April 10, 2023

Texas and Washington Judges Issue Conflicting Rulings on FDA Mifepristone Approval

The Fifth Circuit Court of Appeals and the US Supreme Court have issued preliminary rulings since this post was written. More information will be on our website on Monday, April 17 (and next week's newsletter).

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On April 7, Trump-appointed US District Judge Matthew Kacsmaryk issued a national injunction that would suspend the FDA approval of mifepristone (the first drug used in the abortion pill regimen). Hours later, Obama-appointed US District Judge Thomas Rice issued a conflicting injunction barring the FDA from "altering" the availability of mifepristone in 17 pro-abortion states.

Alliance Defending Freedom (ADF) filed the lawsuit decided by Kacsmaryk. On behalf of pro-life medical organizations and a group of doctors who say they have prescribed mifepristone to women, ADF argued that the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for the treatment of life-threatening illnesses.

In his decision, Kacsmaryk wrote,
”The court does not second-guess F.D.A.’s decision-making lightly. But here, F.D.A. acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating F.D.A. faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”
Kacsmaryk also pointed out that the FDA stonewalled the plaintiff's petition for over 20 years.

"The legality of the 2000 Approval is now before this Court. Why did it take two decades for judicial review in federal court? After all, Plaintiffs’ petitions challenging the 2000 Approval date back to the year 2002, right? Simply put, FDA stonewalled judicial review — until now. Before Plaintiffs filed this case, FDA ignored their petitions for over sixteen years, even though the law requires an agency response within “180 days of receipt of the petition.”But FDA waited 4,971 days to adjudicate Plaintiffs’ first petition and 994 days to adjudicate the second. Had FDA responded to Plaintiffs’ petitions within the 360 total days allotted, this case would have been in federal court decades earlier. Instead, FDA postponed and procrastinated for nearly 6,000 days."

Kacsmaryk placed a one-week stay on his injunction, thus providing the Biden administration time to appeal his decision after the Easter weekend.

National Right to Life President Carol Tobias responded to the ruling, “This decision shines a light on something that the Biden Administration wants to sweep under the rug – that these drugs do not treat or cure disease but kill unborn children and expose their mothers to dangerous side effects. The FDA should be in the business of ensuring safety, not in taking lives.”

Mere hours later, Judge Rice issued a separate injunction prohibiting the FDA from "altering" the availability of mifepristone in 17 pro-abortion states and the District of Columbia. Attorneys general from these states are actively suing the FDA to argue that mifepristone is currently too heavily regulated.

The states affected by Rice's injunction include Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Nevada, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Michigan, and Pennsylvania.

US Attorney General Merrick Garland expressed his intent to appeal Kacsmaryk's decision.