Consumer Demand Is Not Clinical Evidence:
ASBM Challenges HHS Policy Expanding Access to Unapproved Peptides
November 3, 2026
ARLINGTON, VA – The Alliance for Safe Biologic Medicines (ASBM) calls on U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. to withdraw the department’s peptide enforcement-discretion policy, announced October 28th. The policy announcement cites “significant interest” in these peptides as justification for expanded access.
“Consumer demand is not clinical evidence,” says ASBM executive director Michael Reilly, former Associate Deputy Secretary at HHS.
The department’s policy announcement acknowledges that FDA reviewers recommended against listing all six substances. But an advisory committee with newly appointed, industry-connected members backed expanded compounding despite those recommendations. “Changing an advisory committee’s composition does not change the evidence, and marginally-more-reliable sourcing still can’t establish whether a drug works, or whether its benefits outweigh its risks,” Reilly added. ASBM has previously sent two letters to HHS sharing these concerns.
The American Society of Health-System Pharmacists (ASHP) echoed ASBM’s concerns in its own statement: “Relying on enforcement discretion rather than the established rulemaking process is troubling given these products have limited clinical and safety data.” ASHP also questioned whether the enforcement approach would protect consumers and urged aggressive action against noncompliant compounders.
ASBM’s Advisory Board Chair Philip J. Schneider, past president of ASHP, emphasized the importance of FDA oversight during an October 15 ASBM webinar on the topic: “If we bypass these systems, I think we’re abrogating our responsibility to act in the best interest of the public.”
Two recent incidents underscore the need for increased, not reduced oversight: of compounders: FDA received two death reports involving illicit products purported to contain retatrutide, an investigational peptide. Additionally, compounder Apothecary Pharma issued a nationwide recall of its compounded GLP-1 product over contamination concerns; the compounder had previously received a December 2025 FDA warning letter detailing numerous violations found during facility inspection.
ASBM Advisory Board member Ronald Jordan, past president of the American Pharmacists Association (APhA), made the stakes clear in the webinar. He recalled the 2012 New England Compounding Center disaster, in which contaminated steroid injections caused an outbreak that killed 64 people, saying “my concern is we’re headed for another tragedy.”
“HHS should withdraw this policy and let FDA’s scientific findings – not consumer demand or commercial interests – determine whether these peptides belong in patient care and under what circumstances,” said Reilly.
ASBM will be submitting comments urging reconsideration of the policy during the public comment period closing November 13.
