The U.S. House Energy and Commerce (E&C) Health Subcommittee on Wednesday advanced to the full committee legislation reauthorizing user fee programs, including PDUFA and MDUFA. The legislation, H.R. 7667, the Food and Drug Amendment Act, passed 30-0 on a bipartisan vote with provisions to increase clinical trial diversity, modify the accelerated approval pathway and promote generics.
On the Senate side, the HELP Committee introduced the FDA Safety and Landmark Advancements Act (FDASLA). This is a carefully negotiated bipartisan package from Chairwoman Patty Murray and Ranking Member Richard Burr. Included in the introduced bill is reauthorization of the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements, as well as provisions to strengthen oversight of cosmetics and dietary supplements, modernize the regulation of laboratory developed diagnostic tests, bring more competition to the market, and modernize the data used to support medical product development, including alternatives to animal studies.