Compounded Wegovy and Zepbound may disappear under new FDA rules

Some “copycat” versions of popular weight-loss drugs will soon be restricted in the U.S. The change comes as a federal judge declined an injunction that would’ve allowed compounding pharmacies to keep making more affordable versions. 

In a Good Morning America segment, Dr. Tara Narula, ABC News chief medical correspondent, explained how compound-drug creation works to meet demand. “When a drug is in short supply, the FDA allows these compounding pharmacies to essentially create copycat drugs. But when the drug companies say, ‘we are able to meet the demand,’ then those compounding pharmacies can no longer sell those drugs,” Narula said. 

The U.S. Food and Drug Administration (FDA) will now begin restricting the creation of the compound drugs.

In 2022, the popularity of weight-loss drugs was rising too quickly for drug companies to keep up with demand. Patients turned to compound versions, which were made by licensed pharmacists but were not FDA approved. Last year, around 200,000 prescriptions for copies of Novo Nordisk’s weight-loss drug Wegovy alone were being filled each month. But now, the makers of the original versions of the drugs say they are no longer facing shortages and have removed the drugs from the FDA’s shortage list. 

Three weeks ago, the FDA made that declaration in a press release, and, at the same time, announced that selling copycat versions “with rare exceptions” was now “illegal.”

In the release, Dave Moore, president of Novo Nordisk and executive vice president of U.S. operations and global business development, said, “We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand. No one should have to compromise their health due to misinformation and reach for fake or illegitimate knockoff drugs that pose significant safety risks to patients.”

Still, patients who rely on copycat weight-loss drugs pay a fraction of the price tag for the real thing, which averages around $1,000 per month. Narula said that patients’ wallets will certainly be impacted by the FDA’s move. “This is all going to affect people who are getting these drugs, usually at a much lower cost and much easier to find,” Narula said. Telehealth companies, such as Hims & Hers Health, which capitalized on the supply issues by selling compound versions, may also be hard hit. Hims’s shares have already tumbled, dropping 46% since semaglutide was taken off the FDA’s shortage list.

To that end, a Change.org petition organized by the GLP-1 Collective, a nonprofit that advocates for access to the drugs, has sprung into action to combat the FDA’s latest moves. The petition has garnered more than 24,700 signatures at the time of publication. The petition not only urges the FDA to allow compounding pharmacies to keep making the drugs, it also asserts the importance of generic versions of the drugs, insurance coverage, and competitive pricing. 

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