July 29, 2020

FDA Appeals Federal Judge's Suspension of Abortion Pill Regulations

Photo Credit: Halacious / Unsplash
Obama-appointed U.S. District Judge Theodore Chuang suspended the FDA's Risk Evaluation and Mitigation Strategy (REMS) requirements for the abortion pill Mifepristone earlier this month, but on Tuesday the FDA responded by filing an appeal to his decision.

“Particularly in light of the limited timeframe during which a medication abortion or any abortion must occur, such infringement on the right to an abortion would constitute irreparable harm,” Chuang wrote in his ruling. “By causing certain patients to decide between forgoing or substantially delaying abortion care, or risking exposure to COVID-19 for themselves, their children, and family members, the In-Person Requirements present a serious burden to many abortion patients.”

The FDA argued that the REMS requirements are necessary for Mifepristone, and suspending the regulations puts women at risk for health problems that they would otherwise have been protected from.

“Defendants will also suffer irreparable harm in the absence of a stay because they will be unable to enforce requirements that FDA has determined, based on its experience and scientific expertise, are necessary to ensure safe use of Mifeprex,” the FDA appeal reads. “Requiring patients to obtain Mifeprex at a clinic — as has been required for years — does not deprive women of the ‘ability to make a decision to have an abortion.’”

The requirement that women visit a doctor in a clinic before receiving mifepristone protects women by making it more likely that a woman will have an ultrasound before receiving the pills. By completing an ultrasound, doctors will be able to diagnose pregnancy conditions such as ectopic pregnancy (in which an unborn child has implanted itself outside their mother's uterus). Abnormal pregnancy conditions increase the likelihood of complications such as hemorrhage and death which can occur if a woman with such conditions completes the abortion pill regimen.