Biden administration to ask Supreme Court to stop abortion pill curbs

[April 14, 2023]  By Andrew Chung and Brendan Pierson

(Reuters) -U.S. Attorney General Merrick Garland said on Thursday the Justice Department will ask the Supreme Court to intervene to stop restrictions set by a federal judge on the abortion pill mifepristone as President Joe Biden's administration moves to defend access to the drug.

The administration will seek emergency relief from the Supreme Court to defend the U.S. Food and Drug Administration's "scientific judgment and protect Americans' access to safe and effective reproductive care," Garland said in a statement.

Mifepristone, approved by the FDA in 2000, is used in combination with another drug called misoprostol to perform medication abortion, which accounts 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.

The New Orleans-based 5th U.S. Circuit Court of Appeals late on Wednesday put on hold part of last Friday's order by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, that would have removed the drug from the market by suspending the FDA approval while he hears a lawsuit by anti-abortion groups seeking to ban it.

The 5th Circuit, however, declined to block portions of Kacsmaryk's order, reinstating restrictions on the pill's distribution that had been lifted since 2016. In addition to a requirement of three in-person doctor visits to prescribe and dispense the drug, those restrictions include limiting its use to the first seven weeks of pregnancy, down from the current 10.

Kacsmaryk's order was set to take effect at 12 a.m. CDT (0500 GMT) on Saturday, according to the Justice Department. Garland is seeking to have the Supreme Court block Kacsmaryk's order in its entirety.

"We are going to continue to fight in the courts," White House spokesperson Karine Jean-Pierre told reporters traveling with Biden in Ireland. "We believe that the law is on our side, and we will prevail."

Kacsmaryk's ruling conflicts with a different federal judge's decision last Friday ordering the FDA to maintain access to mifepristone with no new restrictions in 17 Democratic-led states and the District of Columbia, which had sued the Biden administration in an effort to loosen restrictions around the drug.

In response to a request for clarification from the administration, U.S. District Judge Thomas Rice in Spokane, Washington affirmed on Thursday that the FDA is forbidden from enforcing any new restrictions in those states, regardless of Kacsmaryk's order.

'THE BOUNDS OF THE LAW'

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.

The Alliance Defending Freedom, the conservative legal group representing the plaintiffs, in a statement on Thursday called the 5th Circuit decision "a significant victory for the doctors we represent, women's health and every American who deserves an accountable federal government acting within the bounds of the law."

Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023. REUTERS/Evelyn Hockstein/File Photo

Removing mifepristone from the market 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 nationwide.

The Supreme Court has a 6-3 conservative majority.

Kacsmaryk found that the FDA exceeded its authority by ignoring "legitimate safety concerns" about mifepristone and relying on "plainly unsound reasoning and studies" when approving it.

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.

The 5th Circuit found that the plaintiffs had waited too long to challenge the original 2000 regulatory approval of mifepristone but were likely to succeed in targeting the agency's decisions in recent years expanding access.

It said the government's arguments for an emergency stay of the ruling focused on the potential harm of pulling mifepristone from the market entirely but that it was "difficult to argue" that the 2016 changes "were so critical to the public given that the nation operated - and mifepristone was administered to millions of women - without them for 16 years."

Major U.S. medical groups, including the American Medical Association and American College of Obstetricians and Gynecologists, have said the judge's ruling is unsupported by science, and that mifepristone's safety has been confirmed by hundreds of studies and more than two decades of experience.

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."

The plaintiffs sought a sympathetic court by suing in Amarillo, where Kacsmaryk is the only federal district judge. Kacsmaryk is a conservative former Christian activist who was appointed to the bench by Republican former President Donald Trump, serving since 2019.

The lawsuit is part of an ongoing effort by anti-abortion activists and Republican officials to further limit abortion access following last year's Supreme Court ruling - one that freed states to outlaw the procedure. Since that decision, 12 U.S. states have outright bans in place while many others prohibit abortion after a certain length of pregnancy.

For an Explainer on the case and what to expect next see:

(Reporting by Brendan Pierson and Andrew Chung in New York; Additional reporting by Steve Holland in Dublin, Ireland, and Trevor Hunnicutt; Editing by Alexia Garamfalvi, Will Dunham, Bill Berkrot and William Mallard)

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.