The US House Energy and Commerce Subcommittee on Health completed its markup process for a package of user fee programs including the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA) and the Generic Drugs User Fee Act (GDUFA), easily passing the legislation unanimously via a voice vote.
The entire markup process was remarkably quick, taking just under a half hour to complete-a stark contrast in a Congress sturggling to pass any piece of legislation on a bipartisan basis.
Only one amendment to the legislation, offered by Subcommittee Chairman Joe Pitts (R-PA), was accepted by the committee. The amendment would require the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) to calculate and publicly release metrics regarding how efficiently it approves drugs every quarter, among other modifications.
The House Energy and Commerce Committee has scheduled a vote on the user fee legislative package on 9 May at 10:00 a.m., after which the legislation would go before the entire House of Representatives to be voted upon.
Politico reports backers of the bill are hoping the bill's unexpectedly rapid progress continues, particularly because the Supreme Court's ruling on the Patient Protection and Affordable Care Act (PPACA) "could politicize the otherwise relatively bipartisan legislation and slow down, if not derail, its passage."
House Energy and Commerce Committee - Health Subcommittee Vote on Legislation to Reauthorize Various FDA User Fee Programs
User Fee Legislation Draft (as of 8 May 2012)
Webcast of the Committee Markup
Chairman Pitts Amendment
Regulatory Focus - Background on the Committee Hearing
Mass Device - FLASH: House panel speeds FDA user fee bill
Politico - House measure on FDA user fees set for markup Thursday
House Energy and Commerce Committee - ICYMI: Bipartisan Support for FDA User Fee Bill
The Pink Sheet - That Was Easy: PDUFA Bill Clears House Subcommittee Without Debate