April 18, 2023

SWHR Statement on Ruling in Alliance for Hippocratic Medicine et al v FDA et al

April 18, 2022The Society for Women’s Health Research issued the following statement in anticipation of the Supreme Court ruling in response to the preliminary ruling of Judge Kacskmaryk of the U.S. District Court for the Northern District of Texas in the Alliance for Hippocratic Medicine et al v FDA et al case.

The Society for Women’s Health Research (SWHR)—the national thought leader in promoting research on biological sex differences in disease and improving women’s health through science, policy, and education—is deeply concerned by the decision of Judge Kacsmaryk to invalidate the U.S. Food and Drug Administration’s (FDA) 23-year-old approval of mifepristone. We are concerned that this ruling sets a harmful precedent for future treatments for women as well as for the potential of the courts to circumvent FDA’s authority, placing medical and science-based decision-making outside the purview of medical and public health professionals.

Since its inception, the FDA has played a critical role in ensuring the safety and well-being of the American public. Its process for approving drugs, biological products, and other treatments is rigorous, following a structured framework that involves analyzing preclinical and clinical data as well strategies for managing risks. The health and safety of our nation is dependent on evidence-based decision-making; it is vital that scientists—not the courts—continue to make decisions related to safety and efficacy of medical products.

As a nation, there is still a need for significant progress to ensure women have equitable access to medications and the care they need when they need it – and this ruling is counter to that aim. Mifepristone can be used for miscarriage and early pregnancy loss, as a treatment for Cushing’s syndrome, and as a treatment for multiple forms of cancer and depression. If the preliminary ruling is successful, it could jeopardize women’s health and other FDA-approved drugs and treatments and undermine an autonomous, science-based institution from being able to fulfill its mission. This ruling puts progress at risk.

SWHR, along with peers in the scientific and public health community, remains confident in the FDA and supports its role in protecting patients across the country. We urge the Fifth Circuit Court of Appeals to expeditiously reverse the judge’s decision and protect FDA’s decision-making authority. The American public—from patients to health care providers—deserves to have confidence in and access to safe and effective treatments. We cannot allow these decisions to be made outside of established scientific process.