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- The Supreme Court agreed to hear arguments in Food and Drug Administration v.
- Mifepristone was first approved by the FDA in September 2000 under the brand name Mifeprex. It's used in combination with misoprostol to terminate early pregnancies.
- The Alliance for Hippocratic medicine, a group of anti-abortion doctors, filed a lawsuit in November 2022 in the U.S.
Supreme Court to Here Arguments in FDA v. Alliance for Hippocratic Medicine on March 26, 2024
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The Supreme Court agreed to hear arguments in Food and Drug Administration v. Alliance for Hippocratic Medicine on March 26, 2024, concerning the FDA’s approval of mifepristone, a medication used for medication abortion. This case challenges over two decades of FDA action regarding the drug’s safety and accessibility.
Background on Mifepristone and FDA Approval
Mifepristone was first approved by the FDA in September 2000 under the brand name Mifeprex. It’s used in combination with misoprostol to terminate early pregnancies. in 2016, the FDA expanded the approved use of mifepristone to allow for its use up to 10 weeks of pregnancy, and in january 2023, the agency further altered regulations to allow the drug to be mailed to patients after a telehealth consultation, removing the requirement for in-person dispensing.These changes were made based on scientific evidence demonstrating the drug’s safety and efficacy.
The Legal Challenge
The Alliance for Hippocratic medicine, a group of anti-abortion doctors, filed a lawsuit in November 2022 in the U.S. District Court for the Northern District of Texas,arguing that the FDA’s approval process for mifepristone was flawed and that the drug is unsafe.They claimed the FDA failed to adequately consider the safety of the drug, particularly for young girls. Judge Matthew Kacsmaryk, appointed by former President Donald trump, initially ruled in April 2023 to suspend the FDA’s approval of mifepristone, a decision that would have effectively banned the drug nationwide.
Court of Appeals and Supreme Court Intervention
The Fifth Circuit Court of Appeals partially stayed Judge Kacsmaryk’s ruling in May 2023, allowing mifepristone to remain available but reinstating restrictions on its distribution, including the in-person dispensing requirement. The FDA and Danco Laboratories,the manufacturer of mifepristone,than appealed to the supreme Court. On December 22, 2023, the Supreme Court agreed to hear the case, consolidating it with a separate challenge brought by the state of Idaho. The Court will specifically address whether the Alliance for Hippocratic Medicine had legal standing to sue and whether the FDA properly followed its procedures when approving and modifying the drug’s label.
Potential Outcomes
The Supreme Court’s decision could have important implications for access to medication abortion nationwide. A ruling in favor of the Alliance for Hippocratic Medicine could lead to stricter regulations on mifepristone, potentially limiting its availability. A ruling upholding the FDA’s actions would preserve the current access to the drug. The Court is expected to issue its decision by late June 2024.
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