Kennedy: peptide plan aims at a 'regulated marketplace'

Health and Human Services Secretary Robert F. Kennedy Jr. on Tuesday, October 20, gave a direct public description of what the administration wants from the FDA’s pending peptide policy. Asked on Fox News’ “The Will Cain Show” about the proposal now at the White House, he said, according to Reuters: “Americans are going to be buying these anyway. Our objective was to make sure that there is a regulated marketplace, so that what they’re getting is what they claim to be, that is safe, that the factories are inspected.”

At the same time, the public record of who is lobbying on the policy has grown. The Office of Information and Regulatory Affairs (OIRA), the part of the Office of Management and Budget that reviews significant agency actions, now lists three outside meetings on it. We first reported the policy’s arrival at OMB in our October 14 story.

Who is meeting the reviewers

Under Executive Order 12866, outside parties may ask to meet OIRA about an action under review, and OIRA publishes a log of those meetings. For the FDA notice titled “Interim Access Policy for Compounding Using Certain Peptides” (RIN 0910-ZD94), the log showed these entries when we checked on October 21:

Meeting (as listed)	Requested by
October 21, 03:00 PM	American Academy of Peptide Medicine
October 23, 02:00 PM	Hims & Hers Health
October 27, 02:00 PM	Alliance for Pharmacy Compounding

The log does not give a time zone or say what any group will argue. All three meetings were marked “Scheduled.”

The three requesters represent different interests. The American Academy of Peptide Medicine speaks for clinicians who prescribe peptides; its meeting request is in the name of Lee Rosebush, whom USA Today identified on October 20 as chairman and general counsel of the Outsourcing Facilities Association, which represents large compounders. The Alliance for Pharmacy Compounding is the trade association for compounding pharmacies, the businesses that would actually prepare the drugs. Its chief executive, Scott Brunner, said on October 16, as quoted by Semafor, that the notice could be “potentially significant, but we don’t yet know what the policy says, which peptides it covers, or what conditions FDA may attach to their compounding.”

Hims & Hers is a publicly traded telehealth company. InsideHealthPolicy reported on October 20 that it plans to meet budget officials on Friday, October 23, after telling investors it would likely offer the substances on its platform. That makes it the first company with a direct commercial stake in selling compounded peptides to appear on the public log for this policy.

What Kennedy’s words do and don’t tell us

Kennedy’s phrase “regulated marketplace” goes further than anything in the public filing. The OIRA listing names no peptides and gives no conditions; the document is classed as a “Notice,” not a proposed or final rule, and it is not marked economically significant.

Reporting so far, including the Associated Press report cited in our earlier story, describes an enforcement-discretion approach: FDA would tell state-licensed pharmacies it does not intend to act against them for compounding certain peptides. That would be a statement of enforcement priorities, not an approval. It would not, on its own, create a licensing system for sellers, and nothing reported so far suggests it would cover products sold online as “research use only,” which sit outside pharmacy law altogether.

Kennedy’s reference to inspected factories does line up with one existing rule. Section 503A already requires pharmacies to buy bulk ingredients from establishments registered with FDA, with a certificate of analysis. Whether the interim policy adds stricter testing or sourcing conditions for peptides is one of the open questions.

What is not known

• The text of the policy, which peptides it lists, and whether it covers 503B outsourcing facilities as well as 503A pharmacies.
• What was said at the October 21 meeting. No account of it had been reported when we published, and OIRA typically adds any handouts to the meeting record afterward.
• Whether FDA will also start the formal rulemaking needed to add any peptide to the 503A bulks list.
• How the July advisory committee votes, in which outside advisers backed six of seven peptides against FDA staff advice, will figure in the final document.

What to watch

The Hims & Hers meeting on October 23 and the compounding group’s meeting on October 27; any materials OIRA posts to the meeting records; and the document itself, which would appear on the review dashboard as concluded before FDA publishes it. We will add each step to this story and to the tracker.