The Supreme Court on Friday temporarily blocked a lower court ruling that would have restricted access to the abortion medication mifepristone from Saturday. The temporary block will maintain status quo access to mifepristone for five days, or until midnight on Wednesday, giving the Supreme Court time to review emergency appeals and consider delaying the ruling any longer.
The freeze is the latest twist in a fast-moving, high-stakes case not only about access to safe and effective abortion medications, but also the fate of the Food and Drug Administration’s overall authority to regulate drugs in the country.
Last week, a Texas federal judge, District Judge Matthew Kacsmaryk, issued a ruling repealing the nearly 23-year-old FDA approval of mifepristone. Kacsmaryk, a Trump-appointed conservative, ruled that the FDA had made a mistake in approving the drug and that there was insufficient data on its safety, despite dozens of studies, decades of field data on millions of pregnancies, and extensive regulatory reviews. instance .
On Wednesday, a three-judge panel of the Court of Appeals for the 5th Circuit in New Orleans blocked most, but not all, of Kacsmaryk’s rulings pending appeal. The panel temporarily lifted Kacsmaryk’s suspension of the FDA approval of mifepristone, which took place in 2000. But it upheld Kacsmaryk’s ruling that would reverse the additional access the FDA granted in 2016.
Under the rollback, mifepristone would have gone from being available up to 10 weeks into a pregnancy to only being available up to seven weeks and would have required in-person doctor visits (no telemedicine), and would no longer have allowed the drug to be delivered through the mail .
Since Wednesday’s ruling, there has been a flurry of emergency appeals from the Justice Department, the drug’s maker, Danco Laboratories, and amicus briefs. Collectively, they argue that Kacsmaryk’s initial ruling and the appeals court ruling contain a slew of errors and shortcomings, from sifting through mifepristone’s data and relying on anecdotes to allowing a judge with no scientific training to second guessing the FDA and putting forward its own inexplicable. rigid framework for drug approval. They also argue that if the ruling holds, virtually no FDA-approved medication would be immune to judicial activism and questioning, causing turmoil in the pharmaceutical industry.
