Eleven States File Briefs Defending the FDA's Abortion Pill Regulation

Eleven states have filed briefs with a federal court asking it to grant a stay of a District Court decision preventing the FDA from enforcing certain abortion pill regulations.

On July 14 last month, District Judge Theodore Chuang decided to suspend the FDA's Risk Evaluation and Mitigation Strategy (REMS) requirements for mifepristone, the first pill in the abortion pill regimen. Later that month, the FDA filed a memorandum to grant the FDA against the District Court's injunction. This would allow the FDA to continue enforcing them while both sides make their cases about the legality of the rules.

The FDA applies REMS regulations to any drugs that have a certain level of risk to patients. Mifepristone applies because women who take the pill are at risk of hemorrhage, severe bleeding, pregnancy complications caused by incomplete abortion, and even death. The risks of the abortion pill are higher if the woman has an undiagnosed pregnancy condition such as ectopic pregnancy.

Among other things, the REMS requires pregnant women to have an in-person appointment with a physician before they can obtain abortion pills. This allows physicians to diagnose conditions like ectopic pregnancy and check the gestational age of the child. If the child has developed past the safe range for a medication abortion, using the abortion pill to complete an abortion poses health risks to the mother. In the event that the pregnant mother's best guess at her child's gestational age is incorrect, this appointment could save the mother's life, even if she decides to follow through and complete a surgical abortion.

Click here to read more.