When U.S. health officials meet next month to reconsider a list of controversial peptide drugs, they will hear from a new set of voices: doctors and pharmacists with deep financial ties to the burgeoning industry of unproven chemicals, reports BritPanorama.
The Food and Drug Administration on Monday released its list of participants for this upcoming meeting, which will evaluate the safety and effectiveness of several popular peptide injections, including some that have been praised by Health Secretary Robert F. Kennedy Jr.
Previous FDA panels on peptide drugs have been composed of academics and researchers. The agency’s new group mainly includes health professionals who prescribe, produce or promote peptides, which have become a wellness trend among athletes, influencers and celebrities.
The two-day meeting exemplifies how Kennedy and his deputies are attempting to reshape U.S. health policy in the mold of the Make America Healthy Again movement. Notably, some of the biggest supporters of this movement are sellers of peptide formulas, despite many experts labeling them as illegal, unapproved drugs.
The substances are sold online and promoted by wellness clinics as a means to build muscle, heal injuries and look younger, although evidence supporting these claims is largely absent. Peptide sellers often evade U.S. regulations by marketing their products as “for research use only,” allowing them to operate outside FDA oversight.
FDA has raised safety concerns about peptides
Many injectable peptides available in the U.S. are produced by compounding pharmacies that create custom medications not provided by traditional drug manufacturers.
For several years, the FDA has issued warnings about the risks associated with injecting chemicals like BPC-157 and TB-500, which remain inadequately studied in humans. Both substances are classified as doping agents by international sports authorities and are among seven peptides slated for review in July.
Previous compositions of the FDA’s panel on drug compounding voted against several peptide ingredients proposed by compounding pharmacies, deeming them too risky for patient use. These earlier panels comprised experts from prestigious institutions such as Duke, Harvard, and Johns Hopkins.
New FDA panel includes peptide proponents
The FDA’s new group features more than half a dozen panelists who operate clinics, online businesses, or pharmacies specializing in peptides frequently combined with other unapproved treatments, including vitamin infusions.
One panel member, Dr. Haleem Mohammed, oversees clinics in Florida that offer injections of peptides, vitamins, testosterone, and weight loss medications. His business operates within a national chain known as Gameday Men’s Health, with the company’s website clarifying that “compounded medications offered through our services are not FDA-approved, and the FDA does not verify their safety.”
Another panelist, Dr. Gabriel Alizaidy, charges $500 for consultations that include “advice on where to safely obtain each peptide or compound.” He actively promotes peptides to thousands of followers on platforms like Instagram and TikTok. His website states that each consultation “is educational in nature and does not constitute medical care, diagnosis, or treatment.”
Additionally, panel member Bobby Harshbarger, a Tennessee state senator with links to the peptide industry, owns a pharmacy that sells compounded medications for various health conditions. His mother, Rep. Diana Harshbarger, also involved in the pharmaceutical field, has previously urged for more lenient FDA regulations regarding specific peptides.
President Donald Trump has upheld Harshbarger’s support for his agenda, commending his efforts publicly. Last year, Trump pardoned Harshbarger’s husband, Robert Harshbarger Jr., who was previously convicted for a drug substitution crime linked to patient treatments.
The three individuals—Mohammed, Alizaidy, and Harshbarger—did not provide immediate comments when approached by the Associated Press for their perspective on the ongoing developments.
Kennedy and his allies previously criticized government panels
The FDA oversees over 30 panels of experts that assist the agency in assessing various drugs, vaccines, and food products.
Advisory meetings are governed by rigorous government transparency mandates in terms of panel composition and financial disclosures. While experts with financial interests can be appointed, they must disclose those relationships, and regulators should assess the significance of their expertise against potential conflicts of interest.
Kennedy and his associates have frequently critiqued federal expert panels, alleging pervasive conflicts of interest within them, although federal evidence contradicts such claims.
Notably, Kennedy previously disbanded the Centers for Disease Control and Prevention’s 17-member vaccine panel, replacing it with a cohort that includes several anti-vaccine advocates. A federal judge later ruled that this action likely violated federal regulations.
Kennedy has publicly expressed his support for peptides, discussing their role in his own recovery from injuries during a podcast appearance.
Former FDA Commissioner Marty Makary has voiced strong criticisms of FDA advisory panels, citing issues of expense, time consumption, and financial conflicts as significant drawbacks. Such meetings saw a marked decline during Makary’s term, with the FDA instead hosting targeted discussions on topics aligned with Kennedy’s interests.
As the debate around peptide regulation progresses, the implications for public health and regulatory practices remain substantial.
