FDA peptides restrictions could ease after advisory panel vote
An FDA advisory panel backed compounding four peptides despite agency scientists citing limited evidence and safety concerns.
By Tom Brennan · Health & Medicine Correspondent
4 min read
An FDA advisory panel voted Thursday to ease FDA peptides restrictions for four compounds, a step that could let compounding pharmacies make them if the agency later agrees. NBC News reported that the recommendation came despite objections from FDA career scientists, who told the panel that evidence for the peptides was limited and safety questions remained.
The Pharmacy Compounding Advisory Committee recommended adding BPC-157, KPV, TB-500 and MOTS-c to a list of substances that compounders may use. The vote does not approve the peptides as FDA-approved drugs; NBC News reported that the FDA would still have to issue a proposed rule before any final change.
What did the FDA panel vote mean for peptides?
The committee’s recommendation would allow the FDA to consider letting compounding pharmacies make the four peptides. It does not mean the agency has found that the products are safe and effective as approved medications.
FDA scientists reviewed BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTS-c for obesity and osteoporosis, according to NBC News. During the meeting, agency staff said they lacked enough data to evaluate some of the compounds and raised a more basic problem: there was no universally accepted chemical formula for each peptide.
Russell Wesdyk, an FDA official, told the panel that the agency had not previously faced a review problem centered on identifying what the product is. The uncertainty, FDA scientists said during the meeting, made evaluation difficult.
Why peptides have drawn attention
NBC News reported that peptides have become more popular in wellness circles and have been promoted by high-profile figures including Health Secretary Robert F. Kennedy Jr. and podcaster Joe Rogan. They are marketed for uses including anti-aging, sleep improvement and healing, according to NBC News.
The compounds have often been sold online in what NBC News described as a gray market. Vendors label them “for research use only,” while they are not FDA-approved drugs. Kennedy has argued that allowing compounding would move buyers away from that market and toward safer products, NBC News reported.
The committee split along lines that reflected the recent reshaping of the panel. NBC News reported that eight members were appointed under Kennedy, including six who run clinics that offer peptides. For BPC-157, KPV and TB-500, all eight of those new appointees voted yes, while six other members voted no and one abstained. For MOTS-c, seven of the new appointees voted yes, five members voted no and two abstained, including one new appointee.
One committee member, Tennessee state Sen. Bobby Harshbarger, is the son of Rep. Diana Harshbarger, R-Tenn., who wrote to Kennedy last year asking that compounders be allowed to make certain peptides, according to NBC News.
How panel members explained their votes
Some members who backed the peptides said their votes reflected concern that patients would otherwise keep buying products outside regulated channels. Dr. Haleem Mohammed, chief medical officer at Gameday Men’s Health in Florida, said his vote for BPC-157 was tied to patient safety, the greater good and medical freedom, NBC News reported.
David Pope, chief pharmacy officer at Xifin Pharmacy Solutions in Georgia, said his yes vote on BPC-157 was meant to return the decision to patients, physicians and pharmacists, according to NBC News. Dr. Gabriel Alizaidy, a clinical researcher at online clinic Maximus, said he supported BPC-157 after finding the available data incomplete.
Other members said the vote could be seen by the public as an endorsement. Dr. Brian Lee, an associate professor of medicine at the Keck School of Medicine of USC, voted no and warned that some compounds might perform no better than placebo, NBC News reported.
Dr. Elizabeth Rebello, an anesthesiologist at the University of Texas MD Anderson Cancer Center, said after voting no on KPV that she was concerned the panel was responding to market demand instead of solid science. The committee was expected to review emideltide, epitalon and semax on Friday, according to NBC News.
This story draws on original reporting from NBC News.