Eli Lilly
The U.S. Food and Drug Administration determined that the
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Compounding industry groups disagreed with the agency's analysis, saying pharmacies still can't get enough of Lilly's drugs.
"The agency's decision to declare the shortage over based on the manufacturer's say-so ignores the facts, violates the law, and puts patient access at risk," the Outsourcing Facilities Association, which sued the FDA, said in a statement. The lawsuit is ongoing, court records show.
Compounded weight-loss medicines have flourished because of shortages of the brand-name drugs, made by Lilly and Novo Nordisk A/S. The business has boomed, bringing in as much as $1 billion annually, bankers estimate. Compounded weight-loss drugs are often cheaper than their brand-name counterparts, which aren't always covered by insurance. And they've been easily available through telehealth companies. Millions of Americans have taken the copycat medicines.
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Hims & Hers Health, a telehealth company that provides copycat versions of Novo's drugs, but not Lilly's, fell as much as 13% in New York. Lilly's shares fell less than 1%.
"Anyone marketing or selling unapproved tirzepatide knockoffs must stop," Lilly said in a statement, using the name of the active ingredient in its drugs. Lilly and Novo have mounted legal and public relations campaigns to curtail the sale of compounded versions of their products, alleging safety and quality concerns. Novo's drugs are still in short supply and are widely compounded.
Compounders have said they make quality medicines using legitimate ingredients and help patients get therapies that would otherwise be unavailable.
In determining the end of the shortage, the FDA considered data provided by Lilly, compounders and others. Even though there is "significant compounding" of Lilly's drugs and some patients taking those drugs will switch to Lilly's brand-name products, the FDA said it expects the company will continue to "meet or exceed projected demand."
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While compounders are generally only allowed to make copies of brand-name drugs during a shortage, some production can continue for a short period of time after it ends, according to federal law. The industry will be allowed to keep making copies of Lilly's drugs for two to three months, depending on the type of compounder, which is longer than the normal grace period, the FDA said Thursday.
The FDA said in October that there was no longer a shortage of Lilly's drugs and that making copies must cease. Compounders sued, causing the FDA to pause enforcement while it reevaluated its decision. The agency didn't respond to a question about the status of the lawsuit.
