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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The interim enforcement policy states that the decision was based on July\u2019s Pharmacy Compounding Advisory Committee meeting. An expert discussed the potential benefits and consequences. HHS has taken action to expand access to six peptides that were key in a controversial meeting this summer. The interim enforcement policy states that, based on the Pharmacy Compounding Advisory Committee (PCAC) meeting that took place in July, \u201cHHS believes that there is significant interest in the use of these peptides in compounding.\u201d So, in an effort \u201cto expand and improve patient access while FDA reviews these substances,\u201d HHS will not take action against physicians, state-licensed pharmacies or federal facilities compounding a drug using the following bulk drug substances on the 503A list:
HHS has taken action to expand access to six peptides. Image: Adobe Stock
BPC-157; epitalon; KPV; MOTS-c; semax; and TB-500. HHS Secretary Robert F. Kennedy Jr. \u201cdetermined that the policy advances patient choice and freedom while appropriately protecting patient safety,\u201d according to the policy. In \u201callowing limited compounding of the substances … under appropriate safeguards, the policy provides patients with a more controlled alternative\u201d to those supplied by foreign manufacturers \u201cthat pose a safety risk to U.S. patients.\u201d Owais Durrani, DO, an emergency medicine physician in Houston told Healio he hoped the \u201cclose votes\u201d in July \u201cwould make the FDA take its time\u201d with peptides. \u201cIn a sense, it did, since the agency never added these to the approved list. The secretary went around that process instead, which skips the rulemaking and public comment that a formal listing would have required,\u201d Durrani said. \u201cThe FDA\u2019s own scientists advised against these compounds, and nothing about the human evidence has changed since the summer. Unilateral decisions that skip the formal review process are dangerous when it comes to human health and science.\u201d During the PCAC meeting, Matthew Lash, JD, acting director of the FDA\u2019s Office of Compounding Quality and Compliance, clarified that compounded drug products are primarily overseen by state regulators and \u201care not FDA-approved,\u201d meaning \u201cthey\u2019ve not been reviewed by the FDA for safety, efficacy or manufacturing quality before marketing.\u201d According to reporting from the Associated Press, FDA\u2019s \u201cscientific staffers had little input on the decision and opposed the changes\u201d in the interim enforcement policy. Citing six people familiar with the development, the AP reported that the document \u201cfaced overwhelming pushback\u201d from those FDA staffers \u201cwho warned it could undermine the agency\u2019s long-standing mission of keeping unsafe health products off the U.S. market.\u201d Durrani said the rule could offer \u201ca genuine benefit for people who are already injecting these\u201d peptides \u201cbecause a prescription filled by a registered pharmacy is a lot safer than a vial from an overseas website where purity can be anyone\u2019s guess.\u201d But his bigger concern is how the public will hear this news. \u201cMost patients will take it as an FDA endorsement, even though HHS has said it isn\u2019t one, and telehealth companies are ready to scale it quickly,\u201d Durrani said. \u201cSome of these compounds act on things like tissue growth and cellular aging, where the long-term questions involve cancer risk, and we have very little human data to answer them. The adverse event reporting requirement is a good addition, though it only matters if someone trustworthy is actually reviewing those reports and acting on them.\u201d Ultimately, Durrani said it is important to remember that \u201cnone of these are approved, and there\u2019s still no established dose or long-term safety data for any of them.\u201d \u201cMost were reviewed for narrow uses like ulcerative colitis or wound healing, while patients will be asking about joints, recovery and longevity,\u201d he concluded. \u201cWith a prescription now required, the responsibility lands on the physician who signs it, so anyone prescribing should do real informed consent, document it and report any adverse events they see. Declining to prescribe these is a completely reasonable choice, and clinicians should be ready for patients who walk in believing these are FDA-cleared.\u201d For more information: Owais Durrani, DO, can be reached at owaisdurrani@gmail.com. Ask a clinical question and tap into Healio AI’s knowledge base.
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