Abortion rights advocates in the United States filed separate lawsuits Wednesday challenging abortion pill restrictions in two states, the first salvo in what is expected to be a protracted legal battle over access to the drug.
The lawsuits claim that the drug restrictions in North Carolina and West Virginia run afoul of federal authorities by the US Food and Drug Administration (FDA), which has approved abortion pills as a safe and effective method of terminating a pregnancy.
The cases were brought by a North Carolina doctor who prescribes the pill, mifepristone, and GenBioPro, which makes a generic version of the drug and is sued in West Virginia.
While the federal lawsuits target specific state laws, they represent key legal tests that could ultimately determine access to abortion for millions of women. Medications have recently overtaken clinical procedures as the most common form of abortion in the US.
The new litigation is based on the longstanding principle that federal law, including FDA decisions, takes precedence over state laws. Indeed, few states have ever tried to outright ban an FDA-approved drug because of past rulings in the agency’s favor.
But with the fall of Roe v. Wade, the legal decision that previously protected abortion as a constitutional right, there is little precedent for the current patchwork of laws governing abortion.
After the Supreme Court overturned the decision in June, previously enacted abortion restrictions went into effect, and two states enacted new ones. Currently, abortion bans at all stages of pregnancy are enforced in 13 states.
On top of that, 19 states — including North Carolina and West Virginia — have separate laws that control how, when and where doctors can prescribe and dispense abortion drugs.
“West Virginia cannot overturn the FDA’s safety and efficacy decisions, nor can it disrupt the national market for this drug,” David Frederick, an attorney representing GenBioPro, said in a statement.
Legal experts predict years of court battles over access to the pill.
North Carolina bans almost all abortions after 20 weeks, with few exceptions for medical emergencies. Doctors can only prescribe abortion drugs after state consultation for their patients and must personally dispense the drug.
The lawsuit — filed by Dr. Amy Bryant, an OB/GYN — 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 released by the Expanding Medication Abortion Access project, a pro-abortion rights group that works on legal challenges to state laws.
The office of North Carolina Attorney General Josh Stein, a defendant in the lawsuit because he is the state’s top law enforcement officer, was reviewing the lawsuit Wednesday, his spokeswoman Nazneen Ahmed wrote in an email. Stein, a Democrat who announced his 2024 gubernatorial bid last week, is an advocate for abortion rights.
In 2000, the FDA approved mifepristone for the termination of pregnancy when used in combination with another drug, misoprostol. The combination is approved for use up to the 10th week of pregnancy.
For more than 20 years, the FDA restricted drug dispensing to a subset of specialty offices and clinics due to safety concerns. In rare cases, the combination of drugs can cause excessive bleeding, which requires 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 to access for many women.
In late 2021, the agency lifted the requirement to take the pill in person, saying a new scientific review showed no increase in safety complications if the drug is taken at home. That change also allowed the pill to be prescribed via telehealth and sent through mail-order pharmacies.
Earlier this year, the FDA further eased restrictions by allowing physical pharmacies to dispense the drug, provided they pass certification.
This change was made at the request of two drug manufacturers: GenBioPro and Danco Laboratories, which produce a version of mifepristone under the name Mifeprex.
In its West Virginia lawsuit, GenBioPro claims the state laws interfere with drug regulations made by the FDA, which has sole authority over the approval and regulation of all U.S. drugs.
West Virginia prohibits most abortions, with some exceptions for victims of rape and incest and in life-threatening medical emergencies and unviable pregnancies. The near-total ban, which came into effect in September, replaces earlier laws on access to abortion pills.
“The ban and restrictions prevent GenBioPro from marketing and distributing mifepristone in West Virginia in accordance with FDA requirements,” the company said in its lawsuit filed in the Southern District.
West Virginia Attorney General Patrick Morrisey said he will defend the new abortion law. “Although abortion drug manufacturers may not like it, the U.S. Supreme Court has made clear that regulating abortion is a state issue,” he said in a statement.
Abortion opponents have filed their own lawsuits seeking to stop the pill’s use, including a lawsuit in Texas alleging that the FDA overstepped its authority in approving the drug. Anti-abortion groups pledged Wednesday to support state abortion restrictions.
“We stand with the people of North Carolina and West Virginia against the abortion lobby’s reckless push to mandate abortion on demand in every state,” said Marjorie Dannenfelser of the group Susan B Anthony Pro-Life America.
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 spasms and contractions of the uterus, causing bleeding and expulsion of pregnancy tissue.