Democratic AGs sue FDA over "unnecessary" abortion pill restrictions

A group of Democratic state attorneys general on Friday filed a lawsuit challenging dispensing restrictions on a key pill used in medication abortion, throwing a new wrinkle into the national battle over drugs used to end pregnancies.

Driving the news: The AGs' suit in U.S. District Court for the Eastern District of Washington contends that the restrictions are "burdensome" and "unnecessary" since the Food and Drug Administration has deemed the drug, mifepristone, safe and effective.

• The challenge came as a federal judge in Texas is weighing a bid by anti-abortion groups to roll back the FDA's approval of mifepristone.
• Those groups arguing that the agency did not properly approve mifepristone — used as part of a two-drug regimen to end pregnancies within 10 weeks gestation.
• The AGs filed a request asking the court to “halt the enforcement of the FDA’s restrictions on mifepristone while the case continues,” per a press release.

Details: The FDA approved mifepristone more than two decades ago under the agency's Risk Evaluation and Mitigation Strategy, a program that adds dispensing restrictions to certain drugs, including requiring specific certifications for those who prescribe them.

• "FDA's decision to continue these burdensome restrictions in January 2023 on a drug that has been on the market for more than two decades with only 'exceedingly rare' adverse events has no basis in science," the AGs lawsuit says.
• "It only serves to make mifepristone harder for doctors to prescribe, harder for pharmacies to fill, harder for patients to access, and more burdensome for the Plaintiff States and their health care providers to dispense."
• REMS restrictions, the lawsuit says, cover "dangerous drugs such as fentanyl and other opioids," and thus it is "improper and discriminatory for FDA to relegate mifepristone ... to the very limited class of dangerous drugs that are subject to a REMS."

Between the lines: While mifepristone is subject to REMS restrictions, misoprostol, the second pill used in medication abortions, is not. Patients can more easily access it at retail or mail-order pharmacies.

• Misoprostol can be used alone to terminate pregnancies, but that regimen is slightly less effective than the mifepristone-misoprostol combination method.

Zoom out: The the AGs' lawsuit is the fourth abortion pill-related case that has been filed since the Supreme Court overturned Roe v. Wade.

• Besides their challenge and the anti-abortion group's case, two lawsuits have been brought in North Carolina and West Virginia challenging the states' abortion bans and restrictions, and they look to answer whether states can regulate and restrict drugs that have been approved by the FDA.

Go deeper: How abortion pills work and why they're in the spotlight