July 23 (Reuters) – A panel of advisers to the U.S. Food and Drug Administration on Thursday began weighing whether it should loosen regulations on seven peptides, the increasingly popular compounded medicines backed by social media influencers and Health Secretary Robert F. Kennedy Jr.
The two-day meeting is pitting the FDA staff, which has advised against allowing for broader pharmacy compounding of the seven peptides saying there is scant evidence to support their safety and effectiveness, against a telehealth industry anxious to tap into what analysts estimate could quickly become a $2 billion to $3 billion market if legitimized.
Injectable versions of peptides, drugs built from the same building blocks the body uses to make proteins, are already being sold widely online for everything from muscle recovery to longevity through a gray market that relies on allowable use of unapproved medicines for research purposes.
The panel has been asked to decide if each of the seven peptides should be designated by the FDA as being allowed to be compounded by pharmacies for patients with a prescription. The Biden administration in 2023 found that nearly 20 peptides raised safety concerns and barred their legal compounding.
Telehealth firm Hims & Hers’ chief medical officer Anant Vinjamoori urged the panel to allow for U.S. compounding of the drugs for patients with prescriptions during the public comment period of the meeting, saying it would end the gray market.
“A no vote would not end those distribution channels or use. It would instead move it deeper into a market with no production or sourcing standards, no physician, no monitoring, and no record…,” said Vinjamoori.
FDA URGES CLINICAL TRIALS
There are many peptides, such as insulin and GLP-1 drugs, that have been approved by the health regulator. The ones being evaluated in the meeting have not gone through such clinical trials, and are being easily purchased online, without any doctor supervision.
Matt Lash, an FDA official, in the meeting on Thursday said the compounded products have not been approved by the FDA and added that compounded products are not required to have labels that notify patients of any safety or doses.
Another official, Russell Wesdyk, encouraged the industry to pursue FDA investigational new drug applications and to conduct trials in humans to evaluate the substances.
The FDA’s staff reviewers had last month in documents advised the panel that the agency should not move in favor of permitting state-licensed compounding pharmacies to do so.
In April, Health Secretary Robert F. Kennedy Jr. reclassified 12 of them as Category 1 substances, the first regulatory step toward adding them to be compounded by pharmacies.
BPC-157, TB-500 IN FOCUS
Among the peptides being discussed on Thursday, BPC-157 and TB-500 have become increasingly popular. BPC-157 is being evaluated for ulcerative colitis, a chronic inflammatory bowel disease, and TB-500 for wound healing.
Hims’ Vinjamoori said the company stands to benefit commercially if BPC-157 were added to the 503A list.
Industry players said a clear backing of compounding will help build the sector for interested consumers.
“Many of my patients are already using these drugs — they’re just getting them from the worst possible places,” said Jessica Duncan, chief medical officer at telehealth company Ivim Health, during the meeting. Duncan told Reuters ahead of the meeting that legal compounding in the U.S. would allow peptides to be studied for popular uses.
(Reporting by Sriparna Roy and Sneha S K in Bengaluru, Amina Niasse in New York; editing by Caroline Humer and Aurora Ellis)
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