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January 25, 2023

Inside the legal debate over abortion pills

Daily Briefing

    A lawsuit filed Wednesday by GenBioPro argues that West Virginia's statewide ban on the abortion pill mifepristone is unconstitutional because FDA has already approved the drug, marking one of a series of lawsuits throughout the United States over the legality of mifepristone.

    Lawsuits filed over the legality of mifepristone

    In September, West Virginia implemented a statewide ban on abortion, including the use of mifepristone. GenBioPro's lawsuit argues the ban violates the Constitution's supremacy clause, which says that federal laws have priority over conflicting state laws. The lawsuit also says the law violates the Constitution's commerce clause, which prohibits states from impairing interstate commerce.

    Skye Perryman, a lawyer for GenBioPro and president of Democracy Forward, said the ban is "an overreach of state authority when a state tries to step in the shoes of F.D.A. and to make safety and efficacy determinations that conflict with and interfere with F.D.A.'s judgments."

    DeShawn Taylor, medical director for GenBioPro, said that state bans on mifepristone "deprive people of the ability to access safe and effective medications and it also jeopardizes our company."

    The case is one of a series of lawsuits that have been filed regarding the legality of mifepristone.

    In North Carolina, Amy Bryant, an abortion provider at the University of North Carolina, filed a lawsuit arguing the state's restrictions on mifepristone go beyond FDA's regulations for the drug.

    According to Eva Temkin, a lawyer representing Bryant, North Carolina requires mifepristone to be taken in the presence of a physician who is first required to provide state-mandated counseling to the patient and then wait 72 hours before providing the mifepristone.

    "Ultimately, F.D.A. has expressly concluded that requirements like the ones that are imposed by North Carolina are not necessary to ensure patient safety and are contrary to F.D.A. regulatory balancing," Temkin said.

    And in Texas, the Alliance for Hippocratic Medicine filed a lawsuit arguing FDA did not adequately review the scientific evidence for mifepristone when the drug was approved in 2000.

    The group argues that FDA abused its power by accelerating the approval of mifepristone, a process that is typically reserved for new drugs that would benefit patients with serious or life-threatening illnesses. The group contends that pregnancy is not an illness and that mifepristone is not safer and more effective than a surgical abortion.

    Christina Francis, CEO of the American Association of Pro-Life Obstetricians, a member of the Alliance for Hippocratic Medicine, said FDA in its approval of mifepristone "reviewed a handful of cherry-picked studies that don't actually look at the full picture" and that FDA officials were "actively endangering the lives of women and girls in the country, especially as they continue to remove safeguard after safeguard."

    What the experts say

    Many legal experts have said the federal government has overarching authority to regulate medications, and that while states may adopt some laws and regulations supplementing federal rules, they cannot impose policies that interfere or contradict FDA standards or requirements.

    "Under the U.S. Constitution, federal law preempts state law when the two clash," said Patricia Zettler, a law professor, and Ameet Sarpatwari, a professor of medicine, in an article published in the New England Journal of Medicine.

    Experts have cited a 2014 case in Massachusetts in which the state aimed to ban Zohydro ER, an opioid, because of concerns the drug could be abused and lead to addiction and overdose. A federal judge sided with the drugmaker, Zogenix, saying that if the state "were able to countermand the F.D.A.'s determinations and substitute its own requirements, it would undermine the F.D.A.'s ability to make drugs available to promote and protect the public health."

    Lawrence Gostin, an expert on public health law at Georgetown Law, said it would be "highly irresponsible" and "reckless" for a judge to overturn FDA's approval of mifepristone, as it would have "disastrous" consequences and would set a "cataclysmic" precedent.

    "You can't have individual states let alone a single judge overturning all of the scientific evidence that's assessed by the federal Food and Drug Administration and usurping that power for itself," Gostin said, adding that such a decision "would mean that any FDA regulatory or approval decision could be subject to the whims of a single federal court or state." (Belluck, New York Times, 1/25; Kimball, CNBC, 1/24)

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