FDA peptide review could lead to new compounding boom

• Some experts worry this growth could come at the expense of patient safety, since there isn't much data on how the substances affect human health.

Driving the news: A Food and Drug Administration advisory panel will evaluate whether to loosen restrictions on compounding — the process of creating customized medications — for seven peptides in a two-day meeting starting Thursday.

• The Biden administration banned more than a dozen peptides from being compounded in 2023 due to safety concerns.
• But Health Secretary Robert F. Kennedy Jr. is a peptide supporter — and user — and has said the administration wants to make the substances more available to consumers.
• The FDA has approved some peptides as medications, like semaglutide. But other largely unstudied products that haven't gone through FDA approval have become popular as supplements or medication alternatives.

State of play: Companies are already making big bets on peptides. Telehealth company Hims & Hers purchased a peptide manufacturing facility last year and is building out a clinical strategy for the substances.

• Samsung Biologics announced plans Monday to buy a Swiss peptide ingredient manufacturing company for about $1.8 billion, Axios Pro's Claire Rychlewski reported.
• Ivim Health, another telehealth platform, sees the ability to offer compounded peptides as a growth opportunity and a way to better serve patients, said chief medical officer Jessica Duncan.
• "We do have patients asking about this, just about every day," said Duncan, an obesity medicine physician.

What they're saying: The compounding pharmacy industry's standing among consumers "is higher than it was at the start of the GLP-1 phenomenon, and I think we have the potential to build on that" with peptides, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding.

• Brunner wants the FDA to allow peptides to be compounded, with guardrails like requirements to use active ingredients from specific vetted sources and report any side effects or other problems.

Zoom in: Supporters of compounding for peptides say consumers are already getting them on the "gray market," and allowing them to be compounded will pave the way for safer production and physician-supervised use.

• "We see a path forward in which we can make these compounds available to people so that they can benefit ... in a way that feels responsible, safe, and rigorous, so that people understand fully what they're getting into," Anant Vinjamoori, Hims' chief medical officer, told Axios.
• Other physicians say the lack of research on these products means they're still too risky for widespread use.

What we're watching: FDA scientists have encouraged the panel not to allow compounding for any of the peptides due to lack of data on their safety for use in humans.

• But many of the advisory committee members appointed by Kennedy have ties to the peptide industry.
• FDA leadership has final authority over the decision, and if it decides to allow compounding, the agency will have to go through a potentially lengthy rulemaking process before peptides could be made.

Go deeper: Chinese fentanyl makers find new U.S. market in peptides