The Food and Drug Administration will hold a meeting in July to consider easing restrictions on seven peptide injections, a move that could open the door to broader use of drugs that have drawn interest from wellness influencers, fitness gurus and celebrities. The agency said in a federal notice on Wednesday that it will ask a panel of outside advisers to review the peptides, then soon remove the chemicals from a restrictive list reserved for unapproved, high-risk drugs.
One of the products under review is BPC-157, which is marketed to heal injuries and reduce inflammation. The decision lands after the FDA, under President Joe Biden, added nearly 20 peptides to a federal list of substances that should not be produced by compounding pharmacies, and after the agency's pharmacy panel previously voted overwhelmingly that the drugs did not meet the criteria for substances that can be safely compounded.
The timing matters because the FDA's panel now has vacancies, and many of the advisers and internal staff who handled the earlier peptide decisions no longer work for the agency. That leaves Robert F. Kennedy Jr. with a chance to influence the process before the July meeting, after repeatedly pledging to loosen regulations on peptides.
Kennedy told Joe Rogan on Wednesday that he is a big fan of peptides and said he has used them himself with really good effect on a couple of injuries. The remarks add a political edge to an already contentious review, because the FDA had previously said the substances present significant safety risks and that most had not been extensively tested in humans.
Peter Lurie, a longtime critic of the agency's peptide push, said, “The Wild West is about to become wilder,” and warned that allowing peptides on the market without clinical testing poses a “profound threat” to the FDA's decades-old system for vetting drugs. He said, “I don't see why one would take the path of a proper drug approval if there is now this less rigorous, alternative path to market,” adding, “Everybody knows the outcome that the secretary wants,” and, “I don't believe for one moment that what's going on here is an honest investigation of whether these products should be compounded.”
The coming vote could reshape the path for more than a half dozen peptide injections that have moved from the margins of medicine into mainstream marketing. For patients, compounders and drug makers, the question now is whether the FDA is preparing to tighten a safety gate it spent years closing, or finally swing it open.
