What would it take to get peptides on the shelf? - NPR

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Peptides have been getting a lot of buzz lately. Last month, the popular and experimental drugs were the topic of a marathon meeting held by the Food and Drug Administration. A panel of advisers supported easier access to half a dozen of these compounds, which are heavily promoted in longevity and wellness circles for all kinds of reasons. So what's next? NPR's Will Stone explains.

WILL STONE, BYLINE: The peptide saga has reached what could be its most confusing chapter, at least for the average consumer.

JESSICA DUNCAN: They are now even more curious. They've heard the word, and they may not have a full understanding.

STONE: Dr. Jessica Duncan is with the telehealth company Ivim Health. She testified at last month's FDA hearing and spent the past week fielding questions from her patients.

DUNCAN: Reminding them this does not mean that they're available yet, you know, and explaining the dangers that they could potentially face if they do try to get them early before they are from a regulated source.

STONE: That's because the panel's recommendations are just that - recommendations. It's still illegal for pharmacies to make these compounds. They're often taken together, sometimes by injection, for injury recovery, muscle growth and fat loss, improving athletic performance, enhancing metabolism and more. What's available right now comes from a gray market, where they're sold under the guise that they're only for research purposes, not human consumption.

HALEEM MOHAMMED: It's a lot seedier than what people think.

STONE: That's Dr. Haleem Mohammed, who was on the FDA panel.

MOHAMMED: That's nowhere I want my patients getting their medications from.

STONE: Mohammed is chief medical officer for Gameday Men's Health, which runs clinics in the U.S. and Canada. During last month's hearing, he voted to reclassify these products so that compounding pharmacies can make them.

MOHAMMED: We're moving towards a regulated pathway for peptides that patients are already using.

STONE: To be clear, these are not approved drugs. They have not been studied in large-scale trials in humans. And the FDA's own scientists disagreed with the panel's decision. But it seems likely the agency will move forward all the same. There's high demand and political pressure. Health Secretary Robert F. Kennedy Jr. has called to make them available. Jesse Dresser is an attorney at Frier Levitt and represents the compounding industry. He says, typically, the next step would be a formal rulemaking process, which could take months to more than a year.

JESSE DRESSER: Whatever options exist to make this a faster process, I think they are going to be leveraged.

STONE: For example, the agency could exercise enforcement discretion and allow these peptides to be made in the meantime while the longer process plays out. Dresser says it's also possible Secretary Kennedy could use his authority to direct the FDA to do this immediately. Though in past situations, this was done to remove a product because of safety concerns.

DRESSER: It's never been used to fast-track or to add a product, but this is a unique scenario, unique product. Unique administration, frankly.

STONE: The explosion of the unregulated market is a real concern. But Ilisa Bernstein says that isn't in and of itself a reason to OK these peptide therapies. Bernstein is a former FDA official and a consultant at Compounding Strategy Advisors.

ILISA BERNSTEIN: FDA needs to follow the science and data, not the public pressure, because once the door is open, any pharmacy can compound these products.

STONE: If the agency ultimately does green-light these peptides, there's a huge industry ready to prescribe. But doctors practicing in more traditional settings will probably be wary. Dr. Harmeet Singh Narula is an endocrinologist at Banner Health in Arizona. He worries about their safety, even if they do come from legitimate pharmacies.

HARMEET SINGH NARULA: This is a significant concern for many of us in this space. I think the commercial enthusiasm is outpacing clinical science here.

STONE: Whatever happens, one thing is certain - talking about peptides is becoming a regular part of his job. Will Stone, NPR News.

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