By PAUL J. WEBER, MATTHEW PERRONE and LINDSAY WHITEHURST (Associated Press)
AUSTIN, Texas (AP) — Access to America’s most widely used abortion method was thrown into uncertainty Friday after conflicting court rulings on the legality of the abortion drug mifepristone that has been widely available for more than 20 years.
For now, the drug approved by the Food and Drug Administration in 2000 appeared to be at least immediately available following two separate rulings handed down within minutes of each other by federal judges in Texas and Washington.
US District Judge Matthew Kacsmaryk, a Trump appointee, ordered a suspension of federal approval of mifepristone in a decision that struck down decades of scientific approval. But that decision came around the same time that Obama-appointed U.S. District Judge Thomas O. Rice essentially ordered the opposite, ordering U.S. authorities not to make any changes that would restrict access to the drug by at least 17 states where Democrats sued. an effort to protect availability.
The extraordinary timing of the competing orders revealed just how much was at stake around the drug nearly a year after the US Supreme Court struck down Roe v. Wade and reduce access to abortion across the country.
“The FDA has an order that says nothing can be done and another that says in seven days I’m going to demand that they revoke the approval of mifepristone,” said Glenn Cohen of Harvard Law School.
The abortion drug has been widely used in the US since it gained FDA approval and there is essentially no precedent for a lone judge to overturn medical decisions by the Food and Drug Administration. Mifepristone is one of two drugs used for medical abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.
Kacsmaryk signed a court order directing the FDA to suspend approval of mifepristone while a lawsuit challenging the drug’s safety and approval continues. His 67-page order gave the government seven days to appeal.
“Simply put, the FDA obstructed judicial review, until now,” Kacsmaryk wrote.
It did not go as far as the plaintiffs wanted in withdrawing or suspending the approval of the chemical abortion drug and removing it from the list of approved drugs.
Federal lawyers representing the FDA are expected to appeal quickly. The White House was reviewing the decision.
Clinics and doctors who prescribe the two-drug combination have said that if mifepristone were withdrawn from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower effectiveness rate for terminating pregnancies, but is widely used in countries where mifepristone is illegal or unavailable.
Mifepristone is part of a two-drug regimen that has long been the standard for medical abortion in the US. Clinics and doctors who prescribe the combination have said they plan to switch to using only misoprostol. The single drug approach is slightly less effective in terminating pregnancies.
The lawsuit in the Texas case was brought by Alliance Defending Freedom, which was also involved in the Mississippi case that led to the overturning of Roe v. Wade. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.
Courts have long delegated to the FDA on questions of drug safety and efficacy. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.
Democrats and abortion advocacy groups criticized the Texas decision.
“Abortion remains legal and accessible here in California and we will not stand idly by as fundamental freedoms are stripped away,” said California Governor Gavin Newsom.
Legal experts warned that the ruling could upend decades of precedent, setting the stage for political groups to rescind other FDA approvals of controversial drugs and vaccines.
“This has never happened before in history, it’s a huge problem,” said Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh School of Law. “You have a federal judge who has no scientific background and questions every scientific decision that the FDA made.”
Still, due to the contradictory nature of the rulings, Greer and other experts said there would be little immediate impact.
“In the short term, nothing is going to change,” Greer said. “This is the time to prepare for the fact that, potentially, within a week, mifepristone will become an off-label drug in this country.”
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Perrone and Whitehurst reported from Washington.
