FDA set to review controversial peptides
Federal health officials will meet with outside advisers this July to consider easing limits on seven unapproved peptides that have been promoted by RFK Jr. and others, a formal advisory review that could affect access ( ). The review centers on whether these peptide injections can be safely produced by pharmacies, and news of the potential loosening sent Hims & Hers Health shares up as much as 12% on the market (bloomberg.com).
The Food and Drug Administration will ask outside advisers in July whether seven peptide ingredients should be allowed back into pharmacy compounding. (fda.gov) The two-day Pharmacy Compounding Advisory Committee meeting is set for July 23 and July 24 at the Food and Drug Administration’s White Oak campus in Silver Spring, Maryland, with a public docket open for comments through July 22. (fda.gov, federalregister.gov) The seven substances on the agenda are BPC-157, KPV, TB-500, MOTs-C, emideltide, Semax and Epitalon, each paired with specific proposed uses such as ulcerative colitis, wound healing, obesity, osteoporosis, sleep disorders, cognitive disorders and vision disorders. (fda.gov) Peptides are short chains of amino acids, the chemical building blocks of proteins, and sellers often market these injections for muscle gain, injury recovery, anti-aging or weight loss. Most of the products under review are not approved drugs, and the Food and Drug Administration has said many peptide claims rest on limited human evidence. (pbs.org, nbcnews.com) The regulatory fight is about compounding, the pharmacy practice of mixing customized medicines when a mass-manufactured product is unavailable or unsuitable for a patient. Under Section 503A, pharmacists and physicians generally can use a bulk ingredient only if it has a United States Pharmacopeia monograph, is a component of an approved drug, or appears on the Food and Drug Administration’s 503A bulks list. (fda.gov) That list matters because inclusion can open a legal path for state-licensed compounders to make patient-specific versions from raw ingredients. The July meeting will address whether these seven peptides belong on that list, and the advisers’ vote will be nonbinding. (fda.gov, fda.gov) The review follows a harder line taken under former President Joe Biden, when the Food and Drug Administration added nearly 20 peptides to a category for substances that should not be compounded because they present significant safety risks. At that time, the agency’s pharmacy advisers voted overwhelmingly that the peptides did not meet the standard for safe compounding. (pbs.org, nbcnews.com) Health and Human Services Secretary Robert F. Kennedy Jr. has repeatedly called for easier access to peptides and has said he used them for his own injuries. The Associated Press reported that the agency also plans to remove the seven chemicals from a more restrictive list for unapproved high-risk drugs while the review moves forward. (nbcnews.com, pbs.org) Critics say that shift could weaken the usual drug-approval system by letting unapproved products reach patients without the clinical testing required of drugmakers. Peter Lurie of the Center for Science in the Public Interest told the Associated Press that allowing peptides onto the market through compounding poses a “profound threat” to the Food and Drug Administration’s vetting framework. (pbs.org, nbcnews.com) Investors immediately treated the review as a possible access expansion. Bloomberg reported that Hims & Hers Health shares rose as much as 12% after Kennedy said regulators would loosen peptide restrictions. (bloomberg.com) The next milestone is the July advisory meeting, where nominators of the substances will be invited to argue for them one by one before the Food and Drug Administration decides whether any of the seven can move onto the compounding list. (fda.gov)
