Fifteen Medical Organizations, 22 States, and the District of Columbia File Briefs in Support of ACOG’s Challenge to FDA Restrictions During the COVID-19 Pandemic

On Wednesday, two coalitions filed briefs in support of a suit filed by ACOG petitioning a federal court to lift requirements for in-person dispensing of mifepristone during the COVID-19 pandemic. Although mifepristone, which is used in miscarriage management and first trimester pregnancy termination, has been proven to be safe and effective when prescribed through telemedicine for patients to receive by mail and take at home, it is subject to an FDA requirement to be dispensed in-person at a hospital, clinic, or medical office. This requirement hinders access to this medical treatment during the COVID-19 pandemic and places both patients and medical staff at risk of unnecessary exposure during the pandemic.

In a brief filed by a coalition of fifteen medical organizations (including, among others, the American Medical Association, American Academy of Family Physicians, and the American Academy of Pediatrics), the groups argued that FDA’s requirements for in-person dispensing are not only medically unnecessary, but do not allow clinicians to exercise their independent medical judgement. This lack of physician and clinician discretion harms patients and clinicians during the current public health emergency. As the brief states: 

"AMA policy provides that physicians individually and collectively share the obligation to ensure that the care patients receive is “safe, effective, patientcentered, timely, efficient, and equitable.” Yet the REMS on mifepristone in the context of abortion and miscarriage care prevent physicians from carryingout this obligation. Rather than evaluating the concerns of each patient individually, clinicians are forced to schedule an in-person visit even when theclinician has determined that such a visit would be detrimental to the patient’s health and well-being. Because of SARS-CoV- 2, medically unnecessary in-person visits are particularly likely to negatively impact patients’ health and well-being."

Of particular concern, these negative impacts fall hardest on patients of color who as a result of systemic inequities already at higher risk of infection, hospitalization, and death from COVID-19, as well as by the nation’s maternal mortality crisis. The brief highlights for the court how the logistical burdens and risks inherent in the required travel to pick up these prescriptions fall inequitably on communities already facing disproportionate harm from the pandemic. “Due to lack of transportation, insufficient funds, and lack of childcare, low-income patients and patients of color are particularly likely to be exposed to unnecessary risks from the in-person dispensing requirement during the pandemic. Clinicians’ inability to exercise their judgment when providing miscarriage and abortion care thus particularly harms these populations.”

In a brief filed by Attorneys General representing twenty-two states and the District of Columbia, the states argued that FDA’s restrictions erode states’ efforts to minimize transmission of COVID-19 through social distancing, while allowing access to essential reproductive health care. The brief states that using telehealth whenever medically appropriate helps limit social interaction which is “critical to maintaining health and safety and preventing a surge in infection rates… it is important for residents to avoid unnecessary travel and in-person contacts.”