Lawsuit says state laws are preempted by FDA’s authority to regulate drug
By Gary D. Robertson
Associated Press
RALEIGH, N.C. (AP) — North Carolina Attorney General Josh Stein won’t defend state restrictions on dispensing abortion pills that are being challenged in a lawsuit and instead will argue the restrictions are preempted by federal regulations protecting access to the pills, Stein’s office said Monday.
The decision by Stein, a Democrat, means Republican legislative leaders who want to keep the restrictions would have to seek to formally intervene in the federal lawsuit, which was filed by Amy Bryant, a physician who prescribes the drug mifepristone.
The lawsuit filed in January in U.S. District Court in Durham, and a separate lawsuit challenging limits on abortion pills in West Virginia, are considered the openings of legal battles over access to the medications. A Texas lawsuit poses a threat to the nationwide availability of medication abortion, which now accounts for the majority of abortions in the U.S. The case filed by abortion opponents seeks to reverse FDA approval of mifepristone.
Bryant’s lawsuit seeks to block enforcement of state laws and rules that it says interferes with the ability to provide mifepristone to patients. The lawsuit cites the authority that Congress gave to the U.S. Food and Drug Administration to regulate the FDA-approved drug.
North Carolina laws require the pill must be dispensed in person after a 72-hour waiting period, the lawsuit says, and only after patients receive state-mandated counseling and in some cases an ultrasound.
Stein, who supports abortion rights and is running for governor next year, is a defendant in the lawsuit along with a district attorney and state health and medical officials. Stein and state Department of Justice attorneys are tasked with defending state laws in court.
In this case, Bryant’s federal preemption arguments “are legally correct,” Sarah Boyce, general counsel at the state Department of Justice, wrote in a letter to legislative lawyers for House Speaker Tim Moore and Senate leader Phil Berger.
“Consistent with its statutory authority, the FDA has determined that restrictions like the ones imposed under North Carolina state law would unduly burden patients’ access to a safe and effective drug,” Boyce wrote. “The department’s filings in the (lawsuit) on behalf of Attorney General Stein will reflect this legal analysis on the merits.”
Spokespeople for Berger and Moore didn’t immediately respond to requests for comment.
The U.S. Supreme Court decision last June that overturned Roe v. Wade — turning decision-making over abortion to the states — has brought renewed focus on medication abortions. Nineteen states — including North Carolina and West Virginia — have laws controlling how, when and where physicians can prescribe and dispense abortion drugs.
In a written statement related to Monday’s letter, Stein said North Carolina’s “restriction of women’s use of the prescriptions they need to exercise their reproductive freedoms violates federal law and the Constitution.”
The FDA approved mifepristone in 2000 to end pregnancy, when used in combination with a second drug, misoprostol. The combination is approved for use up to the 10th week of pregnancy.
The FDA eliminated an in-person requirement for the pill, which can be shipped by mail-order or picked up at brick-and-mortar pharmacies.
