FDA Advisory Panel Recommends Allowing Compounding of Four Peptides
5 verified4 unconfirmed
A Food and Drug Administration advisory committee narrowly voted to recommend that four synthetic peptides be added to the agency’s bulk substances list, which would allow compounding pharmacies to produce custom medications containing them. The decision followed an 11-hour meeting where FDA staff scientists, health care practitioners, and patients testified, with proponents arguing that regulated access would steer patients away from an unregulated gray market and critics warning that expanding access without strong evidence could legitimize treatments with poorly understood risks. The panel’s votes were split, with three of the four peptides receiving an eight-to-six vote in favor and one receiving a seven-to-five vote, each with one abstention. Supporters, including telehealth providers, said that legal compounding would give patients safer options under a prescription, while opponents, including some committee members, cited unknowns about safety and the potential for public confusion. The FDA is not required to follow the panel’s recommendations and is expected to issue a formal decision in several months.
What’s verified
An FDA advisory committee voted to recommend adding four peptides—BPC-157, KPV, TB-500, and MOTs-C—to the agency’s bulks list for compounding pharmacies.
The vote for three of the peptides was eight to six, with one abstention; the vote for MOTs-C was seven to five, with two abstentions.
Proponents argued that allowing compounding would provide patients with safer, regulated access to peptides.
Critics, including FDA scientists, said there is insufficient evidence to demonstrate the safety and effectiveness of these peptides.
The FDA’s final decision is not expected for several months.
Not yet confirmed
Whether specific committee members had ties to peptide-related businesses or telehealth clinics.
The exact number of panelists and their identities, including those who voted against the recommendations.
The extent to which Health and Human Services Secretary Robert F. Kennedy Jr. has publicly supported peptide therapies.
Whether the panel considered additional peptides on a second day of meetings.
Key figures
Anant Vinjamoori, chief medical officer of Hims & Hers
Elizabeth Rebello, anesthesiologist at University of Texas MD Anderson Cancer Center
Jason Nagata, associate professor of pediatrics at University of California San Francisco
Adriane Fugh-Berman, physician and professor at Georgetown University
John Hertig, chair of the Collaborative for Evidence-Based Medicines
Sources: Wired, statnews.com
