New lawsuits target state restrictions on abortion pills

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WASHINGTON (TUSEN) — Abortion rights advocates filed separate lawsuits Wednesday against two states’ restrictions on abortion pills, the opening salvo in what is expected to be a protracted legal battle over access to the drugs.

The lawsuits allege that restrictions on the drugs 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 of terminating 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 was sued in West Virginia.

While the lawsuits target specific state laws, they represent important legal tests that could determine access to abortion for millions of women.

The lawsuit addresses a longstanding legal principle that federal law, including FDA decisions, pre-empts 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 decision in June, previously passed restrictions on abortion went into effect and two states passed new ones. Currently, bans on abortion at all stages of pregnancy are enforced in 13 states, and enforcement is being held back in several other states due to legal issues.

In addition, 19 states, including North Carolina and West Virginia, are placing restrictions on how doctors can prescribe and dispense abortion medications.

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

Legal experts foresee years of litigation over access to the pills.

North Carolina bans almost all abortions after 20 weeks, with minor exceptions for urgent medical emergencies. Any physician prescribing medication abortion must be in the same room as the patient when administering the drug. The state also needs advice before administering the drug.

The lawsuit, filed by Dr. Amy Bryant, argues that such requirements contradict FDA-approved labeling for the drug and hinder its ability to treat patients.

“We know from years of research and practice that medication abortion is safe and effective — there is no medical reason for politicians to interfere or restrict access to it,” Bryant said in a statement from the Expanding Medication Abortion Access project. , an abortion rights group working 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 spokesman Nazneen Ahmed wrote in an email. Stein, a Democrat who last week announced a bid for governor in 2024, 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.

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For more than 20 years, the FDA restricted dispensing of the drug 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, increasing demand even as state laws make it more difficult to get more women on the pill.

In late 2021, the agency removed the personal requirement for the pill, saying a new scientific review showed no increase in safety complications when the drug is taken at home. That change also allowed the pill to be prescribed through telehealth consultations and shipped from mail-order pharmacies.

Earlier this year, the FDA eased restrictions further by allowing brick-and-mortar pharmacies to dispense the drug, provided they undergo certification.

That change was made at the request of the two drug makers: GenBioPro and Danco Laboratories, which makes the brand name Mifeprex.

In its West Virginia lawsuit, GenBioPro argues that state laws violate drug regulations created by the FDA, which has sole authority over the approval and labeling of 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 nonviable 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 said in its lawsuit filed in the Southern Federal District of the United States. state.

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West Virginia Attorney General Patrick Morrisey said he would defend the state’s new abortion law. “While abortion drug manufacturers may not approve, the U.S. Supreme Court has made it clear that regulating abortion is a state matter,” he said in a statement.

Abortion opponents have filed their own lawsuits to block the use of the pill, including a lawsuit in Texas alleging that the FDA overstepped its authority by approving the pill and relaxing restrictions on its use. A decision in that case is expected next month.

According to the Guttmacher Institute, a research group that supports abortion rights, more than half of abortions in the US are now performed with pills rather than surgery.

Mifepristone dilates the cervix and blocks the effects of the hormone progesterone, which is needed to maintain a pregnancy. Misoprostol, a drug also used to treat stomach ulcers, is taken 24 to 48 hours later. It causes the uterus to spasm and contract, causing bleeding and expelling pregnancy tissue.

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The US Express News writers Gary Robertson in Raleigh, NC and Leah Willingham in Charleston, West Virginia contributed to this story.

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The The US Express News Health and Science division is supported by the Science and Educational Media Group of the Howard Hughes Medical Institute. The TUSEN is solely responsible for all content.

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