FDA scientists warn against expanded peptide access as Kennedy reshapes advisory panel
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Federal health scientists are urging caution about expanding access to controversial peptide drugs, even as the U.S. Food and Drug Administration (FDA) reshapes the advisory panel that will consider whether to loosen those restrictions.
FDA career scientists quietly posted recommendations online Monday in several briefing documents advising against easing rules that would let compounding pharmacies produce seven peptides for uses ranging from ulcerative colitis to insomnia and obesity, reports The Washington Post.
The staff scientists determined there was insufficient evidence on the peptides' effectiveness and safety.
The recommendation puts agency experts at odds with U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., a self-described "big fan" of peptides who has said he has used them on injuries with "really good effect."
Also on Monday, the FDA released the list of participants for the two-day July meeting of its Pharmacy Compounding Advisory Committee. At least seven members have ties to peptide businesses or clinics, reports The Associated Press
Peptides, short chains of amino acids, are increasingly marketed by wellness clinics and online sellers as a way to build muscle, heal injuries and slow aging. But many have not gone through rigorous clinical trials.
The FDA has warned about the safety risks of injecting substances like BPC-157 and TB-500, both considered doping agents by international sports authorities.
Previous versions of the same FDA panel were mostly composed of experts from universities including Duke, Harvard and Johns Hopkins, according to AP News. Those panels repeatedly voted against allowing peptide ingredients into compounded medications, declaring them too risky for patients.
The new group instead includes doctors and pharmacists who run peptide clinics, sell peptide injections or promote the substances online, according to The AP.
Also on the panel is Tennessee state Sen. Bobby Harshbarger, a pharmacist whose mother, U.S. Rep. Diana Harshbarger, sent Kennedy a letter last year urging him to relax restrictions on several peptides. Both Harshbargers are Republicans.
HHS spokesperson Emily Hilliard said committee members underwent the same ethics review required of all FDA advisory candidates, and that anyone unable to meet the requirements was removed from consideration, according to The Washington Post.
Outside experts remain skeptical of the overhaul.
"It seems RFK Jr. stacked the committee," Paul Knoepfler, a professor at the University of California, Davis, School of Medicine who tracks unproven peptide use, told The Post. "It sure seems like a group that could overrule FDA staff."
Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former FDA official, said a "reputable" panel typically would exclude members with a financial interest in the outcome of a vote.
The FDA is not required to follow the advice of its advisory committees, but often does.
Its final determination on the seven peptides is expected after the July meeting.
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