In a momentous legal battle that carries significant implications for abortion rights across the nation, a conservative federal appeals court in New Orleans stands poised to enter the fray, examining the long-standing approval by the Food and Drug Administration (FDA) of a commonly used abortion pill. The outcome of this high-stakes dispute has the potential to disrupt the availability of the medication throughout the country.
Scheduled to be heard by a distinguished panel of three judges—Jennifer Walker Elrod, James Ho, and Cory Wilson—the case represents one of the most consequential challenges to abortion rights following the Supreme Court’s decision last June, which effectively overturned the constitutional guarantee to abortion. Elrod was appointed by former President George W. Bush, while Ho and Wilson were selected by former President Donald Trump.
Dubbed Alliance for Hippocratic Medicine v. FDA, the lawsuit was initiated in November by a conservative legal organization on behalf of a coalition of anti-abortion medical associations and physicians. The plaintiffs assert that the FDA made an error in judgment back in 2000 when it granted approval for mifepristone, a drug used in medication abortions, and failed to adequately assess its safety.
The medical groups and doctors involved in the lawsuit not only seek the withdrawal of the FDA’s approval for mifepristone but also aim to undo a series of regulatory measures implemented by the agency since 2016, which facilitated broader access to the drug. These measures include extending the gestational age limit for its use from 7 weeks to 10 weeks, approving a generic version of mifepristone in 2019, and eliminating the requirement for in-person dispensing in 2021.
In early April, a federal judge in Texas issued a temporary order that called for the suspension of the FDA’s approval of mifepristone, triggering a cascade of legal manoeuvres that plunged the status of the abortion pill into uncertainty. Amid this whirlwind, the 5th Circuit Court of Appeals issued a preliminary ruling that narrowed the scope of the district court’s injunction, allowing mifepristone to remain on the market while preserving certain rollbacks of FDA’s regulations since 2016.
Ultimately, the Supreme Court intervened, preserving unrestricted access to mifepristone while the appeals process unfolds. However, it is highly likely that the case will return to the Supreme Court in due course.
At present, the 5th Circuit is deliberating on the Justice Department’s appeal of the April 8 order from U.S. District Judge Matthew Kacsmaryk, a Trump appointee, which suspended the FDA’s approval of mifepristone. The three-judge panel will assess whether the claims presented by the medical groups are subject to judicial review, whether the FDA’s 2000 approval and subsequent actions were legally sound, and whether the district court overstepped its bounds.
The FDA is urging the 5th Circuit to overturn Kacsmaryk’s order, asserting in a brief that if it remains 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,” argued lawyers from the Justice Department, appealing to 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.”
Mifepristone: A Contentious Struggle Unfolds
Emphasizing the widespread usage and importance of mifepristone, the FDA has underscored that over 5 million Americans have relied on the medication to terminate early pregnancies. Medication abortions, which incorporate mifepristone, constitute more than half of all abortions performed in the United States. The Justice Department has further pointed out that serious adverse events associated with mifepristone are exceedingly rare, with the hospitalization rate for complications related to medication abortion falling below 1%.
In contrast, lawyers representing the medical groups under the banner of the Alliance Defending Freedom contend that the FDA prioritized politics over women’s health when granting approval for mifepristone in 2000 and relaxing certain access requirements, such as permitting mail dispensation. In a filing submitted to the 5th Circuit, they assert, “No agency is infallible.” They argue that the crux of their case lies in the assertion that the FDA’s judgment lacked the necessary scientific evidence. The alliance’s lawyers argue that the FDA’s stance, claiming that no court is qualified to scrutinize the agency’s work, exudes an air of hubris and runs counter to federal law.
Drawing upon the Supreme Court’s decision in Roe v. Wade, which devolved authority over abortion policy to the states, the lawyers for the alliance contend that the FDA’s actions regarding mifepristone “subvert the promise” of that ruling. They argue that patients seeking abortion pills in states with stringent abortion restrictions can still obtain them through mail services. In their filing, they criticize the Biden administration and the FDA for what they perceive as an undermining of federalism, accusing them of working to dismantle it, despite the administration’s purported efforts to safeguard access to reproductive health services.
As the legal battle over mifepristone unfolds in the conservative-leaning federal appeals court, the ramifications of the court’s decision will extend far beyond the immediate parties involved. The fate of this commonly used abortion pill hangs in the balance, and the outcome has the potential to reshape the landscape of abortion rights across the nation. With the conservative tilt of the appeals court and the potential for further review by the Supreme Court, both sides of the abortion debate anxiously await the resolution of this critical legal showdown.
The Ramifications of an Anti-FDA Ruling Extend Beyond Abortion Restrictions
The legal battle surrounding mifepristone and the FDA’s decades-old approval of the drug has opened up a new front in the ongoing struggle over abortion rights. Should the court rule against the FDA, the repercussions would extend well beyond states with restrictive abortion laws, potentially leading to the removal of the drug from shelves nationwide.
Supporters of the FDA are also raising concerns that upholding the district court’s order would undermine the agency’s approval process for other medications. A group of 13 former FDA officials warned that such a decision would set the country on a perilous path, reverting to a fragmented regulatory framework that Congress had rejected in 1938. They stressed that courts lack the expertise required to second-guess the FDA’s evaluations of drug safety and efficacy, emphasizing the importance of relying on an expert agency for drug regulation and approval.
Joining the chorus urging the 5th Circuit to reverse the district court’s order are 240 congressional Democrats who argued that it lacks a legal basis, poses a threat to the congressionally mandated drug approval process, and poses significant health risks for pregnant patients. In a court filing, they expressed concerns about the potential harm to the public and emphasized the critical role of the FDA’s drug approval process in ensuring access to life-improving and life-saving medications.
On the other side, a group of 69 Republicans in Congress called on the 5th Circuit to uphold the lower court’s preliminary injunction, contending that the FDA’s approval of mifepristone violated federal law and exceeded the bounds of its authority granted by Congress. They argued that the FDA’s actions undermined public policy considerations and patient safety safeguards put in place by Congress. As this pivotal legal battle continues to unfold, the fate of mifepristone and the FDA’s authority over drug approval hangs in the balance. The ultimate decision by the 5th Circuit Court of Appeals will have far-reaching consequences, shaping the landscape of reproductive rights and impacting the agency’s regulatory powers. With passionate arguments presented by both sides and the weight of public health and access to care at stake, the outcome of this legal clash carries immense significance.