FDA warns compounding pharmacies on weight-loss drugs
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A surge of alternatives to newly popular weight-loss drugs is facing its biggest test yet after the FDA warned companies against skirting regulatory standards to put them on the market now that shortages are waning.
Why it matters: Widespread shortages of GLP-1 drugs such as Novo Nordisk's Ozempic and Wegovy and Eli Lilly's Zepbound and Mounjaro have triggered a rush of companies seeking to exploit a loophole that allows them to sell compounded versions of the injections.
Driving the news: The FDA on Wednesday took tirzepatide injections (Mounjaro and Zepbound) off of its official Drug Shortage List and issued a reminder that "compounded drugs must meet conditions to qualify for exemptions" to be sold to the public.
- Those drugs had been officially designated as in short supply since 2022.
State of play: "Pharmacies must immediately cease preparing and dispensing compounded copies of Mounjaro and Zepbound," the Alliance for Pharmacy Compounding said in a statement.
- Lilly issued its own statement to media saying those mass-producing compounded and counterfeit tirzepatide "need to stop immediately."
- The message was clear: "Compounders beware," Leerink Partners analyst David Risinger wrote today.
The impact: Telehealth platform Hims & Hers, one of the most prominent companies to offer compounded GLP-1 drugs, saw its stock close down 9.6% Thursday.
- Hims doesn't actually offer compounded tirzepatide. It offers a compounded version of semaglutide, the key ingredient in Novo Nordisk's Wegovy, which remains on the FDA's shortage list for now.
State of play: Compounders say they're improving access for people who have been prescribed GLP-1s for diabetes and obesity but are still scrambling to find the drugs, Axios' Tina Reed reported in September.
- Patients will be "caught flat-footed" by the latest FDA decision, Alliance for Pharmacy Compounding CEO Scott Brunner said in a statement.
- "They are being cut-off cold-turkey, their prescription no longer fillable," he said in a statement. "They'll need to get in to see their provider to get a new prescription, and that will take some time."
- "It's possible that so many patients presently taking compounded GLP1s will be eventually switched to the FDA-approved versions – if they can afford them, of course – that it will push tirzepatide injection back into shortage. We'll see," Brunner added.
Yes, but: The influx of alternatives has created regulatory headaches for states that oversee compounding pharmacies, prompted consumer warnings from the FDA, and sparked multiple lawsuits from Lilly and Novo Nordisk seeking to protect their market share, Axios' Tina Reed reported in September.
- A recent study found that nearly half of the online pharmacies selling anti-obesity drugs were doing so without a license from their state board of pharmacy.
The bottom line: The balance of power is shifting back to the brand-name GLP-1 drugmakers.
