Kennedy moves to ease access to six unapproved peptides

Health and Human Services Secretary Robert F. Kennedy Jr. has issued a draft policy that would let certain compounding pharmacies prepare six unapproved peptides promoted for wellness, while leaving the drugs’ legal status and lack of Food and Drug Administration approval unchanged.

The policy, filed Wednesday, says the department does not intend to take enforcement action against licensed pharmacies or physicians for compounding the six substances under specified conditions. They are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. Compounding pharmacies prepare customized medications for individual patients.

“By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative,” Kennedy wrote.

Peptides are chains of amino acids that can have powerful effects in the body. Some, including insulin and peptides used in GLP-1 medications, are FDA-approved. The six covered by Kennedy’s policy are not. NPR reported that their promoted uses include ulcerative colitis for BPC-157, insomnia for Epitalon, wound healing for KPV and TB-500, metabolic health for MOTS-c and migraine for Semax. Evidence of their safety and effectiveness remains sparse.

An FDA advisory panel voted in July to recommend allowing the six to be compounded, but FDA scientists recommended against easing restrictions, citing insufficient evidence of safety and effectiveness. The panel’s vote did not amount to FDA approval. Kennedy cited its recommendation, saying the policy “advances patient choice and freedom while appropriately protecting patient safety.”

An HHS spokesperson told CBS News that the policy requires prescriptions for individual patients, traceable ingredients, quality testing and safety reporting. It also requires ingredients from an FDA-registered maker, a laboratory certificate for raw ingredients and reports of serious side effects. “The policy does not grant FDA approval or establish clinical safety and effectiveness,” the spokesperson said.

NPR reported that the enforcement approach applies to smaller pharmacies known as 503A compounders, not larger 503B outsourcing facilities. Joshua Fritzler, president of Florida-based Olympia and Wesley Pharmaceuticals, told NPR that his company’s smaller facility would probably make only one of the peptides after preparing to do so. “We won’t be able to meet demand,” he said.

Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, called the policy a “more accountable alternative” to gray-market products, according to NPR. He said suppliers and pharmacies would need time to verify that ingredients meet its requirements.

Consumer groups raised objections. NPR reported that Public Citizen’s Dr. Robert Steinbrook said the decision would allow unproven, potentially unsafe peptides to be made and prescribed without fear of federal enforcement, and urged clinicians to discuss contamination and other risks with patients. The Partnership for Safe Medicines had petitioned the FDA to reject the advisory panel’s recommendation, NPR reported.

CBS News reported that a laboratory test of an experimental weight-loss product sold as the peptide retatrutide at a Brooklyn bodega found it contained no peptide. Retatrutide is not among the six substances in Kennedy’s policy.

The draft will be open for public comment from Friday through Nov. 13, CBS News reported. It is intended to remain in place until the FDA finalizes a rule on compounded peptides, though the agency has not proposed one.