n letters dated October 15 and October 26, the Alliance for Safe Biologic Medicines urged HHS Secretary Robert F. Kennedy Jr. to pause plans to expand compounding of unapproved peptides. The letters cite emerging safety concerns, gaps in adverse-event reporting, and advisory committee recommendations that departed from FDA scientists’ findings. ASBM calls for transparent scientific […]
ASBM has released a new fact sheet explaining the risks posed by the Biosimilar Red Tape Elimination Act (BRTEA, S. 1954). Today, FDA evaluates each biosimilar individually before determining whether it is interchangeable—meaning it may be substituted at the pharmacy without the prescribing physician’s approval. BRTEA would eliminate that product-by-product scientific review and automatically deem […]
August 6, 2026 – ARLINGTON, VA The Alliance for Safe Biologic Medicines (ASBM) commends Senators Jerry Moran (R-KS), Tammy Baldwin (D-WI), Shelley Moore Capito (R-WV), Tim Kaine (D-VA), John Boozman (R-AR), and John Hickenlooper (D-CO) for introducing the bipartisan Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act, […]
