By Andrew Chung
WASHINGTON (Reuters) -President Joe Biden’s administration on Friday asked the U.S. Supreme Court to block limits set by lower courts on the abortion pill mifepristone as the federal government seeks to defend access to the drug in the face of mounting abortion bans and restrictions enacted by Republican-led states.
The Justice Department filed an emergency request asking the justices to put on hold a ruling by U.S. District Judge Matthew Kacsmaryk in Texas to significantly restrict the pill’s distribution while litigation in the challenge by anti-abortion groups to mifepristone’s regulatory approval proceeds.
Danco Laboratories, the manufacturer of mifepristone, also asked the U.S. Supreme Court for similar relief on Friday.
Curbing access to mifepristone would deal another major setback to U.S. abortion rights on the national level after the Supreme Court in June 2022 overturned the landmark 1973 Roe v. Wade decision that had legalized the procedure across the country. The Supreme Court has a 6-3 conservative majority.
Kacsmaryk’s order – a preliminary injunction – was set to take effect at 12 a.m. CDT (0500 GMT) on Saturday, according to the Justice Department.
In a case that could also undercut the U.S. Food and Drug Administration’s authority to decide on the safety of drugs, the New Orleans-based 5th U.S. Circuit Court of Appeals on Wednesday declined the administration’s request to block the restrictions ordered by Kacsmaryk on April 7.
The 5th Circuit halted another part of Kacsmaryk’s order that would have suspended the FDA’s approval of the drug, effectively pulling it off the market.
The FDA, which approved mifepristone in 2000, is the U.S. agency that signs off on the safety of food products, drugs and medical devices.
The restrictions set by the lower courts would restore curbs on the medication that had been lifted since 2016 as the FDA steadily expanded access. These revived restrictions include a requirement for three in-person doctor visits in order to obtain it and limiting its use to the first seven weeks of pregnancy, down from the current 10.
The administration said the lower court orders would have “sweeping consequences” for women who need access to mifepristone and the FDA’s scientific judgment authority over drug safety.
Current drug labels for mifepristone do not account for the new limits and would have to be adjusted, a process that could take months, both the Justice Department and Danco said in their filings.
“The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion,” the Justice Department told the justices.
The challengers to mifepristone have called these limits critical safeguards to a medication they consider dangerous. The Justice Department has said the challengers have no basis for second-guessing the FDA’s scientific judgment and that when used as directed, adverse effects of mifepristone are exceedingly rare “just as they are for many common drugs like ibuprofen.”
Mifepristone is used in combination with another drug called misoprostol to perform medication abortion, which accounts for more than half of all U.S. abortions.
Since last year’s Supreme Court decision, 12 U.S. states have put in place outright bans while many others prohibit abortion after a certain length of pregnancy. The latest Republican-led move came in Florida, where Governor Ron DeSantis on Thursday signed a new law that bans most abortions after six weeks of pregnancy, setting the stage for abortion access to be drastically curtailed in the state and across the U.S. South.
Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November seeking to pull approval of misoprostol.
Kacsmaryk found that the FDA, in approving the drug, exceeded its authority by ignoring “legitimate safety concerns” about mifepristone and relying on “plainly unsound reasoning and studies” when approving it.
The 5th Circuit found that the plaintiffs had waited too long to challenge the FDA’s regulatory approval but were likely to succeed in targeting the agency’s decisions in recent years to make access to mifepristone easier.
Health policy and legal experts have said Kacsmaryk’s decision, if allowed to stand, would threaten the FDA’s power to regulate all drugs nationwide and to act as the ultimate arbiter on drug safety. Executives from hundreds of biotech and pharmaceutical industry companies in an open letter called for a reversal of the judge’s “decision to disregard science.”
(Reporting by Andrew Chung in New York; Editing by Will Dunham)
