The peptide saga has reached what could be its most confusing chapter — at least for consumers.The popular — and experimental — drugs received unprecedented attention in late July during a marathon hearing held by a panel that advises the Food and Drug Administration.The panel considered whether to back the production of seven different peptide therapies — and voted in favor of all but one — despite concerns raised by the agency's own scientists.These peptides include some of the most sought-after injectables, BPC-157, TB-500 and MOTS-c.But that recommendation alone doesn't change the status of these substances.It's still illegal for pharmacies in the U.S.
to make these compounds.The FDA staff and leadership now need to review the data and decide whether compounding pharmacies in the U.S.should be allowed to make any of the seven peptides the panel considered.It's a regulatory nuance that Dr.
Jessica Duncan, who spoke in favor of peptides at the FDA meeting, now finds herself explaining to patients who've seen the headlines and want to know when these therapies will be available."They are now even more curious," says Duncan, chief medical officer for the telehealth company IVIM Health."We tell them that the timeline is uncertain."There's no guarantee, but it seems likely the FDA will move forward.
The agency usually follows its advisory committees' recommendations.Plus, there's high demand for these products — and Health Secretary Robert F.Kennedy Jr., whose agency oversees the FDA, has called to make them available.Normally, the agency would move forward through its formal rulemaking process, which could take anywhere from several months to possibly over a year, says Jesse Dresser, a partner at the law firm Frier Levitt who represents compounding pharmacies and others in the industry."It would actually surprise me if this followed the traditional pathway of formal rulemaking," Dresser told NPR.
"Whatever options exist to make this a faster process, ...