U.S. Supreme Court Justice Samuel Alito on Friday temporarily blocked lower court rulings that imposed stricter restrictions on the abortion pill mifepristone.
U.S. Judge Matthew Kacsmaryk of the Northern District of Texas suspended the Food and Drug Administration’s approval of mifepristone last week.
The U.S. Fifth Circuit Court of Appeals blocked that a part of Kacsmaryk’s order and upheld FDA approval. However the appeals court temporarily reimposed stricter restrictions on the use and distribution of mifepristone, which might make it harder for women to access the drug.
Alito blocked those rulings restricting access to mifepristone until 11:59 p.m. ET on Wednesday. Alliance Defending Freedom and Alliance for Hippocratic Medicine, the anti-abortion groups that sued the FDA, are required to file their responses by noon ET Tuesday.
The Supreme Court, which has a conservative majority of 6 to three, will then determine whether mifepristone is to be made more widely available as appeals by the Biden administration are considered. However the court can even vote to reinstate the boundaries after an appeal has been heard.
The final consequence of the national legal battle over mifepristone could significantly limit access to the drug, even in states where abortion stays legal. Mifepristone, used together with one other drug called misoprostol, is essentially the most common approach to abortion in the USA, accounting for about half of all abortions.
U.S. Attorney General Elizabeth Prelogar said the dispute against the FDA “was troubling on every level.” She said the lower court rulings are the primary time that judges have overturned the FDA’s approval of a drug based on a disagreement over the agency’s safety assessment.
“If allowed to enter effect, the lower court rulings would turn the mifepristone regulatory regime the other way up, with huge implications for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its statutory powers,” said Prelogar.
Judges Kurt Engelhardt and Andrew Oldham of the fifth Circuit, who were appointed by former President Donald Trump, effectively rolled back all of the regulatory actions the FDA had taken over the past 20 years.
Appeals court judges blocked delivery of mifepristone by mail, reinstated medical appointments as a condition for receiving the drug, and shortened the timeframe during which women can take it until seven weeks pregnant. Additionally they blocked the 2019 approval of a generic type of mifepristone made by GenBioPro.
The legal landscape surrounding mifepristone has change into a large number and uncertainty over the past week. U.S. Judge Thomas Rice of the Eastern District of Washington issued a competing order for the FDA to keep up access to mifepristone in 17 states and Washington
The U.S. government told the Supreme Court that adhering to the restrictions of the fifth Circuit can be in violation of a Washington State District Court ruling.
The Justice Department said the Texas and appellate court rulings will cause all mifepristone doses in the marketplace to be mislabeled because their labeling won’t comply with the 2000 FDA approval. The government said the labeling revision would take months, stopping women from accessing the drug, which the FDA has approved as a secure and effective alternative to surgical abortion.
Danco Laboratories, the distributor of the abortion pill, said it might not have the ability to sell mifepristone until the FDA took a series of actions to comply with the lower court’s rulings.
“A direct consequence of the Fifth Circuit’s ruling is that the FDA must issue a series of intensive approvals to implement the Fifth Circuit recall. Without these permits, Danco cannot legally sell and distribute mifepristone,” wrote Jessica Ellsworth, a lawyer for the corporate.