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For months, leading medical authorities have implored the FDA to suspend this restriction and give clinicians who provide abortion and miscarriage care the flexibility they need to protect their patients during this crisis. But the administration is intransigent. (Photo: Robin Marty/Flickr)

For months, leading medical authorities have implored the FDA to suspend this restriction and give clinicians who provide abortion and miscarriage care the flexibility they need to protect their patients during this crisis. But the administration is intransigent. (Photo: Robin Marty/Flickr)

The FDA Is Making Needless COVID-19 Risks a Condition of Abortion and Miscarriage Care. We’re Suing.

Against a nationwide medical consensus, the FDA is forcing patients to endure life-threatening risks to access medication to end an early pregnancy or treat a miscarriage.

Julia Kaye

 by Speak Freely / ACLU

The COVID-19 pandemic has swept the globe and upended normal life. In the four months since the first U.S. case was reported, more than 1.5 million people have been infected and 100,000 people have died in the United States. To mitigate risk, public health authorities tell us to get our groceries and prescriptions delivered, wave to grandma from the window, and generally avoid all unnecessary trips and close physical interactions outside the home.        
Consistent with these guidelines, federal agencies have taken every opportunity to encourage telemedicine use and give clinicians the flexibility to forgo unnecessary in-person encounters in accordance with their clinical judgment. They have waived various rules requiring in-person visits, even for controlled substances like opioids.
But there is one striking exception: The U.S. Food and Drug Administration (FDA) continues to subject mifepristone, a safe, effective prescription medication used to end an early pregnancy or treat a miscarriage, to a uniquely burdensome restriction that is jeopardizing the health and lives of patients and clinicians, with particularly dire implications for low-income communities and communities of color.
The FDA requires that the mifepristone pill be dispensed only in a hospital, clinic, or medical office: Patients who have already been evaluated by a clinician through telemedicine or at a prior in-person visit are not allowed to fill their prescription by mail. Instead, they must travel to one of these clinical settings to pick up the pill — even if they are receiving no in-person medical services at that time, and even if they will swallow the medication later at home (as the FDA permits).
For months, leading medical authorities have implored the FDA to suspend this restriction and give clinicians who provide abortion and miscarriage care the flexibility they need to protect their patients during this crisis. But the administration is intransigent.
That’s why today we filed a lawsuit on behalf of a coalition of medical experts and reproductive health, rights, and justice advocates, led by the American College of Obstetricians and Gynecologists (ACOG), challenging the FDA rule that forces patients to take on unnecessary COVID-19 risks as a condition of receiving medication abortion and miscarriage care.
Of the more than 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must obtain in a clinical setting, yet may self-administer unsupervised at home. It’s easy to see why no other drugs carry this restriction: There is no medical reason to dictate where a patient is standing when handed a pill they will put in their pocket to swallow later at home.
There is likewise no reason to impose this requirement on mifepristone, which has been FDA approved for 20 years and used by more than 4 million people. In the FDA’s words, mifepristone’s “efficacy and safety have become well established by both research and experience, and serious complications have proven to be extremely rare.” In fact, the FDA permits mifepristone to be sent to patients’ homes, in larger quantities and doses, when used for a purpose other than early pregnancy termination. 
Yet the FDA has maintained this unnecessary restriction throughout the pandemic — despite CDC guidance specifically encouraging patients to fill prescriptions by mail-order delivery wherever possible, and despite a national medical consensus that mifepristone prescribers need the same flexibility as other clinicians to forgo medically unnecessary in-person visits, consistent with their best clinical judgment, during this crisis.
As is virtually always the case when it comes to restrictions on abortion, the harm here is not borne equally. Low-income people and people of color, who comprise a majority of people seeking abortions, bear the brunt of the FDA’s restrictions. At the best of times, arranging transportation and child care in order to travel to a health care facility to pick up a pill is difficult or impossible for many patients. Some must travel hundreds of miles — or even take a flight — causing severe delays and blocking some patients from accessing abortion care at all.
Now, during a historic unemployment crisis with many schools and day cares shuttered, the FDA is forcing patients to take on life-threatening — and entirely unnecessary — risks in order to access essential health services. This is particularly dangerous for communities of color, who, due to longstanding inequities in access to and quality of health care and other manifestations of structural racism, are dying from COVID-19 at drastically higher rates.
Our coalition of plaintiffs represents tens of thousands of clinicians providing abortion and miscarriage care to patients across the nation, and the department chairs of obstetrics and gynecology at nearly 150 universities. It includes activists and organizers dedicated to removing barriers to high-quality pregnancy-related care that disproportionately harm marginalized communities. They have asked the FDA to do the right thing on mifepristone, but the agency has refused.
Pregnant people should not have to needlessly jeopardize their safety in order to access essential medication abortion and miscarriage care during the pandemic. We’re going to court to ensure that in this time of crisis, people do not have to subject themselves to unnecessary risk to access the reproductive health care they need.

© 2021 ACLU

Julia Kaye

Julia Kaye is a staff attorney with the ACLU's Reproductive Freedom Project.

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