FDA advisory panel on peptide drugs includes industry promoters amid safety concerns
The FDA's upcoming advisory meeting on seven peptide compounds will feature several clinicians and business owners who sell or prescribe the substances, prompting questions about conflicts of interest and the drugs' safety.
The Food and Drug Administration is set to hold a two-day advisory meeting in July to review seven injectable peptides, including BPC-157 and TB-500, that have not been approved for human use. Unlike prior panels that were composed mainly of university researchers, the new committee includes several practitioners and entrepreneurs who market or dispense the compounds.
Panelists include Dr. Haleem Mohammed, who operates a chain of clinics in Florida that sell peptide injections alongside vitamins and hormone therapies, and Dr. Gabriel Alizaidy, who offers paid consultations on peptide and hormone use and promotes the products to a large social-media audience. Another member, Tennessee state senator Bobby Harshbarger, is a pharmacist at his family’s compounding pharmacy that distributes peptide formulations.
The FDA has previously warned about the risks of injecting these chemicals, noting a lack of human studies and classifying them as prohibited doping agents by international sports bodies. Earlier advisory panels, composed of experts from institutions such as Duke and Harvard, voted against allowing the same peptide ingredients, citing safety concerns.
Regulatory rules require panelists to disclose any financial ties to the industry, and the agency must justify the inclusion of members with potential conflicts. Critics, including former FDA commissioner Marty Makary, have argued that advisory panels can be costly and subject to conflicts of interest, while supporters of the peptides argue for relaxed restrictions.
The meeting will be conducted under standard transparency guidelines, and the FDA has not yet released a final decision on the peptide proposals.