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Health Groups Oppose FDA’s Attempt to Limit Abortion Pill Access

Aug. 5, 2020, 3:36 PM

A drug used to induce abortions should be accessible by mail while the the federal Food & Drug Administration appeals an order lifting its in-person dispensing requirement during the Covid-19 pandemic, women’s health-care providers told a federal appeals court.

The providers, including the American College of Obstetricians & Gynecologists, filed a response Tuesday to the FDA’s request that the U.S. Court of Appeals for the Fourth Circuit allow it to enforce a requirement that mifepristone be distributed only through hospitals, clinics, and doctor’s offices until the court decides if an injunction against it was properly granted.

Mifepristone is one of a two-drug combination used to end a pregnancy in its earliest stage. FDA requires the drug to be distributed to women in person, which subjects them to an unacceptable risk of contracting Covid-19, the providers said in a lawsuit challenging the rule.

The FDA says the rule is needed to ensure the drug is used safely.

Blocking the injunction wasn’t warranted because the providers are likely to win on appeal, the groups said. FDA didn’t produce any evidence that in-person dispensing doesn’t unduly burden women’s right to abortion during the pandemic, they said.

Additionally, the agency’s argument that the in-person rule exposes women to only minimal risks was contradicted by its support for telemedicine and its decision to waive in-person dispensing requirements for other drugs while public health emergency is in effect, the groups said.

The American Medical Association, American Academy of Family Physicians, American Academy of Pediatrics, Abortion Care Network, American College of Nurse-Midwives, and other provider groups filed a friend of the court brief also opposing a stay pending appeal.

New York, California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia, Washington, and the District of Columbia also opposed the stay.

FDA asked the Fourth Circuit to stay the order pending appeal on July 30, the same day the U.S. District Court for the District of Maryland denied a similar motion. Its appeal from the injunction was docketed July 29.

Indiana, Louisiana, Alabama, Arkansas, Idaho, Kentucky, Mississippi, Missouri, Nebraska, Oklahoma, and Texas filed a friend of the court brief supporting FDA Monday.

Arnold & Porter Kaye Scholer LLP and the American Civil Liberties Union Foundation represents the providers. The U.S. Department of Justice represents FDA.

Wilmer Cutler Pickering Hale & Dorr LLP respresents the amici provider groups. The New York Attorney General’s Office is lead counsel for the states opposing the stay. The Indiana Attorney General’s Office, the Louisiana Attorney General’s Office, and Schaerr Jaffe LLP represent the states supporting FDA.

The case is Am. Coll. of Obstetricians & Gynecologists v. U.S. Food & Drug Admin., 4th Cir., No. 20-1824, brief filed 8/4/20.

To contact the reporter on this story: Mary Anne Pazanowski in Washington at mpazanowski@bloomberglaw.com

To contact the editor responsible for this story: Rob Tricchinelli at rtricchinelli@bloomberglaw.com

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