U.S. Supreme Court Justice Samuel Alito on Friday temporarily blocked lower court rulings that imposed tighter restrictions on the abortion pill mifepristone.
U.S. Judge Matthew Kacsmaryk of the U.S. 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 kept the FDA approval in place. However the appeals court temporarily re-imposed tighter restrictions on how mifepristone is used and distributed, which might make it tougher for girls to access the drug.
Alito blocked those rulings restricting mifepristone access until 11:59 p.m. ET Wednesday. The Alliance Defending Freedom and the Alliance for Hippocratic Medicine, the antiabortion groups who sued the FDA, are required to file their response by noon ET Tuesday.
The Supreme Court, which has a 6-3 conservative majority, will next determine whether to maintain mifepristone more broadly available because the Biden administration’s appeal plays out. However the court could also vote to place the bounds back in place because the appeal is resolved.
The last word final result of the national legal battle over mifepristone could sharply limit access to the medication, even in states where abortion stays legal. Mifepristone, used together with one other drug called misoprostol, is essentially the most common method to terminate a pregnancy within the U.S., accounting for about half of all abortions.
U.S. Solicitor General Elizabeth Prelogar said the litigation against the FDA “has been troubling at every level.” She said the lower court rulings are the primary time judges have repealed the conditions of an FDA drug approval based on a disagreement over the agency’s judgement about safety.Â
“If allowed to take effect, the lower courts’ orders would upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority,” Prelogar said.
Judges Kurt Engelhardt and Andrew Oldham of the fifth Circuit, who were appointed by former President Donald Trump, effectively rolled back every regulatory motion the FDA has taken on mifepristone over the past 20 years.
The appeals court judges blocked mail delivery of mifepristone, re-imposed doctor visits as a condition of receiving the drug, and shortened the timeframe when women can take it to the seventh week of pregnancy. In addition they blocked the 2019 approval of the generic type of mifepristone made by GenBioPro.
The legal landscape surrounding mifepristone has grow to be messy and unsure over the past week. U.S. Judge Thomas Rice within the Eastern District of Washington issued a competing order that the FDA maintain access to mifepristone in 17 states and Washington D.C.
The U.S. government told the Supreme Court that abiding by the fifth Circuit restrictions would put it in violation of the Washington state district court order.
The Justice Department said the Texas and appeals court rulings would make all doses of mifepristone available on the market misbranded because their labelling would not be consistent with the 2000 FDA approval. The federal government said it could take months to readjust the labelling, which might deny women access to drug that the FDA approved as a secure and effective alternative to surgical abortion.
Danco Laboratories, the distributor of the abortion pill, said it could not give you the option to market mifepristone until the FDA takes a series of actions to implement the lower court rulings.
“The direct consequence of the Fifth Circuit’s ruling is that FDA must effectuate a series of in depth approvals to implement the Fifth Circuit’s rollback. Without those approvals, Danco cannot legally market and distribute mifepristone,” wrote Jessica Ellsworth, the corporate’s attorney.
