U.S. Supreme Court Justice Temporarily Blocks Tighter Restrictions on Abortion Pill
(CTN News) – On Friday, Justice Samuel Alito of the United States Supreme Court temporarily stopped decisions from lower courts that would have placed greater limitations on the abortion drug mifepristone.
Appeals Court Re-Imposes Tighter Restrictions on Mifepristone
Last Monday, U.S. District Judge Matthew Kacsmaryk of Texas’s Northern District temporarily halted the FDA’s approval of mifepristone.
Kacsmaryk’s order was partially blocked by the U.S. 5th Circuit Court of Appeals, which ultimately preserved the FDA’s approval.
Unfortunately, the appeals court has temporarily reinstated stricter limitations on using and distributing mifepristone, making it more difficult for women to obtain the drug.
Until Wednesday at 11:59 p.m. ET, Alito stayed the orders that would have limited access to mifepristone. Tuesday at noon Eastern Time, the FDA has asked for a response to their lawsuit from the antiabortion group Alliance Defending Freedom and the Alliance for Hippocrates Medicine.
As the appeal from the Biden administration plays out, the Supreme Court, currently controlled by a conservative 6-3 majority, will determine whether to keep mifepristone more widely available. While the case is being heard, the court could also decide to reinstate the restrictions.
Even States with Legal Abortion Could Face Restrictions
Legal proceedings on a national scale have the potential to severely restrict access to mifepristone, even in states where abortion is still legal. About half of all abortions in the United States involve mifepristone in conjunction with another medicine called misoprostol.
The litigation against the FDA “has been troubling at every level,” according to U.S. Solicitor General Elizabeth Prelogar. She noted that this is the first time judges have reversed the terms of an FDA drug approval due to a disagreement with the agency’s safety assessment.
Prelogar argued that if the lower court’s orders were allowed to stand, they would have far-reaching ramifications for the pharmaceutical company, women who require access to the medicine, and FDA’s ability to fulfill its statutory power.
Every regulation action the FDA has taken on mifepristone over the past 20 years has been effectively turned back by judges Kurt Engelhardt and Andrew Oldham of the 5th Circuit appointed by former President Donald Trump.
The judges on the appeals court have stopped mifepristone from being sent by mail, reinstated mandatory doctor visits, and limited the period during which women can take the drug to the seventh week of pregnancy. They also prevented GenBioPro’s generic mifepristone from being approved in 2019.
Legal Battle Over Mifepristone Could Limit Access to Medication
Over the past week, mifepristone’s legal status has become murky and unclear. In a separate ruling, U.S. District Judge Thomas Rice of the Eastern District of Washington ordered the Food and Drug Administration to continue providing mifepristone to clinics in 17 states and the District of Columbia.
The United States government argued to the Supreme Court that it would breach the Washington state district court ruling if it followed the constraints set by the 5th Circuit.
After the verdicts in Texas and the appeals court, the Justice Department stated all mifepristone doses would be misbranded since their labels wouldn’t match the FDA’s 2000 approval.
The FDA authorized this drug as a safe and effective alternative to surgical abortion, but the government claims it will take months to adapt the labeling, preventing women from accessing this medication.
Abortion pill distributor Danco Laboratories has claimed it will have to wait for the FDA to complete several steps before it can legally sell mifepristone.
To put the Fifth Circuit’s rollback into action, FDA must carry out a string of substantial approvals, which is a direct result of the court’s order. Danco’s attorney, Jessica Ellsworth, argued that the business couldn’t sell mifepristone without the necessary permissions.