Ozempic’s popularity has spawned a market of cheaper, imitation versions

The Jacksonville, Fla., clinic — called Slym Wellness — is part of a flourishing industry around the new generation of weight-loss drugs, which have proved so effective that patients are clamoring for more than drugmakers can churn out. Last year, the U.S. Food and Drug Administration declared Ozempic and Wegovy in shortage, a designation that allows specialized pharmacies to mix up their own, cheaper versions of the blockbuster drugs.

Since then, a parallel marketplace with no modern precedent has sprung up, attracting both licensed medical professionals and entrepreneurs with histories ranging from regulatory violations to armed robbery. While clinics like Slym Wellness prescribe off-brand weight-loss medication following FDA policy, others are riding the boom in a legally gray area.

The Washington Post found more than two dozen websites that bypass doctors and pharmacies completely to sell semaglutide — the active ingredient in Ozempic and Wegovy — directly to consumers, usually with disclaimers that it’s not for human use. One group, Doctor’s Medical Weight Loss Partnership, charges would-be clinic owners $100,000 to get a piece of the action and has wrongly advertised the off-brand medications as FDA-approved.

“This method of providing access scares me,” David Kessler, a former FDA commissioner, said of the gold rush, which is putting weight-loss medications into the hands of patients who often don’t know their original source and pedigree. “Problems are going to happen.”

So far, many patients seem unconcerned. FDA data does not suggest that pharmacy-made semaglutide is causing widespread harm. But in May, the FDA warned consumers that they can’t know for sure what they’re getting when they buy off-brand semaglutide even from a licensed compounding pharmacy. And “purchasing medicine online from unregulated, unlicensed sources,” the agency said, “can expose patients to potentially unsafe products.”

Compounding pharmacies are the custom tailors of the pharmaceutical world. About 7,500 operate in the United States, and their main job is modifying prescription drugs for people who need personalized formulations, for instance because of an allergy to an ingredient in an FDA-approved medication. The pharmacies are inspected by state and federal authorities. However, compounded medications do not carry the FDA’s seal of approval, and the agency says they are typically not as safe as drugs that undergo rigorous agency review.

Under normal circumstances, compounders aren’t allowed to make copious copies of an FDA-approved drug — unless the agency lists it in shortage, as it has with semaglutide, and they meet certain requirements. The ingredient has remained in short supply since March 2022, when the FDA placed Wegovy, an obesity drug, on its shortage list. Ozempic, a diabetes drug, joined the list five months later. With their list prices exceeding $900 for a month’s supply and the lack of an FDA-approved generic version, compounding pharmacies have begun to function as an alternative, cheaper source for the highly sought drugs that often aren’t covered by insurance for weight-loss.

“Semaglutide is a very unique situation,” said Michigan pharmacist David Miller, who sits on the board of the Alliance for Pharmacy Compounding, a trade group. “In and of itself,” the extended shortage “for a multibillion-dollar drug is unheard of,” he said.

Total prescriptions have nearly doubled for Ozempic and more than quadrupled for Wegovy over the past year, according to TD Cowen analysts. Novo Nordisk, which makes both drugs, has racked up the equivalent of about $7.8 billion in sales of the drugs in the first half of 2023, according to its financial statements. That’s roughly 85 percent more than the same period a year ago.

Novo’s chief executive recently told CNN that it could take “quite some years” before it can fully meet the…