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 review, independent examination of potential conflicts of interest, and stronger safeguards before access expands. The follow-up letter also questions the consistency of demanding greater scrutiny of FDA-approved vaccines while easing access to injectable peptides whose safety and effectiveness remain unestablished.