Report: Fight Over FDA User Fee Bills Threatening To Derail Legislation
Posted 25 April 2012 | By
Riders and add-ons in legislation intended to help fund the US Food and Drug Administration (FDA) through industry-paid user fees are threatening to derail the entire legislation, reports Politico.
A number of user fee bills, including the Prescription Drug User Fee Act, the Medical Device User Fee Act, the Generic Drug User Fee Act and the Biosimilars and Interchangeable Products User Fee Act are all being wrapped up into a single piece of legislation inside of the House and Senate, respectively.
Because the funding the bills provide is necessary to fund FDA, the bills are likely to be one of the only pieces of healthcare legislation to pass during the remainder of the Congressional term, notes Politico.
That attention is attracting a number of policy riders, add-ons and legislative changes, notes Politico, and some of them are attracting quite a bit of controversy. Among them:
- A provision inserted into the Republican-drafted House version of the user fee legislation by Rep. Mike Rogers (R-MI) would mandate FDA take into account the promotion of economic growth and job creation as part of the agency's core mission. That provision has attracted little support in the Senate, reports Politico, and has also been derided by FDA's executives and the Pew Health Group.
- There are also differences in provisions to help spur antibiotic development, reports Politico. The House version of antibiotic development incentives applies to all antibiotics, while the Senate restricts those provisions to drugs intended to treat "serious or life-threatening conditions."
- Friction remains over medical device regulations. While some House members and organizations, including Rep. Edward Markey (D-MA) and Consumers Union have been pushing to tighten regulatory standards and the 510(k) pathway, the medical device industry and numerous other Representatives have been furiously pushing for looser restrictions.
Politico - FDA bill up in the air over proposed changes
Regulatory Focus - House PDUFA Draft: Make FDA's Review Process Take Into Account Job Creation
Regulatory Focus - Drafts of PDUFA, MDUFA Released in House, Senate
See all Regulatory Focus News on the PDUFA Legislation
See all Regulatory Focus News on the MDUFA Legislation
See all Regulatory Focus News on the GDUFA Legislation