FDA Outlines When It Will Pull a Drug’s Breakthrough Status

Promising drugs to fulfill unmet medical needs could lose an FDA special status if emerging data show they won’t offer a substantial benefit or if another treatment comes to market, under an agency proposal released Thursday.

The Food and Drug Administration released draft guidance on rescinding a drug’s breakthrough therapy status, which aims to expedite the regulatory process and speed treatment access for patients facing serious conditions. A pharmaceutical company can receive breakthrough status if early data show the drug will offer substantial improvement over what’s currently available.

Drugs deemed breakthrough typically reach market two years faster than other ...