Pharmaceutical companies that produce customized medications are suing the FDA because the agency announced that the shortage of a weight-loss drug called Wegovy is over. These companies often make their own versions of medications when there is a shortage. Some of the drugs involved include Wegovy and possibly others like Ozempic, which is also used for weight management. The lawsuit likely stems from the fact that once a shortage is declared over, these companies may no longer be allowed to compound their versions of the drug.

Summary for a General Audience:

Drug makers who create alternative versions of medications are suing the Food and Drug Administration (FDA) over its decision to remove Novo Nordisk’s drug, semaglutide, from a list of drugs in short supply. This decision prevents these companies from making and selling their own versions of the drug, which is used in Novo Nordisk’s Wegovy for weight loss and Ozempic for diabetes. The lawsuit argues that this decision will limit patient access to important treatments.

Previously, when semaglutide was on the shortage list, these drug makers could produce their own versions to help meet demand. A similar lawsuit was filed earlier about another drug, tirzepatide from Eli Lilly, which is still in court.

Hims & Hers, a company that sells these alternative versions, will now advise its customers to look for other options. Since the FDA’s decision, the company’s stock has dropped significantly. Hims & Hers plans to stop offering their version of semaglutide by the FDA’s deadline in April or May 2024, depending on their authorization type.

The lawsuit claims the FDA’s decision was unfair and made without proper notice or public input. It argues that there are still issues with semaglutide supply and accuses the FDA of acting in a way that benefits certain interests and raises drug prices.

Despite this setback, Hims & Hers expects to generate significant revenue from weight loss drugs by focusing on personalizing doses to reduce side effects.

Both Novo Nordisk and Eli Lilly are opposing the production of these alternative drugs, citing potential risks. Lilly has also introduced a new pricing strategy for its drug Zepbound, offering lower prices for certain doses to make them more affordable.