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January 27, 2023
Health Law Weekly

President Announces New Efforts to Ensure Access to Medication Abortions

  • January 27, 2023

President Biden is directing three federal agencies to consider new guidance aimed at ensuring patients, providers, and pharmacies have access to the abortion pill, mifepristone.

The move came after the Food and Drug Administration (FDA) earlier this month approved a regulatory change that allows retail pharmacies to sell mifepristone directly to patients if they apply for certification from the drug’s manufacturers.

In a January 22 Presidential Memorandum, Biden cited reports of efforts to suppress access to medication abortion that “have stoked confusion, sowed fear, and may prevent patients from accessing safe and effective FDA-approved medication.”

The memo requires the Department of Health and Human Services Secretary, the Attorney General, and the Secretary of Homeland Security to issue the guidance within 60 days and consider taking further actions to educate individuals on their ability to seek legal reproductive care.

The memo also directs the agency heads to provide the Interagency Task Force on Reproductive Healthcare Access, which was established under an executive order issued in July 2022, with information on potential barriers that patients and providers are facing in seeking or providing legal access to mifepristone or other reproductive health care and whether any additional institutional resources may be necessary to address those barriers.

The FDA approved January 3 a modification to mifepristone’s risk evaluation and mitigation strategy (REMS). Under the original REMS, only a physician could dispense mifepristone to patients. In 2021, during the COVID-19 pandemic, the Biden administration temporarily lifted the in-person requirement to allow mifepristone to be prescribed via telemedicine and delivered by mail. The updated REMS makes that change permanent as well as allowing certified retail pharmacies to dispense the drug directly to patients. 

Mifepristone, taken in combination with a second drug misoprostol, is used to end a pregnancy through ten weeks gestation (70 days or less since the first day of the last menstrual period).

In a January 2022 statement marking the 50th anniversary of Roe v. Wade, Biden vowed to “continue to fight to protect a women’s right to choose,” but also emphasized that Congress must act to enshrine Roe’s protections in federal law. “[I]t’s the only way we can fully secure a woman’s right to choose in every state,” Biden said.

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