FDA says drugs approved in U.S. before Europe

Americans in the past year got access to 24 new medicines before they became available anywhere else, U.S. drug regulators said as they seek to show they are doing enough to promote medical innovation.

Releasing a report on the approvals in the year ended on September 30, the Food and Drug Administration also said it had approved 35 drugs, the second-highest number in the past decade after 37 new treatments reached the U.S. market in 2009.

The FDA also used the report to highlight how user fees from brand-name drugmakers such as Pfizer and AstraZeneca have helped it speed up review times.

The agency has drawn fire from some manufacturers for being too cautious in reviewing medical products, hindering U.S. innovation and competitiveness with unnecessarily tough requirements.

In the past, the FDA has attributed lower approval numbers to a decline in applications from drugmakers.

Janet Woodcock, the head of the FDA’s drugs center, said there had not been significantly more applications recently, but they had been of higher quality, making approval more likely.

The report showed 22 of the 35 drugs were approved in their first review cycle, meaning manufacturers provided enough data right away, without the FDA having to ask for more information that could delay the process.

“The point we’re trying to make is that when high-quality science, good applications come before us, we are able to act swiftly and surely, and we are able to apply considerable regulatory flexibility in our application review process,” FDA Commissioner Margaret Hamburg told reporters on a call.

The FDA report said about half the drugs were “significant therapeutic advances” over existing medicines, including seven treatments for cancer and 10 for rare diseases.

The agency report mirrors a similar finding in June from the nonprofit advocacy group Friends of Cancer Research, which found new cancer drugs reach the U.S. market several months before they go on sale in Europe.

Much of the recent criticism of the agency, however, has come from the medical device industry, which has said the FDA is driving companies to Europe, where developers and investors see a quick path to market.

Consumer advocates, meanwhile, say the FDA may sacrifice safety for speed and should demand more data from companies.

The report comes as the FDA is in negotiations with the medical device industry over user fees that help pay for product reviews. Device makers have said higher fees in the past have not led to speedier review times.

But in the report, the FDA said fees from brand-name drugmakers helped it approve 34 of the 35 drugs on schedule.

“At the present time, MDUFA (medical device user fees) is a younger program, and it pays for a much smaller percentage of the overall device review program, and I think that makes a difference as well,” Hamburg said, when comparing device fees to those from the pharmaceutical industry.

###

By Anna Yukhananov and Alina Selyukh

WASHINGTON