Comment from Physicians for Human Rights

Dear Commissioner Makary, On behalf of Physicians for Human Rights (PHR), we submit this comment in full support of citizen petitions FDA-2025-P-0377-0001; FDA-2025-P-1576-0001; FDA-2025-P-2162-0001 that, among other measures, request the FDA to refrain from imposing additional restrictions on mifepristone. Recently, PHR and over 370 health care workers and 1974 allies wrote to you voicing their concerns on the recently announced FDA review of mifepristone.1 This comment consolidates these submissions and echoes support for the safety of mifepristone and its continued approval by the FDA. The FDA’s initial approval of mifepristone, also known by the brand name Mifeprex and RU486, in 2000 was predicated on years of rigorous, evidence-based research demonstrating the overwhelming safety and efficacy of mifepristone in use. It is recognized by the World Health Organization as a core medication on the Model List of Essential Medicines due to its safety, efficacy, and importance to health systems worldwide.2 In addition to its use in combination with misoprostol to assist abortion, mifepristone has been approved for the treatment of Cushing syndrome under the brand name Korlym since 2012. It is also under investigational use in the United States and other countries for the treatment of mental health and neurological conditions such as depression, dementia, post-traumatic stress disorder, Gulf War syndrome, delirium, suicide, psychosis, catatonia, and cognitive deterioration; cancers – particularly breast cancer; endometriosis; and uterine fibroids. Prior, post-approval updates to mifepristone access and REMS scheduling have similarly echoed the consensus of the existing literature, which demonstrates, based on concrete data and thousands of patients' experiences, that delivery of mifepristone is overwhelmingly safe and integral to the health of thousands of Americans. PHR has conducted extensive research on the impacts of abortion bans on US patients and clinicians, including specifically assessing the effects of depressed access to Mifeprex. These findings, most recently published in the brief “Cascading Harms: How Abortion Bans Lead to Discriminatory Care Across Medical Specialties,”3 demonstrated the negative repercussions of mifepristone restrictions on reproductive and non-reproductive clinicians. More than 100 peer-reviewed clinical studies have been conducted on mifepristone to assess its long-term safety, all of which showed the drug to be safe and effective.4 As PHR5 and other coalitions of experts and reproductive health scientists6 have expressed, the methodology and conclusions of the Ethics and Public Policy Center (EPPC) report which the present review of mifepristone is based fails to meet the high evidentiary, transparency, and methodological standards required of objective, empirical research.7 In contrast to the non-transparent data, unsubstantiated conclusions, and skewed methodological framing of the EPPC, the FDA’s prescribing information cites the findings of 10 clinical trials with more than 30,000 patients which show that serious adverse effects occur in fewer than 0.5% of patients.8 Similar reviews and studies have found comparable rates in both in-person and telehealth delivery of mifepristone.9 Periodic reviews of medication are a meaningful and valuable tool to ensure patient safety, but they must be grounded in established medical evidence and scientific rigor. Rejecting medical precedent and injecting partisan politics into this process not only foments disinformation and undermines public trust in American health care authorities but also directly harms patients who depend on mifepristone for safe, effective care. PHR and its medical partners echo the requests included in the four petitions referenced above to reject additional restrictions on access to mifepristone for reproductive and non-reproductive use in the United States. As experts and health care providers, we urge the FDA to support evidence-based standards and align its regulatory standards with established patient-centered care. Sincerely, Physicians for Human Rights