Peptide group to meet with White House over pending regulatory plan

The U.S. Food and Drug Administration (FDA) has submitted a proposed "interim access policy" to the White House for review, according to a government filing. This policy would allow compounding pharmacies to temporarily produce and sell previously restricted peptides. The move comes amid growing interest in these substances, particularly among supporters of Health and Human Services Secretary Robert F. Kennedy Jr., who has expressed strong support for expanding access to peptides. The FDA's filing with the Office of Management and Budget does not provide specific details about the policy. However, it follows an advisory panel meeting in July where the FDA's Pharmacy Compounding Advisory Committee (PCAC) voted to permit the production of six peptides used to treat conditions such as insomnia, obesity, and wound healing. These substances were among 14 previously banned due to potential serious safety risks. Kennedy, who describes himself as a "big fan of peptides," argues that compounding pharmacies should be allowed to sell these substances because many Americans are turning to unsafe, "gray market" versions produced abroad. He claims that these alternatives are being sold on platforms like TikTok and pose significant health risks. Despite the PCAC's approval, the decision was controversial. FDA scientists evaluated the six peptides and found insufficient evidence to support their efficacy or safety. For example, agency researchers noted that there is a lack of evidence regarding the effectiveness of BPC-157 for treating ulcerative colitis. Similar findings were reported for the other five peptides. The American Academy of Peptide Medicine is set to meet with the Office of Management and Budget to discuss the pending regulation. Alliance for Pharmacy Compounding CEO Scott Brunner stated that the notice could be potentially significant, though the exact terms of the policy, the peptides covered, and any conditions attached to compounding remain unclear. The proposed policy aligns with broader efforts by the Trump administration and the Make America Healthy Again movement to promote access to unproven products. Some prominent figures within the movement are known to sell peptide injections and supplements. The FDA previously listed BPC-157 and more than a dozen other injectable peptides as too risky for compounding. The interim policy aims to provide temporary access to these substances while the agency works on developing long-term regulations. The White House filing does not specify the exact scope of the policy, but sources indicate it is intended to allow pharmacies to temporarily compound some of the most popular peptides, including BPC-157, which is marketed for muscle building and injury healing. As the policy awaits final approval, stakeholders continue to monitor developments closely. The outcome could significantly influence the availability and regulation of peptides in the United States.