Supreme Court Reviews Mifepristone Access in Major Abortion Pill Case
March 29, 2024
The Supreme Court recently deliberated on a pivotal case, Alliance for Hippocratic Medicine v. FDA, that could determine future access to mifepristone, an essential medication used in over half of all abortions. This case is the most significant since the Dobbs decision reversed Roe v. Wade. Anti-abortion groups are challenging the FDA’s approval of mifepristone and its subsequent adjustments to broaden access, including telemedicine prescriptions and mail delivery, which were facilitated by the pandemic.
Mifepristone was approved by the FDA in 2000, with its usage period extended from seven to ten weeks of pregnancy in 2016. The plaintiffs argue that the FDA overstepped its regulatory bounds with these decisions. A ruling in favor of the plaintiffs could revoke mifepristone’s telehealth access, impacting even states where abortion is protected.
Beyond reproductive rights, the case could have broader implications for the pharmaceutical industry and the FDA’s authority in drug approval and regulation. Sarah Alwardt of Avalere Health highlighted concerns that an adverse ruling could challenge the FDA’s scientific jurisdiction, potentially opening the door for legal disputes over drug approvals based on ideological grounds.
The pharmaceutical industry has rallied in defense of the FDA, emphasizing mifepristone’s safety and the precedent that judicial interference could set for future drug approvals. Leaders from Pfizer and Genentech, among others, have publicly supported the FDA’s regulatory capabilities, underscoring the potential ramifications for the biopharma sector.
During the oral arguments, conservative Justices Neil Gorsuch and Amy Coney Barrett displayed skepticism toward the plaintiffs’ standing, questioning the direct harm claimed by anti-abortion doctors due to expanded access to mifepristone. Their sentiments, echoed by Justice Ketanji Brown Jackson, suggest a recognition of the FDA’s and the pharmaceutical experts’ authority over drug safety and efficacy matters.
The court’s decision, anticipated by late June, holds significant consequences not only for abortion access but also for the pharmaceutical industry’s regulatory landscape.
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[Source: MM+M, March 26th, 2024]
