FDA faces Roche blackmail claim, launches mifepristone safety study and reviews voucher program pause request

Roche has publicly accused the United States of blackmail in a dispute that surfaced in recent FDA discussions. The company’s allegation adds tension to ongoing regulatory dialogues.

The Food and Drug Administration announced a new safety study focused on the abortion medication mifepristone. The study aims to gather additional data on the drug’s safety profile.

Separately, a coalition of drugmakers and patient advocacy groups petitioned the FDA to pause the National Priority Voucher program that was introduced under former commissioner Marty Markary. The groups seek a review of the program’s impact and procedures.

The article also references a recent court ruling concerning "skinny labels," though specific details of the decision were not provided.