New Lawsuit Challenges FDA Restriction That Imposes Life-Threatening Risks on Patients Seeking Abortion and Miscarriage Care

The American Civil Liberties Union (ACLU) filed a lawsuit today on behalf of a coalition of medical experts led by the American College of Obstetricians and Gynecologists (ACOG). The legal action challenges a U.S. Food and Drug Administration (FDA) rule that subjects patients to unnecessary COVID-19 risks as a condition of receiving a medication used for early abortion and miscarriage treatment.

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. Specifically, the FDA requires patients to travel to a hospital, clinic, or medical office to pick up the mifepristone. Because of this restriction, patients who have already been evaluated by a clinician (using telehealth or at a prior in-person visit) cannot fill their mifepristone prescription by mail. Instead, they must incur unnecessary COVID-19 risk and travel to one of these clinical settings to pick up the pill — even when they will be receiving no in-person medical services at that time and will swallow the pill later at home (as the FDA permits).

“At every other turn during this pandemic, the federal government is trying to make it easier for patients to get the medical care they need without unnecessary health care visits that jeopardize their safety,” said Julia Kaye, staff attorney at the ACLU Reproductive Freedom Project. “But when it comes to patients who need to end an early pregnancy or treat a miscarriage, the administration is forcing them to travel to a hospital, clinic, or medical office just to pick up a pill they are already permitted to swallow later at home. This administration apparently would rather subject patients and clinicians to life-threatening medical risks than lift an unnecessary barrier to abortion care.”

For years, the medical community has opposed these restrictions on mifepristone as they have no medical basis or patient safety benefit. Despite months of petitioning from leading medical authorities, including the ACOG, the FDA has refused to halt this in-person dispensing requirement even during the COVID-19 pandemic. By contrast, the FDA and other federal agencies have suspended in-person requirements for other medications.

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. When used for purposes other than pregnancy termination, the FDA permits mifepristone to be mailed directly to the patient’s home in higher doses and quantities. 

The failure to lift this in-person dispensing requirement has particularly severe implications for communities of color and low-income communities, who make up the majority of impacted patients and who are already suffering severe complications and dying from COVID-19 at disproportionately high rates.

The plaintiffs in this case are: ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong Women of Color Reproductive Justice Collective, and an individual family medicine physician. The lawsuit is brought by the ACLU and the law firm Arnold & Porter.

Statements from plaintiffs are below:

Eva Chalas, M.D., F.A.C.O.G., F.A.C.S, president of ACOG:
“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. 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.”

Monica Simpson, executive director of SisterSong Women of Color Reproductive Justice Collective:
“COVID-19 is causing devastating consequences in every corner of the country, but nowhere more so than in communities of color and Indigenous communities. Because of longstanding disparities in access to and quality of health care and other manifestations of structural racism, Black and Brown people are more likely to have preexisting health conditions that increase the likelihood of severe illness and death from COVID-19. It is unconscionable that the FDA is subjecting women of color, who are disproportionately represented among patients seeking abortion and miscarriage care, to life-threatening viral risks as a condition of obtaining these urgent reproductive health services.”

David Chelmow, M.D., president of the Council of University Chairs of Obstetrics and Gynecology:
"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.”

Barbara Keber, M.D., F.A.A.F.P., president of the New York State Academy of Family Physicians:
“The COVID-19 crisis has hit New York State particularly hard, with devastating consequences for patients across our state and the family medicine doctors who care for them. The FDA is restricting access to mifepristone in spite of overwhelming medical evidence that it is among the safest drugs in use. There is no medically justifiable reason to restrict use of mifepristone, and certainly not in the current crisis when adhering to these restrictions is only exposing patients and providers to severe and unnecessary medical risk.”

In addition to the case filed 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.