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HHS and FDA send interim access policy for compounded peptides to OMB for review…

Sources (4)

The peptide narrative has moved from an advisory committee recommendation to the first step of actual administrative policy. On 15 Oct HHS and the FDA sent an interim access policy for certain compounded peptides to OMB. It takes the enforcement discretion route:

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for now the regulators will take no enforcement action against 503A compounding pharmacies that produce designated peptides. The OMB filing names no specific peptides; AP's sources named BPC-157. In July the PCAC recommended, by 8 votes to 6, that BPC-157, KPV, TB-500, MOTS-c, epitalon and Semax be added to the 503A list. If the White House approves, the door opens before formal rulemaking lands, and the launch timing of the major peptides moves forward from next year and beyond. HIMS has already run API stability and validation tests on the relevant peptides at its Menlo Park plant. Dudum has said the company's operating model is to wait for full and final FDA rulemaking, while also saying HIMS can move extremely quickly if the FDA moves the peptides to Category 1. The direction adds points, but the weighting is neutral to cautious: the policy is still at OMB review with no effective date, and the efficacy and compliance tail risks remain.

Key evidence

  • On 15 Oct HHS and the FDA sent an interim access policy for certain compounded peptides to the White House Office of Management and Budget (OMB) for review (posted on the reginfo.gov/OMB government site and cross-checked by AP, Reuters and MedPage)
  • The mechanism is enforcement discretion: the regulators will temporarily take no enforcement action against 503A compounding pharmacies that produce designated peptides
  • The OMB filing names no specific peptides; AP's sources named BPC-157. In July the PCAC advisory committee recommended, by 8 votes to 6, adding 6 of the 7 peptides to the 503A list: BPC-157, KPV, TB-500, MOTS-c, epitalon and Semax
  • The timeline for delivery has moved up markedly: earlier (on the Dudum call on Monday 10 Aug) the view was that until year end only wellness peptides needing no approval (sermorelin, glutathione, NAD+) could hold the place, and the real 503A major peptides would have to wait for the FDA's final rulemaking (months to years)
  • HIMS uses the 503A channel and has already built capacity: the Menlo Park plant has long run API stability and validation tests on the relevant peptides (recorded 10 Aug). Dudum said the company's operating model is to wait for full and final FDA rulemaking, while also saying HIMS can move extremely quickly if the FDA moves the peptides to Category 1
  • AP reported analyst estimates of $2 billion to $3 billion for the peptide market, and the window for the opportunity to pay off has moved forward

Catalysts to watch

  • The White House OMB ruling on the interim access policy: approval makes it effective, with a date
  • Further progress on formal FDA rulemaking (months to years)
  • Whether Q4 profit can jump, the real proof point for the core tension (whether the peptides are cleared does not change the short-term earnings quality problem)
  • HIMS's first comments on peptide revenue guidance and capacity utilisation in the November earnings season
  • The regulators' follow-up response to the gaps in efficacy evidence and to cases of harm to users

Risks

  • The policy has only reached OMB review: the White House has not approved it and there is no effective date. Submission is not implementation
  • Temporary enforcement discretion is not permanent legalisation and can be withdrawn at any time, so legal certainty is weak
  • The gap in efficacy evidence is unresolved: several media outlets reported cases of harm after users took these peptides, and BPC-157, TB-500 and MOTS-c have no human RCT endpoint data
  • The outstanding FTC privacy lawsuit and the securities class action: the tail risk of selling products with unproven efficacy in a period of heightened compliance sensitivity rises in step
  • The core tension is unchanged: revenue up 38% year on year against earnings quality and compliance costs eating into results from both sides, with gross margin compressed to 64% and a swing to an $86.3 million loss

Sources 4

  1. reginfo.gov/OMB government site notice, 15 Oct: Interim Access Policy for Compounding Using Certain Peptides
  2. AP, 15 Oct: HHS and FDA send interim peptide policy to OMB
  3. Reuters, 15 Oct: cross-reporting on the same topic
  4. MedPage, 15 Oct: same topic, plus the context of cases of harm to users

A brief is a lead for our research, not a verified conclusion or advice.