Medication abortion faces its next legal hurdle this week in a case with major implications for reproductive rights as well as prescription-drug regulation.
A three-judge panel of the Fifth Circuit Court of Appeals in New Orleans on Wednesday will hold a hearing in a case involving the abortion pill mifepristone. The case, filed last fall by a group of anti-abortion advocates, challenges the Food and Drug Administration’s approval of the drug. The U.S. Supreme Court late last month blocked a lower court ruling that would have halted the availability of mifepristone, sending the case back to the Fifth Circuit.
Mifepristone, first approved by the FDA in 2000, is part of a two-drug regimen used in the vast majority of medication abortions, which account for more than half of all abortions in the U.S. The Supreme Court’s decision last year overturning the longstanding Constitutional right to abortion heightened the focus on medication abortion, which for many people is more accessible than procedural abortion methods. Only about 55% of U.S. women of reproductive age live in a county that has an abortion provider, according to Guttmacher Institute, a reproductive rights nonprofit. Mifepristone can be provided via telehealth in many areas.
More broadly, “this entire case calls into question the autonomy of the FDA,” with implications reaching far beyond abortion, said Kelly Baden, Guttmacher’s vice president for public policy. “The possibility of putting politics so squarely above science and evidence could harm us all,” Baden said.
The case before the Fifth Circuit was filed last fall by the Alliance for Hippocratic Medicine and other anti-abortion groups who alleged that mifepristone is unsafe and that the FDA’s approval and later modifications of conditions for the drug’s use were outside the agency’s authority. A judge in the U.S. District Court for the Northern District of Texas Amarillo Division in early April issued a preliminary injunction suspending mifepristone’s approval. The Biden administration appealed to the Fifth Circuit, which blocked the lower court’s suspension of the drug’s initial approval but upheld other parts of the ruling overturning subsequent FDA changes that expanded access to mifepristone.
In response to an application from the Biden administration, the Supreme Court then froze the Texas ruling while the litigation continues — allowing mifepristone to remain available, where abortion is still legal, while the case grinds through the courts. Ultimately, the case is likely to wind up back before the Supreme Court, experts say.
In documents filed with the Fifth Circuit in recent weeks, the plaintiffs challenging mifepristone’s approval said the crux of their argument “is that FDA’s judgment was not based on the required scientific evidence,” adding that “the agency’s position–that no court is worthy of checking FDA’s work–reeks of hubris” and is contrary to federal law. The federal government responded in a court filing that “Americans have been safely using mifepristone for over two decades”; more than 5 million U.S. women have used the drug to terminate pregnancies; and that the plaintiffs don’t have the legal standing to raise any of their challenges.
Pharmaceutical companies and investors are watching the case closely. In a friend-of-the-court brief filed with the Fifth Circuit early this month, drugmakers including Pfizer
PFE,
and Gilead Sciences
GILD,
said that the Texas court ruling had “unreasonably found fault with FDA’s sound scientific judgments” and misapplied the governing drug-approval laws. The lower court’s logic “would create chaos for the drug-approval process, not least by inviting any plaintiff to challenge the approval of any drug, regardless of how long the drug has been on the market or how spurious the grounds,” the brief said. Such an outcome, according to the brief, would “chill crucial research and development, undermine the viability of investments in this important sector, and wreak havoc on drug development and approval generally,” harming patients and providers as well as the entire pharmaceutical industry.
In recent weeks, more legal questions have piled onto mifepristone as some groups seek to preserve and expand access to medication abortion. Independent abortion providers in Virginia, Montana and Kansas last week filed suit against the FDA, claiming that certain agency restrictions on mifepristone’s use have impeded access to medication abortion and should be discarded. And a Washington state federal judge in early April ruled that FDA should be barred from taking any steps to reduce mifepristone availability in 17 states and the District of Columbia.
The multiple lawsuits underscore that medication abortion is “a lightning rod” in a chaotic and complex legal landscape, Guttmacher’s Baden said, “which really does not benefit anybody, least of all people who need to access to reproductive healthcare.”
