US Supreme Court Justice Samuel Alito on Friday temporarily blocked rulings by lower courts that imposed tighter restrictions on the abortion pill mifepristone.
US Judge Matthew Kacsmaryk of the US Northern District of Texas last week stayed the Food and Drug Administration’s approval of mifepristone.
The US 5th Circuit Court of Appeals blocked that part of Kacsmaryk’s order and allowed the FDA approval to stand. However, the Court of Appeals temporarily reinstated stricter restrictions on the use and distribution of mifepristone, which would make it more difficult for women to access the drug.
Alito blocked those decisions that limited access to mifepristone until 11:59 p.m. ET Wednesday. The Alliance Defending Freedom and Alliance for Hippocratic Medicine, the anti-abortion groups that have sued the FDA, have until noon Tuesday ET to submit their response.
The Supreme Court, which has a 6-3 Conservative majority, will next decide whether to keep mifepristone more widely available while the Biden administration’s appeal expires. But the court could also vote to reinstate the limits once the appeal is decided.
The final outcome of the national litigation over mifepristone could severely limit access to the drug, even in states where abortion remains legal. Mifepristone, used in combination with another drug called misoprostol, is the most common method of abortion in the United States, accounting for about half of all abortions.
US Attorney General Elizabeth Prelogar said the lawsuit against the FDA was “disturbing on every level.” She said the lower court rulings are the first time judges have overturned the terms of an FDA drug approval because of a disagreement over the agency’s ruling on safety.
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“If enacted, the lower court orders would upend the regulatory system for mifepristone, with far-reaching implications for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its statutory authority ‘ said Prelogar.
5th Circuit Justices Kurt Engelhardt and Andrew Oldham, appointed by former President Donald Trump, have reversed virtually all regulatory action the FDA has taken against mifepristone over the past 20 years.
Court of Appeal judges blocked mail delivery of mifepristone, reinstated doctor visits as a condition of receiving the drug, and shortened the time frame that women can take it up to the seventh week of pregnancy. They also blocked approval of GenBioPro’s generic form of mifepristone in 2019.
The legal landscape surrounding mifepristone has become chaotic and uncertain over the past week. US Judge Thomas Rice in the Eastern District of Washington issued a competing order that the FDA maintain access to mifepristone in 17 states and Washington DC
The US government told the Supreme Court that complying with the 5th Circuit’s restrictions would violate the Washington State District Court’s order.
The Justice Department said the Texas and Circuit Court of Appeals rulings would mislabel all doses of mifepristone on the market because their labeling would not align with the 2000 FDA approval. The government said it would take months to realign labeling, which would deny women access to drugs approved by the FDA as safe and effective alternatives to surgical abortion.
Danco Laboratories, the distributor of the abortion pill, said it would not be able to commercialize mifepristone until the FDA took a series of actions to implement the lower court’s rulings.
“The direct consequence of the Fifth Circuit’s decision is that the FDA must obtain a comprehensive set of approvals in order to implement the Fifth Circuit’s retraction. Without these approvals, Danco cannot legally market and distribute mifepristone,” wrote Jessica Ellsworth, the company’s attorney.
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