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FDA loosens restrictions on medication abortion drug

The agency said it would permanently change two requirements related to medication abortions that would expand the drug's availability

Reproductive rights activists hold cut-out letters during a protest outside the Supreme Court on Dec. 1.
Reproductive rights activists hold cut-out letters during a protest outside the Supreme Court on Dec. 1. (Photo by Bill Clark/CQ Roll Call)

The Food and Drug Administration announced Thursday it would permanently change two requirements related to medication abortions that would expand how widely the drug could be administered nationwide.

Medication abortion refers to a nonsurgical procedure that induces an abortion. It involves taking two pills — mifepristone and, 24 to 48 hours later, misoprostol — to cause an abortion or for miscarriage management.

The FDA approved mifepristone in 2000, but the drug has been subject to more restrictions than most medications. A policy known as Risk Evaluation and Mitigation Strategies, or REMS, prevents mifepristone from being dispensed in pharmacies due to concerns it may result in serious complications.

Because of this, a pregnant woman seeking a medication abortion — most common in the first 10 weeks of pregnancy — must receive the drug from a clinician in person.

Under current regulations, a provider who wishes to prescribe medication abortions must be registered with the drug manufacturer to stock and dispense mifepristone, also known as RU-486. Some providers have criticized these additional steps as limiting access because it can be complicated and because many medical facilities may oppose stocking the drug.

The change announced Thursday would make two key changes to mifepristone access. It would remove a requirement that the drug must be dispensed by the provider in a clinic or hospital and would allow a certified pharmacy to dispense the drug.

Restrictions to medication abortions have been layered onto other barriers in many states.

Information from the Guttmacher Institute, a left-leaning reproductive health organization, shows that 32 states prevent the drug from being dispensed by nonphysicians such as advanced practice providers. Nineteen states also prohibit using telemedicine for medication abortions.

Abortion-rights supporters argue that mifepristone should face fewer restrictions, arguing that while patients must receive mifepristone in a clinic, they are not required to take the drug there.

“Today’s news is a victory for public health and health equity. Let’s be clear: The FDA followed the science in arriving at this decision. There is overwhelming evidence that medication abortion can be safely and effectively provided through telehealth,” said Alexis McGill Johnson, president and CEO of Planned Parenthood Federation of America. “With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Abortion opponents have pushed to keep the restrictions in place as a way to prevent possible medical complications. They are also working to pursue state-based restrictions on medication abortion.

Texas implemented legislation in December that would reduce the window for providing a medication abortion from 70 days to 49 days — less than what the FDA has recommended.

Speaking at a press briefing Thursday, Marjorie Dannenfelser, president of the Susan B. Anthony List, said the change was worrisome.

“It changes the debate from the sidewalk to the lonely bathroom,” she said. “That change means that we are less engaged in the public arena because it is secret and behind closed doors.”

The Advancing New Standards in Reproductive Health, or ANSIRH, program within the University of California, San Francisco’s Bixby Center for Global Reproductive Health analyzed data on 11,319 abortions within the California Medicaid system and found that 0.3 percent of medication abortions resulted in a serious adverse event.

Changing policies

The pandemic has renewed interest in reviewing restrictions on mifepristone, which have been the subject of litigation.

The American Civil Liberties Union has been challenging the federal restrictions on behalf of a Hawaiian family medicine physician. The ACLU has argued that because of the restrictions, women in Kauai must fly to another island to receive abortion care.

The ACLU and medical groups issued a second challenge last May asking to waive the in-person dispensing requirement during the pandemic.

A coalition of 55 groups wrote to the administration in March 2021 asking officials to review the restrictions.

FDA acting Commissioner Janet Woodcock lifted the in-person dispensing requirement in April 2021 during the pandemic — a move that soon prompted criticism by over 100 GOP lawmakers in a letter to Woodcock.

Robert Califf, whose confirmation hearing before the Senate Health, Education, Labor and Pensions Committee was on Tuesday, has been under fire from some conservatives because of changes to the drug’s labeling that happened during his tenure at the FDA in 2016. At the time, the FDA increased the window of when the drug could be used from 49 days to 70 days’ gestation. 

But the FDA also left the in-person dispensing requirement in place, a hurdle that abortion rights supporters have continued to argue is unnecessary.

Democrats have pushed for expanding access to medication abortion.

A House-passed bill by Rep. Judy Chu, D-Calif., would protect abortion access and the ability for health providers to perform them. The bill would prohibit limits on providing abortion, including restrictions on prescribing mifepristone by telemedicine.

Senate Majority Leader Charles E. Schumer, D-N.Y., has committed to bringing the bill to the floor, but it faces an uphill battle to cross the 60-vote threshold.

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