Are Congress's FDA Reform Efforts in Vain?
by Matthew Madia, 7/5/2007
Today, The Washington Post published a good article by David Brown which discusses Congress's recent efforts to renew the Prescription Drug User Fee Act and to reform drug safety at FDA.
The must-pass legislation will improve FDA's ability to conduct post-market surveillance. While FDA needs more authority in this area, the article rightly points out post-market surveillance is "the regulatory equivalent of chasing the horses after they are out of the barn."
The article also gets to one of the real concerns about the idea of user fees: drug makers are funding the regulation of their own products. The process has let Congress off the hook in funding an essential function of government. In predicting the impact of the legislation, the article states:
it seems likely that heavy reliance on user fees — rather than appropriations by Congress &mdash will continue to be a key feature of pharmaceutical regulation.
