Washington — A conservative federal appeals court in New Orleans is poised to weigh in on the high-stakes legal showdown targeting the Food and Drug Administration’s decades-old approval of a commonly used abortion pill, the outcome of which could disrupt its availability nationwide.
The dispute will be heard by a panel of three judges, Jennifer Walker Elrod, James Ho and Cory Wilson, and is one of the most significant involving abortion rights in the wake of the Supreme Court’s decision last June that reversed the constitutional right to abortion. Elrod was appointed by former President George W. Bush, while Ho and Wilson were tapped by former President Donald Trump.
The case, Alliance for Hippocratic Medicine v. FDA, was brought in November by a conservative legal organization on behalf of a group of anti-abortion medical associations and physicians. The plaintiffs argued the FDA erred in 2000 when it approved the pill mifepristone, one of two drugs used in a medication abortion, and failed to adequately consider its safety.
In addition to pushing for the FDA’s approval of mifepristone to be withdrawn, the medical groups and doctors sought to unwind a series of steps taken by the agency since 2016 that made the drug more easily available, including an expansion of the gestational age limit for using the drug from 7 weeks to 10 weeks, approval of a generic version of mifepristone in 2019 and removal of an in-person dispensing requirement in 2021.
A federal judge in Texas issued a temporary order in early April that said the FDA’s approval of mifepristone should be suspended, kicking off a frenetic series of court orders that thrust the legal status of the abortion pill into uncertainty. Among those was a preliminary decision by the 5th Circuit that narrowed the district court’s injunction, allowing mifepristone to remain on the market, but leaving in place portions that rolled back the FDA’s changes since 2016.
The Supreme Court ultimately preserved full access to mifepristone while the appeals process plays out, though the case is almost certain to land before the justices again.
Before the 5th Circuit on Wednesday is the Justice Department’s appeal of the April 8 order from U.S. District Judge Matthew Kacsmaryk, a Trump appointee, that suspended the FDA’s approval of mifepristone. The three-judge panel is set to consider whether the claims brought by the medical groups are judicially reviewable, whether the FDA’s 2000 approval and subsequent actions were lawful and whether the district court abused its discretion.
The FDA is urging the 5th Circuit to reverse Kacsmaryk’s order, arguing in a brief that if left intact, the decision “would upend the status quo based on the court’s deeply misguided assessment of mifepristone’s safety.”
“The district court’s order would thwart FDA’s scientific judgment and profoundly harm women who rely on mifepristone as an alternative to more burdensome and invasive surgical abortions,” Justice Department lawyers told the 5th Circuit. “Those harms would be felt throughout the Nation because mifepristone has lawful uses in every State — even those with restrictive abortion laws.”
The battle over mifepristone
The FDA has stressed that more than 5 million Americans have taken mifepristone to end their early pregnancies, and medication abortions account for more than half of all abortions in the U.S. Serious adverse events associated with mifepristone are also “exceedingly rare,” the Justice Department noted, with the rate of hospitalization related to medication abortion under 1%.
But lawyers for the Alliance Defending Freedom, which is representing the medical groups, argue that the FDA “put politics above women’s health” when approved mifepristone in 2000 and removed certain requirements surrounding access to it, including allowing it to be dispensed through the mail.
“No agency is infallible,” they told the 5th Circuit in a filing. “The crux of plaintiffs’ arguments is that FDA’s judgment was not based on the required scientific evidence. The agency’s position — that no court is worthy of checking FDA’s work — reeks of hubris and is contrary to” federal law.
Citing the Supreme Court’s decision overturning Roe, which left abortion policy to the states, lawyers for the alliance said the FDA’s actions regarding mifepristone “subvert the promise” of that ruling, as patients seeking abortion pills in states with stringent limits on the procedure can still obtain them by mail.
“Instead of respecting federalism, the Biden administration and FDA have worked to dismantle it,” they wrote, in reference to the administration’s efforts to protect access to reproductive health services.
Decision against FDA would reach beyond states restricting abortion
The legal challenge targeting mifepristone and the FDA’s 23-year-old approval of the drug opened a new front in the ongoing fight over abortion, and a decision against the agency would reach beyond the states that restrict abortion, as suspending its approval could mean the drug would be pulled off shelves nationwide.
The FDA’s backers are also sounding the alarm that if the district court’s order is allowed to stand, it would undermine the agency’s approval process for other drugs.
“The decision below sets the country on a dangerous path back to the piecemeal regulatory scheme that Congress rejected in 1938, when Congress decided that the best way to protect the public health and promote access to safe and effective medication was to rely on an expert agency to regulate and approve drugs,” a group of 13 former FDA officials wrote in a friend-of-the-court brief. “Courts lack the expertise to step into FDA’s shoes by second-guessing FDA’s experts on the safety and efficacy of drugs.”
Also urging the 5th Circuit to reverse the district court’s order are 240 congressional Democrats, who argued it has “no basis in law, threatens the congressionally mandated drug approval process, and poses a serious health risk” to pregnant patients.
“The district court’s order not only misapplies the law but also threatens to harm members of the public, many of whom rely on the availability of mifepristone for reproductive care — and many more of whom rely on the integrity of FDA’s drug approval process for continued access to life-improving and lifesaving drugs,” they wrote in a court filing.
A group of 69 Republicans in Congress, however, told the 5th Circuit that it should leave the lower court’s preliminary injunction in place, claiming the FDA contravened federal law and exceeded the scope of its authority from Congress.
“The FDA’s unlawful approval and deregulation of chemical abortion drugs subverts Congress’ public policy considerations and safeguards for patient safety,” they argued in a friend-of-the-court brief.