Lawyer Commentary Mondaq United States Mifepristone Update: Texas Judge Probes Extent To Which Court Can Affect The FDA's Approval

Mifepristone Update: Texas Judge Probes Extent To Which Court Can Affect The FDA's Approval

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After a four-hour hearing held March 15, 2023 on a preliminary injunction motion, which, as we previously posted, seeks to overturn the Food and Drug Administration's ("FDA") long-standing approval of the drug mifepristone for use in the termination of early pregnancies in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, Judge Matthew Kacsmaryk stated he would issue an order and an opinion "as soon as possible" but did not give a precise timeline for a ruling. The Plaintiffs' motion broadly requests that the court withdraw or suspend the approvals of "chemical abortion drugs" including misoprostol, the second component of the regimen approved by the FDA for terminating a pregnancy through medication. Misoprostol, however, is also approved for the treatment of gastric ulcers, and Plaintiffs did not provide any arguments in their motion to support the withdrawal of this drug.

Although the press was permitted to attend the hearing, news coverage has been limited and without significant detail of the back-and-forth between the judge and the parties. Nevertheless, the judge's questions, as reported by the press, revealed to some degree his concerns about the case and the scope of the relief being requested. For example, according to news reports, the judge asked lawyers for the Plaintiffs to point to any precedent where a court issued an injunction immediately revoking or suspending the marketing of a drug long after it had been approved by the FDA...

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