Report: User Fees Could Be In Peril in Partisan Congress
A Bloomberg Government study claims a partisan Congress seeking to make changes to the US Food and Drug Administration (FDA) and the user fee legislation that funds it could put the entire package of user fee legislation in jeopardy.
The pieces of user fee legislation currently before Congress included the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act(MDUFA), the Generic Drugs User Fee Act (GDUFA), and the Biosimilar and Interchangeable Products User Fee Act (BSUFA).
Unlike some pieces of FDA legislation, user fee legislation must be reauthorized every five years, explained Brian Rye, healthcare analyst at Bloomberg Government, in an interview outlining his study, "Assessing the Importance of Congress's User-Fee Reauthorization Process."
"In an ordinary year, it might not be a problem to get the legislation reauthorized," said Rye. "However, given the divided congress and the fact that there's going to be a presidential election this year-which is the first time a reauthorization is taking place during an election cycle--there's a good chance that something could happen to either delay the reauthorization process or that congress could want to introduce some things that FDA didn't ask for."
"The question is, if that happens, is there an effect on drug approval times and on drug companies," added Rye.
As Regulatory Focus explained in January, the legislation has to overcome some atypical election-year hurdles to get through the congressional markup process this year. These include a much shorter Congressional calendar due to Congress returning to their respective home districts to campaign for re-election and the presence of national political conventions.
The House of Representatives is only scheduled to be in session for eight days in September, while the Senate is only scheduled to be in session for 11 days. The current MDUFA and PDUFA pieces of legislation end on 30 September 2012.
Read more:
Bloomberg - Congress May Put FDA User Fees at Risk
Regulatory Focus - FDA Misses MDUFA Deadline, Putting Legislation in Jeopardy