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 (FDA) 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.