Update 4/19/2023 3:58 pm ET: Supreme Court Justice Samuel Alito has extended his temporary stay by lower court order. Currently staying until midnight on Friday 21st April 2023. This stay will retain current access to the abortion and abortion drug mifepristone for an additional two days.
Original Story Apr 18, 2023 11:09 PM ET: The U.S. Supreme Court has decided not only the nationwide availability of the safe and effective abortion and abortion drug mifepristone, but the fate of the critical, A ruling on a serious lawsuit may be forthcoming. of the Food and Drug Administration’s overall authority to regulate drugs in the country.
If you haven’t followed along, here’s everything you need to know before the High Court makes its next move.
Case: Alliance for Hippocratic Medicine v. FDA
The lawsuit began in federal court in Texas last November. file a lawsuit against the FDA, It argued that the approval and regulation of mifepristone by regulatory agencies was illegal. Predictably, District Judge Matthew Kaxmalik said, provisional injunction On April 7, it revoked the FDA’s 2000 approval and ruled that FDA actions from 2016 through 2021, including relaxing restrictions on drug use and access, were also unlawful. Kacsmaryk granted his seven-day suspension of the order, giving the government time to appeal the ruling and seek a longer freeze. Without intervention, mifepristone could have been banned from markets nationwide on April 15.
However, the case soon moved to the Fifth Circuit Court of Appeals in New Orleans, where a panel of three more conservative judges ruled. Undisclosed Orders for April 12th It only partially upheld Kacsmaryk’s decision. The committee temporarily blocked his Kacsmaryk’s central decision to revoke the drug’s approval in 2000, but upheld his decision on his 2016 to 2021 actions with the FDA. This meant access to Mifepristone could be rolled back to his pre-2016 state on April 15th. It could only be used up to 7 weeks gestation, not 10 weeks, and there were no restrictions such as telemedicine prescriptions or mail dispensing.
The federal government immediately asked the High Court to intervene, and late Friday, April 14, Supreme Court Judge Samuel Alito temporarily stayed Kacsmaryk’s remaining orders until midnight Wednesday, granting Mifepristone a full refund. maintained access. This stay gives the Supreme Court time to consider appeals and grant longer stays as the case progresses, and may issue another ruling before the time expires.
The FDA, former regulatory agencies, numerous health and medical institutions, hundreds of biotechnology executives, the pharmaceutical industry’s powerful trade association (PhRMA), and numerous legal experts all agree that mifepristone is safe and effective. Yes, and FDA claims it is within its expertise. and the authority to approve and regulate that drug. They also argue that the Kacsmaryk decision sets a dangerous precedent that allows non-expert judges to second-orderly infer the FDA’s scientific and medical expertise. , the first case in which a district judge revoked an FDA approval based in part on allegations that the agency misunderstood the science, potentially jeopardizing virtually all FDA-approved drugs. opened the door to certain judicial activities.
as a group of The former FDA employee is listed in one of many Amicus briefs. If brought to the Supreme Court, anti-vaccine advocates could seek to withdraw life-saving vaccines from the market, and pharmaceutical companies could ask judges to revoke their approvals or limit their use, thereby banning competitors’ products. It could seek to block it, which could confuse pharmaceutical companies with FDA refusals. After spending millions on research and development, you can get a second opinion in court.
