Competing rulings by federal judges in Texas and Washington on Friday plunged the future of mifepristone, a key abortion drug, into uncertainty.
A ruling by U.S. District Judge Matthew Kacsmaryk in Texas, a Trump appointee, put a halt on government approval of the drug, potentially decimating access to medication abortion nationwide. But just minutes later, a federal judge in Washington, Obama appointee U.S. District Judge Thomas O. Rice, ordered the Food and Drug Administration not to make any changes that would restrict access to the drug in 17 states and D.C. that sued to expand access to mifepristone.
The consequences of the rulings, at least in the short term, will be that access to mifepristone remains unchanged, because Kacsmaryk gave seven days for the federal government to appeal, which the Justice Department has committed to do.
The legal battle seems destined for argument before the nation's Supreme Court Justices, an upcoming challenge that is worrying abortion rights advocates about access to a drug long hailed as safe by federal regulators.
"FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone," said Glenn Cohen of Harvard Law School.
Kacsmaryk's ruling in Texas means health care providers could be barred from prescribing mifepristone, even in states were abortion is legal. In-clinic, procedural abortion care will not be affected by the ruling.
A coalition led by the conservative legal advocacy organization Alliance Defending Freedom in November filed a federal lawsuit in Amarillo, Texas, arguing the drug comes with medical risks and should be pulled from the market. Kacsmaryk in Texas sided with anti-abortion groups in the case.
Abortion access advocates said the ruling could have severe consequences on people’s ability to access abortion and miscarriage care, especially after the overturning of Roe v. Wade.
What does the ruling to pause FDA approval mean?
Kacsmaryk ordered the FDA to stay mifepristone's approval as the lawsuit continues. He did not go as far as plaintiffs wanted by immediately withdrawing FDA approval for the drug.
Still, it could affect medication abortion access for about 64.5 million women of reproductive age nationwide, according to an analysis released Feb. 10 by NARAL Pro-Choice America.
Lorie Chaiten, senior staff attorney at the ACLU's Reproductive Freedom Project, said the ruling could "create an unprecedented disruption to healthcare access."
The decision "will unleash a public health crisis by removing health care options for millions of people," said Jenny Ma, senior counsel at the Center for Reproductive Rights.
The Alliance Defending Freedom, the conservative group that brought the lawsuit, celebrated the ruling out of Texas on Friday.
"This is a significant victory for the doctors and medical associations we represent and more importantly, the health and safety of women and girls," Senior Counsel Erik Baptist said.
Vice President Kamala Harris warned it could set a precedent impacting Americans' ability to access medication prescribed by their doctors.
"Simply put: this decision undermines the FDA’s ability to approve safe and effective medications—from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin—based on science, not politics," Harris said in a statement.
What is mifepristone and medication abortion?
Even before the U.S. Supreme Court last year struck down the constitutional right to abortion granted by Roe v. Wade, medication abortion accounted for more than half of all abortions in the United States, according to the Guttmacher Institute, a research and policy organization that supports abortion rights.
The FDA approved mifepristone for medication abortion in 2000. The drug is typically taken in a two-step regimen along with another medication called misoprostol. The U.S. Department of Health and Human Services, the American Medical Association and the American College of Obstetricians and Gynecologists call mifepristone a safe and effective abortion medication and a component of treatment and management for early pregnancy loss or miscarriage.
"The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation," American Medical Association President Dr. Jack Resneck Jr. said.
What could happen next?
It wasn't immediately clear what the immediate impact of dueling rulings from federal judges would be, but advocates say the situation breeds "chaos and confusion."
"My administration will fight this ruling," President Joe Biden said of the Texas decision. "The lawsuit, and this ruling, is another unprecedented step in taking away basic freedoms from women and putting their health at risk."
U.S. Attorney General Merrick Garland said that the Justice Department "strongly disagrees" with the ruling from Texas and will appeal it, and is reviewing the decision from Washington.
The ruling from the District Court for the Northern District of Texas "overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective. The Department will continue to defend the FDA’s decision," Garland said.
Evan Masingill, CEO of GenBioPro, the manufacturer of mifepristone, said the company is reviewing both rulings and will continue to make the drug available.
"Nothing in the court's order (in Texas) changes the decades of science and evidence regarding mifepristone's safety and efficacy," Masingill said.
While the FDA could choose to restart the approval process if an effort to revoke approval succeeds, this may take years, Chaiten said.
In a statement, NARAL Pro-Choice America said the two competing rulings will almost certainly end up before the Supreme Court.
Filing lawsuit in Amarillo part of legal strategy
Several legal experts said it was no accident the complaint was filed in Amarillo, Texas, where the only judge is Kacsmaryk, an appointee of former President Donald Trump who has a history of conservative rulings.
"This is one single judge in Texas, a state that has already banned abortion, deciding the medication abortion access of every single person across the country," Ma said.
Alliance Defending Freedom, which filed the suit, is considered an anti-LGBTQ hate group by the Southern Poverty Law Center. The group told USA TODAY it "categorically rejects" this classification, calling it a "deliberate mischaracterization of our work."
Providers rush to consider misoprostol-only options
Providers nationwide are rushing to shift to misoprostol-only protocols for medication abortions, and clinics have already begun ordering more misoprostol supplies, said Ashley Brink, clinic director at Trust Women Kansas in Wichita.
She said misoprostol-only methods have been used globally for years as "a safe and effective alternative" to using both mifepristone and misoprostol.
Studies show misoprostol-only methods are less effective than the two-step regimen.
Ruling to hit marginalized communities hardest
Low-income and people of color could be disproportionately impacted by Kacsmaryk's ruling, experts say. A Centers for Disease Control and Prevention analysis showed about 67% of U.S. abortion seekers were non-white.
Terri-Ann Thompson, senior researcher at Ibis Reproductive Health, said the ruling disregards patient preference, cost and travel burdens of marginalized communities.
"One of the reasons, among many, that people actually choose a medication abortion is because it is the less costly option of the abortion options available," she said. "It's a racial justice issue and economic disadvantage is at the root."
Lupe Rodríguez, executive director at the National Latina Institute for Reproductive Justice, said many immigrant women are accustomed to medication abortion and prefer it.
Contributing: John Fritze, USA TODAY; The Associated Press
Source link
