Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, “has set a precedent for diminishing F.D.A.’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry” according to a public statement by a group of pharmaceutical industry leaders. The judge's ruling in Alliance for Hippocratic Medicine v. FDA declares void the FDA's 23 year old approval of the drug which is part of a long available treatment to induce abortion and to avoid further harm by women who have already suffered miscarriage.
The order conflicts with another issued by Thomas O. Rice, a U.S. District Judge in Washington State. The State of Washington and fifteen other states obtained a preliminary injunction" barring the Food & Drug Administration from
"altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. 355-1 in Plaintiff States."
The United States has filed an emergency motion for a stay of the nationwide order issued by Kacsmaryk. The U.S. argues that
"Plaintiffs’ conduct confirms that there is no basis for extraordinary nationwide relief that would upend a decades-long status quo and inflict grave harm on women, the medical system, and the public. "
The existence fo the two orders presents difficulties, So the U.S. has filed a motion for clarification asking Judge Rice what his order means in the event the stay of the Texas order is denied and the order in Hippocratic Medicine goes into effect.
- GWC
4/11/23
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