FDA Expands Peptide Compounding Access, But Doctors Urge Patience for Safety Data

Dr. Frank Contacessa, an internist at Custom Care Medical, stated Sunday that while peptide-based therapies are not new—note that popular diabetes and weight-loss medications such as Ozempic and Mounjaro are themselves peptide drugs—the specific compounds under FDA review carry limited evidence for safe use.

“The peptide story is not new. These particular ones are,” Contacessa said. “I agree with what the FDA is doing here, which is expanding access and being able to allow people to get these drugs compounded and control things a little bit more.”

The compounds have generated significant interest for their potential uses in anti-aging, recovery, sleep, and energy enhancement. This follows a vote by the Food and Drug Administration’s Pharmacy Compounding Advisory Committee that recommended adding six peptides to the list of substances licensed pharmacies may compound while rejecting a seventh peptide, contrary to FDA staff recommendations.

Contacessa emphasized physicians should proceed cautiously due to limited evidence supporting many newly considered peptides. “I think there’s a lot of potential here. I’m not ready to use this in clinical practice on my own patients yet just because there’s not enough data,” he said. “But I think there’s a couple here on the horizon that have a lot of potential, particularly in the anti-aging recovery.”

Contacessa also raised theoretical risks associated with some peptides designed for healing. “There’s a couple of concerns too. So now if you’re going to have something that promotes recovery, you might also promote something like cancer cells,” he noted. “There are some concerns there. Maybe not, but I think there’s enough reason to be hesitant. We can’t allow the excitement to outpace the science.”

Lee Rosebush, chair of the American Academy of Peptide Medicine and author of The Peptide Revolution, took a different stance, arguing that patients and physicians should determine whether peptide therapies are appropriate. “To me, it’s a pretty simple question: Should patients have safe access to these? And unfortunately, what we’ve had at this point is regulators stepping between the most sacred relationship there is between a health care provider and their patient,” Rosebush said. “It’s not the FDA’s job to make that decision. It’s what’s in the patient’s best interest and what’s the provider’s best interest.”

Rosebush, who testified before the advisory committee, criticized the FDA for failing to review evidence submitted by his organization prior to the hearing. He noted that the American Academy of Peptide Medicine provided safety information covering more than 16 million doses of BPC, one of the peptides under consideration, along with a U.S.-based randomized, placebo-controlled clinical trial. “Unfortunately, during the hearings, we actually heard the FDA have to admit they didn’t review it,” Rosebush said. The academy also established a Peptide Council to help accredit pharmacies and develop standards for manufacturing compounded peptide products safely.

“The material that we provided over to the agency included human trials domestically, done domestically, made under domestic standards,” he added. “If the FDA needed more time, they should have set a different deadline. They didn’t do it because we met the agency’s deadline.”