A fast-moving legal and regulatory battle over a copycat Wegovy pill prompted its maker, the telehealth company Hims & Hers, to pull the product from the market two days after its launch in early February.
The saga isn’t over, as the manufacturer of the original Wegovy pill, Novo Nordisk, has filed a lawsuit alleging copyright infringement.
The announcement immediately drew skepticism from obesity specialists and regulators, who cautioned that compounded drugs are not approved by the U.S. Food and Drug Administration (FDA) and are not required to undergo large clinical trials to prove safety, effectiveness (including consistent absorption), and manufacturing quality.
FDA Threatens Legal Action on Compounded GLP-1s
One day after Hims & Hers launched their compounded semaglutide pill, federal officials responded. The FDA’s commissioner, Martin A. Makary, MD, MPH, announced that the agency intended to take “decisive steps” to restrict non-FDA-approved compounded drugs that are mass-marketed as alternatives to approved GLP-1s.
“These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy,” Dr. Makary said in a statement.
The FDA also warned companies against marketing compounded GLP-1 products as “generic” versions of FDA-approved drugs or claiming they are clinically proven to deliver the same results.
Soon after, Mike Stuart, general counsel for tktktk, posted on X that the U.S. Department of Health and Human Services had referred Hims & Hers to the Department of Justice for investigation over potential violations of the Federal Food, Drug, and Cosmetic Act and other federal statutes, which Makary reposted.
Hims & Hers Action May Be a ‘Tipping Point’
On Saturday, February 7, Hims & Hers said it would stop offering the pill.
“Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry,” the company said in a statement posted to X. “As a result, we have decided to stop offering access to this treatment.”
The reversal was not sufficient for the maker of Wegovy. On Monday, February 9, Novo Nordisk filed a U.S. patent infringement lawsuit against Hims & Hers, covering both pill and injectable versions of semaglutide products. It’s the first time Novo Nordisk has filed a U.S. patent case against a compounder.
The Danish company is asking the court to permanently bar Hims from selling compounded drugs that it alleges infringe on its patents and is seeking monetary damages.
“There is now a growing chorus of parties that have said, ‘Enough is enough on the compounding situation in the United States,’” said Novo Nordisk’s general counsel, John Kuckelman, as reported by Reuters; he called the Hims & Hers pill launch a “tipping point.”
Tensions Rise Between Drug Accessibility and Safety
Hims & Hers frames the lawsuit as a “blatant attack” by Novo on “millions of Americans who rely on compounded medications for access to personalized care.”
“Once again, Big Pharma is weaponizing the U.S. judicial system to limit consumer choice,” said a Hims spokesperson.
When the company first announced the compounded semaglutide pill, experts told Everyday Health that expanded access shouldn’t come at the expense of rigorous safety and efficacy testing.
“These products have not been tested in large, randomized clinical trials, may vary in strength or purity, and may not even contain the same active ingredient as FDA-approved semaglutide,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston.
“Obesity is a chronic disease that deserves evidence-based treatment. Lowering standards for safety and efficacy for people with obesity reinforces harmful inequities in care,” Dr. Stanford said. “Patients should not be asked to accept unproven therapies simply because effective, FDA-approved options are expensive or difficult to access.”
The Future of Compounded GLP-1s Is Uncertain
Under U.S. law, compounding pharmacies are allowed to create customized medications in certain circumstances, such as when a patient needs a dose or formulation that’s different from what is commercially available.
The initial rollout of new GLP-1 drugs was plagued by shortages, and compounding pharmacies like Hims & Hers stepped in to fill high demand.
It’s unclear what the future holds for people who have relied on compounded GLP-1s. The FDA statement suggests that other companies offering unapproved versions of the weight loss drugs may be subject to legal action, including injunction and seizure of the drugs.
Read the full article here
