April 14, 2020

Warren, Murray, Baldwin Urge FDA to Improve Access to Medication Abortion Drug Mifepristone Amid COVID-19 Pandemic

Easing In-Person Dispensing Restrictions Would Increase Access to Abortion Care Without Risking Health of Patients or Providers

Text of Letter (PDF)

Washington, D.C. - United States Senator Elizabeth Warren (D-Mass.), a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, along with HELP Committee Ranking Member Patty Murray (D-Wash.) and HELP Committee member Senator Tammy Baldwin (D-Wisc.), wrote to the Food and Drug Administration (FDA) urging the agency to ensure Americans can access essential, time sensitive health care -- including medication abortion care -- during the coronavirus disease 2019 (COVID-19) pandemic. The senators sent the letter in light of new guidance issued by the FDA stating that it does not intend to take enforcement action for noncompliance with certain restrictions on drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) in light of the public health emergency.

"People who need an abortion cannot delay care and should not needlessly risk coronavirus exposure," the senators wrote. "Given the years of scientific evidence indicating that medication abortion is a safe and effective treatment, we ask that FDA take immediate steps to temporarily exercise enforcement discretion on in-person dispensing requirements, so that people can more easily access abortion care without putting themselves or their health care providers at risk of infection from COVID-19."

Mifepristone, the first of two drugs used to complete a medication abortion or treat a miscarriage, has been heavily restricted and regulated by FDA since it was approved in the United States in September 2000. Currently, it can only be prescribed and administered by "certified" health care providers who themselves are required to register with the manufacturer and are responsible for obtaining mifepristone supplies. In addition, mifepristone can only be dispensed to patients in clinics, medical offices, and hospitals by a certified health care provider.

In their letter to FDA Commissioner Stephen Hahn, the senators urged FDA to temporarily lift the restricted distribution of mifepristone, noting that these requirements restrict access to medication abortion because mifepristone, unlike most medications, is not available at pharmacies and only a limited number of providers are able to prescribe the drug. The senators cited scientific evidence showing that medication abortion is a safe and effective procedure, and argued that FDA's requirement to only impose restrictions on drug distribution if the risks outweigh the benefits should be reevaluated in light of the current COVID-19 crisis.

"FDA has recognized the importance of giving health care providers discretion in this area during the current public health emergency, and should consider providing similar flexibility here, rather than letting any ideological objection to abortion care prevent health care providers from offering the safest care options to their patients," the senators continued.

Earlier this week, a coalition of 21 attorneys general wrote to the U.S. Department of Health and Human Services and the FDA, calling on the agencies to lift restrictions on mifepristone and allow women to access time-sensitive reproductive care via telehealth during the COVID-19 pandemic.