Biotech ex­ecs say mifepri­s­tone de­ci­sion would 'u­pend' FDA's new drug ap­pli­ca­tion process

Dozens of biotech ex­ec­u­tives ar­gued in a court brief on Tues­day that a Texas court’s re­cent de­ci­sion to sus­pend mifepri­s­tone’s decades-long ap­proval would “up­end” the FDA’s new drug ap­pli­ca­tion process.

The am­i­cus, or “friend of the court,” brief is signed by more than 150 or­ga­ni­za­tions and ex­ec­u­tives, in­clud­ing Pfiz­er, Gilead and the in­dus­try trade group BIO. They ar­gue that the Texas court “bad­ly mis­ap­plied” drug ap­proval and ad­min­is­tra­tive laws in its de­ci­sion, which would re­sult in a chill on R&D and in­vest­ment, as well as “wide­spread harm to pa­tients.”

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