FDA user fee act passes both House and Senate, ready for conference

07/13/2007

The House recently approved the FDA Amendment Act of 2007, which would increase user fees collected from pharmaceutical and medical device companies for staffing and post-market surveillance of FDA-approved drugs.  The House measure (H.R. 2900) will now go to conference committee with the version the Senate passed in early May.

“It is by no means perfect,” a spokeswoman for Rep. Michael Burgess said of the bill, which passed from the House floor with bipartisan support July 11.  “But it’s good enough to get to conference where details, like conflict of interest, will have to be hammered out,” she added. Burgess, a Texas physician and Republican member of the Health subcommittee of the Energy and Commerce Committee, favors a loosening of the conflict-of-interest components of the bill.  

Though the Senate and House versions are largely similar, there are a few central differences that must be resolved in conference.  One is language in the Senate bill that would make a pathway toward giving FDA authority to approve  biogenerics; H.R.2900 did not address biogenerics, and Committee Chair John Dingell (D-Mich.) may not compromise on the heavily-lobbied issue. Another difference is the fine schedule listed for companies who undertake false of misleading advertising, which is steeper in the House version.

An earlier inclusion that gave the FDA authority to prohibit direct-to–consumer advertising on new, less-tested drugs was dropped from both bills, but a provision restricting financial relationships of advisory board members with drugmakers was retained. 

According to the BNA daily health care report, the House version would also reauthorize a current FDA practice that gives drugmakers a six-month marketing exclusivity bonus for finding new pediatric uses for their drugs. 

For more coverage, check out:
The Wall Street Journal (subscription required)
Kaiser Health Policy Report (subscription required)