Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. In addition to offering her support for PDUFA V, Hamburg also discussed renewal of legislation for promoting pediatric drug testing, the need of FDA to invest in science and innovation, and the agency’s efforts in confronting the continual challenges of globalization. In tackling globalization, a basic question arises: does the United States face a pharmaceutical manufacturing disconnect?

In her testimony, Hamburg offered numbers to show the FDA’s record in reviewing applications for new drugs. In fiscal year 2011, FDA approved 35 new drugs, and almost 70% of these drugs were approved by FDA before any other regulatory agency, including the European Medicines Agency. Of 57 novel drugs approved by both FDA and the European Union between 2006 and 2010, 43, or 75%, were approved first in the United States. Preliminary data show that in 2011, over half of all new active drug substances were first launched in the US.

Although Hamburg offered these numbers to show the agency’s record in approving new drugs, they offer another important insight: namely, the US is an important source and market for drug innovation and pharmaceuticals. The US is the largest national market for pharmaceuticals, accounting for 36%, or $310.6 billion, of the $856 billion global pharmaceutical market in 2010, according to data from the IMS Institute for Healthcare Informatics. The top five EU markets (United Kingdom, France, Germany, Italy, and Spain) accounted for 17%, or $147.4 billion, in 2010. Emerging pharmaceutical markets, which include the BRIC countries (Brazil, Russia, India, and China) and 13 other emerging markets collectively accounted for $150.5 billion, or nearly 18%, of the global pharmaceutical market in 2010, according to IMS.

The data reveal the attractiveness of the US for launching new drugs and marketing existing drugs, but when it comes to manufacturing drug products or active ingredients, the US falls short. Approximately 40% of the drugs consumed in the US are manufactured outside the US, and up to 80% of the APIs in those drugs come from foreign sources, noted Hamburg in her testimony.

In her testimony, Hamburg outlined FDA’s efforts to deal with this increased globalization. In July 2011, FDA published a special report, “Pathway to Global Product Safety and Quality,”  a global strategy and action plan for the agency to more effectively oversee the safety of all products that reach US consumers. As detailed in the plan, over the next decade, FDA will focus on strengthened collaboration, improved information- sharing and gathering, data-driven risk analytics, and better allocation of resources through partnerships with counterpart regulatory agencies, other government entities, international organizations, and other key stakeholders, including industry.

Although these efforts by FDA are important and necessary from a public health and safety perspective, the underlying fundamentals engender a larger public policy question beyond the scope of FDA’s regulatory strategy. In a competitive global economy, what should the US be doing to encourage, cultivate, and retain domestic manufacturing of drug products and APIs? In this election year, debates over how to stimulate economic and employment growth are center stage, but what is noticeably absent is a focused plan to stimulate growth in the bio/pharmaceutical industry, a coveted source of high-technology, science-based innovation. That is one debate that is certainly worth having and one that hopefully will be had.

In response to off-label inquiries about a drug, biopharma companies can use the kind of boilerplate they’ve been inserting on social media sites for years – thanks for your comment, here’s our contact information, call us for more information – but they cannot address the question publicly, where it appears, a privilege many hoped would be included in FDA’s long-promised and long-awaited social media guidelines. Companies must also include a “mechanism for providing readily accessible current FDA-required labeling,” but cannot include a link to anything that could be construed as promotional, like a “product website, product promotional materials, firm websites, or third-party websites.” Guidance on responding to unsolicited requests for off-label information was published in the Federal Register a few days before the end of 2011.

Responding to an unsolicited off-label question/comment is only appropriate when a specific brand is named, and if the question is “broad in nature,” drug companies should “appropriately narrow the question.” FDA recognizes the fact that companies are “capable of responding to requests about their own products in a truthful, non-misleading, and accurate manner,” and that companies probably know more about their own products than other self-appointed responders:

It can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are made in public forums, especially since other responders may not provide or have access to the most accurate and up-to-date medical product information.

Unlike other forum responders, who can comment publicly in response to any question, manufacturers must wait for the original commenter to respond to the boilerplate message with contact information, before providing “any substantive communication about off-label uses for the product, in response to the original unsolicited off-label question,” and that communication must occur “solely between the firm and the individual who made the request…the firm should not make its detailed response with off-label information publicly available within the same forum.”

FDA’s guidance on industries’ social media interaction with patients, at least with respect to off-label inquiries, seems to be: Don’t participate publicly. According to the guidance document, this sentiment reflects a concern that publicly posted off-label information – in response to an unsolicited query – would be available for an indefinite period of time, and would also reach the eyes of readers who have not requested such information. Even if the drug information is accurate when it’s posted, it may not be accurate next month. For viewers who didn’t ask about an off-label use, but are still party to a public response, the information itself, regardless of its scientific merit, “may promote a product for a use or condition for which FDA has not approved or cleared.”

Those companies that would like to respond to an individual with a question, assuming that person has called or emailed the company in response to the provision of contact information – contact info that leads to a firm’s medical or scientific department, not a marketing department, the guidance clearly states – should include the following materials, according to the document:

• FDA—required drug label
• A prominent statement saying the product has not been FDA approved
• A prominent statement disclosing approved indications, if any
• A prominent statement of all important safety info, including box warnings, if any
• A complete list of references for all of the information disseminated in the response (firms should use peer-reviewed articles whenever possible)

Companies should also maintain the following records about off-label responses:

• The nature of the request for information, including the name, address and affiliation of the requestor
• Records regarding the information provided to the requestor
• Any follow-up inquires or questions from the requestor

The guidance is open for comment for 90 days. Here’s the Federal Register entry.

FDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s lower levels of approvals—21 drugs in 2010 and 25 in 2009—caused concern throughout the industry and in Congress. We may feel grateful to FDA, but we also should ask how the agency achieved this high number of approvals.

One technique was accelerated approval for drugs to treat serious diseases. This authority allows the agency to approve a drug based on clinical data showing that it is reasonably likely to have a clinical benefit, even if data do not demonstrate that the drug has this benefit. Almost half of the newly approved drugs received Priority Review because they had the potential to offer major advances in treatment, or because no adequate therapy existed. FDA sets a six-month target date to review such drugs.

Although these changes in procedure are well-intentioned, we may legitimately ask how they will affect patients’ safety. After all, GSK’s diabetes drug Avandia received fast-track approval, but an article published in The New England Journal of Medicine later linked the drug to an increased risk of heart attacks. The Wall Street Journal notes that a Senate Finance Committee report last year accused the company of hiding data showing Avandia’s cardiovascular risks, and GSK has just agreed to pay the US government $3 billion to settle this and other claims.

Creating a short timeline for drug approval could hurt the agency’s reviews of clinical data. FDA approved Pfizer’s smoking-cessation drug Chantix after an accelerated priority-review process. The agency concluded that the drug did not increase the risk of psychiatric problems such as depression. But researchers from Wake Forest Baptist Medical Center found that Chantix was eight times more likely to result in suicidal behavior or depression than nicotine-replacement products. One reason for the discrepancy could be that, unlike FDA, the researchers performed disproportionality analysis on the data—a technique that is increasingly being used to find links in side-effect data that normally escape detection in clinical trials.

FDA’s staff includes well-vetted and experienced scientists, but they need sufficient time to work thoughtfully and thoroughly. Even though the agency’s initiative has increased the number of new-drug approvals, it may also be increasing the risk that a company can hide negative data from regulators, or that the agency’s own analyses will not be as complete as they could be. In light of the problems with Avandia and the conflicting studies about Chantix, I think FDA should review its efforts to promote innovation to be sure that the agency maintains high standards for drug safety.

Erik Greb

A routine monthly inspection carried out by the Food and Drugs Administration (FDA) authorities in the state of Maharashtra, India, last month noted an increase in the number of sub-standard drug samples raising apprehensions about the availability of safe and genuine drugs in the state.
Officials pointed out that 26 drug samples were found to be spurious, compared with the 16 samples that were not-of-standard quality detected in May and 20 in April. Reportedly, some Ampicillin and Amoxycillin formulations did not have any active ingredients, while others had 6% to 30%. Thiamine tablets with Vitamin B1 and diclofenac sodium, Paracetamol and Magnesium Trisilicate tablets were also found to be sub-standard, officials said.

While some of the offenders are well-known drug manufacturers (like Alkem Laboratories for omeprazole capsules and Venus Biosciences for Odicin-200), many are small drugmakers, such as Affy Pharma for levocetirizine tablets, Medipol Pharmaceuticals India for clauvmentin dry syrup, Endolabs for paracetamol tablets, Softsule for DIAX OD, Therachem Laboratories for Metflox, Medopharm for Miliclav dry syrup/ amoxycilin and potassium CLA.S, Biocin Healthcare for Thyomin tablets and Nuclotec Remedies for Digizyme syrup.

Sub-standard drugs from India has been a major issue for some time now, though the FDA says its crackdown has ensured a significant drop in the number over the past six months.* In a bid to further counter the spurious drug menace, as of next month, India has also made it mandatory for all pharmaceutical exporters to send their shipments under a trace-and-track surveillance system.

The move will not only pose a hurdle to domestic spurious drug manufacturers , but will also counter drug manufacturers in countries like China who pass off their fake medicines as Indian products. A sizeable number of fake drugs seized in the other countries carry a ‘Made in India’ label, though there is ample evidence that they could be actually made in other countries.

The European Union has also decided to not seize Indian drug dispatches that use Europe as a transit point. According to a new understanding between India and the EU, none of the customs authorities in the 27-nation EU bloc will confiscate any drug dispatches meant for third country destinations like Latin America or Africa. Earlier, some of the EU customs authorities, mainly the Netherlands and France, had confiscated several Indian off-patent generic drug consignments going to Brazil via European ports over alleged infringement of EU intellectual property rights (IPR). Protesting the action, India and Brazil filed a case against the EU in the World Trade Organization. Though this case is related to alleged infringement of IPR, it brought to the fore the issue of sub-standard drugs. Indian pharmaceutical exports total about $10 billion per annum, comprising mainly generic drugs. The government wants to raise these exports to $25 billion over the next three years. Actions like the seizure of drug consignments in the EU ports or charges of sub-standard drugs imported from India can well derail the whole process.

In its continued effort, the government has appointed Karnataka drugs controller B.R. Jagashetty to spearhead a sub-group on spurious and adulterated drugs. The group will support the Task Force constituted to formulate a long-term policy and strategy for strengthening the drug sector in the country.
The government also plans to provide financial assistance to small drugmakers to upgrade their manufacturing plants to World Health Organization standards, effectively tackling the root of the problem.

* Through a special congressional appropriation in the 2008-2009 federal budget, the FDA was given funds to open a series of permanent liaison offices abroad. These include two in India, located in Mumbai and New Delhi. The others are in China [Beijing, Shanghai, and Guangzou] Latin America [Santiago, Mexico City and San Jose, Costa Rica], Africa [Pretoria], the Middle-East [Amman] and Europe [Brussels].

But the single most effective tool in the Bad Ad program’s toolkit, according to Arnie Friede, principal at Arnold I. Friede & Associates, and a former associate chief counsel at FDA, is fear. Or rather, in terrorem, a “Latin term that lawyers use” to mean frightening someone into compliance, says Friede.

When the program launched, FDA Commissioner Margaret Hamburg sent an explanatory letter to “more than 33,000” physicians, a fraction of the roughly 972,000 physicians in the US. Sales force management and reps themselves will have to decide if they are willing to play Russian roulette with a physician who may or may not be an informer. “FDA is trying to create the perception that the rep doesn’t know if the doctor is or is not a friend,” says Friede. “Accordingly, reps should be on the straight and narrow.” For FDA, the conversation between a rep and a doctor is one of the hardest areas to regulate efficiently, according to Friede. Creating in terrorem means prevention, he says.

Concerns about the Bad Ad program being abused by competing brands seem to be unfounded. According to FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC), only 4% of the complaints that came in since last May were anonymous. Friede says complaining to DDMAC about competing brand messages is not something new, to be facilitated by the Bad Ad program. “There are plenty of channels for competitive complaints with DDMAC,” says Friede. Companies wishing to complain about marketing materials anonymously can simply do it through a law firm, Friede says, adding that “people that live in glass houses shouldn’t throw stones.”

Of the 328 submissions to the Bad Ad program, 188 came from HCPs, 116 from consumers, and 24 were submitted by industry representatives. The program will be expanded this year, according to DDMAC, to include a “web-based continuing education program,” and a new focus on med students and early career HCPs. FDA will also seek collaborations with medical, pharmacy and nursing schools to “enhance student education.”

The new “Office of Drug Security, Integrity & Recalls (ODSIR)” will “take the lead in dealing with issues such as supply chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls,” Woodcock wrote in the memo. Organizationally, the ODSIR division will be housed along with three other divisions under the Office of Compliance. As a result, the Office of Compliance will be turned into a “Super Office,” meaning it houses subordinate offices.

Woodcock tapped Deb Autor, director of the compliance office, to lead the super office. Autor is behind FDA’s efforts – beginning in 2006 – to eradicate unapproved products from the market.

“The drug industry we regulate has become a global enterprise, and our mission of ensuring the safety, quality, and integrity of drugs for the American people has become an increasingly complex challenge,” Woodcock wrote in the memo.

Earlier this month, FDA released a five-year, forward-looking strategic priorities report—“Responding to the Public Health Challenges of the 21^st Century”—that outlines what the industry plans to accomplish between now and 2015. “It’s no secret that FDA’s responsibilities have increased significantly over the past several years,” says the report. “We will address these challenges and aim to fulfill our mission by embracing innovation and actively pursuing partnerships with federal, state, and local agencies; international authorities; academia; non-government organizations; and the private sector.”

Five key priorities are discussed in the report:

1. Advance Regulatory and Science Innovation

The report defines regulatory science as “the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, and performance of FDA-regulated products.”

“Recent innovative breakthroughs in science and technology … have the potential to transform our ability to prevent, diagnose, and treat disease,” reads the report. Such advancements could lead to more personalized medicine, while advances in research and information technologies can lead to more successful preventive health initiatives.

The report calls for a “robust regulatory science program” and recognizes that FDA needs to foster innovation and actively participate in research initiatives. FDA will focus on implementing a plan “for expanding and modernizing the field of regulatory science within the agency,” so that regulatory science does not fall behind the rate of medical innovation.

2. Strengthen the Safety and Integrity of the Global Supply Chain

The rapid increase of globalization has raised new challenges for the industry and for FDA. Among those challenges, according to the report, are: increasing volume and complexity of imported products; a patchwork of foreign, federal, and state oversight of product safety, grater opportunities for fraud; greater risk of national security threats; and a lack of accountability at any one stop on the supply chain. An increase of contaminated foods and other international scares have served as sufficient warning and “forced FDA to reevaluate its approach to supply-chain safety,” according to the report. “The growing challenges of globalization have far outstripped the FDA’s resources for inspection and quality monitoring, and the inability to maintain adequate oversight means potential risk to consumers grows every year.”

The solution, according to FDA, is to focus on prevention of globalization-related problems, by requiring more information about supply-chains and closer monitoring throughout a product’s life cycle. The report calls for closer collaboration on the foreign, federal, and state levels, including a new “global alliance of regulators” that would provide early indicators of supply chain threats and problems.

3. Strengthen Compliance and Enforcement Activities to Support Public Health

“FDA enforcement actions affect not only the manufacturing and distribution of food, drugs, biologics, medical devices, tobacco, and cosmetics, but also their development and marketing,” says the report. “Enhancing FDA’s compliance and enforcement programs will strengthen the agency’s focus on preventing problems and responding rapidly when violations occur.”

Deadlines for industry to respond to significant inspection findings; new processes to prioritize follow-up inspections; and FDA’s criminal enforcement program which deters non-compliance, all go a long way in supporting public health. But long before a product reaches consumers, safe manufacture and delivery are essential as well. To that end, the report says that FDA will work more closely with regulatory authorities on the local and state level, to “enable faster identification of threats to the public health and quicker response times … to reduce the likelihood of harmful products being manufactured and distributed.”

4. Expand Efforts to Meet the Needs of Special Populations

FDA addresses here the underrepresentation in clinical trials of certain populations, including women, minorities, and the pediatric population. Because of this, the report claims, “Questions regarding effectiveness, pediatric dosing, and side effects for drugs often go unanswered.”

FDA plans to combat these problems by collaborating with the EU, Japan, Australia, and Canada in efforts to ensure that children are “enrolled in scientifically and ethically sound trials”; advancing women’s health through grants and increased research efforts; overcoming language barriers to make health information available to the target population; and through the recent creation of a new Office of Minority Health.

5. Advanced Medical Countermeasures and Emergency Preparedness

“Despite considerable financial and human resource investments since [September 11] 2001, the United States does not yet have the range of medical countermeasures (MCMs) it requires to … respond to a deliberate chemical, biological, radiological, or nuclear event or naturally occurring infectious disease outbreaks,” states the report. Because of complex regulatory concerns and slow time-to-market, there are currently very few FDA-approved MCMs available to respond to such a threat, and they can’t quickly be made once a threat is discovered (think vaccines for HINI, for instance).

Consequently, FDA has created an MCM Action Plan that involves enhancing the regulatory review process for MCMs; advancing regulatory science for MCM development and evaluation; and optimizing the legal, regulatory, and policy framework for effective public health response. In addition, says the report, “FDA remains committed to advancing its emergency preparedness and response capabilities.”

The Obama Administration’s signal achievement to date — passage of comprehensive health reform legislation — continues to inspire confusion and contradictions across the political spectrum. Despite its scope, the bill is dismissed by many Democrats for what it does not do, while the GOP references “Obamacare” as a decisive step toward the apocalypse of socialized medicine. Howard Dean, 2008 presidential candidate, former Vermont governor and chair of the Democratic National Committee [DNC], added some additional twists to the reform debate in a talk to senior pharma executives hosted by the Gerson Lehrman Group [GLG] in New York last Thursday.

Dean, now of counsel to the law firm McKenna Long & Aldridge, dismissed Obama ‘s position that the 2010 reform would “bend” the cost curve. Why? Because little has been done to change the economic incentive of providers to charge by procedure rather than on the basis of a full episode of care. Fee-for-service remains the payment bedrock of the US system. Until it changes, costs will continue to rise.

Dean reiterated his view that Obamacare will accelerate a transition away from the current employer-based approach to financing health care. “There is a negative incentive in the law for small business to continue providing health benefits to workers,” Dean said. “I expect that once the state insurance exchanges are up and running small businesses will opt to pay the penalty for not providing coverage and simply give workers a bonus or subsidy of a few hundred dollars to help them purchase insurance under the individual mandate.” Conversely, the largest employers are likely to keep to the status quo as they prefer to control their exposure to insurance costs. Hence, like so much of the reform package, the outcome is a mixed bag: there will be less diversity, flexibility and choice in the system as the government role increases, but US industry will be more competitive in global markets due to having to shoulder less of the burden of covering workers for essential health care services.

Perhaps due to his new role as an adviser toMcKenna’s biotech clients, Dean professed some views that are anathema to his own party caucus. These included support for the 12-year period of data exclusivity agreed by the Administration, PhRMA and BIO to advance the registration of follow-on biologics. Dean predicted that despite some backtracking from congressional Democrats to push the protection period down to seven years, the pledge will be kept – at 12 years. Next, while noting the financial impact of malpractice on providers has been overstated, Dean said he parts with his caucus by supporting tort reform, the centerpiece of which should be allowance for arbitration panels as an alternative to the constitutional right of victims to trial.

Finally, Dean pushed for actions to raise the “certainty index” for investors in big pharma and biotech. This includes mediating more directly between the FDA and Congress, the agency’s most hostile stakeholder. “Pressures from Congress against the FDA have created an overly politicized decision-making chain on the licensing of new therapies, to the detriment of the industry’s long-term future in the US,“ Dean said. Other actions he suggested industry pursue focused squarely on educating around the following issues: that medicines actually save money, when assessed in comparison to most other health interventions; explaining how the average price tag of financing a clinical trial has doubled over the past five years; drug companies, not academia or the NIH, do the heavy lifting in bringing new treatments to market; that manufacturing the next generation of large biologics is complex, risky and expensive; and why tax incentives in the US emphasize less productive short-term objectives rather than the long-term payout responsive to biotech’s development cycle of more than a decade. That education should begin with Congress, which is “increasingly anti-science and ignorant about what is needed to seed drug innovation.”

Dean flipped a question illustrative of one of the biggest challenges to implementing health reform: how strictly should evidence be applied to drive decisions on access to the most costly new medicines? The power given in countries like the UK to formal cost-effectiveness evaluation in deciding who gets a new drug is “unlikely to find a receptive audience here,” Dean said in response to a question from J&J. “Action to force suppliers to bear some or all of the risk in meeting the cost of a new treatment is a drag on innovation too. “But is it worth paying $100,000 or more for a new drug that will extend the life of a cancer patient for a few months? This is a societal debate that must involve more players than industry and the insurers.”

However, Dean admitted that politicians like him are unlikely to initiate that discussion, even if as a result some drug investors might find a better place for their money by purchasing a new Porsche.

And the verdict on the staying power of health reform? To Dean it has everything to do with employment. “If the jobless rate falls below eight per cent by early 2012, Obama gets his second term and the reform law is here to stay.”

Those two products – AstraZeneca’s Brilique (Brilinta in the US), a blood thinner, and Pharming’s Ruconest (Rhucin in the US) – were held up during FDA’s review process. Brilique (ticagrelor), AstraZeneca’s leading pipeline drug, was approved last December for patients in the EU with acute coronary syndromes, which includes a high risk of heart attack.

In the US, however, AstraZeneca received a complete response letter from FDA in December, addressing concerns about ticagrelor’s efficacy in American subjects, and requesting additional data from the company’s PLATO trials. AstraZeneca said in a reply to FDA that differences in efficacy across geographies were the result of interactions with high-dose aspirin. The company, and most analysts, expect ticagrelor to gain FDA approval this July. Brilique/Brilinta is a direct competitor of Sanofi-Aventis’ and Bristol-Myers Squibb’s Plavix, a blockbuster drug several times over, but Plavix faces patent expiration in the US next year, and has already gone off-patent in some European countries. Thomson Reuters Pharma put global sales of Brilique/Brilinta at $185 million in 2011, and an estimated $1 billion by 2014.

Pharming’s Ruconest/Rhucin, a drug extracted from the milk of transgenic rabbits, was approved in the European Economic Area (EEA) – which includes the EU plus Iceland, Liechtenstein and Norway – but FDA rejected its biologics license application in late February, citing insufficient clinical trial data. FDA did grant an orphan designation for the product. Pharming, a biopharma based in the Netherlands, developed Ruconest/Rhucin, a recombinant human C1 inhibitor, to treat a rare genetic disease called hereditary angioedema (HAE), which causes swelling. The drug is the company’s first to reach the commercial stage.

Marketing partners on Ruconest/Rhucin include Santarus in the US, Laboratorios del Dr. Esteve in Spain, Portugal, Greece and Andorra, and Swedish Orphan Biovitrum International (SOBI) for all other European companies. Saloni Shah, managing editor, drug information at Thomson Reuters, said in an email that Ruconest is an example of companies coming together to “offer new hope to HAE” patients. Approximately 1 in 30,000 people worldwide suffers from HAE, according to Pharming estimates.

The other three top new approvals singled out by Thomson Reuters include Forest Laboratories’ Teflaro, an injectable for bacterial pneumonia and infections; Halaven, a breast cancer drug from Eisai; and Kombiglyze XR, a combination pill for diabetes, from AstraZeneca and Bristol-Myers Squibb (BMS). Teflaro is expected to generate global sales of $514 million by 2015, and Halaven, a late stage drug for patients with metastatic breast cancer who have received at least two prior chemotherapy regimens, is expected to generate sales of $414.6 million by 2014, according to Thomson Reuters Pharma estimates.

AstraZeneca and BMS’s Kombiglyze XR, an extended-release drug combining saxagliptin, the active ingredient in AstraZeneca and BMS’s Onglyza, and metformin, the active ingredient in BMS’s Glucophage, is set to pull in close to half a billion dollars by 2015, according to Thomson Reuters Pharma. Shah said the drug “offers patients the ideal medication: a once-a-day oral tablet which combines two existing drugs, making disease management easier.”

Other drugs to keep an eye on, according to Thomson Reuters’ “The Ones to Watch” report, include Phase 3 treatments such as ArTiMist, a malaria drug developed by Star Medical and Eastland Medical Systems, ChimeriVax Dengue, a Sanofi Pasteur drug for dengue virus infection, and Merck’s V-212, for chickenpox and shingles, among others. The report, published in February, covered new drug approvals and pipeline candidates through then end of December, 2010.

A new FDA report summarizes the new drug approvals for 2010, and highlights some surprising numbers compared to years past.

According to a recent FDA report, FDA’s Center for Drug Evaluation and Research (CDER) approved 21 New Molecular Entities (NMEs) in 2010, which is less than in 2009 (26) and 2008 (24), but greater than the two years previous to that.

Looking back even further at a ten-year average, since 2001, CDER has averaged slightly fewer than 23 NME approvals per year (22.9), closer to the 21 approved in 2010. Of the past decade, 2004 clocked in as the year with the highest number of NMEs approved (36), ten more than the next highest approval year, 2009 (26). The lowest approval number of the decade came in 2002 (17). It’s also important to note when lookin back over data of the past decade that 2004-2010 represents applications for NMEs filed under New Drug Applications (NDAs) and therapeutic biologics filed under Original Biologic License Applications (BLAs), but that 2001-2003 does not include therapeutic biologics.

The report also notes that “if the number of applications does not increase, CDER does not expect to see much of a year-to-year increase in approvals.