By Andrew Chung
WASHINGTON (Reuters) -The abortion pill mifepristone may not be available for months if limits on it set by lower courts are allowed to take effect, President Joe Biden's administration and the drug's manufacturer told the U.S. Supreme Court on Friday as they fight to defend access to the drug.
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 that would significantly restrict the pill's distribution while litigation in a challenge by anti-abortion groups to mifepristone's regulatory approval proceeds.
Kacsmaryk's order - a preliminary injunction - was set to take effect at 12 a.m. CDT (0500 GMT) on Saturday.
Biden's administration is seeking to defend the availability of mifepristone in the face of mounting abortion bans and restrictions enacted by Republican-led states since 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 6-3 conservative majority.
The Justice Department said the lower court orders issued in the past week limiting mifepristone's availability would have "sweeping consequences" for women who need access to it and the FDA's scientific judgment authority over drug safety.
Mifepristone, approved by the U.S. Food and Drug Administration in 2000, is used in combination with another drug called misoprostol to perform medication abortions, which account for more than half of all U.S. abortions. The FDA is the U.S. agency that signs off on the safety of food products, drugs and medical devices.
Danco Laboratories, mifepristone's manufacturer, also asked the Supreme Court for similar relief on Friday. The company said it may be forced to halt operations in the face of regulatory uncertainty.
Current drug labels for mifepristone do not account for the new limits and would have to be adjusted, a process that could last months, the Justice Department and Danco said in their filings. The generic version of mifepristone would also lose its approval, the department said.
"The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion," the department told the justices.
In a case that could also undercut the FDA'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.
'FUNDAMENTAL ERRORS'
"To the government's knowledge, this is the first time any court has abrogated FDA's conditions on a drug's approval based on a disagreement with the agency's judgment about safety - much less done so after those conditions have been in effect for years. And the lower courts reached that unprecedented result only through a series of fundamental errors," the Justice Department said in its filing.
The restrictions set by the lower courts would restore curbs on mifepristone that had been lifted since 2016 as the FDA steadily expanded access. These revived restrictions include a requirement for three in-person doctor visits to obtain mifepristone and limiting its use to the first seven weeks of pregnancy, down from the current 10.
Some 61% of Americans, including 51% of Republicans, oppose efforts to restrict access to abortion pills, according to a Reuters/Ipsos poll concluded on Wednesday. Just 37% of respondents said they trusted the Supreme Court to act impartially in abortion-related cases.
The challengers to mifepristone have called the restrictions 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."
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.
(Reporting by Andrew Chung in New York; Editing by Will Dunham)
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