Oversight Committee Congresswomen Urge FDA to Lift Restrictions Preventing Access to Mifepristone
Washington, D.C. (Feb. 9, 2021)—Today, Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, and Committee Member Rep. Ayanna Pressley, Chair of the Pro-Choice Caucus’s Abortion Rights and Access Task Force, led all Democratic Committee congresswomen in sending a letter asking the Food and Drug Administration (FDA) to lift the medically unnecessary in-person dispensing requirement for mifepristone—a prescription medication that has been used to safely end early pregnancies in the United States for more than two decades.
“Imposing this requirement in the midst of a deadly pandemic—one that has disproportionately impacted communities of color across the United States—needlessly places patients and providers in harm’s way, and further entrenches longstanding health inequities,” the Members wrote.
The FDA created the Risk Evaluation and Mitigation Strategies (REMS) program to ensure the safe use of medications that pose “serious safety concerns” to patients. During the coronavirus pandemic, FDA suspended certain in-person REMS requirements, citing the health risks and difficulties they pose for patients who are quarantining or self-isolating. However, FDA declined to suspend the in-person dispensing requirement for mifepristone, despite data showing that less than 0.1% of patients who take mifepristone experience major adverse effects. By comparison, hundreds of people in the United States who carry their pregnancies to term die annually in childbirth.
Of the more than 20,000 drugs regulated by the FDA, mifepristone is the only one FDA requires patients to obtain in-person, but does not place restrictions on the ability of patients to self-administer unsupervised. According to the American College of Obstetricians and Gynecologists (ACOG), FDA’s REMS restrictions for mifepristone “have no medical basis, provide no patient benefit, and unnecessarily restrict access to care.”
“In light of the clear danger that the reinstated requirement poses to people seeking comprehensive reproductive health care at the height of the coronavirus pandemic, we urge you to immediately eliminate the medically unnecessary in-person dispensing requirement for mifepristone,” the Members added.
Click here to read the letter to the FDA.
Following a lawsuit led by ACOG, on July 13, 2020 the U.S. District Court for the District of Maryland ordered FDA to suspend the in-person dispensing requirement for mifepristone during the coronavirus pandemic, noting that in-person requirements had been waived for many other drugs in the interest of public health. The Trump Administration requested a stay on the District Court’s injunction, which was granted by the Supreme Court on January 12, 2021, reinstating the in-person dispensing requirement for mifepristone.