WASHINGTON (AP) — Abortion rights supporters filed separate lawsuits Wednesday challenging two states’ restrictions on abortion pills, the opening salvo in what is expected to be a protracted legal battle over access to abortion pills. medications.
The lawsuits argue that drug limits in North Carolina and West Virginia violate the federal authority of the U.S. Food and Drug Administration, which has approved the abortion pill as a safe and effective method. effective in terminating pregnancy.
The cases were brought by a North Carolina doctor who prescribed the pill, mifepristone and GenBioPro, which makes a generic version of the drug and sued in West Virginia.
Although the lawsuits target specific state laws, they represent key legal tests that could determine access to abortion for millions of women.
The litigation rests on a long-standing legal principle that federal law, including FDA decisions, prevails over state laws. Indeed, few states have ever attempted to completely ban an FDA-approved drug because of previous 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, previously enacted restrictions on abortion went into effect and two states enacted new ones. Currently, the ban on abortion at all stages of pregnancy is followed in 13 states and its application is suspended in several other states due to legal challenges.
On top of that, 19 states — including North Carolina and West Virginia — place limits on how doctors can prescribe and dispense abortive drugs.
“West Virginia cannot override the FDA’s safety and efficacy determinations or disrupt the domestic market for this drug,” David Frederick, an attorney representing GenBioPro, said in a statement.
Legal experts predict years of legal battles over access to the pills.
North Carolina bans nearly all abortions after 20 weeks, with a few exceptions for urgent medical emergencies. Any physician prescribing a medical abortion should be in the same room as the patient while the medication is being administered. The state also requires counseling before receiving the drug.
The lawsuit, filed by Dr. Amy Bryant, argues that such requirements contradict FDA-approved labeling for the drug and interfere with its ability to treat patients.
“We know from years of research and use that medical abortion is safe and effective — there is no medical reason for politicians to interfere or restrict access,” Bryant said in a statement provided by the Expanding Medication Abortion Access Project, an abortion rights advocacy group. work on legal challenges to state laws.
Attorney General Josh Stein’s office, who is charged in the lawsuit because he is the state’s chief law enforcement officer, was reviewing the complaint on Wednesday, Stein’s spokesman Nazneen Ahmed wrote in an email. Stein, a Democrat who announced a 2024 gubernatorial bid last week, is a strong proponent of abortion rights.
The FDA approved mifepristone in 2000 for terminating 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 restricted distribution of the drug to a subset of specialty offices and clinics, due to safety concerns. In rare cases, the drug combination 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, increasing demand even as state laws make the pills harder to get to more women.
At the end of 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 via telehealth consultations and shipped from mail-order pharmacies.
Earlier this year, the FDA further eased restrictions by allowing brick-and-mortar pharmacies to dispense the drug, as long as they are certified.
This change was made at the request of two drugmakers: GenBioPro and Danco Laboratories, which manufactures the brand name Mifeprex.
In its West Virginia lawsuit, GenBioPro argues that state laws interfere with drug regulations made by the FDA, which has exclusive authority over the approval and labeling of all US 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 non-viable pregnancies.
“The ban and restrictions prevent GenBioPro from marketing and distributing mifepristone in West Virginia in accordance with FDA requirements,” the company says in its lawsuit filed in the state’s southern federal district.
West Virginia Attorney General Patrick Morrisey said he would defend the state’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 state,” he said in a statement.
Abortion opponents have filed their own lawsuits seeking to block use of the pill, including a lawsuit in Texas arguing that the FDA exceeded its authority in approving the pill and relaxing limits on its use. A decision in the case is expected next month.
More than half of abortions in the United States 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 needed 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 pushing out pregnancy tissue.
Associated Press writers Gary Robertson in Raleigh, North Carolina and Leah Willingham in Charleston, West Virginia contributed to this story.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Science and Education Media Group. The AP is solely responsible for all content.