Numerous interested parties across and beyond the health care industry filed briefs at the Supreme Court Tuesday (Jan. 30) warning the high-profile case over FDA’s prescribing changes for the abortion drug mifepristone could upend the agency’s broader drug approval process, including drug industry stakeholders who say the Fifth Circuit Court of Appeals decision in the case has “alarmed the entire pharmaceutical industry.”
Arguments in the case FDA et. al. vs. Alliance for Hippocratic Medicine et. al. are scheduled for March 26. The justices will consider whether to invalidate FDA’s changes to the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone made since 2016, including FDA’s decision to allow telehealth prescribing of the drug. In their amicus briefs, health organizations argued that judicial interference with FDA’s regulatory decision-making would create chaos and uncertainty throughout the health system. They said that mifepristone’s safety and effectiveness are well-established, and that the accessibility of medication abortion is essential to protect the health and dignity of patients who need abortion care or experience early pregnancy loss.
The Supreme Court received briefs in support of FDA from a broad range of stakeholders Tuesday. Amicus briefs supporting the plaintiffs have yet to be posted.
Briefs were submitted on behalf of organizations representing physicians, psychologists, nurses, physician associates, and social workers. Others who submitted briefs include representatives of the pharmaceutical industry, experts on FDA law, 263 members of Congress, a group of governors, over 600 state legislators, civil rights and women’s rights organizations, patient advocates, and others.
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