FDA boasts of 35 drug approvals in past year amid criticisms

As the chorus of critics of the FDA seems to grow louder every year, agency officials made sure yesterday that its uptick in drug approvals during the past year was known far and wide. The message seemed to rebut the claims of lawmakers and industry advocates that the agency's chokeholds have prevented innovative new medicines from reaching the market.

The FDA said in a statement that its 35 drug approvals over its past fiscal year were among the most in a year during the past decade. As if to silence those who say overseas regulators are more supportive of new drugs than the FDA, U.S. regulators touted that 24 of the 35 approvals were made before other countries gave the drugs market green lights for those new meds, according to their statement.

Yet these aren't the salad days for drugmakers. Drug approval levels have trended downward since the mid-1990s and even 2009 saw more market nods from U.S. regulators, with 37, than the past year. As drug approvals have generally slowed, the pharmaceutical industry's spending on research and development has about doubled since 2000 and hit $50 billion last year, the Associated Press reported. While the industry has struggled to make its R&D groups more productive, many have thrown blame at the FDA for not stamping approvals on more drugs that developers spend a fortune on to usher through trials.

FDA officials defended those criticisms with the data on approvals yesterday. "I want to underscore that we approved a set of drugs that are truly medically important, and in fact did so in a way that made these drugs available to Americans before other places around the world," FDA boss Dr. Margaret Hamburg said, as quoted by The New York Times.

The agency has provided developers of new cancer drugs a streamlined review process if their treatments offer breakthroughs for patients, and this trend contributed greatly to the uptick in approvals over the past year. For instance, the FDA stamped an approval on Seattle Genetics' ($SGEN) cancer drug Adcetris in August based on promising data from a pair of promising single-arm studies, and the agency made a special note that the drug was the first approved treatment for Hodgkin's lymphoma in more than three decades.

Despite the FDA's record during the past fiscal year, there's likely to be more wrangling on Capitol Hill as the agency fights for funding to keep its programs alive. Yesterday, however, the day belonged to Hamburg and her agency.

- here's the FDA release
- check out the NYT's story
- and the AP article

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