Tell the FDA: Protect Access to Mifepristone | Physicians for Human Rights

Tell the FDA: Protect Access to Mifepristone

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Mifepristone has been used safely and effectively in the United States for more than two decades. But a new review by the U.S. Food and Drug Administration (FDA) threatens to limit access to this essential medication.

PHR is calling on the FDA to uphold science, not politics. Our letter to top FDA officials underscores decades of evidence and more than 100 peer-reviewed clinical studies that confirm mifepristone’s safety and efficacy – not only to assist in abortion care but to treat a variety of mental health and neurological conditions, cancers, and other conditions such as endometriosis. Any barriers would directly harm patients and undermine trust in public health.

By signing on to our letter, health professionals and supporters will help add the credibility and authority needed to ensure the FDA follows the evidence – not ideology.

Add your name to our call for action today.

Message
Your Message
Protect access to mifepristone
Dear Dr. Makary, Dr. Vasisht, Dr. Brenner, and Dr. Tidmarsh,

I am writing to express grave concern about the integrity of the FDA’s proposed review of mifepristone and to urge you to act in line with longstanding, peer-reviewed evidence establishing the safety of this medication that contraindicates the need for increased restrictions.

Mifepristone, also known by the brand name Mifeprex and RU486, has been approved by the FDA since 2000. 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. 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.

A new report, “Cascading Harms: How Abortion Bans Lead to Discriminatory Care Across Medical Specialties” by Physicians for Human Rights emphasizes the importance of access to mifepristone across medical care including and beyond reproductive health care. Interviews with clinicians in multiple medical specialties across 20 states further show how abortion restrictions in fields ranging from rheumatology, dermatology, pulmonology/critical care medicine, oncology, hematology, neurology, cardiology, and obstetrics and gynecology compromise the quality and effectiveness of medical care across reproductive and non-reproductive specialties.

Recent comments submitted by a coalition of reproductive health scientists have also explained the relevant research on mifepristone safety and deep flaws in the methodology of the report on which the current proposed review is based. More than 100 peer-reviewed clinical studies have been published examining the safety and efficacy of mifepristone in pregnancy termination. All have concluded that mifepristone is safe and effective. Moreover, these studies have been able to collect and analyze longer-term outcomes, which show no lasting effects.

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.

Evidence-based treatment is critical for equitable health outcomes. I urge you to act in the interest of patients, not politics, and reject further restrictions on mifepristone.

Sincerely,

[First Name] [Last Name]