Federal Court Blocks FDA Restriction That Unnecessarily Imposes COVID-19 Risks on Patients Seeking Abortion Care

A federal district court ruled today that the U.S. Food and Drug Administration (FDA) must temporarily suspend enforcement of a restriction on a medication used for early abortion that subjects patients to COVID-19 risks by forcing them to make an unnecessary trip to their health care provider just to pick up the medication and sign a form. The ruling comes in response to a lawsuit filed by the American Civil Liberties Union on behalf of a coalition of medical experts and reproductive justice advocates, led by the American College of Obstetricians and Gynecologists (ACOG).

At issue in this case is a restriction on an FDA-approved prescription drug, mifepristone, which is used in combination with another drug, misoprostol, to safely and effectively end early pregnancies and treat early miscarriage. Even during the pandemic, the FDA continued to require patients to travel to a hospital, clinic, or medical office to pick up the mifepristone, prohibiting patients who had already been evaluated by a clinician (using telehealth or at a prior in-person visit) from filling their mifepristone prescription by mail. The requirement imposes unnecessary COVID-19 risks and other burdens by forcing patients to travel to one of these clinical settings solely to pick up the medication and sign a form, even though, based on safety data, the FDA already permits patients to swallow the pill later at home.

The court issued a preliminary injunction today that blocks the FDA from enforcing this requirement when mifepristone is used for early abortion care, though the court did not suspend the restriction in cases where the medication is used as part of miscarriage treatment. The injunction will remain in place until at least 30 days after the end of the federal government's declared public health emergency, which the U.S. Department of Health and Human Services has indicated it intends to renew later this month.

The court's ruling is particularly important for communities of color and low-income communities, who make up the majority of impacted patients and who are suffering severe complications and dying from COVID-19 at disproportionately high rates.

"Today's decision means that the Trump administration can no longer force patients to incur unnecessary COVID-19 risks as the price of getting abortion care." said Julia Kaye, staff attorney at the ACLU Reproductive Freedom Project. "Like so many of the administration's actions, its refusal to suspend this irrational restriction during the pandemic -- despite urgent requests from the nation's leading medical authorities -- was particularly dangerous for people of color and low-income communities, who are disproportionately suffering severe harm from COVID-19. We look forward to a day when federal reproductive health care policy is grounded in science, not animus, and this medically baseless requirement is lifted once and for all."

The ruling comes after the FDA ignored requests from leading medical authorities, including ACOG, asking the agency to lift this restriction. By contrast, the FDA and other federal agencies have suspended in-person requirements for other medications during the pandemic. In addition to the plaintiffs in this case, which represent more than 60,000 obstetricians-gynecologists as well as the chairs of obstetrics and gynecology departments at nearly 150 universities, other leading medical groups, including the American Medical Association, filed a brief in support of plaintiffs' request to lift the restriction.

Of the more than 20,000 drug products the FDA regulates, the mifepristone product used to end an early pregnancy or provide miscarriage care is the only medication the FDA requires patients to pick up in-person even though they may self-administer it at home without clinical supervision. When used for purposes other than pregnancy termination, the FDA permits mifepristone to be mailed directly to a patient's home in higher doses and quantities.

The medical community has opposed these restrictions on mifepristone for years, as they have no medical basis. In addition to the case decided today, the ACLU has another case challenging a broader range of FDA restrictions on medication abortion care that was filed prior to the COVID-19 pandemic. More information on that challenge can be found here.

The following are statements from the plaintiffs in this case:

Eva Chalas, M.D., FACOG, FACS, president of ACOG:
"Suspending the REMS requirement for mifepristone for early pregnancy termination represents a necessary step forward in our collective work toward health equity during this unprecedented time of pandemic. Today's ruling represents a victory for patients, who should not have to face the additional burden of increased COVID-19 exposure as a condition of receiving their prescribed mifepristone. It also represents a victory for the dedicated clinicians who are working to provide needed care without unnecessary exposure of patients, their families and the members of the healthcare team, to the novel coronavirus. Nonetheless, we are disappointed that the injunction issued by the Court does not apply to women experiencing miscarriage and the clinicians treating them. We will continue our advocacy to seek removal of these restrictions during the pandemic."

Monica Simpson, executive director of SisterSong Women of Color Reproductive Justice Collective:
"The FDA's medically unjustified requirement has long stood in the way of communities of color getting the reproductive health care we need -- and now, during the pandemic, it is putting us at unnecessary risk for COVID-19. Today's ruling recognized the simple truth that people should not be forced to choose between getting the care they need and protecting their health. This Administration should stop spending its time trying to make it harder for people of color to get the medical care we need, and instead trust us to make our own reproductive decisions and remove barriers that violate or prohibit our human right to self-determination."

David Chelmow, M.D., president of the Council of University Chairs of Obstetrics and Gynecology:
"As Chairs of Ob-Gyn departments at medical schools and hospitals across the country, we know how critical it is for patients to get the care they need without making unnecessary trips to their medical providers. Today, science prevailed over politics and the federal court ruled that patients are now able to access early abortion care during the pandemic without unnecessary risk. We are disappointed that the Court did not grant the same access to patients needing mifepristone for miscarriage care. We ask the FDA to listen to the medical experts and lift these baseless restrictions once and for all."

Jason Matuszak, M.D., FAAFP, President of New York State Academy of Family Physicians:
"In New York, we learned early on how critical it is to avoid unnecessary travel. Yet the FDA has insisted, with no medical justification, on requiring patients to come in person to a physician's office just to pick up a pill they are already permitted to self-administer at home. We are grateful that, as a result of today's ruling, medication abortion patients will no longer have to expose themselves to unnecessary medical risk just to get the care they need."