Pharmaceutical company and doctor sue access to abortion pills, in federal power test cases

In lawsuits that could impact abortion access nationwide, drugmaker GenBioPro and a North Carolina doctor filed separate federal lawsuits on Wednesday seeking to overturn state restrictions. on the abortifacient drug mifepristone.

GenBioPro, which makes the pill, filed its lawsuit in West Virginia, naming as defendants a county attorney and state attorney general Patrick Morrisey, who said in a statement that his state’s law was “clearly constitutional”.

GenBioPro and the North Carolina lawsuit filed by Dr. Amy Bryant argue that their state’s restrictions on the abortion pill violate rules set by the Food and Drug Administration, the federal agency charged by law with determining the access and safety of medicines.

“North Carolina cannot step into (the) FDA’s shoes to impose restrictions on access to drugs that the FDA has deemed inappropriate and that have upset the careful balance that the FDA has been instructed by the Congress to find,” according to the lawsuit filed on Bryant’s behalf by the King law firm. & Spalding in the United States District Court for the Central District of North Carolina.

GenBioPro’s lawsuit argues much the same: “Federal law prevails over the West Virginia ban and restrictions. These laws impermissibly restrict patient access to mifepristone and the opportunity and GenBioPro’s ability to market, promote and sell the drug in the state.”

Since the Supreme Court overturned Roe v. Wade in June, at least 14 states stopped nearly all abortions, including access to medical abortion, either because of laws passed by state legislators or because of confusion over the laws.

Limited access has led to growing demand for mifepristone, a unique pill that ends early pregnancy by blocking the hormone progesterone.

According to FDA rules, mifepristone can only be prescribed by certified providers who understand how the drug works and agree to watch for potential complications or medical conditions such as ectopic pregnancy, which require immediate medical attention. . But the FDA also says mifepristone is safe enough to be provided through telehealth appointments and mailed to a patient without evaluating them in person.

Earlier this month, the FDA expanded rules to allow retail pharmacies to dispense the drug for the first time, provided they follow certain rules. Some drugstore chains like Walgreens and CVS say they are considering joining the program but are still sorting out details.

But many states, including North Carolina and West Virginia, have their own rules when it comes to dispensing the drug.

PHOTO: Boxes of mifepristone medication sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Alabama on March 16, 2022.

Boxes of mifepristone sit on a shelf at the West Alabama Women’s Center in Tuscaloosa, Alabama on March 16, 2022.

Allen G. Breed/AP, FILE

In North Carolina, for example, mifepristone is allowed in early pregnancy under FDA rules. But the state also requires the patient to obtain the drug through a physician at a specially licensed surgical facility. The state also requires state-mandated counseling 72 hours prior to any abortion.

In a statement to ABC News, Bryant said she sued because there was “no medical reason for politicians to interfere or restrict access” to the drug.

“These burdensome restrictions on medical abortion are forcing doctors to deal with unnecessary restrictions on patient care and on the healthcare system,” she said.

Bryant’s attorney, Eva Temkin, argued federal rules for state drug regulation when the two conflict.

“Congress has made it clear that the FDA is responsible for establishing regulatory controls for this drug to ensure safety and patient access in the least burdensome manner,” she said.

Abortion rights advocates hope this type of “federal preemption” case will test a new legal strategy that could be applied in other states.

They also see North Carolina as a hopeful place to try it. While Republicans control both houses of the state legislature, the administration is led by Democratic Gov. Roy Cooper. The lawsuit names North Carolina Attorney General Josh Stein as defendant; Stein, a Democrat, last week announced his candidacy for governor in 2024.

A spokesperson for Stein told ABC News they are looking into the complaint.

Morrisey, the attorney general of West Virginia, said in his statement that we stand ready to fully defend West Virginia’s new abortion law. While it may not sit well with manufacturers of abortion drugs, the United States Supreme Court has made it clear that abortion regulation is a matter of the state. I will stay strong for the life of the unborn child and I will not back down.”

“No state has ever blocked access to an FDA-approved drug before and it shouldn’t start now,” said Kirsten Moore, director of the Expanding Medication Abortion Access project. “We can’t have a Swiss cheese of the drugs you can get” in different parts of the country.

Anti-abortion groups are awaiting a decision on their own case in Texas. The Alliance Defending Freedom (ADF) filed a lawsuit last fall on behalf of other abortion rights organizations, claiming the FDA was wrong to approve mifepristone decades ago. . This case could lead to a national injunction over the distribution of the pill before finally ending up in the Supreme Court.

“We urge the court to reject the marketing and distribution of … chemical abortion drugs so that the health, safety and well-being of women are protected,” an ADF lawyer said in November.

ABC News’ Mary Kekatos contributed to this report.