On February 29, FDA Commissioner Margaret Hamburg delivered FDA’s budget request in testimony before the U.S. House Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA and Related Agencies. FDA is of course a very large agency with varied responsibilities that are ever-growing and so there was a lot to say. Twenty pages worth, in fact. There was a lot of information contained in it, some of which I did not know. And I thought it would be handy to organize some of it by category as a handy reference tool. Here goes.
- In FY 2011, FDA approved 35 innovative drugs, among the highest number in a year in the past decade with the exception of 2009;
- Of the 35 new drugs approved last year, 34 met their PDUFA date;
- Of the 57 novel drugs approved by both FDA and the EU between 2006 and 2010, 75% were approved first in the U.S. and all 23 cancer drugs were approved in the U.S. first;
- For priority review products approved between 2006 and 2010, FDA’s median time to approval was six months (183 days), more than twice as fast as the EU time to approve those drugs, which took a median time of 13.2 months (403 days);
- For standard review of drugs, FDA’s median time to approval was 13 months (396 days), which is 53 days faster than the EU time to approval of 14.7 months (449 days);
- Nearly 40% of the drugs American take are made overseas;
- 80% of active pharmaceutical ingredients are imported into the U.S.
- FDA is responsible for regulating the safety of four-fifths of the nation’s food supply;
- FDA-regulated imported food products come from more than 300,000 foreign facilities located in 200 countries;
- Food imports have increased nine-fold since 1993;
- 70% of seafood and 35% of fresh produce in the U.S. comes from foreign countries
- Approximately one-half of the medical devices used in the U.S. are imported;
- FDA completes 90% of its 510(k) reviews in 90 days or less
The FY 2013 budget weighs in at $4.5 billion for FDA which is an increase of 17% over the previous year – 98% of which is to be covered through increases in existing user fees and bringing new user fees on line. One point Commissioner Hamburg stressed repeated is that the world is changing rapidly and certainly the budget request and some of these statistics bear that out clearly.