US appeals Texas abortion pill ruling as states stockpile the drug

[April 11, 2023]  By Jonathan Stempel

WASHINGTON (Reuters) -The U.S. government on Monday appealed a Texas judge's decision to suspend the Food and Drug Administration's 23-year-old approval of a key abortion drug, saying the ruling endangered women's health by blocking access to a pill long deemed safe.

In a filing with the 5th U.S. Circuit Court of Appeals, the Department of Justice called Judge Matthew Kacsmaryk's decision on the drug mifepristone "especially unwarranted" because it would undermine the FDA's scientific judgment and harm women for whom the drug is medically necessary.

The Justice Department also said the anti-abortion groups that sought to overturn the FDA's approval had no right to sue in the first place, saying they could not show they were harmed and had left the approval unchallenged for years.

Kacsmaryk's decision "upended decades of reliance by blocking FDA's approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court's own misguided assessment of the drug's safety," the department said.

The Amarillo-based judge, an appointee of former Republican President Donald Trump, had ruled on Friday that the FDA exceeded its authority by ignoring mifepristone's risks and relying on "plainly unsound reasoning" when approving it.

Mifepristone is part of a two-drug regimen, also including misoprostol, for medication abortions in the first 10 weeks of pregnancy. The drugs account for more than half of all U.S. abortions.

STATES TAKE ACTION

In response to Kacsmaryk's decision, California's Democratic Governor Gavin Newsom on Monday said his state had secured an "emergency stockpile" of up to 2 million misoprostol pills.

Massachusetts Governor Maura Healey, also a Democrat, on Monday said her state is stockpiling mifepristone. Washington's Democratic Governor Jay Inslee took similar action last week.

Mifepristone is available under the brand name Mifeprex and as a generic. Danco Laboratories LLC, which makes Mifeprex, is also appealing Kacsmaryk's decision.

Separately, more than 300 biotechnology and pharmaceutical industry executives including Pfizer Inc Chief Executive Albert Bourla signed an open letter calling for a reversal of the judge's decision.

Kacsmaryk stayed his decision for seven days to allow the Biden administration time to appeal.

The Justice Department asked the appeals court to extend the stay by April 13, and that a stay remain in place until any appeals, including to the Supreme Court, are resolved.

Erin Hawley, a lawyer representing the anti-abortion groups, said in a statement on Monday: "By illegally approving dangerous chemical abortion drugs, and imposing its mail-order abortion regime, the FDA put women in harm's way, and the agency should be held accountable."

A patient prepares to take mifepristone, the first pill given in a medical abortion, at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023. REUTERS/Evelyn Hockstein

Kacsmaryk ruled just 18 minutes before a federal judge in Washington state issued a contradictory ruling that directed the FDA to keep the drug available in 17 states.

In a Monday filing in that case, the Justice Department asked the judge there to clarify what should happen if Kacsmaryk's order took effect.

WHITE HOUSE DEFENDS FDA

The conflicting rulings could foreshadow a resolution by the Supreme Court, which last June overturned the 1973 Roe v. Wade decision, eliminating a constitutional right to abortion.

The Supreme Court has a 6-3 conservative majority. The New Orleans-based 5th Circuit also has a conservative reputation, with three-quarters of its active judges appointed by Republican presidents.

"This administration stands by the FDA and is prepared for this legal fight, and we will continue our work to protect reproductive rights," White House spokesperson Karine Jean-Pierre said.

Twenty-three Democratic-led or leaning states plus Washington, D.C. also urged a reversal of Kacsmaryk's decision, saying the Supreme Court left it to elected officials to safeguard abortion access in states that allow the procedure.

Monday's appeal came in a case brought by anti-abortion groups led by the Alliance for Hippocratic Medicine, which was formed last August.

They accused the FDA of failing to consider during its approval process for mifepristone the drug's safety when used by girls under age 18.

The plaintiffs sought a sympathetic court by suing in Amarillo, where Kacsmaryk is the only federal district judge.

Kacsmaryk had written critically about Roe v. Wade, and the former Christian legal activist's courtroom is a popular destination for conservatives challenging Biden policies.

Twelve U.S. states ban abortion, while 14 others ban it at some point after six to 22 weeks of pregnancy, according to the nonprofit Guttmacher Institute, which supports abortion rights.

Some abortion providers have said they would consider a less-effective misoprostol-only regimen if mifepristone were withdrawn.

The case is Alliance for Hippocratic Medicine et al v FDA et al, 5th U.S. Circuit Court of Appeals, No. 23-10362.

(Reporting by Jonathan Stempel in New York; and Kanishka Singh, Caitlin Webber and Moira Warburton in Washington; Editing by Bill Berkrot)

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