Supreme Court seems poised to keep abortion medication accessible
Examining the FDA's Regulatory Authority and the Standing of Anti-Abortion Doctors who Forum Shop
On Tuesday, the Supreme Court seemed likely to support the Food and Drug Administration regarding its regulations on the widely used abortion pill, mifepristone, focusing onc whether the group of doctors opposing these regulations had the appropriate legal standing to bring the case to federal court. The justices scrutinized the doctors' group's challenge to the FDA's decisions that facilitated easier access to the medication.
The controversy centers on the FDA's decisions to expand access to mifepristone, a drug used for medication abortions. A group of anti-abortion doctors, the Alliance for Hippocratic Medicine, sued the FDA, arguing these decisions exceeded the agency's authority and compromised safety. They contend the FDA's actions, including allowing mifepristone to be mailed and prescribed without in-person visits, neglect adequate safety assessments
Mifepristone is a medication used primarily in combination with another drug, misoprostol, to terminate early pregnancies, a regimen known as medication abortion. Approved by the U.S. Food and Drug Administration (FDA) in 2000, mifepristone works by blocking the hormone progesterone, which is necessary for a pregnancy to continue. When followed by misoprostol, which induces uterine contractions, this two-step process allows for the termination of a pregnancy up to the 10th week.
Over the years, the FDA has made regulatory changes to increase access to mifepristone, including extending its use up to 10 weeks of pregnancy, reducing the number of required in-person visits, and allowing it to be prescribed via telemedicine and mailed to patients. These adaptations have made medication abortions an increasingly utilized option in the United States, especially in the context of varying state laws regarding surgical abortion following the Supreme Court's reversal of Roe v. Wade.
The mifepristone case initiated by a group of doctors, Alliance for Hippocratic Medicine, in Amarillo, Texas, brings to the forefront the legal challenges against the FDA's regulation of the drug used in medication abortions. This choice of jurisdiction strategically placed the case under Judge Matthew Kacsmaryk, known for his conservative leanings, illustrating the plaintiffs' aim to leverage the judicial landscape to their advantage.
The core of the dispute centers on the FDA's decisions regarding mifepristone use through the 10th week of pregnancy, permitting prescriptions by non-physicians, and eliminating the requirement for an in-person visit before prescribing the drug. The plaintiffs argue that the FDA exceeded its regulatory authority and neglected proper safety assessments in these expansions.
As the case escalated to the Supreme Court, the justices delved into the issue of standing, scrutinizing whether the plaintiff doctors and their associations faced direct harm sufficient to challenge the FDA’s actions. Representing the FDA, Solicitor General Elizabeth Prelogar highlighted the contingent nature of the plaintiffs' purported harm, emphasizing the significant legal protections, including federal conscience exemptions, that mitigate the likelihood of such harm materializing.
Justices Alito and Roberts questioned the implications of standing on regulatory oversight, probing whether a pathway exists for addressing perceived unlawful FDA actions. In contrast, Justices Kagan, Barrett, Kavanaugh, and Jackson focused on dismissing the case based on the plaintiffs' speculative standing, considering the comprehensive federal conscience exemptions and the implausible sequence of events necessary for the plaintiffs to encounter harm.
A decision in the case is expected by June of this year.