Abortion rights advocates rally outside the U.S. Supreme Court on April 14, 2023 in Washington, DC to speak out against restrictions on abortion pills.
Olivier Douliery | AFP | Getty Images
On Friday, U.S. Supreme Court Justice Samuel Alito temporarily blocked lower court rulings that imposed tougher restrictions on the abortion pill mifepristone.
US Judge Matthew Kacsmaryk of the Northern US District of Texas suspended the Food and Drug Administration’s approval of mifepristone last week.
The US 5th Circuit Court of Appeals blocked that part of Kacsmaryk’s order and upheld the FDA approval. But the appeals court temporarily reimposed tighter restrictions on how mifepristone is used and distributed, which would make it harder for women to access the drug.
Alito blocked those decisions restricting access to mifepristone until 11:59 p.m. Wednesday.
The end result of the nationwide legal battle over mifepristone could severely limit access to the drugs, even in states where abortion remains legal. Mifepristone, used in combination with another drug called misoprostol, is the most common method of terminating a pregnancy in the United States, accounting for about half of all abortions.
US Solicitor General Elizabeth Prelogar said the litigation against the FDA “has been troubling on every level.” She said the lower court rulings were the first time judges have overturned the terms of an FDA drug approval based on a disagreement over the agency’s safety judgment.
“If allowed to go into effect, the lower court orders would upend the regulatory regime for mifepristone, with far-reaching consequences for the pharmaceutical industry, the women who need access to the drug, and the FDA’s ability to implement its statutory authority,” Prelogar said.
5th Circuit Judges Kurt Engelhardt and Andrew Oldham, who were appointed by former President Donald Trump, effectively reversed every regulatory action the FDA has taken on mifepristone over the past 20 years.
Appeals court judges blocked courier delivery of mifepristone, reimposed doctor visits as a condition of receiving the drug and shortened the time frame in which women can take it until the seventh week of pregnancy. They also blocked approval in 2019 of the generic form of mifepristone made by GenBioPro.
The Department of Justice said lower court rulings would make all doses of mifepristone on the market mislabeled because their labeling would not comply with FDA approval in 2000. The government said it would take months to re-adjust labeling, which would prevent women from accessing drugs the FDA has approved as a safe and effective alternative to surgical abortion.
Danco Laboratories, the abortion pill’s distributor, said it would not be able to market mifepristone until the FDA took a series of steps to implement lower court rulings.
“The direct consequence of the Fifth Circuit’s decision is that the FDA must complete a series of extensive approvals to implement the Fifth Circuit rollback. Without these approvals, Danco cannot legally market and distribute mifepristone,” wrote Jessica Ellsworth, the company’s attorney.