Washington, DC – The American College of Obstetricians and Gynecologists (ACOG) took another step toward achieving equitable access to care for patients during the COVID-19 pandemic by asking a federal court to require the U.S. Food and Drug Administration (FDA) to suspend a harmful FDA restriction on mifepristone. Joining ACOG as plaintiffs in today’s lawsuit are the Council of University Chairs of Obstetrics and Gynecology, the New York Academy of Family Physicians, and SisterSong Women of Color Reproductive Justice Collective.
Mifepristone is an evidence-based treatment prescribed for management of early pregnancy loss as well as induced abortion. Although mifepristone has long been proven to be safe and effective when prescribed through telemedicine and can be safely taken in the comfort of a patient’s home, outdated FDA restrictions require mifepristone to be dispensed in a hospital, clinic, or medical office.
“Of the more than 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must receive in person at a hospital, clinic, or medical office, yet may self-administer, unsupervised, at a location of their choosing,” says the complaint, which was filed today by the American Civil Liberties Union and the international law firm Arnold & Porter.
For years, the medical community has opposed these restrictions, which have no medical basis, provide no patient benefit, and unnecessarily restrict access to care.
In the current COVID-19 pandemic, these burdensome requirements are especially harmful and must be lifted. The requirements disproportionately affect patients from underserved communities who are burdened by the need to travel, arrange childcare, and present to their chosen clinician in person for the dispensing of the medication. Forcing physicians to dispense this drug in person puts patients at increased risk of COVID-19 as a condition of obtaining abortion or miscarriage care and needlessly raises exposure risks for clinicians and other health care staff.
“Our request in this case is simple: the federal government should permit patients seeking safe and effective reproductive health care, which includes care for miscarriage and termination of pregnancy, the same ability to access care and protect themselves from exposure as patients in other contexts are afforded,” said Eva Chalas, MD, FACOG, FACS, president of ACOG.
People of color have been disproportionately impacted by infections, hospitalizations, and deaths from COVID-19, as well as by the nation’s maternal mortality crisis. The FDA’s restrictions on mifepristone only serve to increase the risk faced by the communities that are already inequitably facing harm from the pandemic.
“During the COVID-19 pandemic, the health care community—from individual physicians to
government agencies—has come together to identify safe, effective ways to provide patients with the care that they need, including through telemedicine. The FDA’s decision to maintain medically unnecessary restrictions on mifepristone is a glaring exception, which results in discrimination in access and threatens to harm patients and their clinicians during a time of national crisis. Lifting the barriers to mifepristone will allow women, including those from underserved communities that are disproportionately affected by both COVID-19 and the ongoing maternal health crisis, the ability to obtain necessary and essential evidence-based care without having to risk potential life-threatening exposure,” Dr. Chalas added.
David Chelmow, MD, FACOG, president of the Council of University Chairs of Obstetrics and Gynecology, added, "The medical community must be able to use all the tools at our disposal, including telehealth care where appropriate, to meet patients' essential medical needs while protecting them from coronavirus. The next generation of health care practitioners must be taught the most safe, effective, and patient-centered care, even during a public health emergency. The FDA’s unique restriction on mifepristone prevents clinicians from exercising their medical judgment during this pandemic, limits the ability to provide the optimal medication for miscarriage and abortion care, and needlessly jeopardizes the safety of patients.”
About the American College of Obstetricians and Gynecologists
The American College of Obstetricians and Gynecologists (ACOG) is the nation’s leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of 60,000 members, ACOG strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women’s health care. acog.org