Committee Unanimously Approves the FDA Reform Act

May 10, 2012

WASHINGTON, DC - The House Energy and Commerce Committee, chaired by Rep. Fred Upton (R-MI), today unanimously approved the “Food and Drug Administration Reform Act,” H.R. 5651, by a vote of 46 to 0. The legislation ensures continuation of various FDA programs, including the Prescription Drug User Fee Act and Medical Device User Fee Act, and authorizes new user fee programs, the Generic Drug User Fee Act and Biosimilars User Fee Act, to facilitate the review and approval of life-saving and life-improving drugs and medical devices. As part of the agreement, FDA will commit to certain performance goals, fostering more interaction, predictability, and certainty between industry and FDA. The legislation also includes reforms to ensure patients receive quality care and timely access to new therapies while promoting innovation and job creation. Click here to read a legislative summary.

”The FDA Reform Act contains important metrics that will hold the FDA accountable for its performance, will help provide new therapies to our nation’s children, significantly improve scientific exchange at FDA’s advisory committees and ensure transparency and public input in the development of FDA’s guidance documents,” said Chairman Upton. “Finally, it will help our nation’s patients, doctors, nurses and hospitals as they deal with drug shortages.

”We have had an open and deliberative process, and I would like to thank Health Subcommittee Chairman Pitts and Ranking Member Pallone for the manner in which the subcommittee has conducted this important work.  As we put this package together, I wanted to ensure that it fostered American innovation, which is essential in getting new treatments to patients and creating American jobs.  Because of the hard work of the committee members on both side of the aisle, I think we have done that.”