rewrite this title FDA panel backs easier access to peptides

Advisers to the Food and Drug Administration are backing popular peptide therapies. They voted to allow specialized pharmacies to make them despite agency scientists’ recommendations against it.

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Advisers to the Food and Drug Administration are supporting peptide therapies, experimental drugs which are in high demand online for athletic performance, longevity and more. An expert panel meets for a second day today. NPR’s Will Stone reports.

WILL STONE, BYLINE: In a series of narrow votes, the panel recommended the FDA lift the current restrictions so that specialized pharmacies in the U.S. can legally make these compounds. There’s BPC-157, TB-500, MOTS-c. None of these have undergone large-scale trials in humans, and they are not approved drugs. But Health Secretary Robert F. Kennedy Jr., whose agency oversees the FDA, has publicly endorsed opening up access. The peptide industry, from compounding pharmacies to large telehealth companies, made their case during hours of public comment. Their argument hinges on the perils of the unregulated marketplace, that many Americans are now injecting themselves with unvetted substances sourced from overseas.

BRIGHAM BUHLER: We are not here advocating for the Wild West.

STONE: That’s Brigham Buhler, who runs a telehealth company called Ways2Well that markets hormone optimization and peptides.

BUHLER: What we are advocating for is to slow down or shut down the gray and black market and to allow patients to have a safe and effective manufacturing process with the proper checks and balances.

STONE: Meanwhile, the FDA’s own scientists recommended against unwinding the restrictions on any of the peptides. They said it was hard to even characterize the compounds. Some had no published studies in humans, and there were safety concerns like the potential to encourage cancer growth or trigger a massive immune response. Dr. Elizabeth Rebello is an anesthesiologist at the University of Texas MD Anderson Cancer Center and one of those on the panel who repeatedly voted no.

ELIZABETH REBELLO: And I’m concerned that we’re responding to a market-induced demand rather than a decision based on solid science.

STONE: But Rebello was ultimately in the minority. The panel itself was under scrutiny. Many of the new members who voted favorably have ties to the peptide industry, though a spokesperson for the Department of Health and Human Services said they were vetted for conflicts. The panel meets again today to look at three other peptide therapies. The FDA doesn’t have to follow their recommendations, but typically, it does.

Will Stone, NPR News.

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