The US House of Representatives' Energy and Commerce Committee is set to hold a vote on Thursday, 10 May on a collection of user fee legislation being dubbed the Food and Drug Administration (FDA) Reform Act of 2012.
The bill would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, authorize the Generic Drug User Fee Act and the Biosimilars and Interchangeable Products User Fee Act, and make a number of reforms to FDA's review processes and authorities.
The bill entered a markup process on 9 May 2012, and appears to have significant support in both the Senate and the House.
"My hope is that the full committee will favorably report this bill tomorrow and then we can have the bill on the House floor later this month," said committee Chairman Fred Upton in prepared remarks. "That will give us time to work with our good friends in the Senate to have this bill to the president before the 4th of July."
Upton added the legislation needs to be enacted "by the end of June," presumably due to a confluence of factors including an impending Supreme Court decision on the Affordable Care Act and the Presidential campaign season kicking into high gear.
The committee also highlighted an enormous amount of support from stakeholders, including industry groups, medical societies, non-profit foundations and companies.
The bill's path through congress has thus far been unexpectedly smooth after overcoming a few pre-markup hiccups.
The Senate's version of the user fee legislation, dubbed the FDA Safety and Innovation Act (FDASIA) was approved by its Health, Education, Labor and Pensions Committee on 25 April with strong support while the House's Energy and Commerce Subcommittee on Health unanimously approved the FDA Reform Act on 8 May.
Upon approval by the House Energy and Commerce Committee, the FDA Reform Act will be put on the House of Representatives' floor calendar for an eventual vote before the entire chamber, after which a negotiating process will begin to iron out differences between the Senate's and House's respective versions of the legislation.
House Energy and Commerce Committee - Full Committee Vote on the Food and Drug Administration Reform Act of 2012
FDA Reform Act of 2012
Stakeholders Support of the FDA Reform Act
Opening Statement by Chairman Fred Upton, Committee on Energy and Commerce Markup - May 9, 2012
Regulatory Focus - House Subcommittee Passes User Fee Reauthorization Legislation
Regulatory Focus - User Fee Bill Appears Ready to Pass House Subcommittee
Regulatory Focus - User Fee Act Passes Senate Panel While Tensions Escalate in the House