Supporters of abortion rights in the United States filed separate lawsuits on Wednesday against two states. abortion pills restrictions, firing into what is expected to be a protracted legal battle over access to medicines.
The lawsuits argue that drug restrictions in North Carolina and West Virginia contravene the federal authority of the US Food and Drug Administration (FDA), which And he agreed The abortion pill as a safe and effective way to terminate a pregnancy.
The cases have been filed by a North Carolina doctor who prescribes the birth control pill, mifepristone, and the company GenBioPro, which makes a generic version of the drug and has been sued in West Virginia.
While federal lawsuits target specific state laws, they are the major legal tests that can ultimately decide access to abortion to millions of women. Medications have recently overtaken clinic procedures as the most common form of abortion in the United States.
The new litigation is turning to a longstanding tenet that federal law, including FDA decisions, precedes state laws. In fact, few states have ever attempted to completely ban an FDA-approved drug because of previous rulings in favor of the agency.
But with a fall Roe v. Wadethe legal decision that previously protected abortion as a constitutional right, there is little precedent for the current array of laws governing abortion.
After the Supreme Court overturned the decision in June, previous restrictions on abortion were adopted and two states adopted new ones. Currently, Abortion is prohibited At all stages of pregnancy it is monitored in 13 states.
Moreover, 19 states — including North Carolina and West Virginia — have separate laws controlling how, when, and where doctors can prescribe and distribute abortion drugs.
“The state of West Virginia cannot override FDA decisions on safety and efficacy, and cannot disrupt the national market for this drug,” David Frederick, the attorney representing GenBioPro, said in a statement.
Legal experts predict years of court battles over access to the pills.
North Carolina bans nearly all abortions after 20 weeks, with narrow exceptions for urgent medical emergencies. Physicians can prescribe medication for abortion only after state-mandated counseling for their patients and must dispense the medication in person.
The lawsuit — filed by Dr. Amy Bryant, an obstetrician-gynecologist — alleges that such requirements are inconsistent with the drug’s FDA-approved designation, and interfere with its ability to treat patients.
Bryant said in a statement provided by the Expanding Mediation Abortion Access Project, a pro-abortion rights group working on legal challenges to state laws.
His spokesperson, Nazneen Ahmed, wrote in an email that the office of North Carolina Attorney General Josh Stein, who is the defendant in the complaint because he is the state’s top law enforcement official, was reviewing the complaint on Wednesday. Stein, a Democrat who announced last week he will run for governor in 2024, is a supporter of abortion rights.
The US Food and Drug Administration approved mifepristone in 2000 for termination of pregnancy when used in combination with a second medication, misoprostol. The combination is approved for use up to the 10th week of pregnancy.
For more than 20 years, the Food and Drug Administration has restricted distribution of the drug to a subset of specialty offices and clinics due to safety concerns. In rare cases, the combination of medications 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, driving demand even as state laws make it more difficult for many women to get the pills.
In late 2021, the agency removed the requirement for personal presence of the pills, saying a new scientific review showed no increase in safety complications if the drug was taken at home. This change also allowed birth control pills to be prescribed via telehealth and shipped by mail-order pharmacies.
Earlier this year, the Food and Drug Administration (FDA) eased restrictions by allowing traditional pharmacies to distribute the drug, provided it undergoes certification.
This change was made at the request of the drug’s two manufacturers: GenBioPro and Danco Laboratories, which make a brand-name version of mifepristone called Mifeprex.
In its lawsuit in West Virginia, GenBioPro argues that state laws interfere with drug regulations drafted by the Food and Drug Administration, which has sole authority over the approval and regulation of all US 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 was signed into law in September, replaces previous laws regarding access to abortion pills.
“The ban and restrictions make it impossible for GenBioPro to market and distribute mifepristone in West Virginia in accordance with FDA requirements,” the company stated in the lawsuit filed in the state’s Southern Federal District.
West Virginia Attorney General Patrick Morrissey said he would defend the new abortion law. “While the order may not suit abortion drug manufacturers, the US Supreme Court has made it 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 from being used, including one in Texas arguing that the Food and Drug Administration has exceeded its authority to approve the drug. On Wednesday, anti-abortion groups promised to support state restrictions on abortion.
“We stand with the people of North Carolina and West Virginia against the abortion lobby’s reckless pressure to mandate abortion on demand in every state,” said Marjorie Dannenfelser of the pro-life group Susan B. Anthony.
Mifepristone dilates the cervix and blocks the effects of the hormone progesterone, which is necessary to maintain a pregnancy. Misoprostol, a medicine also used to treat stomach ulcers, is taken 24 to 48 hours later. It causes the uterus to contract and contract, which leads to bleeding and expulsion of the pregnancy tissue.