Abortion advocates painted a bleak picture Monday of what would happen if a Texas ruling on an abortion medication was allowed to stand, suggesting all federally-approved medications—including birth control and vaccines—could be under attack.
The ruling issued Friday by Matthew Kacsmaryk, a Trump-appointed federal judge in Texas, temporarily rescinded the Food and Drug Administration’s approval for mifepristone, one of two drugs used in medication abortion procedures. According to legal experts, it marked the first time a judge has ever overruled an FDA approval.
If this ruling is allowed to stand, abortion rights advocates warned, it has the potential to upend the entire FDA approval process—not just for abortion medications, but for any drug on the market.
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Under this ruling, “virtually anybody who opposes an FDA-approved drug could drag the agency into court to challenge their decision,” said Center for Reproductive Rights President Nancy Northup in a press call. Those drugs could include medications like emergency contraception, birth control, or even vaccines.
“The implications of this case go far beyond [abortion],”added Jennifer Dalven, director of the ACLU Reproductive Freedom Project. “If the courts allow this, it will radically change the process for approving new drugs and chill innovation.”
Medication abortion, or the combination of mifepristone and misoprostol, now accounts for more than half of all abortion procedures in the United States. Mifepristone has a serious complication risk of less than 1 percent, according to a wide-ranging review of the data conducted by The New York Times.
Kacsmaryk’s decision came in response to a lawsuit filed by a coalition of anti-abortion groups called the Alliance Defending Freedom, which claims the FDA improperly approved the drug more than 20 years ago.
Jane Henny, the FDA commissioner at the time the drug was approved, defended the approval process in a separate press call Monday, calling it “comprehensive” and “quite thorough.”
She noted that the approval of mifepristone had been reviewed multiple times over the last 20 years, including a 2016 review by the Government Accountability Office that found there was “no political intervention in that process.” Further reviews by the FDA actually resulted in a loosening of restrictions around the dispensing of the drug, after further studies and years of use proved its safety and effectiveness.
Henny, too, warned of the dangerous implications of letting a judge overturn the agency’s decisions.
“This kind of ruling would set a very dangerous precedent for the FDA’s authority in terms of other new medications that might warrant movement into the marketplace,” she said. “We would be entering totally uncharted territory in that regard.”
The women’s warnings echoed those issued by the Biden administration over the weekend. In an interview with CNN on Sunday, HHS Secretary Xavier Becerra said the decision could “turn upside down the entire FDA approval process.”
“You’re talking about every kind of drug,” he said. “You’re talking about our vaccines. You’re talking about insulin. You’re talking about the new Alzheimer’s drugs that may come on.”
Kacsmaryk’s ruling is a preliminary injunction, meaning it holds only until he hears the full case and issues a final ruling. Kacsmaryk gave until Friday for the ruling to take effect or be overturned, and the Biden administration has already filed an appeal of the ruling to the Fifth Circuit Court of Appeals. If the Fifth Circuit does not overturn the injunction, the administration will likely appeal the case up to the Supreme Court.
A judge in Washington State issued a dueling ruling Friday in a case filed by attorneys general from 17 states and the District of Columbia. That judge, Thomas O. Rice, ordered the FDA not to limit availability of mifepristone in those jurisdictions. The Department of Justice has filed a motion to clarify in that case.
Providers were hesitant to say what they would do if the ruling were allowed to take effect Friday, noting that a lot of legal decisions could occur between now and then. But spokespeople from Planned Parenthood and from the Center for Reproductive Rights, which represents a number of independent clinics, said some providers were preparing to provide medications using only misoprostol if necessary.
Regardless, said Center for Reproductive Rights attorney Jenna Ma, “if mifepristone becomes inaccessible, there will be a mass shock to the provision of care in states where access to abortion remains.”
