WASHINGTON (AP) — Abortion rights advocates filed separate lawsuits Wednesday challenging abortion pill restrictions in two states, the first step in what is expected to be a protracted legal battle over access to the drugs.
The lawsuits argue that the drug limits in North Carolina and West Virginia conflict with the federal authority of the U.S. Food and Drug Administration, which has approved the abortion pill as a safe and effective method to end pregnancy.
The cases were filed by a North Carolina doctor who prescribes the pill, mifepristone, and GenBioPro, which makes a generic version of the drug, and sued in West Virginia.
While the lawsuits target specific state laws, they represent key legal tests that could determine abortion access for millions of women.
The appeal is based on a longstanding legal principle that federal law, including FDA decisions, preempts state laws. Indeed, few states have ever tried to outright ban an FDA-approved drug because of past rulings in favor of the agency.
But with the fall of Roe v. Wade, there is little precedent for the current legal patchwork of laws governing abortion.
After the Supreme Court overturned the ruling in June, past abortion restrictions began to be passed and two states adopted new ones. Currently, bans on abortion at all stages of pregnancy are followed in 13 states, and enforcement is suspended in several other states due to legal challenges.
Additionally, 19 states — including North Carolina and West Virginia — impose limits on how doctors can prescribe and administer abortion drugs.
“West Virginia cannot override the FDA’s determinations of safety and efficacy, nor can it disrupt the national market for this drug,” said David Frederick, an attorney representing GenBioPro.
Legal experts predict years of legal battles over access to the pills.
North Carolina bans nearly all abortions after 20 weeks, with minor exceptions for urgent medical emergencies. Any doctor who prescribes abortion medication is required to be in the same room as the patient when the medication is administered. The state also requires counseling before taking the drug.
The lawsuit, filed by Dr. Amy Bryant, alleges that such requirements conflict with the drug’s FDA-approved labeling and interfere with her ability to treat patients.
“We know from years of research and use that medication abortion is safe and effective — there is no medical reason for politicians to interfere or limit access to it,” Bryant said in a statement provided by Expanding Medication Abortion Access, a abortion rights group. work on legal challenges to state laws;
The office of Attorney General Josh Stein, who is a defendant in the complaint because he is the state’s chief law enforcement officer, was reviewing the complaint Wednesday, Stein’s spokeswoman Nazneen Ahmed wrote in an email. Stein, a Democrat who last week announced a 2024 run for governor, is a strong supporter of abortion rights.
The FDA approved mifepristone in 2000 to terminate pregnancy when used in combination with a second drug, misoprostol. The combination is approved for use up to the 10th week of pregnancy.
For more than 20 years, the FDA limited the drug’s administration to a subset of specialty offices and clinics due to safety concerns. In rare cases the combination of drugs can cause excessive bleeding, requiring emergency care. But since the start of the COVID-19 pandemic, the agency has repeatedly eased restrictions and expanded access, boosting demand even as state laws make the pills harder for more women to get.
In late 2021, the agency eliminated the requirement for the pill in person, saying a new scientific review showed no increase in safety complications if the drug is taken at home. This change also allowed the pill to be prescribed through telemedicine consultations and shipped through mail-order pharmacies.
Earlier this year, the FDA further eased restrictions by allowing pharmacies to dispense the drug, provided they undergo certification.
This change was made at the request of the two drug manufacturers: GenBioPro and Danco Laboratories, which makes the brand name Mifeprex.
In its West Virginia lawsuit, GenBioPro argues that the state laws interfere with drug regulations created by the FDA, which has sole authority to approve and label all U.S. drugs.
West Virginia law prohibits most abortions, with some exceptions for victims of rape and incest and in cases of life-threatening medical emergencies and unviable pregnancies.
“The ban and restrictions make it impossible for GenBioPro to market and distribute mifepristone in West Virginia in accordance with FDA requirements,” the company says in the lawsuit filed in the state’s Southern District.
West Virginia Attorney General Patrick Morrisey said he will defend the state’s new abortion law. “While it may not sit well with abortion drug manufacturers, the U.S. Supreme Court has made clear that the regulation of abortion is a state matter,” he said in a statement.
Abortion opponents have filed their own lawsuits to block the pill’s use, including a Texas lawsuit claiming the FDA overstepped its authority in approving the pill and loosening restrictions on its use. A decision on that case is expected next month.
More than half of abortions in the U.S. are now performed with pills rather than surgery, according to the Guttmacher Institute, a research group that supports abortion rights.
Mifepristone dilates the cervix and blocks the effects of the hormone progesterone, which is necessary to maintain pregnancy. Misoprostol, a drug also used to treat stomach ulcers, is taken 24 to 48 hours later. It causes the uterus to cramp and contract, causing bleeding and shedding of pregnancy tissue.
Associated Press writers Gary Robertson in Raleigh, NC and Leah Willingham in Charleston, WV contributed to this story.
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