“The evidence is crystal clear: Mifepristone is safe and effective, and the FDA’s unique restrictions provide no safety benefit while severely burdening patient’s ability to access care. … If the FDA follows the science, we should soon see the removal of these barriers to care.”
—Julia Kaye, staff attorney at ACLU’s Reproductive Freedom Project
On Friday, May 7, the Biden administration announced that the U.S. Food and Drug Administration (FDA) will undertake a review of longstanding restrictions on the medication mifepristone used for miscarriage and abortion care. The announcement came as part of a joint legal filing in the ACLU lawsuit Cheslius v. Becerra, challenging the restrictions.
“This is promising news, and reflects the Biden administration’s commitment to follow the science,” said Kirsten Moore, director of Expanding Medication Abortion Access Project.
The announcement follows an FDA decision last month to lift in-person dispensing requirements on mifepristone for the duration of the pandemic.
“The FDA decision to comprehensively reevaluate restrictions on mifepristone coming on the heels of the FDA decision to suspend the in-person requirements during the COVID-19 public health emergency feels like, finally, science and common sense have a foothold on this issue and some long overdue progress,” said Julia Kaye, staff attorney at ACLU’s Reproductive Freedom Project which represents the plaintiffs in Cheslius v. Becerra.
The FDA was facing a Friday deadline to file a brief defending their mifepristone restrictions. The parties agreed to stay the litigation until December 1, 2021.
“There is no reason why patients in abortion and miscarriage care should be singled out for unjustified and burdensome regulations,” Kaye told Ms. “We are very hopeful that the outcome of the FDA review will be a full elimination of the restrictions.”
Approved by FDA for use during the first 10 weeks of gestation, medication abortion uses two types of pills: mifepristone, which interrupts the flow of the hormone progesterone that sustains the pregnancy, and misoprostol, which causes contractions to expel the contents of the uterus. This combination of pills is more than 95 percent effective and is a safe way to end an early pregnancy. According to the Guttmacher Institute, medication abortion now accounts for over 60 percent of abortions in the first 10 weeks of pregnancy.
Despite its safety, the FDA restricts distribution of mifepristone through a drug safety program called the Risk and Evaluation Mitigation System (REMS). Under this program, the FDA prohibits retail pharmacies from stocking and distributing mifepristone and requires that the medication be dispensed only in certain health care facilities through a certified prescriber.
“The evidence is crystal clear that mifepristone is safe and effective and that the FDA’s unique restrictions provide no safety benefit while severely burdening patient’s ability to access care,” Kaye told Ms. “Leading medical authorities, including the American Medical Association and the American College of Obstetricians and Gynecologists, uniformly call for the elimination of these unjustified restrictions. Given all of that, if the FDA follows the science, we should soon see the removal of these barriers to care.”
Other advocates agree that the restrictions are outdated and not medically necessary.
“Medication abortion care has a 20-year track record as a safe and effective option for ending an early pregnancy,” said Moore. ”We believe the review will confirm why it’s important to eliminate these outdated restrictions. Women should be able to receive their prescription for medication abortion in the way that makes the most sense for them and providers shouldn’t have to jump through hoops to deliver the best care for their patients.”
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