FDA Approval Of Abortion Pill Mifepristone Is Revoked By Federal Judge

There were two important and seemingly (but not actually) conflicting federal district court rulings regarding the abortion pill Mifepristone, which obtained FDA approval 23 years ago. In a Texas case, the court ruled that the FDA approval was improper and revoked, with his ruling stayed for 7 days to give time for an emergency appeal. In Washington State, a district court judge prohibited the FDA from changing its protocols as to Mifepristone, but limited his ruling to 17 blue state plaintiffs, and in any event prohibiting the FDA from taking action does not preempt the revocation of approval by the Texas federal court.

MORE TO FOLLOW

Ed Whelan provides a handy ‘guide’ to the Texas decision:

Plaintiff medical associations have standing, both associational (pp. 7-11) and organizational (pp. 11-13), allege injuries that are concreted and redressable (pp. 13-17), and are within the statutory zone of interests (pp. 16-18). Their claims are reviewable and are not untimely or unexhausted (pp. 18-31).Plaintiffs are likely to succeed on their challenges to the FDA’s 2021 actions (pp. 32-39). Federal law prohibits the mailing of abortion drugs (pp. 32-38), and the FDA’s actions violate administrative law (pp. 38-39).Plaintiffs are likely to succeed on their challenges to the FDA’s pre-2021 actions (pp. 39-60). The FDA’s 2000 approval violated Subpart H (pp. 39-48), and its pre-2021 actions were arbitrary and capricious (pp. 49-60).Plaintiffs face a substantial threat of irreparable harm (pp. 61-63), and a preliminary injunction would serve the public interest (pp. 63-65).An APA stay of the FDA approval is more appropriate than ordering withdrawal or suspension of the approval (pp. 65-66).

In describing the two rulings, the NY Times notes that the Texas Judge was a Trump appointee, but neglects to mention which president nominated the Washington State judge (care to guess?*):

The order by Judge Kacsmaryk, a Trump appointee who has written critically about Roe v. Wade, is an initial ruling in a case that could result in the most consequential abortion decision since the Supreme Court overturned Roe v. Wade last June.The lawsuit, filed by a coalition of anti-abortion groups and doctors, seeks to end more than 20 years of legal use of mifepristone, the first pill in the two-drug medication abortion regimen.The lawsuit in Washington State was filed against the F.D.A. by a dozen Democratic attorneys general. In a preliminary injunction in that case, Judge Thomas O. Rice blocked the agency from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”

I don’t see the rulings as inconsistent, though some disagree. The Washington State order prohibits the FDA from taking any steps with regard to the drug, but the Texas ruling revokes approval ab initio, so there’s nothing for the FDA to do.

2. Pursuant to Federal Rule of Civil Procedure 65(a), Defendants and their officers, agents, servants, employees, attorneys, and any person in active concert or participation, are PRELIMINARILY ENJOINED 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 reaction is as you would expect:

(*Obama)

Tags: Abortion

CLICK HERE FOR FULL VERSION OF THIS STORY