HHS sends peptide "interim access policy" for compounding pharmacies to White House review

Mixed · 2A peptides "interim access policy" was submitted to the White House for review, according to a posting on a government website on Thursday 15 October. The plan went to the Office of Management and Budget, which reviews federal rules with potentially significant economic impact. 1 2 Centre · 1The filing gives no specifics. Two people familiar with the plan told the Associated Press, speaking anonymously, that it is meant to let pharmacies temporarily compound some of the most popular peptides, including BPC-157, a chemical promoted to build muscle and heal injuries. 1 Mixed · 2The mechanism would be "enforcement discretion": the FDA would assure compounding pharmacies they will not be targeted for making certain peptides, by choosing not to enforce some of its own regulations. 1 2

Mixed · 2Formally adding the peptides to the FDA's list of substances that can be compounded would require federal rulemaking, which could take years and involve multiple rounds of public comment. AP said it was unclear whether the administration still plans to pursue that route. Ars Technica said the enforcement discretion could ease access in place of that rulemaking or while it runs. 1 2 Centre · 1The peptides at issue have not been approved by the FDA for these uses, and most of the data comes from animal studies. They are popular for bulking up, looking younger or boosting energy. The FDA had earlier put BPC-157 and more than a dozen other injectable peptides on its list of substances too risky to compound, citing possible contamination, allergic reactions and tumour growth. 1 Centre · 1Health Secretary Robert F. Kennedy Jr. favours the drugs. Before joining the administration, Kennedy said "FDA’s war" on peptides would end. As secretary, Kennedy has argued that US compounding pharmacies must be allowed to sell peptides because Americans are turning to "gray market" products made in China and elsewhere. 1

Mixed · 2In April the FDA said it would reconsider 12 peptides. In June, according to Ars Technica, Kennedy appointed nine new members to a 13-member advisory panel, and at least six of them have ties to peptide-related businesses and clinics. In July the panel recommended dropping restrictions on six of the seven peptides it considered, against the conclusion of FDA staff scientists, who said none had been studied enough to establish safety and effectiveness. 2 1 Mixed · 2Some Kennedy allies who sell peptides praised the proposal online; wellness clinic operator Brigham Buhler wrote on X, "This is huge," and framed it as a matter of "MEDICAL FREEDOM." The Center for Science in the Public Interest, led by president Pete Lurie, wrote to Acting FDA Commissioner Kyle Diamantas this week urging him to disregard the panel's recommendations, warning that "charlatans" would otherwise put consumers at risk. 1 2 Mixed · 2Commercial interest is growing: telehealth providers Hims & Hers and Noom have said they plan to offer peptides if federal access is eased, and Wall Street analysts estimate the market at $2 billion to $3 billion. HHS did not immediately respond to AP's request for comment, and did not respond to Ars Technica's. 1 2