The agency is allowing patients to access mifepristone by mail during the pandemic following ACLU litigation and calls from medical experts

WASHINGTON — The U.S. Food and Drug Administration (FDA) sent a letter today to the American College of Obstetricians and Gynecologists (ACOG) indicating it is suspending enforcement of a policy that forces patients to risk unnecessary exposure to COVID-19 as a condition of accessing mifepristone, medication used for early abortion and miscarriage care.

The American Civil Liberties Union brought litigation on behalf of ACOG and other leading medical and reproductive justice organizations last May to block this policy, which requires patients to pick up the pill in person at a health center, even though they may take it later at a time and place of their choosing. During the pandemic, this requirement has exposed patients to needless COVID-19 risks relating to transportation, childcare, and other interpersonal contact.

“This important step will ensure that abortion and miscarriage patients will no longer be forced to unnecessarily risk exposure to a deadly virus in order to access time sensitive, essential health care,” said Georgeanne Usova, senior legislative counsel at the ACLU. “But we cannot stop here: the restrictions on medication abortion are outdated and have obstructed patients’ access for far too long. We urge the FDA to comprehensively evaluate them to ensure that patients can get the care they need without medically unnecessary, harmful obstacles — even after the pandemic ends.”

By creating additional structural barriers to accessing care, this policy is particularly harmful for people of color and people with low incomes, who make up the majority of impacted patients and who are suffering severe complications and dying from COVID-19 at disproportionately high rates. The FDA’s response comes a year after leading medical authorities, including ACOG, first called on the agency to suspend this dangerous policy in line with the government’s approach to other health care services during the public health emergency.

“ACOG applauds the U.S. Food and Drug Administration (FDA) for acknowledging the strong safety and efficacy profile of mifepristone, which is used for termination of early pregnancy and management of miscarriage,” said Maureen G. Phipps, MD, MPH, chief executive officer of the American College of Obstetricians and Gynecologists (ACOG). “By halting enforcement of the in-person dispensing requirement during the COVID-19 pandemic, the FDA is recognizing and responding to the available evidence – which has clearly and definitively demonstrated that the in-person dispensing requirement for mifepristone is unnecessary and restrictive.”

Last summer a federal court ruled that FDA must allow patients to receive their mifepristone prescriptions by mail.  However, in January, the Supreme Court stepped in and permitted the Trump administration to reinstate the policy, once again putting patients and their families at needless risk. Last month, reproductive rights, health, and justice organizations sent a letter and petitions signed by more than 200,000 supporters urging the administration to take immediate action to suspend this harmful requirement and expand access to medication abortion.

Even before the pandemic, leading medical organizations — including the American Medical Association, ACOG, and the American Academy of Family Physicians — uniformly oppose FDA’s restrictions on mifepristone, which the ACLU is currently challenging in separate litigation. Of the 20,000 drugs FDA regulates, mifepristone is the only one the agency requires patients to pick up in person at a health center even though they may take it later at a time and place of their choosing.   

The plaintiffs in ACLU’s litigation challenging the in-person pick-up requirement during the COVID-19 pandemic 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 doctor.

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