Doctor Groups Sue FDA to Ease U.S. Restrictions on Abortion Pill

(Bloomberg) -- Women’s health groups, including the American College of Obstetricians and Gynecologists, sued the U.S. Food and Drug Administration to allow patients to receive a prescribed abortion pill by mail rather than only in person at a hospital, clinic or doctor’s office.

The restriction on mail distribution of the drug, mifepristone, is unnecessary and only increases health risks for patients during the Covid-19 pandemic, the groups said in their lawsuit, according to the American Civil Liberties Union, which filed the case Wednesday in Maryland federal court.

The suit joins others the ACLU has filed to fight abortion restrictions since the spread of coronavirus that prevented women from being able to terminate unwanted pregnancies. Several states imposed bans by saying abortions were non-essential treatments at a time when medical resources needed to be devoted to the virus.

“When it comes to patients who need to end an early pregnancy or treat a miscarriage, the administration is forcing them to travel unnecessarily to a hospital, clinic, or medical office just to pick up a pill they are already permitted to swallow later at home,” ACLU attorney Julia Kaye said in a statement. “It is unconscionable that the administration is singling out these patients for life-threatening risks.”

The FDA regulates more than 20,000 drugs, but the abortion pill is the only one that the FDA requires be picked up in person, according to the ACLU. Mifepristone is sold as a brand drug by Danco Laboratories LLC and in a generic pill by GenBioPro Inc.

Women’s health groups, including the ACOG, had called for the FDA to loosen restrictions prior to the pandemic, but the virus has increased public pressure to do so.

Some U.S. senators, including Elizabeth Warren of Massachusetts, wrote a letter to the FDA commissioner in April asking the agency to temporarily loosen the in-person dispensing requirement as a result of Covid-19. They argued the drug was found to be safe, including in a study of more than 13,000 women that showed 0.01% of patients experienced infections that required hospitalization.

“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,” said David Chelmow, President of the University Chairs of Obstetrics and Gynecology, which is a plaintiff in the lawsuit.

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