Hims等远程医疗公司敦促FDA放宽肽类复方限制，但委员会尚未投票

Telehealth companies including Hims & Hers Health Inc. and Noom Inc. urged a panel of experts to recommend legalizing a handful of popular peptides, while calling for more oversight and the creation of a system to report side effects.

Hims Chief Medical Officer Anant Vinjamoori warned the experts on Thursday morning that people aren’t waiting for US regulators to legalize the peptides, which are purported to help with everything from wound healing to wrinkly skin. If the committee votes against them, it would only move consumers deeper into the black market, he said.

“We can choose to build on the foundation that peptides like BPC-157 have given us and find a responsible way forward,” Vinjamoori told a packed room at the US Food and Drug Administration’s campus in White Oaks, Maryland. “Or we can decline to engage, cede the ground to the gray market, deny patients any real choice and give up the chance to understand these compounds well enough to use them safely.”

The meeting comes as peptides have exploded in popularity, with wellness clinics, telehealth companies and online retailers promoting dozens of compounds for everything from muscle recovery and anti-aging to sleep and cognitive performance. Unlike traditional medicine, such as weight-loss drugs from Eli Lilly & Co. and Novo Nordisk A/S, most popular peptides haven’t undergone the rigorous clinical testing required for FDA approval, leaving regulators grappling with how to oversee the rapidly growing market.

A range of companies from telehealth firms to compounding pharmacies are ready to pounce on the opportunity. Leerink Partners analyst Michael Cherny’s current model points to a roughly $2.2 billion market for the telehealth platforms alone.

Read More: Black-Market Peptides Fuel a Multibillion-Dollar Gold Rush

Hims, which owns a peptide manufacturing facility in California, has said it plans to offer peptides if US regulators legalize them. However, the company isn’t rushing into the market right away.

Hims shares rose 1.8% at 10:01 a.m. in New York.

At issue is whether seven peptides should be added to a list of substances that compounding pharmacies can use to prepare customized prescriptions. Many popular peptides were banned three years ago over safety concerns, leading patients to seek them out on the black market. While the Pharmacy Compounding Advisory Committee’s recommendations aren’t binding, the FDA has historically given weight to its advice, making the vote an important signal for what the agency may do.

Health and Human Services Secretary Robert F. Kennedy Jr., a fan of peptides himself, has embraced the compounds as part a broader push to expand access to alternative treatments.

Read More: What Are Injectable Peptides? Do They Actually Work?: Explainer

Career FDA scientists, by contrast, concluded in briefing documents ahead of the meeting that none of the seven peptides under review had sufficient evidence of safety and effectiveness to justify broader compounding. Their position sets up a closely watched test of whether the outside experts will align with the staff recommendations — or political ones.

In public comments submitted before the meeting, the American Pharmacists Association said it supported the FDA career staff’s recommendation not to add the seven peptides to the list, citing limited clinical data and patient safety.