in the method for identifying and extracting the nuclei of the eggs being used. Previous unsuccessful attempts damaged the eggs during the nucleus extraction step, leading to eggs that were not fully functional and failed to divide and develop. “Mitalipov’s group developed two stem cell lines using the technique. However, their development used over 300 monkey eggs––a success rate of only 0.7%.”

The new research has been published as an advanced online publication in the journal Nature by scientists from the Oregon Health & Science University (OHSU), US. Read the article

China’s stand on imports upsets US (posted 21 November 2007)
A recent Chinese directive that calls for new safety inspections for foreign-made medical devices, but not for those made in China, has upset some officials in the US, according to a recent New York Times article.

Despite efforts made by Treasury Secretary Henry M. Paulson Jr. to ease economic tensions between the US and China, the new directive “seems part of a recent pattern in which Chinese officials issue new regulations aimed at favoring Chinese industries over foreign competitors,” reports the article.

“There is clearly a growing economic nationalism in China that is leading to discrimination against foreign investors in pillar sectors of the economy,” Myron Brilliant, Vice President for Asia at the United States Chamber of Commerce, told The New York Times.

Paulson is planning a visit to China in early December with other cabinet members to engage in another round of strategic economic dialogue that he began in September 2006 to defuse lingering trade disputes. Read the article

China revises GMPs (posted 15 November 2007)
China’s State Food and Drug Administration (SFDA) has revised its Good Manufacturing Practices (GMPs) in an effort to increase quality systems standards for pharmaceutical manufacturers. The new standards are scheduled to go into effect 1 January 2008.

“The new standards will only allow drug makers who have zero serious flaws to be certified, an improvement from the old version whereby a drug maker with three serious flaws could pass assessment and be certified if the flaws could be fixed in a certain time frame,” reports PharmAsia News. There are 259 inspection items in the revised GMP standards. Of these, 92 will be listed as key Items. Failure to pass any of these key Items will be considered a serious flaw.

Experts say that the change in the number of serious flaws will not significantly impact multinational companies (MNCs), since the revised GMP rules reflect standards currently held by MNCs and US companies. Read the article

FDA considers pharmacist-to-patient prescription drug sales (posted 15 November 2007)
US FDA experts met recently to consider the creation of a new class of drugs that could be sold by pharmacists ‘behind-the-counter’. According to a recent US News article, if FDA supports the proposal, pharmacists might someday bypass doctors and directly provide consumers with certain drugs that now require a prescription.

“There are several reasons that FDA is considering the proposal. Among these is the assertion that the plan improves pharmacist interaction with patients and ensures safe and effective use of drugs requiring a prescription,” reports US News, “In addition, allowing certain drugs to be sold without a prescription might boost patient access to medications that are typically underused, especially by patients who don't have health insurance, experts said.” Read the article

Drug-resistant TB code sequenced by South African scientists (posted 15 November 2007)
The entire genome of a strain of extremely drug-resistant Mycobacterium tuberculosis (XDR-TB) has recently been sequenced by South African scientists, who hope the information will contribute to developing better diagnostics and treatments for the disease, according to a recent article in SciDev.Net. James Sakwa, manager of the National Genomics Platform, told SciDev.Net that the breakthrough was achieved by using "pyro-sequencing" technology, where massive amounts of information are produced in parallel. According to Sakwa, the next step will be to develop a diagnostic kit that can quickly and efficiently diagnose this strain of XDR-TB. “Currently diagnosis can take up to a month,” he says. Willem Sturm, dean of the School of Medicine and head of the research team, released a statement saying the sequencing of the genome was a major breakthrough. "The successful sequencing has, in a short space of time, now led to a focus on drug and vaccine development which will enable clinicians to treat the disease," Sturm added. Read the article

Injunction granted against new patent rule (posted 8 November 2007)
A federal court in Virginia recently granted a British pharmaceutical company’s request for a preliminary injunction to block the US Patent and Trademark Office from implementing a new rule. The blocked rule would reduce the number of times a patent applicant can contest or amend rejected or pending patent claims.

According to The Wall Street Journal, applicants could previously file an unlimited number of amendments or continuations. Under the new rules, applicants would be allowed to file only two continuations. Anything above that will need to be accompanied by an explanation justifying the request.

The pharmaceutical company’s claim to the federal court is that the proposed rules will cause it, “and other company’s like it,” irreparable harm. “Continuations are considered an important tool by patent applicants, particularly in the pharmaceuticals industry, because new information about an invention often comes to light after the initial patent application has been filed. This information can be added to the application via a continuation, allowing the applicant to retain the original filing date, which is critical in the ultracompetitive pharmaceutical and technology sectors,” reports the Wall Street Journal.

The rule was originally made so that the Patent and Trademark Office could reduce its massive application backlog. Read the article

UK ban on drug-coated stents upsets cardiologists (posted 8 November 2007)
A decision by the UK’s National Institute for Health and Clinical Excellence (NICE) to ban drug-coated stents there has angered cardiologists. Some doctors warn the ban will cost both lives and money, citing recent research indicating that drug-coated stents significantly reduce serious cardiac-events in high-risk patients.

According an article in The Daily Mail, a study conducted by Swiss investigators showed a 50% reduction in serious cardiac events, including second operations and heart attack, in patients getting drug-coated stents rather than bare metal stents. “The death rate was also lower among those in this group who got DES,” the article reports.

Drug-coated stents are tiny tubes inserted into damaged arteries. They release drugs to prevent them from narrowing, a technique that many claim is better for some patients than bare metal stents. Read the article

More challenges ahead for pharma market (posted 8 November 2007)
IMS Health, a pharmaceutical market intelligence firm, has released its annual forecast for the pharma industry. The report predicts more challenges head for the sector in the coming year. According to a DrugReseacher.com article, IMS predicts industry growth at 5%–6% over the course of 2008, a drop from the 6%–7% rate of 2007.

“The US is set to experience an all-time low in pharmaceutical sales growth over 2008 according to IMS, managing no more than 5% growth over the year,” the article says, “This figure also reflects the growth expected in the five largest European markets, with Japan forecast to grow by just 1%–2%.” Emerging markets, however, are expected to grow at a healthier rate, with markets in China, Brazil, Mexico, South Korea, Turkey and Russia expecting a 12%–13% growth rate to $85–$90bn US.

Some of the challenges facing the industry over the next year include patent expirations and loss of revenues, safety issues surrounding medicines and an increase in generics competition within the biotech sector. According to DrugResearcher, “The preparations that many companies are already making to steel themselves for the years ahead are somewhat necessary for many to be able to compete effectively in a changing marketplace.” Read the article

EU to consider Afghan opium proposal (posted 8 November 2007)
The European Parliament recently backed a proposal to divert Afghanistan’s illegal opium supply for legal use in analgesics. The proposal grants opium-producing licenses to whole villages, as long as their crops are being processed into morphine for medical purposes. To discourage illegal diversion, the entire village will lose its license if any farmer is found selling their crop to be made into heroine.

According to DrugResearcher.com, The Senlis Council, a think-tank for security and counter-narcotics issues, developed the plan as a solution to the illegal opium trade and the shortage of medical opiates, especially in developing countries. “Opium poppy accumulates the alkaloids morphine, codeine and thebaine and Afghanistan produces 93% of the opiates on the world market.”

Similar programs have been successful in India, Thailand and Turkey. There is still considerable opposition to the proposal from many sources, even though the European Parliament has given it a thumbs up. The proposal will undergo consideration by European Union foreign ministers later this month. Read the article

Stem cells may restore damaged memory (posted 8 November 2007)
The brain’s own stem cells may be able to restore memory after an injury, according to a new study involving mice. A team of researchers at the University of California, Irvine, were able to bring memories of mice, whose brains were damaged by lesions, back to healthy levels up to only three months after receiving treatment.

According to US News & World Report, the lead researcher, Mathew Blurton-Jones, said, "This is one of the first reports that you can take a stem cell transplantation approach and restore memory… There is a lot of awareness that stem cells might be useful in treating diseases that cause loss of motor function, but this study shows that they might benefit memory in stroke or traumatic brain injury, and potentially Alzheimer's disease."

The researchers injected each mouse with about 200,000 neural stem cells. The results of the research indicate that the mice who received the stem cells could remember their surroundings with the same accuracy as healthy mice—approximately 70% of the time. However, the mice that didn’t receive the stem cells still had memory deficits, including up to a 40% surrounding recall rate. Read the article

US FDA publishes Notice on the New Prescription Drug User Fee Program (posted 1 November 2007)
The US FDA has published a Notice, entitled the User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biologic Products; Request for Notification of Participation and Number of Advertisements for Review, as a result of new legislation recently passed into law on 27 September—the Food and Drug Administration Amendments Act of 2007 (FDAAA).

According to Eyes on FDA, the notice asks companies to decide whether or not they plan to participate in the New Prescription Drug User Fee Program and how many advertisements they would have reviewed under the program.

“The law creates a new user fee program for the review of DTC prescription drug television ads in advance of their airing. If you get reviewed - no Warning Letter. If you don't and you do get a Warning Letter, it can be a painful one. But FDA wants to know now how many you will be submitting so that the user fee that is going to be charged can be calculated,” according to Eye on FDA. Read the article

European drug maker to have generic biotech available by next year (posted 1 November 2007)
A European drug manufacturer hopes to have a generic anemia drug on the market by early next year. The drug maker recently said they received a ‘positive opinion’ recommending European Union approval of a generic copy of the anti-anemia drug Epogen, a blockbuster biotech used for kidney dialysis patients and cancer patients.

According to a recent Chicago Tribune article, The Committee for Medicinal Products, the European equivalent of the US Food and Drug Administration advisory panel, has cleared the way for the company to launch the drug in European countries in early 2008.

“The ‘positive opinion’ is significant because it shows regulators are getting serious about approving generic versions of expensive biotech drugs,” says the Chicago Tribune. “The U.S., however, is not prepared to approve their generic versions.”

The US Congress is currently working on a bill to allow generic competition of biotech drugs, but analysts claim the bill is unlikely to win congressional approval this year. Read the article

MHRA invites researchers to use their data (posted 1 November 2007)
U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting the research community to use valuable data that is now housed on MHRA’s General Practice Research Database (GPRD) and the Yellow Card Scheme.

Professor Sir Alasdair Breckenridge, Chairman of the MHRA said in an MHRA press release, “The potential of the data we hold at MHRA for public health research is unparalleled and I am delighted that the launch of ISAC’s first report shows that this is increasingly recognised by researchers,” and that, “Information on approved studies in the report will help more researchers make successful applications to use MHRA data in the interests of public health.”

The call by the MHRA comes on the publication today of the first-ever annual report by the Independent Scientific Advisory Committee (ISAC). Topics covered have included: genetics, research into long-term conditions, cancer, drug safety and epidemiology. The annual report also provides useful information to researchers wishing to apply for data to ensure a smooth journey through the review process. Read the article

Singapore’s biomedical output slowing down (posted 1 November 2007)
Singapore’s output of its biomedical manufacturing sector shows signs of slowing down compared to this time last year. According to data compiled by Singapore’s Economic Development Board (EDB), Singapore’s biomedical manufacturing sector contracted almost 30% over September compared to the same time last year, says a recent In-PharmaTechnologist article.

“This decline was primarily due to a significant 37.1% drop from the pharmaceutical sector, the result of a different mix of active pharmaceutical ingredients being manufactured in the country,” says In-PharmaTechnologist. The article also states, however, that “August's figures made for more encouraging reading, with pharmaceuticals showing growth of 52.6% on last year according to the EDB, driven by high value APIs that helped push the biomedical manufacturing cluster as a whole to exhibit 18.7% growth over the first eight months of the year compared to 2006.”

Over the past few years Singapore has become increasingly attractive to companies looking for a competitive location for biopharmaceutical and biotech-based activities, and has succeeded in attracting eight of the world's top pharma companies. Read the article

Pharma lends a helping hand (posted 1 November 2007)
A recent DrugResearcher.com article documents numerous recent efforts by big pharma firms to ‘lend a helping hand’ during times of crises. “Despite often attracting a barrage of negative publicity, particularly in regard to a perception of putting profits before people” says the article, “big pharma firms are still capable of showing their human side in times of crises.”

Examples of big pharma generosity listed in the article include numerous firms donating assistance—including monetary donations, medicines, food, water and tents—following a recent earthquake in Peru, as well as the efforts currently being made to offer assistance to the victims of the recent fires crises in California. Read the article

October 2007

US FDA begins requiring approval for legacy drugs (posted 25 October 2007)
US FDA has begun requiring approval for thousands of drugs that have never before had to go through the agency’s approval process. Known as “legacy drugs,” these drugs have been prescribed for at least 25 years and have a history of safety and efficacy. According to a recent New York Times article, some smaller companies see this as potentially detrimental to small drug manufacturers.

The agency began its campaign against manufactures of these unapproved drugs in June 2006, ordering companies that make products that it deems potentially unsafe to file new drug applications or take the product off the market. According to The New York Times, Peter Pitts, president of the nonprofit Center for Medicine in the Public Interest and a former FDA associate commissioner, says the issue is complicated. “Many of these drugs were grandfathered in when the current approval process was instituted,” he said.

To counter the agency’s recent crackdown on the legacy drugs, a trade group representing about 50 small to medium-size companies has submitted a bill to Congress that would create a cheaper and simpler process for gaining FDA approval. Read the article

China’s price limits concern device manufacturers (posted 25 October 2007)
China’s government will likely place strict price limits on medical devices imported into the country, following a revised rule recently released to industry. An earlier draft of the rule, issued in 2006, raised concerns with the US and European drug industry. The recent version of that draft does little to assuage these concerns, says PharmAsia News, “and appears to impose even stricter pricing controls than the earlier proposal.” According to US industry sources, China’s National Development & Reform Commission hopes to finalize the regulation by year’s end and promulgate it in 2008. Read the article

Report questions EU drug regulations (posted 25 October 2007)
A new report on EU drug regulations claims that not enough new drugs are being required by the European Medicines Agency (EMEA) to have added value to already available treatments. The report, titled, How can we regulate medicines better,” was published in the 20 October issue of BMJ.

According to Drugreseacher, the report states, "Too many drugs are approved on the basis of surrogate end points that are not valid predictors of therapeutic end points… It is easier to get to the market by proving a new product is similar to standard available treatments than by failing to show it is superior.” The report suggests that in order to overcome this issue an element of independent research should be done by non-profit organizations. Independent research currently occurs only after approval. Read the article

Companies get help as small businesses under MDUFMA (posted 25 October 2007)
According to a recent FDA News bulletin, an updated guidance document will help companies that are attempting to qualify as a small business under the Medical Device User Fee and Modernization Act (MDUFMA).

“The fiscal 2008 fee rates under MDUFMA that took effect Oct. 1 provide a 50 percent discount for small business on submissions other than 510(k) premarket notifications, 30-day notices and 513(g) requests for classification information,” the bulletin says.

The document, “FY 2008 Medical Device User Fee Small Business Qualification and Certification,” can be seen at: www.fda.gov/cdrh/mdufma/guidance/2008.pdf. Read the article

Pharmaceuticals structures more efficiently fingerprinted (posted 25 October 2007)
US FDA has approved a record 682 generic drugs in fiscal-year 2007, one-third more than in the previous year. FDA plans to speed up the review process even more for generic drugs, as the agency faces a backlog of 1,300 generic drug applications, up from about 800 a year ago.

"These applications represent a vast scope of products—and over half are still protected by patents. There is no way we could approve all of these applications," Gary Buehler, FDA director for generic drugs, told Reuters reporters on a conference call.

A request is now before the US Congress that may provide more resources to the agency to help with this increase in generic drug applications. However, the agency’s plans are, as of now, based upon its current funds and staff. Read the article

EMEA sees strong level of applications (posted 18 October 2007)
The European Medicines Agency (EMEA) continues to receive a strong level of marketing authorization applications, with the Agency receiving a total of 42 applications by mid-2007 and an anticipated 52 by the end of the year. This follows a record number of applications in 2006.

Applications for biosimiliar medicines were a significant area of growth, according to a recent EMEA press release. Eight biosimiliar applications were made in the first half of 2007, and eight more are expected by year’s end.

In a recent half-year report presented by Thomas Lönngran, EMEA Executive Director, the Agency’s Management Board highlighted two major achievements from the first half year: “One is the Agency’s progress on implementing the new Paediatric Regulation, including the successful establishment of the Paediatric Committee (PDCO). The other is the roll-out of a new data analysis system for EudraVigilance, the European pharmacovigilance data-processing network management system, to all competent authorities in the EU Member States, which has significantly improved the systems capabilities to monitor the safety of medicines.” Read the article

Drug companies urged to assess new US FDA reform bill (posted 18 October 2007)
US FDA has warned pharmaceutical companies to immediately begin assessing if their drugs are subject to the risk evaluation and mitigation strategies provisions of the FDA Amendments Act, which will become effective early next year.

The risk evaluation and mitigation strategies provisions of the FDA Amendments Act (REMS provisions) will become effective 180 days after the 27 September enactment date of FDAAA. Companies have another 180 days to submit their REMS for approval.

Industry, however, has so far been lax in its approach to developing plans, says a recent FDALesgislativeWatch article: “The agency says that only about 25 percent of 130 plan submissions received by December 2006 follow FDA guidance for organization of the materials (⁴"The Pink Sheet" March 5, 2007, p. 9).”

According to FDALesgislativeWatch, participants at a recent audioconference were warned that their pharmaceutical companies “need to immediately begin assessing whether their drugs are subject to” the REMS provisions., Read the article

China receives US FDA approval for drug exportation (posted 18 October 2007)
A small Chinese drug manufacturing company received US FDA approval for an AIDS drug this summer, a move that demonstrates the growth of China’s increasingly competitive pharmaceutical industry, according to a recent Wall Street Journal article. This approval marks the first time a Chinese company has won permission to export finished pills to the US.

According to the article, India’s generic-export industry is still significantly larger than China’s. However, China is demonstrating evidence of being on course to eventually rival India in drug exports. “Even as Chinese products are drawing increased scrutiny, the nation's generic-drug industry is gearing up for the export of finished medicines,” says the Wall Street Journal, “The industry is still small -- India's generics-export powerhouse is 10 times as big. But China is already the world's largest producer of raw materials for drugs, and manufacturing those raw materials is a steppingstone to making the completed product.” Read the article

Regulation may lead to fewer drug rep visits in US state (posted 18 October 2007)
A two-year-old Minnesota regulation on the amount of gifts pharmaceutical representatives can present to doctors may have decreased the number of visits doctors there are accepting from drug company reps. The number of visits between Minnesota primary care doctors and reps in the state has decreased by about twice the rate of decline reported by primary care doctors nationwide, according to The New York Times, citing a recent survey that tracks pharmaceutical marketing.

“Two years after Minnesota officials forbade drug makers to give doctors more than $50 worth of food or other gifts per year, drug company sales representatives there are having a far harder time marketing to doctors…the effect on drug makers has been profound,” the article says. A few Minnesota hospitals and clinics have begun banning routine or unscheduled visits all together.

Currently, Minnesota is the only state to limit gifts to doctors, but according to the article that could soon change: “New Jersey’s attorney general, Anne Milgram, who announced on Sept. 18 the creation of a task force to examine ways to limit the gifts and money that drug and device makers give doctors, said in an interview that she planned to look closely at Minnesota’s food limit.” Read the article

US FDA sees increase in generics applications (posted 11 October 2007)
US FDA has approved a record 682 generic drugs in fiscal-year 2007, one-third more than in the previous year. FDA plans to speed up the review process even more for generic drugs, as the agency faces a backlog of 1,300 generic drug applications, up from about 800 a year ago.

"These applications represent a vast scope of products—and over half are still protected by patents. There is no way we could approve all of these applications," Gary Buehler, FDA director for generic drugs, told Reuters reporters on a conference call.

A request is now before the US Congress that may provide more resources to the agency to help with this increase in generic drug applications. However, the agency’s plans are, as of now, based upon its current funds and staff. Read the article

Japan likely to continue medical device payment reductions (posted 11 October 2007)
Japan is likely to expand its practice of foreign average pricing and continue payment reductions on medical devices. The possibility of expanded reductions comes despite continued pressure by the US medical device industry, who see Japan as, “a mostly untapped market hindered by government barriers,” says a recent article in Pharmasia News.

Under foreign average pricing, if the domestic market price of a new medical device is more than two times as high as the average price in the United States, the UK, France and Germany (or 1.5 times as high for existing products), the Japanese price is reduced by up to 25%.

According to the article, Japan cut payments for medical devices by 330 billion yen, about $2.8 billion, between 2002 and 2006. Read the article

US FDA urges device manufacturers to adopt new program (posted 11 October 2007)
FDA’s electronic Medical Device Reporting (eMDR) process will soon be mandatory, the agency says. In the meantime, device manufacturers are being urged to voluntarily adopt the program before they will be required to do so, says a recent Medical Devices Today article.

According to that article: “A draft rule mandating electronic reporting is being completed within CDRH and will likely be released for public comment by February, Don St. Pierre, head of FDA's Postmarket Transformation Management Group, said Sept. 25 at the Regulatory Affairs Professionals Society annual meeting in Boston.”

Pierre noted, in the same article, that paper reports must currently be entered into FDA’s database manually ‘at great expense’. The eMDR program is intended to both help CDRH identify patterns in adverse events more effectively, as well as reduce the overwhelming number of paper adverse events reports submitted by manufacturers. Read the article

Experts divided on stem cells for failing hearts (posted 11 October 2007)
Experts are still divided on how effective stem cell injections are for treating a failing heart, according to a recent ScienceNOW Daily News article. During a recent 2-day symposium on cardiovascular regenerative medicine at the National Institutes of Health in Bethesda Md., researchers debated the future of cardiac cell therapy. “So far, the treatment seems safe,” reports ScienceNOW, “But it is not at all clear which stem cells should be given, or by what method—or, most importantly, whether patients who get them are likelier to survive.”

Cardiologists have long been approaching cell therapy as a way to prevent decay of heart muscle after a heart attack, and to restore muscle after it has died. For the most part, clinical trials have been a success in regenerating heart muscle or preventing heart attacks, according to many of the researchers. However, according to ScienceNOW, three of the four largest clinical trials have failed to indicate demonstrated improvement in what is called the ‘ejection fraction’—measured as an increase in the amount of blood pumped.

According to the article, some researchers believe it’s time to embark on a large-scale clinical trail,” to discover once and for all whether cell therapy keeps heart patients alive and improves health.” Read the article

New US drug safety bill signed into law (posted 4 October 2007)
A new drug safety bill, recently signed into law by President Bush, grants FDA more power over the safety of prescription drugs, says a recent Associated Press article. The legislation, according to The Associated Press, will shift FDA’s attention away from experimental drugs pending approval and more toward those already on the market, giving the agency more power to act when worrisome problems arise. The Food and Drug Administration Amendments Act of 2007 renews for five years programs to collect fees from drug and medical manufacturers. According to AP, “FDA will be able to fine drug companies for not completing follow-up studies on their drugs after they’ve won government approval. Those studies frequently remain undone, often leaving important safety questions unanswered.” Read the article

EMEA releases guideline on excipients (posted 4 October 2007)
The European Medicines Agency (EMEA) recently released a final guideline on data submission requirements for excipients in marketing authorization applications that exempt products currently in the clinical stages of development. According to FDA News, the bulletin states EMEA recommends “firms consider the principles in the guideline during the development stages of drug candidates.”

In addition to exempting drugs in the clinical stages of development, EMEA also modified a section from the earlier draft guideline concerning the use of antioxidants and antimicrobial preservatives, adding a recommendation that “the concentration of such preservatives in pharmaceuticals should be at the lowest feasible level.”

According to FDANews: “In explaining that both antioxidants (used to improve the stability of medicines) and antimicrobial preservatives (used to prevent microbial proliferation) are usually harmful to living cells, the EMEA says that use of such agents should be avoided whenever possible, particularly in pediatric formulations.” Read the article

British research teams receive funding (posted 4 October 2007)
The Bioprocessing Research Industry Club (BRIC) has issued new funding to research teams at British universities. BRIC is awarding ₤3.5m ( $7.13m US) to eight projects at seven universities, says BiopharmaReporter.com, in the hopes it will help, “develop faster and more efficient development and manufacturing processes for biopharmaceuticals.”The eight universities receiving funding are: The Universities of Birmingham, Imperial College London, Manchester, Newcastle, Sheffield and Strathclyde. This is the second of a projected three rounds of investments. According Biopharma Reporter, the first investment of ₤ 5m ( $10.18m US ) was made a year ago, to nine projects at ten universities. The third and last round of investments will be announced next month, and is expected to be of a similar amount as the previous two. Read the article

September 2007

Generic biotech drugs won’t be in new drug-safety legislation (posted 20 September 2007)
Senior lawmakers considering new drug-safety legislation have decided not to include a measure allowing cheaper copies of biotech medications after the measure met opposition from House members, says a recent article at Bloomberg.com. The drug-safety legislation is expected to be considered by the US Congress later this month.

The provision on generics is “off the table,” Michael Mahaffey, a spokesman for the Senate health committee Republicans, said in an interview with Bloomberg. “There's a widespread general agreement that's something they'd take up another time.”

Generic versions of conventional drugs made through chemical synthesis are regularly approved by FDA, however current law does not allow the routine approval of copies of biotech drugs. Biotech companies say their complex products cannot be simply copied without risking dangerous side effects. Read the article

European Commission seeks extra funding for “Eurostars” (posted 20 September 2007)
The European Commission hopes to raise €800m in extra funds for research-performing small and medium-sized enterprises (SMEs) across Europe, through a new program called Eurostars, says a recent article by DrugResearcher According to this article, Eurostars is designed to finance new partnerships between research and development (R&D) SMEs and the 27 EU Member States. Commissioner Janez Potočnik is quoted in the article. "Creating strong links between public and private funding, Eurostars will give a boost to R&D performing SMEs, allowing them to collaborate with the best research teams in Europe, and to transform new ideas into successful businesses," says Potočnik.

The EC will contribute €100m to the program with an additional €300m invested by the countries themselves. According to the EC, this will eventually mobilize up to €400m in extra private funding. The EC’s goal is to make participating countries pool their national research funding in favor of SMEs, which they believe will result in more efficient use of funds.

According to DrugReseacher, “SMEs represent 99 percent of all enterprises in Europe and their small size, flexible organisation and commitment to research allows them to take advantage of a fast-changing economic environment, seize new market opportunities and create new jobs.” Read the article

FDARA likely to have major impact on drug development (posted 20 September 2007)
The Food and Drug Administration Revitalization Act (FDARA) is likely to drastically change both the manner in which companies seek FDA approval as well as support marketed products with further research, according to a recent article. FDARA is a “once-in-forty-years” overhaul of FDAauthority, says Cole Werble in The RPM Report. According to this article, the act will bring the FDA’s drug safety activities “back up to par with the agency’s focus on drug efficacy.”

Separate versions of the act were passed by the House and Senate during the last four months and are currently being forged into one bill in pre-conference discussions. During a 12 September briefing on drug safety in Washington, DC, former FDA commissioners pointed out two major changes they saw resulting from FDARA.

The first of these involves Phase IV, strategic research. The new public-private postmarketing surveillance project featured in FDARAA will change the dominance of Phase IV by drug sponsors, says Mark McClellan, MD, who was the first FDA commissioner in the George W. Bush administration (2002-2004). The “postmarketing period will move out of the control of the pharmaceutical industry,” says McClellan.

The second fundamental change involves “faster NDA/BLA approvals for narrow, precise indications.” According to David Kessler, MD, FDARA offers “a form of tighter safety controls through risk management plans and postmarketing surveillance that could represent a new version of conditional approval.” Kessler was FDA commissioner under George H.W. Bush and Clinton (1990-1997). Read the article

China’s first center for food and drug safety officially open (posted 20 September 2007)
China’s first center for food and drug safety officially opened 28 August. Shanghai’s new Safety Research Center for Food and Drugs will focus on research regarding food and drug safety policies, as well as the administration’s supervision mechanism, says a recent PharmAsia News article. The article interviewed Chen Yizhen, superintendent of the Shanghai Food and Drug Administration (FDA) Science and Technology Information Institution and deputy director of Shanghai FDA. Chen states that every year hundreds of research projects are carried out by different FDA departments. The new research center has been established to manage this research and solve problems in a more efficient manner.

The new research center will, according to Chen, provide “a platform to conduct further research on governmental policies and consolidate all the loose research conducted previously,” says PharmAsia News.

Shanghai has four other FDA institutions in addition to the new research center. The other four institutions include three inspection institutions and one evaluation institution. The new research center will “focus research on the policies and supervision administration, while the other institutions will focus on the technologies and methods used during the inspection and supervision,” says Zhang Renwei, a doctor at the research center. Read the article

FDA and Gene Logic to collaborate on standards for genomics (posted 20 September 2007)
FDA and Gene Logic will collaborate to share quality control methods and metrics for genomic data submissions to the agency. Because there are currently no federal or industry standards for genomic data assessment, the purpose of this collaboration is to develop a set of standards for genomic data sent to the regulator, according to a recent DrugResearcher article.

"Currently there are no industry standards in place for microarray data submission to the FDA, and projects focused on understanding the QC issues will help drive the development of baseline standards for the submission of microarray data to the FDA in the future," a senior FDA official is quoted in the article saying.

The collaboration is a part of FDA’s Critical Path Initiative, an effort to stimulate the use of new scientific and technical methods, intended to “improve the predictability and efficiency of drug development from laboratory concept to commercially approved medicines,” says BusinessWire. The results of the collaboration will be released publicly as an initial step towards formulating industry-wide standards for genomic data submissions to FDA. Read the article

Related resource:

• FDA and Gene Logic to set genomic industry standards

China announces pharma reforms (posted 13 September 2007)
In a continuing effort to improve its pharmaceutical industry, China’s State Food and Drug Administration (SFDA) has announced target areas of reform, which include both increasing the number of staff at injectable drug products production sites and tightening regulations on wholesalers and distributors of pharmaceutical ingredients, says a recent article at BioPharma Reporter.

SFDA plans to emphasize scrutiny on parenteral drug manufacturing. “Injectable drugs are particularly sensitive to contamination and carry greater safety risks than drugs delivered by other methods and so the agency said it plans to take particular care to ensure that the formulation and ingredients and production techniques for these drugs adhere to good manufacturing practice (GMP),” reports BioPharma Reporter.

The agency will also review the licenses of any pharmaceutical ingredient wholesaler or distributor that began operating in 2006, carefully monitoring those supplying highly restricted substances. In addition, SFDA will conduct on-site inspections of all drug products for which marketing applications were submitted and/or approved between January and August 2006. Read the article

US panel urges “fundamental change” in import monitoring (posted 13 September 2007)
A US panel on import safety has called for a “fundamental change” in import monitoring. These proposed changes, proposed by the Bush Administration panel, urge government agencies into greater collaboration on monitoring the riskiest products, according to The Washington Post.

The panel, headed by Health and Human Services Secretary Michael Leavitt, produced a 22-page report that “identified deficiencies including ‘siloed systems, ’ -- in which the various federal and state agencies used computers and other automated systems that were not integrated and could not share data,” reported The Washington Post. The article reports that the main parts of the new strategy are “to ensure U.S. government agencies who share authority over food safety collaborate and use interoperable computers; to boost accountability, enforcement and deterrence; and to promote the use of the newest technologies and science”

The panel also recommended implementation of the 2006 Security and Accountability for Every Port Act, requiring all 34 federal agencies with authority over imports to build a "single window" check system by 2009. The report is currently undergoing a 60-day review period. Read the article

Related resource:

• Full report (pdf-2MB)

Hybrid embryo research allowed in UK (posted 13 September 2007)
UK’s Human Fertilisation and Embryology Authority (HFEA) has agreed to allow Cytoplasmic Hybrid research there on a case-by-case basis, approving—but tightly regulating—the research. Moving forward eight months after debate on whether or not to allow the research began, HEFA’s decision specified that all planned research project must first be deemed “necessary and desirable” before being authorized, says Drug Researcher.

"This is not a total green light for cytoplasmic hybrid research, but recognition that this area of research can, with caution and careful scrutiny, be permitted," said a HFEA, statement. "Individual research teams should be able to undertake research projects involving the creation of cytoplasmic hybrid embryos if they can demonstrate, to the satisfaction of an HFEA license committee, that their planned research project is both necessary and desirable… [as well as being] likely to lead to scientific or medical advancements."

According to Drug Researcher, “The real need for such research is the shortage of human embryos left over from fertility treatments, from which stem cells can be generated.” Read the article

No serious problems in tissue recovery industry (posted 13 September 2007)
A study to evaluate how well the tissue recovery industry follows FDA regulations found no serious problems, according to a report by the agency’s Human Tissue Task Force (HTTF). Providing human tissue for transplants is a growing and increasingly complex industry. The HTTF was set up in August 2006. According to a recent article in Medical News Today, last year’s discovery of two companies that were breaching regulations and potentially putting recipients at risk prompted the study. However, earlier this year, FDA’s Office of Regulatory Affairs (ORA), “carried out a ‘blitz’ inspection of 153 major human tissue recovery companies between last October and March this year. They found some minor irregularities but none that would put transplant recipients at risk.”

According to Medical News Today, “The HTTF's report makes several recommendations for tightening up compliance to the new regulations, help the agency better understand what is going on, and develop guides and plan future inspections.” Read the article

Biotech industry among those most affected by new US patent rules (posted 6 September 2007)
New rules being implemented by the US Patent and Trademark Office will have an adverse effect on biotechnology companies seeking to protect their inventions, says FDAlegislativewatch.com. Currently, applicants are able to file an unlimited number of patent continuation applications. However, the new rules will limit the number of continuation and continuation-in-part applications an inventor can submit. Applicants who submit more than the proscribed number of any of these applications will also need to document why the information could not have been included in an earlier submission.

Patent applicants will be allowed to submit two continuation or continuation-in-part applications, and also be limited to one request for continued examination of a patent. According to FDAlegislativewatch.com, “Since biotech companies file the largest number of these applications, which add new claims or disclosures to an original application, they will be among those most affected by the new policy.” Read the article

Pseudoephedrine drugs retain their OTC status in UK (posted 6 September 2007)
Despite tighter controls on cold and flu remedies containing pseudoephedrine and ephedrine by UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the drugs will still retain their over-the-counter (OTC) status in UK. Earlier this year, health authorities consid, ered tackling the problem of OTC ephedrine- and pseudoephedrine-based drugs being used in the production of the Class A controlled drug methylamphetamine (crystal meth), by reclassifying them as prescription-only. However, according to in-Pharmatechnologist.com, “A decision to reclassify to prescription-only was described by pharmaceutical industry professionals at the time as a "disproportionate response to the problem" and could have a variety of impacts, including a drive by manufacturers to reformulate products to stay in the OTC game, which could be an expensive and risky process.” The MHRA has decided to retain the OTC status of these drugs, with the following amendments: package sizes will be restricted, there will be an imposed limit of one pack per customer, and a recommendation that sales of the drugs be limited to pharmacists, says in-Pharmatechnologist. “The MHRA also announced the legal status of the products would be reclassified to prescription-only in July 2009 if the current measures to be implemented did not control the risk that the drugs could be misused.” Read the article

Study reveals no increased death risk with drug-coated stents (posted 6 September 2007)
After evaluating the health risks of drug-coated stents, researchers at Sweden’s Uppsala Clinical Centre concluded the devices are not dangerous to patients, but should be used selectively.

The new research was conducted in response to major concerns raised last year suggesting that patients treated with the stents were more likely to develop potentially fatal blood clots months or years after their surgery.

According to CNNMoney.com, the recent follow-up study does not indicate, “an increased risk of death compared with bare-metal stents,” but it does suggest that “the benefits of these devices are limited and that the risk of developing blood clots remains.” Read the article

First individual human genome decoded (posted 6 September 2007)
Dr. J Craig Venter’s research team recently announced it has decoded a new version of the human genome. Some experts believe this new genome is an improvement over the human genome project completed in 2003 by a government-financed consortium of academic centers. “The consortium’s genome, thought immensely useful to biologists,” says the New York Times, “was full of gaps and only complete in the sense that it was the best that could be done with existing technology.” According to a recent Agence France-Presse(AFP) article, the earlier efforts at decoding the human genome “were flawed and greatly underestimated genetic diversity…because the whole had been assembled from a hodgepodge of DNA taken from several individuals.”

The main difference between the consortium’s genome and Venter’s, says the New York Times article, is that the consortium project came from a group of people from different racial and ethnic backgrounds and comprised only half the DNA contained in a normal cell, while Venter’s research reveals the first individual genome ever sequenced—his own. “Venter’s research indicates that in 44% of Venter’s genes, the copies from his mother differ from those inherited from his father,” the article says. These findings overturn a previous assumption in the scientific community that all human begins are 99.9% identical.

The research has sparked some controversy among ethicists who question the possible abuses that may occur once the coding of individual genomes makes personal health information more easily accessible. Venter, however, believes the benefits outweigh the risks, and that the information provided will be at most only an indicator of risk. “The genome is far from perfect,” says CNN, “[Venter] doesn't see it as an absolute, but rather as a clue. It's an indicator of risk, but not a certainty. For example, Venter has a normal risk for skin cancer, but still he recently battled melanoma.” Read the article

Related Resource:

• First individual human genome decoded
• In the Genome Race, the Sequel Is Personal

August 2007

Drug launches must localize to find global success (posted 30 August 2007)
New research indicates that pharmaceutical companies that customize the promotion of new drugs to the nuances of individual countries have greater success on a global scale than companies that do not adapt to local markets. IMS Health, a Connecticut-based research firm, recently examined 4,225 drug launches in an effort to better understand what it takes for a pharmaceutical company’s drug launch to be successful on a global scale. Of the 4,225 drug launches, only 35 managed to become first or second market leaders within two years, in two or more countries, says CNNMoney.com. The research indicates that to achieve a successful launch of a blockbuster drug, “the sales force must understand the nuances of different countries and customize its promotion to match international health plans.”

According to CNN Money, the IMS Health study identified the most successful drug launches of all time as: Pfizer Inc.'s cholesterol-lowering Lipitor and sexual dysfunction drug Viagra, GlaxoSmithKline's diabetes treatment Avandia, Eli Lilly & Co.'s anti-psychotic Zyprexa and Merck & Co. Inc.'s osteoporosis drug Fosamax. According to the same study, raising awareness in doctors and patients is essential to a drug’s success, “These drugs took over various markets by making them bigger, not just by taking over market share in stagnant industries,” the article states. Read the article

European Commission wants more info about nanotech (posted 30 August 2007)
The European Commission’s 2006 report on the potential health risks of nanotechnologies has been rewritten at the request of the EC in an effort to make the subject more understandable for both the food industry and the public. The original report stated that new risk assessment methods are needed to assess the properties of nanoparticles. Greenfacts, which specializes in making scientific reports comprehensible to laymen, told Food Productions Daily that, “the original document was written for scientists. We have rewritten it to bring the subject into a wider domain.”

The EC requested the rewrite after the original report’s summary indicated that industry players and consumers need to better understand the subject of nanotechnology because it will have a giant impact upon the food industry. According to Nutraingredients.com, in a report published last month, “the consultancy Helmut Kaiser said that the nanotechnology food packaging industry could be worth as much as €22bn ($30bn), based on current market value estimates, while some estimates said the market could be worth €740bn ($1tn) by 2013.”

Nanotechnologies are currently being used by the food industry to improve , the quality of packaging materials; however, “The report stated that new risk assessment methods are needed because chemicals in their nanoparticle form have potentially very different properties than their larger physical forms,” says Nutraingredients.com. The original report by the EC, Themodified Opinion (after public consultation) on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies, claims more research is needed about the potential human health risks of nontechnologies. Read the article

FDA considers outsourcing some jobs (posted 30 August 2007)
A decision is expected next month as to whether FDA will outsource hundreds of jobs to private companies. A recent Washington Post article indicates that FDA is reviews over 300 positions, “to determine whether could be performed cheaper and better by the private sector.”

The National Treasury Employees Union is urging Congress to oppose the agency’s plan. Colleen Kelly, the union’s president, is quoted in the article saying, “It is a disgrace given the recent crises we experienced with our food supply and other imports.”

FDA spokesman Chris Kelly told Washington Post that only administrative jobs not directly involved in food-safety inspections are under review. These jobs are classified as “commercial” and do not have to be performed by government employees.” Read the article

First US based cell-derived flu vaccine plant being constructed (posted 30 August 2007)
The first ever cell culture-derived flu vaccine plant in the United States is currently being constructed in North Carolina. The Novartis manufacturing facility, expected to be completed in 2009 with initial vaccine production in 2011, will be capable of producing 50 million doses of seasonal trivalent flu vaccine and up to 150m doses of monovalent vaccine.

Novartis’ investment in the site was funded in part by a 2006 multi-million dollar grant from the US Department of Health and Human Services (HHS), says DrugResearcher.com, “The HHS's aim is to be able to domestically produce 600 million doses of flu vaccine within six months of a pandemic outbreak declaration - a quarter of which could come from the Novartis facility.”

According to a recent DrugReseacher.com article, cell-based systems like the one being constructed by Novartis may be the potential future of vaccine manufacturing, “shunning the traditional yet cumbersome egg-based manufacturing techniques.”

According to the Center for Infectious Disease Research & Policy (CIDRAP), HHS cited several advantages of using cell-culture technology instead of egg-based to make flu vaccines: “Viruses don't need to be adapted to grow in eggs, and manufacturers can freeze cells in advance and then thaw and grow them in large volumes in the event of a shortage or pandemic. Also, the method is safe from certain risks associated with egg-based production, such as the chance of eggs being contaminated by various poultry diseases. Finally, cell-based vaccines could be used by people who can't receive the currently licensed vaccines because they are allergic to eggs.” Read the article

Related Resource:

• HHS funds development of cell-based flu vaccines

FDA proposes new rating system for sunscreens (posted 30 August 2007)
FDA has proposed a new rating system for alerting consumers about a sunscreen’s effectiveness in blocking UVA rays. FDA says this is necessary because most commercial sunscreens currently screen out only ultraviolet B (UVB), overlooking the fact that ultraviolet A (UVA) also increases skin cancer risks and skin aging. The new rating system would alert consumers about a sunscreen’s effectiveness in blocking both forms of UVA rays.

According to a recent Washington Post article, “The agency has long been looking into making recommendations on UVA protection, Dr. Douglas C. Throckmorton, the deputy director of FDA's Center for Drug Evaluation and Research, said during a mid-afternoon teleconference. Only now has the agency settled on which tests it will accept for rating UVA protection, he said.”

The new system is now undergoing a 90-day public comment period before being published. The appearance of any new labeling is not expected to occur until 2009 at the earliest. Read the article

Poland trying to increase market potential for trials (posted 23 August 2007)
Poland’s clinical trials market is expected to grow 10-12% this year, says Polish market research firm PMR, according to in-Pharmatechnologist. For the past few years, pharmaceutical companies have been gradually moving toward conducting clinical trials in emerging markets, rather than in Western Europe and the US. Central Eastern European Countries like Russia and Poland are becoming increasingly attractive emerging markets, “with relatively close proximities to the West, along with treatment-naïve populations of a Caucasian gene pool,” says in-Pharmatechnologist.

While Poland holds potential, “excessive red-tape, bureaucratic chaos and no standardized requirements for trial documentation,” were commonly listed as concerns in the PMR study. The most commonly cited deterrent is Poland’s “cumbersome process for registering a trail with the Central Register of Clinical Trials (CEBK).”

However, the article indicates CEBK has since taken steps to streamline and simplify the registration process: “One particular improvement in the legislation, according to PMR, is the fact that clinical trial applicants will not be obliged to submit copies of contracts confirmed by a notary, which were dubbed by survey participants as an ‘unnecessary bureaucracy.’” Read the article

Report examines decrease in FDA drug approvals (posted 23 August 2007)
FDA has been increasingly reluctant to approve new drugs, according to a report on the decline of new produ