Los Angeles Times

Lawsuits target restrictio­ns on abortion pills

West Virginia and North Carolina are accused of violating FDA authority.

- By Matthew Perrone Perrone writes for the Associated Press.

WASHINGTON — Supporters of abortion rights filed separate lawsuits on Wednesday challengin­g two states’ abortion pill restrictio­ns, the opening salvo in what’s expected to be a protracted legal battle over access to the medication­s.

The lawsuits argue that limits on the drugs in North Carolina and West Virginia run afoul of the federal authority of the U.S. Food and Drug Administra­tion, which has approved the abortion pill as a safe and effective method for ending pregnancy.

The North Carolina case was brought by a physician who wants to keep prescribin­g the pill, mifepristo­ne. West Virginia is being sued by GenBioPro, which makes a generic version of the drug.

While the lawsuits in federal court target specific state laws, they represent key legal tests that could eventually determine access to abortion for millions of people. Medication recently overtook in-clinic procedures as the most common form of abortion in the United States.

The new litigation turns on a long-standing principle that federal law, including FDA decisions, preempts state laws. Few states have tried to fully ban an FDA-approved drug due to past rulings in the agency’s favor.

But with the fall of Roe vs. Wade last year, there’s little precedent for the current patchwork of laws governing abortion.

After the Supreme Court overturned the decision in June, some states’ previously adopted abortion restrictio­ns kicked in, and two states adopted new ones. Currently, bans on abortion at all stages of pregnancy are being followed in 13 states.

On top of that, 19 states — including North Carolina and West Virginia — have separate laws controllin­g how, when and where physicians can prescribe and dispense abortion drugs.

“West Virginia cannot override the FDA’s safety and efficacy determinat­ions, nor can it disrupt the national market for this medication,” David Frederick, an attorney representi­ng GenBioPro, said in a statement.

Legal experts foresee years of court battles over access to the pills.

North Carolina bans nearly all abortions after 20 weeks, with narrow exceptions for medical emergencie­s. Physicians there can prescribe abortion medication only after state-mandated counseling for their patients, and must dispense the drug in person.

The lawsuit, filed by Dr. Amy Bryant, an obstetrici­an and gynecologi­st, argues that such requiremen­ts contradict FDA-approved labeling for the drug and interfere with her ability to treat patients.

“We know from years of research and use that medication abortion is safe and effective — there’s no medical reason for politician­s to interfere or restrict access to it,” Bryant said in a statement provided by the Expanding Medication Abortion Access Project, a group working on legal challenges to state laws.

The office of North Carolina Atty. Gen. Josh Stein, who is a defendant in the suit because he’s the state’s chief law enforcemen­t officer, was reviewing the complaint on Wednesday, his spokespers­on Nazneen Ahmed wrote in an email. Stein, a Democrat who announced last week that he would run for governor in 2024, is an abortion rights supporter.

The FDA approved mifepristo­ne in 2000 to end pregnancy 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 dispensing of the drug to a subset of specialty offices and clinics due to safety concerns. In rare cases, the drug combinatio­n can cause excess bleeding, requiring emergency care. But during the COVID-19 pandemic, the agency has repeatedly eased restrictio­ns and expanded access, increasing demand even as state laws make the pills harder for many to get.

In late 2021, the agency eliminated the in-person requiremen­t for the pill, saying a new scientific review showed no increase in safety complicati­ons when patients take the drug at home. That change also permitted the pill to be prescribed via telehealth appointmen­ts and shipped by mail-order pharmacies.

This month the FDA further loosened restrictio­ns by allowing brick-and-mortar pharmacies to dispense the drug, provided they undergo certificat­ion.

That change was made at the request of drug manufactur­ers GenBioPro and Danco Laboratori­es, which makes the brand Mifeprex.

In its West Virginia lawsuit, GenBioPro argues that state laws interfere with drug regulation­s crafted by the FDA, which has sole authority over the approval and regulation of drugs in the U.S.

West Virginia’s law prohibits most abortions, with some exceptions for rape and incest victims and in cases of life-threatenin­g medical emergencie­s and nonviable pregnancie­s. The near-total ban, signed into law in September, supersedes earlier laws on abortion pill access.

“The ban and restrictio­ns make it impossible for GenBioPro to market and distribute mifepristo­ne in West Virginia in accordance with FDA’s requiremen­ts,” the company states in its suit, filed in the state’s southern federal district.

West Virginia Atty. Gen. Patrick Morrisey said he would defend the new abortion law.

“While it may not sit well with manufactur­ers of abortion drugs, the U.S. Supreme Court has made it clear that regulating abortion is a state issue,” he said in a statement.

Opponents of abortion have filed their own lawsuits seeking to halt use of the pill, including a Texas suit arguing that the FDA oversteppe­d its authority in approving the medication. Antiaborti­on groups vowed Wednesday to support state abortion limits.

“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 sustain a 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, which causes bleeding and expels pregnancy tissue.

 ?? Allen G. Breed Associated Press ?? THE FDA approved mifepristo­ne in 2000 and began making it more accessible during the pandemic.
Allen G. Breed Associated Press THE FDA approved mifepristo­ne in 2000 and began making it more accessible during the pandemic.

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