RFK Jr. to ease access to unapproved peptides, draft policy states
Health and Human Services Secretary Robert F. Kennedy Jr. took steps this week that could open up access to certain unapproved peptide drugs that are being promoted for wellness.
In a draft policy filed Wednesday, Kennedy said he had determined that compounding pharmacies could prepare six specific peptides — BPC-157, Epitalon, KPV, MOTS-c, Semax, TB-500 — even though they do not have approval from the Food and Drug Administration.
"By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative," Kennedy wrote.
Compounding pharmacies mix ingredients to prepare customized medications for individual patients.
Although they are not FDA approved, the six peptides in Kennedy's new policy are often still marketed with health claims.
The Department of Health and Human Services "did not intend to take action" against licensed pharmacies or physicians that compound "a drug product using a peptide bulk drug substance that is not a component of an FDA-approved drug product," Kennedy's policy said.
Peptides are small proteins that can have powerful effects. There are several, such as insulin, that are FDA approved as being safe and effective. GLP-1 medications used for weight loss and to treat diabetes also contain FDA approved peptides.
In July, an FDA advisory panel voted to recommend allowing the six unapproved peptides to be used in compounding, although that decision did not constitute FDA approval. That vote, however, went against the recommendations of the FDA's own scientists, who said there isn't enough evidence of safety and effectiveness for each of the six peptides to make such a determination.
Kennedy cited that panel's recommendation in his decision, saying he had determined the policy "advances patient choice and freedom while appropriately protecting patient safety."
In a statement provided to CBS News, an HHS spokesperson said that pharmacies will have to do quality testing and safety reporting, and that should help patients know what is in these peptide drugs that are currently being sold by unregulated sources.
"The policy does not grant FDA approval or establish clinical safety and effectiveness," the HHS spokesperson said. "It requires patient-specific prescriptions, traceable ingredients, quality testing, and safety reporting to hold compounders accountable and give patients an alternative to unregulated sellers."
The draft policy requires an FDA-registered ingredient maker, a lab certificate for the raw ingredients, and reports of serious side effects.
In a CBS News investigation published last week, a laboratory test was conducted on an experimental peptide weight-loss drug known as retatrutide that was purchased from a bodega in Brooklyn, New York.
The lab test, however, found that the sample of retatrutide purchased from the bodega did not contain a peptide at all.
A CBS News investigation last summer found that dozens of clinics across the country, staffed by licensed physicians and nurse practitioners, have been openly advertising retatrutide even though it has not been reviewed by the FDA and remains in clinical trials by drug giant Eli Lilly.
Kennedy's draft policy will be open to public comment beginning Friday through Nov. 13. The policy will remain in place until the FDA finalizes a rule regarding compounded peptides. However, at this point, the FDA has not proposed one.
Dr. Céline Gounder, Adam Yamaguchi and Kerry Breen contributed to this report.
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