WHAT YOU NEED TO KNOW:
- A coalition of 12 Democratic state attorneys general is suing the FDA, accusing the agency of excessively regulating the abortion pill mifepristone.
- The lawsuit asks the FDA to lift additional layers of regulation above and beyond those for typical prescription drugs and make access to the medication more available to women across the country.
- The lawsuit comes as a federal judge in a separate case in Texas is considering whether to overturn the FDA’s approval of the abortion drug, setting up the possibility of conflicting rulings by different federal judges.
A group of Democratic state attorneys general is suing the U.S. Food and Drug Administration (FDA) over its regulation of the abortion pill mifepristone, according to an NPR report. The lawsuit, filed in federal court in Washington state, accuses the FDA of placing excessive restrictions on the drug that are not required for other prescription medications. Mifepristone was approved by the FDA more than 20 years ago to induce first-trimester abortions in combination with a second drug, misoprostol.
The attorneys general are asking the court to declare the drug to be safe and effective, and to invalidate the additional regulation, known as a Risk Evaluation and Mitigation Strategy (REMS), which they say is unnecessary. According to the report, the REMS has been applied only to a few dozen high-risk prescription drugs, such as fentanyl and other opioids.
The lawsuit argues that the FDA is “singling out mifepristone…for a unique set of restrictions,” and seeks to make the medication more accessible to women across the country.
While the Biden administration has relaxed some restrictions on the drug in recent years, prescribers are still subject to additional rules, such as special certification requirements. The lawsuit is also being filed as a federal judge in Texas is considering whether to overturn the FDA’s approval of the abortion drug, which could lead to conflicting rulings. Washington state Attorney General Bob Ferguson, who co-led the lawsuit, said the question of how to regulate mifepristone could end up before the U.S. Supreme Court.
The lawsuit has sparked debate on both sides of the abortion rights issue. The anti-abortion legal group Alliance Defending Freedom is currently leading a challenge to mifepristone’s approval in Texas. Erik Baptist, senior counsel with the group, called it “highly ironic” that the same attorneys general who filed a brief in support of the FDA’s approval of the drug in Texas are now suing the agency over its regulation of the drug.
Meanwhile, major medical groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, have filed an amicus brief in the Texas case calling mifepristone “thoroughly studied” and “conclusively safe.”