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Despite being patented products without any approved generics, sky-high demand for GLP-1 drugs like Ozempic and Mounjaro has allowed telehealth companies to sell products with the same active ingredient without FDA approval.

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Online companies like Noom and Hims & Hers this year began selling compounded semaglutide, the active ingredient in Ozempic and Wegovy, thanks to the branded versions being in shortage for years now.

When FDA-approved drugs are in shortage, compounding pharmacies are allowed to sell compounded versions of the drugs to ensure patients can continue receiving care.  

Compounded semaglutide is not a generic alternative to these drugs. More often, compounded drugs are tailored specifically for a patient who can’t take the FDA-approved version. This may be because they’re allergic to a dye in the medicine or are unable to swallow pills. 

Because compounded drugs are specific to a patient, they are not FDA-approved, though the pharmacies that make them are regulated by the agency. The compounded GLP-1s that Noom and Hims & Hers are selling are roughly a fifth of the monthly cost of a drug like Ozempic.

Drugmakers like Novo Nordisk and Eli Lilly have launched legal battles against makers of what they call “copycat” drugs, which they claim are contaminated and of subpar quality.  

A spokesperson for Lilly told The Hill the company is “deeply concerned about the proliferation of counterfeit, fake, and other unapproved and untested” products being sold through telehealth platforms. 

Because these products are not sold in the autoinjectors that branded GLP-1s are, the FDA has also flagged concerns over reports of people taking miscalculated doses.

This current situation would theoretically end once drugs like semaglutide and tirzepatide are no longer considered in shortage. But those in the compounding pharmacy space believe increased demand will perpetuate the shortage and expanded uptake through compounders will require some nuance for patients if and when it ends.

“We'll see them right back on the drug shortage list because of the extraordinary demand. And so, I think we're going to see eventually an on-and-off of the shortage list,” Scott Brunner, CEO of the Alliance for Pharmacy Compounding, told The Hill. 

Welcome to The Hill’s Health Care newsletter, we’re Nathaniel Weixel, Joseph Choi and Alejandra O'Connell-Domenech — every week we follow the latest moves on how Washington impacts your health.

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