The Supreme Court on Friday temporarily blocked a lower court ruling that would have restricted access to the abortion drug mifepristone starting on Saturday. The temporary block will keep access to mifepristone for five days, or until midnight on Wednesday, giving the high court time to review emergency appeals and consider issuing a longer stay on the ruling.
The freeze is a new change in the pace of movement, a high issue on not only access to safe and effective abortion medicine but also the fate of the general authority of Food and Drug to prescribe drugs in the country.
Last week, a federal judge in Texas, District Judge Matthew Kacsmaryk, issued a ruling revoking the nearly 23-year-old FDA approval of mifepristone. Kacsmaryk, the conservative representative of Donald Trump, concluded that the FDA made a mistake in approving the drug and that there was insufficient data on its safety, despite many studies, years of real-world data on millions of pregnancies, and numerous reviews from the regulatory agency. .
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 ruling, pending an appeal. The committee temporarily attacked Kacsmaryk’s suspension of the FDA approval of mifepristone, which occurred in 2000. But it took place in Kacsmaryk’s position of the judgment that will reverse the access to the supplement granted by the FDA in 2016.
Under the change, mifepristone would have gone from being available up to 10 weeks into pregnancy to only being available up to seven weeks and would have required in-person doctor visits (not telemedicine), and the drug would no longer be allowed to be dispensed. by mail.
Similar emergency petitions from the Department of Justice, the drug’s maker, Danco Laboratories, and amicus briefs have been filed since Wednesday’s ruling. Collectively, they argue that Kacsmaryk’s first verdict and the appeals court’s verdict are riddled with errors and flaws, from cherry-picking mifepristone data and relying on anecdotes to make a judge without scientific training guess. to the second FDA and produce its own. inexplicably rigid process for drug approvals. They also argue that if the ruling stands, almost no FDA-approved drug will be immune to judicial activism and second-guessing, throwing the pharmaceutical industry into chaos.