Updated Dec. 15 at 1:15 p.m. PT.
In mid-July, a federal judge in Maryland issued an 80-page decision temporarily suspending enforcement of an FDA restriction on the abortion pill, forcing patients to make an unnecessary trip to their health care provider just to pick up the medication and sign a form.
U.S. District Court Judge Theodore Chuang ruled the FDA requirement of in-person visits during the pandemic imposes a “substantial obstacle” to abortion health care that is likely unconstitutional. Judge Chuang’s order allows patients to receive mifepristone from their doctors through the mail.
The 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,” said Dr. Eva Chalas, MD, president of the American College of Obstetricians and Gynecologists, which brought the suit on behalf of a coalition of medical experts, along with SisterSong Women of Color Reproductive Justice Collective.
In December, abortion advocates logged another victory when a federal court upheld its suspension on in-person requirements for those seeking a medication abortion. (In October, the Supreme Court had returned the case to the lower court.)
Mifepristone Restrictions Have No Medical Basis
Mifepristone is used in combination with another medication—misoprostol—to safely and effectively end early pregnancy. Plaintiffs in the case argued the FDA’s restriction meant patients must travel to a hospital, clinic or office just to pick up the medication—even when their physician had already evaluated them and prescribed mifepristone, and even though the FDA allows patients to self-administer the medication at home without clinical supervision.
The medical community has opposed these restrictions on mifepristone for years—as they have no medical basis.
“Mifepristone is a safe medication and FDA’s in-person dispensing requirements provide no medical benefit to patients. There is no basis for FDA’s decision to treat mifepristone differently than other medications. Requiring in-person dispensing of mifepristone needlessly threatens both patients and clinicians,” said Dr. Chalas.
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The FDA approved mifepristone in 2000 for use within the U.S.—but due to anti-abortion political pressure, the agency restricted the medication under the Risk Evaluation and Mitigation Strategy (REMS) drug safety program, despite the fact that mifepristone is very safe. The FDA prohibited pharmacies from selling the mifepristone, instead requiring patients to obtain the medication directly from registered physicians.
The COVID-19 pandemic, along with updated standards of care for medication abortion, spurred a challenge to the FDA restriction.
Until now, standard medical protocols recommended an ultrasound and Rh blood test before medication abortion was administered, both of which required office visits. These protocols limited the use of telemedicine abortion for medication abortion—so no one challenged the FDA restriction until recently.
But reproductive health providers are now advocating for better, science-based medical protocols that do not require in-person tests. ACOG issued guidance on March 30 stating that clinicians can perform an assessment, counseling and consent for medication abortion by video or telephone, and that an ultrasound and Rh testing is not necessary.
Similarly, the Reproductive Health Access Project has issued a “no-touch” medication abortion protocol, eliminating the need for in-person visits and tests. Tests are often not necessary because patients can reliably tell their doctors when their last period began (to determine gestational age) and their blood type.
These changes, along with the increase of telemedicine during the pandemic, led to the legal challenge to the FDA restriction on mifepristone.
“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,” said Monica Simpson, executive director of SisterSong Women of Color Reproductive Justice Collective.
“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.”
Judge Chuang’s 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.
“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, which represents the plaintiffs and has filed another case challenging a broader range of FDA restrictions on medication abortion care.
“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.”
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