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 demand for Wegovy. In the meantime, it has sued nearly a dozen clinics and pharmacies that market or dispense alternative versions, accusing some of infringing its trademarks and others of selling “unapproved new drugs” in violation of state laws.

Despite reports of undesirable side effects, semaglutide-based drugs got another boost last month after a clinical trial showed Wegovy dramatically reduced the risk of heart problems for overweight people. “We continue to engage with regulatory authorities to keep them informed of the details of supply challenges,” a Novo spokesperson said.

‘A whole nother league’

Many people look to social media for advice on losing weight, entering a marketplace of paid influencers and telehealth firms advertising their services.

That’s where Eric, a 37-year-old petrochemical worker in Houston, found QuickMD. He wanted to lose weight but knew his insurance wouldn’t cover the pricey brand-name drugs. The telehealth firm, which says it has a nationwide reach, presented a more affordable solution.

For $579 — and a potential wait of six weeks or more — QuickMD offered a month’s dose of brand-name Ozempic. Or patients could order a package of “semaglutide sodium,” presented as a comparable product for less than half that price that could ship in a week.

One detail QuickMD left out: The FDA doesn’t consider semaglutide sodium to be the same ingredient in approved drugs like Ozempic and Wegovy. Instead, it has said the sodium version shouldn’t be used to make copies of the drugs in shortage and has “not been shown to be safe and effective.”

Eric, who spoke on the condition that his last name not be used to discuss a private medical matter, ordered the semaglutide sodium. He said he lost 10 pounds in six weeks.

Of all the weight-loss methods he’s tried, he said, “semaglutide is in a whole nother league, man.”

It’s not clear whether Eric in fact received semaglutide sodium. He said the medication came from the Florida-based pharmacy Hallandale, which said it doesn’t use the salt version. After an inquiry from The Post, QuickMD removed references to semaglutide sodium from its website.

The sodium was offered as part of a “90-day pilot program that already ended,” QuickMD said in an emailed statement. “The specific program you’re referring to is no longer offered at QuickMD.”

Jen Witherspoon, a 46-year-old dental office manager in Austin, also found her weight-loss solution on social media. Witherspoon was taking Mounjaro, another new diabetes drug often prescribed off-label for weight loss that also is in shortage. But Mounjaro made her feel nauseated, and she began looking into compounded drugs as an alternative.

She settled on MinuteMD, a telehealth provider that advertised tirzepatide, the active ingredient in Mounjaro.

As recently as July, MinuteMD’s website described tirzepatide as FDA-approved, though the compounded version isn’t. The language was recently revised. MinuteMD founder Joe Stiver said by email that the company “does not advertise any of its compounded products as FDA-approved.”

Stiver, 31, founded MinuteMD in Ohio in 2021. The telehealth service is the latest project in an entrepreneurial medical career that got off to an inauspicious start in 2014, when Stiver was sentenced at age 23 for illegally selling steroids, Ohio court records show. In 2020, Stiver pleaded guilty to a federal money-laundering charge related to the earlier conviction.

Asked about his criminal record, Stiver wrote: “I firmly believe you cannot judge a person’s character by a single incident; rather, you should evaluate someone on how they have overcome obstacles in their life.” He said he has worked to rehabilitate himself, and his companies donated medical equipment during the pandemic.

Witherspoon said she knew nothing about Stiver’s record but isn’t bothered by it, saying she believes in second chances. She said she found the company’s process easy to use and was impressed by the comprehensive lab work it required before writing a prescription.

More importantly, Witherspoon said she had hardly any side effects after a month on compounded tirzepatide. “I was like, okay, this is fantastic,” she said.

In April, she signed a contract with MinuteMD to promote her experience on social media.

‘We make it in our lab at a low cost’

Even as compounding pharmacies have become an essential cog in the business of off-brand weight-loss medications, they also have become a source of some intrigue: The pharmacies are tight-lipped about where they obtain the raw semaglutide, which doesn’t come from Novo Nordisk, and the recipe could deviate from the drugmaker’s patented product.

Take the case of Tailor Made Compounding pharmacy outside Lexington, Ky. In March 2022, FDA inspectors cited Tailor Made for using semaglutide approved only for research, not for patient use. Research-grade products can put patients at risk because they haven’t been reviewed by the FDA for safety, purity or quality, according to the agency.

In an email, Ross Jordan, one of Tailor Made’s owners, denied that the pharmacy used research-grade semaglutide. He said that…