Health Secretary Robert F. Kennedy Jr. has unilaterally issued a rule allowing specialty pharmacies to sell six specific peptide drugs, overruling scientists at the Food and Drug Administration who say there is insufficient evidence of their effectiveness and that they may be dangerous.
The rule, titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," was made available Wednesday on the Federal Register, with final publication set for October 30. It does not change the regulatory status of the peptides but states the Department of Health and Human Services will no longer take enforcement action against compounding pharmacies that produce and sell them, effectively giving a green light to their manufacture.
The peptides are popular among members of Kennedy's Make America Health Again movement, and many prominent MAHA figures and Kennedy allies sell them. Kennedy has said he uses some of the peptides and called himself a "big fan."
In 2023, the FDA removed the six peptides from a list of drugs eligible for compounding, citing safety concerns. Kennedy's new rule sidesteps the need to formally undo that FDA action.
He had quietly proposed the rule earlier this month.
Analysis
Why This Matters
- The rule bypasses the FDA's scientific review process, allowing potentially unproven drugs to reach consumers without formal approval.
- It sets a precedent for the Health and Human Services secretary to overrule agency experts on drug safety decisions.
- The peptides are already being sold by figures in the Make America Health Again movement, raising questions about conflicts of interest and regulatory oversight.
Background
The FDA removed the six peptides from a list of drugs that can be made by compounding pharmacies in 2023, citing safety risks. Robert F. Kennedy Jr., a longtime vaccine skeptic and health contrarian, was appointed Health Secretary and has promoted alternative health products. The Make America Health Again movement advocates for reduced regulation on such products. Compounding pharmacies produce customized versions of drugs, but in some cases they make specialty drugs in bulk.
Key Perspectives
- Robert F. Kennedy Jr.: Called himself a "big fan" of the peptides and supports their availability to the public.
- FDA scientists: Continue to say there is insufficient evidence to show the peptides are effective and that they are potentially dangerous.
- Compounding pharmacies and MAHA figures: Sell the six peptides and stand to benefit from the rule's enforcement discretion.
What to Watch
- Whether the FDA or public health groups challenge the rule in court or through administrative procedures.
- Whether adverse health events linked to the peptides emerge and prompt renewed scrutiny.
- Whether Kennedy extends similar enforcement discretion to other unapproved drugs or treatments.
Checked
11 claims in this story checked against 1 source: 11 supported.
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- SupportedRFK Jr. overruled the FDA in issuing the rule.Ars Technica - All content: “Robert F. Kennedy has unilaterally passed a rule that will allow specialty pharmacies to sell six specific peptide drugs, overruling scientists at the Food and Drug Administration.”
- SupportedThe rule allows specialty pharmacies to sell six specific peptide drugs.Ars Technica - All content: “Robert F. Kennedy has unilaterally passed a rule that will allow specialty pharmacies to sell six specific peptide drugs”
- SupportedFDA scientists say there is insufficient evidence of the peptides’ effectiveness and that they may be dangerous.Ars Technica - All content: “FDA scientists continue to say there is insufficient evidence to show if they're effective and they are potentially dangerous.”
- SupportedKennedy says he uses some of the peptides.Ars Technica - All content: “Kennedy said he uses some of the peptides and called himself a "big fan."”
- SupportedKennedy called himself a “big fan.”Ars Technica - All content: “Kennedy said he uses some of the peptides and called himself a "big fan."”
- SupportedThe rule was made available Wednesday on the Federal Register, with final publication set for October 30.Ars Technica - All content: “The rule is titled "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" and was made available Wednesday on the Federal Register , with the final publication data set for October 30.”
- SupportedThe rule does not change the peptides’ regulatory status and says HHS will no longer take enforcement action against compounding pharmacies for making them.Ars Technica - All content: “The rule does not change the regulatory status of the peptide; instead, it states the Department of Health and Human Services (HHS) will no longer take enforcement action against compounding pharmacies for making the peptides”
- SupportedThe peptides are popular among MAHA members, and many prominent MAHA figures and Kennedy allies sell them.Ars Technica - All content: “The peptides are popular among members of Kennedy's Make America Health Again movement and many prominent MAHA figures and Kennedy allies sell them.”
- SupportedIn 2023, the FDA removed the six peptides from a list of drugs that can be made by compounding pharmacies because of safety concerns.Ars Technica - All content: “In 2023, the safety concerns led the FDA to remove the six peptides from a list of drugs that can be made by specialty pharmacies called compounding pharmacies”
- SupportedKennedy’s rule sidesteps the need to formally undo the FDA’s 2023 action.Ars Technica - All content: “Kennedy's new rule sidesteps the need to formally undo that FDA action.”
- SupportedKennedy had quietly proposed the rule earlier this month.Ars Technica - All content: “Kennedy had quietly proposed this rule earlier this month.”