CSPI argues against peptides in JAMA before OIRA meeting

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Take. Expect the peptide plan to come back with more conditions than sellers asked for. Every condition costs money, which favors big telehealth brands over single clinics. We'd hold peptide ad budgets flat until the text is public.

Peter Lurie and two colleagues at the Center for Science in the Public Interest published a JAMA Viewpoint on Monday. They urge FDA not to follow July's advisory committee votes on seven peptides. CSPI's release says approving them "would create a huge, largely unregulated market." It also says FDA's proposal at the White House "would apparently lead to non-enforcement of many FDA regulations." CSPI meets OIRA, the White House office reviewing the plan, today at 2:30 p.m.

Dr. Anant Vinjamoori, chief medical officer of Hims & Hers, made the selling side's case on X Friday. He wrote that he had "just wrapped a meeting with OIRA" on the plan. He added, "Countless Americans are already using peptides right now." Sen. Roger Marshall wrote FDA last Wednesday asking it not to enforce against compounding of some peptides, per the Alliance for Pharmacy Compounding. APC says his letter sets conditions. Ingredients would come from FDA-registered makers under drug-quality rules. Compounding would happen only at registered 503B outsourcing facilities or state-licensed 503A pharmacies, for an identified patient. FDA's advisory committee would keep reviewing safety. The letter itself has not been posted. A senator's letter is pressure, not law.

FDA sent the plan to OIRA on Oct. 14 as a notice-stage Interim Access Policy, not a rule, per OIRA's meeting log. Review runs 90 days, to about Jan. 12, with one 30-day extension possible. No meeting materials have posted. Even a friendly plan won't settle the ad question. LegitScript, which ad platforms use to vet pharmacy advertisers, wrote in September that "only a final rule actually changes the regulatory status" of a substance.

[Medspa]

Private equity firms that built med spa and GLP-1 clinic chains face their first real exits in 2027, PitchBook reported Friday. A banker quoted in the piece says buyers get serious at $15 million to $20 million of EBITDA. A strong platform could fetch 14 to 15 times pro forma EBITDA if four numbers are all growing: same-store sales, patient count, ticket size and provider retention. Cascadia Capital's Josh Mastracci says PE money is moving to cash-pay models run by mid-level providers "with less regulatory exposure." Thurston Group may sell Alpha Aesthetics Partners, a 37-location chain, as soon as 2027. The biggest ask hasn't cleared. LaserAway sought more than $2 billion on about $150 million of EBITDA, per an earlier PitchBook report. That sale process is no longer active. We think buyers will pay the top multiple only for chains growing on all four counts.

[Telehealth]

Strive Specialties, a compounding pharmacy, sued Eli Lilly and Novo Nordisk in Texas in January. It argued their exclusive telehealth deals shut out compounded GLP-1s. Judge Micaela Alvarez dismissed that claim in August. The court ruled on Strive's request to reconsider on Friday, per the docket. Law360 reports the judge denied it, saying Strive's argument rested on its "own misunderstanding." No appeal has been filed. The drugmakers' deals with telehealth brands stand.

[Everyone]

The Office of the National Coordinator for Health IT certifies the electronic health record software that practices need for some Medicare programs. Its new final rule removes or revises a set of those certification criteria, per the Federal Register inspection copy. ONC puts the savings at $1.55 billion in present value, or $108.1 million a year, mostly for software vendors. The rule publishes Wednesday. Most of it takes effect in late December. Most cash-pay clinics don't use certified software.

[Prescriber]

FDA's import alert now lets in orforglipron, the drug in Lilly's Foundayo pill, from three makers it added this month. Mochi's site lists a compounded version "as low as $31."

Our board lists each seller's regular price from its own public page on the date shown. Rows dated 10/25 were read Sunday between about 9:05 and 9:25 a.m. ET. Intro offers are left out. Compounded drugs are not FDA-approved. Fees are listed separately and never added in.

GLP-1, compounded, per month

FDA warning letters are FDA's allegations, not court findings. Bayan's GLP-1 products add vitamin B6.

GLP-1, brand, per month, checked 10/25

LillyDirect's price rises at higher strengths. NovoCare's $199 new-patient offer is left out.

Men's TRT, per month

Kyzatrex is FDA-approved. Compounded testosterone is not.

Women's HRT, per month

Peptides, per month, checked 10/25

All six are compounded. Each price covers medication and visits, per the seller. TelaCure doesn't say whether its $199 monthly peptide membership is also required. FDA lists ipamorelin in Category 2, its list of substances flagged for safety risks in compounding. A listed price is not a statement of legality or safety.

NAD+

Session prices and monthly prices are different products.

Medspa, checked 10/25

Ever/Body doesn't name its toxin or filler brands.

Labs, checked 10/25

Function and InsideTracker don't state renewal prices.

Seller-stated prices on the date shown. Not a rate card.

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ODR Price Board. Public cash-pay prices for compounded GLP-1s, peptides, TRT and women's HRT from more than 130 sellers. Each row shows the date we checked it. See the full board free

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Optimized Daily Report is business news for clinic operators. Not medical, legal, or investment advice. Company claims are the company's.