FDA panel reviews peptides, Merck wins HIV license
The FDA advisory panel voted to allow compounding pharmacies to prepare the peptide drugs BPC‑157, KPV, TB‑500 and MOTS‑c, a move welcomed by supporters of experimental therapies and by U.S. Health and Human Services Secretary Robert F. Kennedy Jr.
Panel recommendation amid safety concerns
According to the report, the panel’s recommendation comes despite internal FDA staff urging against loosening restrictions. Staff members highlighted gaps in safety data and limited evidence of efficacy for the four peptides, which have gained a niche following among users seeking off‑label benefits.
The advisory body’s vote is not binding. The final decision rests with the agency, which will consider the panel recommendation alongside its own assessments. Critics have suggested the panel was “stacked” by Kennedy, noting that several members have ties to entities that could profit from broader peptide access.
Panelists argued that permitting compounding pharmacies to make the substances could improve patient access, especially for individuals who have turned to these compounds despite the lack of formal approval.
The agency’s final ruling is expected later this week, after the panel’s vote on additional compounds scheduled for Friday.
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The panel’s recommendation also aligns with broader market trends. Demand for peptide‑based products has risen in recent years, driven by online communities and social media promotion. This increase in consumer interest has prompted both manufacturers and regulators to reassess how such substances fit within existing drug approval pathways.
Should the FDA ultimately lift the restrictions, compounding pharmacies would be required to follow strict quality‑control protocols. The agency has indicated that any change would be accompanied by new guidance to ensure that compounded peptides meet safety standards comparable to those of FDA‑approved drugs.
Patients currently using the peptides are advised to consult their healthcare providers before making any changes to their treatment plans. Until a final decision is announced, the status of these compounds remains uncertain, and pharmacies may continue to operate under existing rules that limit their preparation.
The future remains uncertain.
