White House review
FDA's peptide compounding policy
FDA's proposed interim policy covers which peptides pharmacies can compound. The White House budget office (OMB) has been reviewing it since Oct. 14. The American Academy of Peptide Medicine meets the reviewers on Wednesday, and Hims & Hers meets them on Friday.
- White House received FDA's interim policy on compounded peptides.
- Wed., Oct. 21American Academy of Peptide Medicine meets the White House, 3 p.m.
- Fri., Oct. 23Hims & Hers meets the White House, 2 p.m.
- Jan. 12, 202790-day review ends, by our count.
- Feb. 11, 2027Review ends if extended once, by our count.
Executive Order 12866 gives the White House 90 days to review, plus one 30-day extension. The end dates are our math.
Background
FDA hasn't published the policy text
The only public account of what the policy would allow comes fromAP. Under it, pharmacies could compound popular peptides such as BPC-157 for a while without FDA coming after them. That is enforcement discretion, and FDA can take it back.
Doctors for America asked OMB on Oct. 16 to send the policy back to FDA. DFA also asks OMB to block the policy for any peptide that isn't on FDA's Category 1 list, the bulk substances pharmacies may compound from during FDA's review. It names BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax. DFA says FDA's own staff scientists recommended in July that none of the seven peptides reviewed be added to the compounding list. FDA's Pharmacy Compounding Advisory Committee overrode them 8-6, and its vote is only a recommendation. DFA adds that one newly appointed committee member runs an anti-aging clinic that sells a BPC-157 product for $149.
The meeting log doesn't say what Hims & Hers will argue. Our Oct. 20 issue misstated the review deadline. The correction is on the About page.
Our take
Until the White House finishes its review and FDA publishes the text, we wouldn't sign a peptide supply contract or buy peptide ads on the strength of an 8-6 advisory vote.
Sources