The Supreme Court on Friday temporarily stayed a lower court ruling that would have restricted access to the abortion drug mifepristone beginning Saturday. It will be maintained for five days, or until midnight Wednesday, giving the High Court time to consider an emergency appeal and to consider an extension of the sentence.
The freeze is the latest turn in a fast-moving, high-risk litigation over the fate of not only access to safe and effective abortion drugs, but the Food and Drug Administration’s overall authority to regulate drugs in the country.
Last week, District Judge Matthew Kaksmalik, a federal judge in Texas, ruled to cancel nearly 23 years of FDA approval of mifepristone. Kaksmalik, who was nominated by conservative Donald Trump, has come a long way in spite of dozens of studies, decades of real-world data on millions of pregnancies, and extensive review from regulators. However, the FDA made a mistake in approving the drug and determined that there were insufficient data on its safety.
On Wednesday, a panel of three judges in the Fifth Circuit Court of Appeals in New Orleans blocked most, but not all, of the Kacsmaryk decisions pending appeal. The committee temporarily reversed his Kacsmaryk suspension on FDA approval of mifepristone in 2000.
Under the rollback, mifepristone was only available until the 10th week of pregnancy, but now it is only available until the 7th week, requiring an in-person doctor visit (not telemedicine) and the use of the drug. You will not be able to distributed by email.
Since Wednesday’s ruling, a flurry of emergency appeals have been filed from the Department of Justice, drug makers, Danko Laboratories, and Amicus Brief. From arbitrarily choosing Princeton’s data and relying on anecdotes to allowing judges without scientific training to speculate about the FDA and inexplicably form their own opinions, there are many errors and misconceptions. Claims to be defective. A strict framework for drug approval. They also argue that if the ruling is upheld, effectively FDA-approved drugs will be impervious to judicial action and retrials, throwing the pharmaceutical industry into turmoil.
