FDA Chief Signals Crackdown on Companies Marketing Illegal Copycat Drugs

‘The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs,’ FDA commissioner Marty Makary said.

FDA Commissioner Marty Makary speaks during an announcement at the Department of Health and Human Services in Washington on Dec. 18, 2025. Alex Wong/Getty Images

The U.S. Food and Drug Administration will take action against companies that mass-market illegal copycat versions of FDA-approved drugs, FDA Commissioner Marty Makary said on Feb. 5.

Makary warned that some companies are marketing drugs as comparable to FDA-approved products without safety verification.

“The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs,” the FDA commissioner said on X.

He did not specify what actions the agency may pursue or whether it has identified any companies involved in such conduct. The FDA has not issued an official statement in regards to Makary’s post.

This came as Novo Nordisk announced on Feb. 5 that it would take legal and regulatory action against Hims & Hers Health, which recently offered a $49 compounded version of Novo Nordisk’s Wegovy weight-loss pill.

Novo Nordisk received approval for its injectable drug Wegovy in December and launched it in January. Wegovy contains semaglutide, which belongs to a class of drugs called GLP-1 agonists, and is used to help people with obesity lose weight.

Hims & Hers said on Feb. 5 that its compounded semaglutide pill contains the same active ingredient as Wegovy and that all ingredients were sourced from FDA-registered facilities, but noted that compounded drugs are not FDA-approved for safety, effectiveness, or quality.

“We have spent years building the infrastructure required to put the power of choice back into the hands of the individual, and we are committed to ensuring providers can always make the best clinical decision for their patients with an array of safe options to help find care that fits their lifestyle,” Hims & Hers CEO Andrew Dudum said in a statement.

Novo Nordisk has warned that compounded semaglutide that has not been approved by the FDA may contain impurities, unnecessary additives, and untested doses, which could pose a risk to patients.

“Only Novo Nordisk manufactures an FDA-approved Wegovy pill formulated with SNAC technology, which facilitates semaglutide absorption when administered orally,” the company said in a Feb. 5 statement.

The FDA had previously placed semaglutide injection products on its shortage list in 2022 due to increased demand, but declared the shortage resolved in February last year.

The agency said at the time that it would exercise enforcement discretion through April 22, 2025, allowing pharmacy compounding, dispensing, or distributing semaglutide injection products that are essentially a copy of an FDA-approved product during that period.

The FDA also said that it may still “take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.”

Rob Sabo contributed to this report.