Senate to vote on ‘the oofahs’, critical to future of FDA

The beginning of today’s Senate Health, Education, Labor and Pensions (HELP) Committee sounded like a comedy skit with Senator Mike Enzi outlining the difference between ‘the oofahs’ (PDUFA, BSUFA, MDUFMA, etc.) as relates to user fee agreements covering drugs, medical devices, generic drugs, and biosimilar products. Once the chuckles ended, the Committee called for swift passage of the legislation before the current agreement expire in September.

The user fee agreement combines accountability, transparency and added resources for FDA. “Put simply, the agreement is good for FDA; it is good for industry; and most of all, it is good for American patients.” In a press release, AdvaMed said that the device industry appreciates efforts by several Congress members who have introduced legislative proposals to give FDA the Among those testifying included officials from PhRMA, the Generic Pharmaceutical Association, AdvaMed and BIO, as well as Dr. Janet Woodcock (CDER) and Dr. Jeffrey Shuren (CDRH) from FDA.

http://www.beaker.com/blog/index.php/2012/04/03/senate-to-vote-on-the-oofahs-critical-to-future-of-fda/