House Approves FDA Reform Act with Overwhelming Bipartisan Support

WASHINGTON, DC - The House of Representatives today approved the bipartisan Food and Drug Administration Reform Act, H.R. 5651, by a vote of 387 to 5. The legislation, which works to strengthen the United States’ leadership position in an industry that supports millions of American jobs, 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 timely access to new therapies while promoting innovation and job creation.