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FDA panel considers easing peptide restrictions

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− Health FDA panel supports broadening access to peptides popular on the gray market Updated July 23, 20268:13 PM ET Originally published July 23, 20265:00 AM ET Heard on All Things Considered By Will Stone A panel of advisers to the Food and Drug Administration is making recommendations on seven popular peptides.
+ Health FDA panel supports broadening access to peptides popular on the gray market Updated July 24, 20265:20 PM ET Originally published July 23, 20265:00 AM ET Heard on All Things Considered By Will Stone A panel of advisers to the Food and Drug Administration is making recommendations on seven popular peptides.
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− A panel of advisers to the Food and Drug Administration is recommending that the federal government green-light the production of four popular peptides by specialized pharmacies in the U.S.
+ A slate of popular peptide therapies has won the backing of a key advisory panel to the federal government – a step that could eventually open up broader access to the experimental drugs.
− The actions came during a highly anticipated two-day meeting that began Thursday to consider whether current Biden-era restrictions on production of seven different peptides — none of which are approved drugs — should be lifted.
+ In a marathon two-day meeting, the panel of doctors, academics and pharmacists recommended the Food and Drug Administration reclassify almost all of the compounds under consideration so that specialized pharmacies in the U.S. could begin offering them.
Health RFK Jr.
− defends his health agenda and Trump's proposed budget cuts in hearing Analyses by FDA scientists didn't support easing restrictions on BPC-157, often used for ulcerative colitis, or KPV, a peptide used for inflammation. That was also the case for two other peptides considered later Thursday: MOTS-c, used for obesity and osteoporosis, and TB-500 for wound healing.
+ defends his health agenda and Trump's proposed budget cuts in hearing Seven different peptide therapies — none of which are FDA-approved drugs — were under consideration.
− Despite the FDA analyses, the panel voted identically for BPC-157 and KPV: 8-6 in favor and one abstention.
+ Currently, these peptides can't be made in the U.S., except for research purposes, leading many peptide users to buy unvetted substances sold online, with disclaimers such as "for research use only" and "not for human consumption." By narrow margins, the panel voted in favor of all but one.
− (There were two separate votes on each peptide because there are two chemical variants under review for each one.) The advisers also voted in favor of MOTS-c and TB-500.
+ The FDA isn't required to follow advisory committee recommendations but typically does.
− The committee's backing represents a win for the peptide industry and consumers who support use of peptides. It also signals potential support for the other peptides on the agenda.
+ The outcome represents a win for Health Secretary Robert F Kennedy Jr., who has publicly supported peptide therapies, and the broader wellness and longevity industry, which stands to profit substantially.
− The recommendations could pave the way for the FDA to reclassify the compounds so they can be obtained from specialized pharmacies in the U.S. The FDA isn't bound by the committee's recommendations but typically follows them.
Short Wave Does the science of peptides live up to the hype?
− Health Secretary Robert F Kennedy Jr., who ultimately oversees the FDA, has publicly endorsed easing restrictions on peptides.
+ These peptides are promoted for a wide range of uses and are often taken together, including for injury recovery, muscle growth and fat loss, improving athletic performance, enhancing metabolism and more.
− The advisory panel was recently overhauled, and many of the new members have ties to the peptide industry, leading to criticism about potential conflicts of interest.
+ If the agency takes the panel's recommendations, clinicians could have the ability to prescribe six peptide therapies: BPC-157, MOTS-c, KPV, TB-500, Epitalon and Semax.
− Additional voting members were added this week.
+ A compound called Emideltide, sometimes used for insomnia, was the only one to receive a down vote.
+ The panel's endorsement of peptides was a striking rejection of the FDA's stance against them. While the level of evidence for each compound varies, all of them lack the kind of large, well-controlled trials in humans that are necessary to establish safety and effectiveness, which is required for drug approvals.
Peptides are strings of amino acids — smaller than a protein — that often act as signaling molecules in our bodies and carry out many critical functions. They can be synthesized and delivered as drugs, often by injection. Some of those, like insulin, are naturally occurring in the body. Others are modified versions, as with the blockbuster GLP-1 obesity drugs.
− As with all the compounds under consideration, BPC-157 and KPV haven't undergone the same kind of large-scale trials as those peptide medications to establish safety and effectiveness, which is required for FDA drug approvals. And yet the therapies have attracted enormous attention in the wellness space.
+ Scientists for the agency spoke extensively about the lack of reliable data for any of the seven peptides before the committee.
− They're typically promoted together and often taken in combination for injury recovery, muscle growth and fat loss, improving athletic performance, enhancing metabolism and more.
+ They advised the panel to vote no.
− The discussion around BPC-157 was a study in contrasts — and signals the favorable direction the committee could likely take for all the compounds at issue.
+ In some cases, they couldn't find any published clinical studies in humans – and there were safety concerns like the potential to encourage cancer growth or to trigger a massive immune response.
− For nearly two hours of public comment, the panel heard mostly from clinicians whose companies offer peptides and representatives of the compounding pharmacy industry. Many described the perils of the gray market for these substances, which are sold online with disclaimers, such as "for research use only" and "not for human consumption." "Many of my patients are already using these drugs. They're just getting them from the worst possible places," Dr. Jessica Duncan, chief medical officer of the telehealth company IVIM Health, told the panel.
+ A "foundational challenge" was simply defining the substances because the chemical composition for peptides labeled with the same name varied considerably, explained FDA official Russell Wesdyk.
− "The question in front of you isn't whether people will use these.
+ "You will see many many different forms," he said, "We can't create quality standards until we actually know what it is." The divide among the experts on the panel was a study in contrasts. Ahead of the meeting, eight new members were appointed.
− They already are," she said. "It's whether they use them with a doctor and a licensed pharmacy or completely alone." Meanwhile, the FDA's own scientists made the case for keeping the restrictions in place and spoke extensively about the lack of available data on safety and efficacy.
+ Most have ties to the peptide industry and include physicians who work for medical practices and companies that promote them.
− Most of the evidence on BPC-157 — which is based on a peptide found in human stomach juices — comes from preclinical work involving animals, and is quite limited for humans.
+ In almost all cases, they voted in favor of lifting restrictions.
− Beyond that, FDA official Russell Wesdyk said a "foundational challenge" with BPC-157 and all the substances under consideration is that the agency can't actually define what they are.
+ A spokesperson for the Department of Health and Human Services pushed back on criticism about potential conflicts of interest and said all underwent the standard ethics and vetting process. "I think it's about patient access," said Dr.
− There is variation in chemical composition for peptides labeled with the same name, he explained.
+ Asare Christian, one of the panel members who runs a Pennsylvania-based clinic that advertises peptide protocols and hormone optimization.
− "You will see many many different forms," he said, "We can't create quality standards until we actually know what it is." The FDA committee was tasked with reviewing data that supports using these peptides to treat specific conditions — in the case of BPC-157 for treating ulcerative colitis, an inflammatory bowel disease.
+ That sentiment was echoed throughout the many hours of public comment.
− However, if the FDA ultimately reclassifies them and they are produced by compounding pharmacies in the U.S., clinicians would have discretion to write prescriptions outside of those narrow indications.
+ Compounding pharmacies, large telehealth providers and others from the industry underscored the perils of the unregulated marketplace, with some offering anecdotes of patients obtaining unmarked vials from sketchy suppliers.
− During the meeting, industry groups said the agency's review did not reflect more recent scientific data on BPC-157 and other compounds, including results from other human studies that had been submitted ahead of time. Staff said it would take those into account before making a final decision.
+ "What we are advocating for is not the Wild West," said Brigham Buhler, who runs a telehealth company that offers hormone optimization and peptides and is an ally of Secretary Kennedy.
− Some committee members directly echoed the sentiments of those in the industry who spoke at the meeting, including Dr.
+ "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," he told the panel. But some panelists were skeptical of that argument. "I'm concerned that we are responding to market induced demand rather than a decision based in solid science," Dr.
− Kris Wusterhausen, founder of a Texas-based medical practice that advertises hormone optimization and peptide therapies.
+ Elizabeth Rebello, an anaesthesiologist at the University of Texas MD Anderson Cancer Center, commented after casting a no vote.
− "Once you see the effects of BPC, you can't unsee it," he said while explaining his yes vote.
+ The FDA committee was tasked with reviewing data that supports using these peptides to treat a variety of specific conditions, such as BPC-157 for treating ulcerative colitis, an inflammatory bowel disease.
− But others worried that placing the products on the FDA's official list for compounding will send the wrong message to the public, which may not be aware of the limited data for humans.
+ However, if the FDA ultimately reclassifies them and they are produced by compounding pharmacies in the U.S., clinicians would have discretion to write prescriptions outside of those narrow indications.
+ During the meeting, industry groups — and some on the panel — repeatedly criticized the FDA presentations for not reflecting more recent scientific data on the substances, including results from other human studies that had been submitted ahead of time. FDA staff said they had considered everything submitted by the meeting deadline and would still take new information into account as they weigh next steps. The decision to place the products on the FDA's official list for compounding doesn't come close to the standards for drug approval, but some worry that nuance will not be clear to the public, which may not be aware of the limited data for humans.
"I think this endorsement can be potentially harmful and I cannot in good conscience vote yes," said Dr. Brian Lee, a member of the panel and an associate professor at the Keck School of Medicine of USC.
− On Friday, the panel will review three other peptides: Emideltide, Epitalon and Semax.
+ If the FDA moves to reclassify the peptides so that compounding pharmacies can make them, it will be through a formal rulemaking process that could stretch into next year or 2028. There is a possibility that Kennedy could invoke special authority to make them available sooner.
+ The panel is scheduled to meet again in February to consider additional peptide therapies.
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