Demonstrators march towards the U.S. Capitol and the Supreme Court on March 26, 2024. (Jemal Countess / Getty Images for Women’s March) |
BY AZIZA AHMED | The Supreme Court heard oral arguments Tuesday in FDA v. Alliance for Hippocratic Medicine. The case concerns the drug mifepristone, one of the two medications used to complete a self-induced abortion.
In 2000, the drug was initially approved by the FDA with overwhelming evidence that it was safe. The approval, however, was made contingent on regulations that currently operate under the banner of Risk Evaluation and Mitigation Strategy, or REMS. The REMS allowed for additional restrictions, including mandating that the drug be accessed in person at a clinic. The FDA eventually altered the regulations to make it more accessible—first, in 2016, then again in 2021 during the pandemic: The FDA stopped requiring patients to access the drug in person, which was both in line with evidence and necessary in the context of the pandemic.
In Tuesday’s case, the Alliance for Hippocratic Medicine and physician plaintiffs challenged the 2016 and 2021 changes. The plaintiffs would like the FDA regulations to shift back to what they were in 2000—which would make the contemporary regulation of mifepristone out of sync with evidence.
The case is taking place against a bigger backdrop: The Supreme Court is critical of the administrative state, and this case could offer an opportunity to take a big blow at one agency, the FDA, essentially making the FDA regulation of drugs subject to court decisions and individual’s personal objections to providing a medication. Alongside the broader considerations of the administrative agency, the conservative members of the court, who decided Dobbs, are not sympathetic to the plight of people who need abortions.
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