By Sriparna Roy, Amina Niasse and Sneha S K
July 23 (Reuters) – A majority of the U.S. Food and Drug Administration’s panel of outside advisers on Thursday voted to allow pharmacies to compound the first of seven in its review of widely used 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.
Eight of the members voted in favor to add the peptide known as BPC-157 to the list, which is promoted by its supporters for healing injuries, reducing inflammation, and improving gut health. Six members voted against it, while one member abstained.
Shares of telehealth firm Hims & Hers – which spoke in favor of peptides at the meeting – rose 8%. Analysts said the positive vote signaled regulatory support for the company’s plans to offer the products.
Melissa Loseke, a panel member and Chief Medical Officer at Re-new Institute in Omaha, which uses peptides in its treatements, said she was concerned about threats to patient safety from contaminated products and unregulated sources and thus voted “yes.”
The 14-member committee prior to the meeting added seven people who operate or work for clinics or businesses selling peptide treatments.
Many members who voted in favor could stand to gain from allowing BPC-157 for compounding, said Paul Knoepfler, a professor of cell biology at UC Davis: “How is that acceptable?”
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.
Industry players said a clear backing of compounding will help build the sector for interested consumers.
Hims’ Chief Medical Officer Anant Vinjamoori told the panel the company stands to benefit commercially if BPC-157 were added to the list.
(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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