A Trump-appointed federal judge in Texas on Friday invalidated the Food and Drug Administration’s two-decade-old approval of the abortion pill mifepristone, issuing a verdict that could imperil access to medical abortions nationwide.
The decision, from U.S. District Court Judge Matthew Kacsmaryk, was quickly followed by a conflicting ruling from a judge in Washington state that ordered the FDA to maintain the pill’s availability in 17 states where Democratic attorneys general had sued to protect access.
The drug will continue to be available at least through the end of next week as Kacsmaryk stayed the effective date of his order for seven days.
In a statement Friday, President Joe Biden said his administration would fight the ruling, and the Department of Justice has filed an appeal of the decision.
“This does not just affect women in Texas — if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state,” Biden said in the statement.
The consequences of Kacsmaryk’s verdict could ripple beyond abortion, too, and impact the FDA’s oversight of the drug approval process.
“If more cases like this follow, which question the FDA’s expertise and authority over the approval of drugs, access to many drugs, some of which are life-saving, could be endangered,” Allison Whelan, Assistant Professor of Law at Georgia State University College of Law, said in an interview prior to the decision.
Issued late Friday before a holiday weekend, Kacsmaryk’s verdict came almost a month after he held an oral hearing in the case, which was filed by the Alliance for Hippocratic Medicine on behalf of conservative anti-abortion groups and doctors. The groups argued mifepristone should never have been approved and called for its removal from the market, suing the FDA and the Health and Human Services Department.
In its lawsuit, the alliance claimed the FDA misapplied its process for granting accelerated approval, which is meant for drugs that treat “serious and life-threatening illnesses.” Pregnancy, the group said, shouldn’t be considered an illness.
Lawyers defending the FDA noted in response how the FDA evaluated “extensive scientific data” over the drug’s two decades on the market, according to an Axios transcript of the March hearing.
Used with another drug called misoprostol, mifepristone is a safe and common procedure for abortions, accounting for over half of all procedures in 2020. It’s considered to be highly effective and safe.
Originally approved in 2000 for use through seven weeks of gestation, the drug’s labeling now allows administration through 10 weeks. Demand for the medication has increased since the overturning of Roe v. Wade in June 2022, when the Supreme Court reversed a 50-year-old precedent that provided the constitutional right to an abortion.
“FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy,” the agency said in a statement.
It’s not clear, though, how the FDA will contend with both Kacsmaryk’s order and the conflicting decision from the federal judge in Washington. Typically, withdrawing a drug’s approval is a lengthy process that involves public hearings and significant review of scientific evidence. With the Biden administration’s appeal, too, the case may end up before the Supreme Court.
Even before the judge’s verdict, though, newly enacted state abortion laws have had an impact on pharmacies’ distribution of mifepristone. In February, Walgreens said it would not distribute the abortion pill in at least 20 states after pressure from the Republican attorneys general. The pharmacy giant later clarified it would only dispense the drug where it is “legally permissible to do so.”
The Texas case could be one of several that target the pill. On March 17, Wyoming became the first state to ban abortion pills after Gov. Mark Gordan signed the bill into law. Any physicians or persons that prescribe abortion medication can face a fine of up to $9,000 and prison time of up to six months.