Beyond Funding at FDA

Just How Radical Does FDA Reform Need to Be?

As we've heard often enough over the years, the FDA is woefully underfunded in the views of many. Indeed, by federal agency standards it is tiny--about $2 bil for the whole shmoo, of which approximately 25% is CDER. And then the inevitable stat that follows--the agency regulates close to 25% of U.S. goods and services.

The Miami Examiner had a brief piece on FDA funding in response to the Poison Peanut episode. The link is below

http://www.examiner.com/x-2196-Miami-Health-Examiner~y2009m2d2-Presidents-Obamas-call-for-FDA-investigation-should-address-funding-shortage-expert-says

But the questions remain: If most of the old guard senior managers remain in place; if the various means continue that have seemed only to increase suppression of scientific debate; if the agency is viewed as a stepping stone to getting a "real job" in pharma (as one of my students recently told me she was advised); if PDUFA and its trimmings continue....What, exactly, will more money buy us? And what should it buy us?

You all know what the IOM, GAO, Science Board, et. al. have said. Are these reforms sufficient? Is there a chance in Hoboken they will happen?