People often think of abortion as a surgical procedure. However, a significant percentage of abortions in the U.S. involve medication rather than surgery. Abortion providers often prescribe a two-drug regimen to end a pregnancy, consisting of mifepristone and misoprostol. (Mifepristone blocks progesterone, while misoprostol empties the uterus.) The federal Food and Drug Administration has approved the use of mifepristone since 2000, reflecting its widespread acceptance in the medical profession.
After the U.S. Supreme Court overturned Roe v. Wade in 2022, though, many states imposed sweeping abortion bans. One of these states was West Virginia, which prohibits abortion throughout pregnancy except in narrow circumstances, such as medical emergencies or certain situations involving sexual assault. The ban covers medication abortions as well as surgical procedures.
GenBioPro, which manufactures generic mifepristone, challenged the West Virginia abortion ban as it applies to medication abortion. It argued that a federal law called the Food and Drug Administration Amendments Act “preempts” the state law, barring its enforcement. Rooted in the Supremacy Clause of the Constitution, preemption may occur when federal regulations occupy a field so thoroughly that states have no room to enact their own regulations. It also may occur when it’s impossible to comply with both federal and state laws, or when a state law poses an obstacle to achieving the purpose of the federal law.
GenBioPro argued that the regulatory scheme imposed by the FDAAA for certain high-risk drugs like mifepristone triggered “field preemption.” It also claimed that the state law interfered with what it saw as a federal effort to balance drug safety with patient access. The federal trial court rejected these arguments, and last week a panel of the Fourth Circuit Court of Appeals did as well.
The majority in a 2-1 decision ruled that Congress didn’t intend the FDAAA to override the traditional authority of states to protect the health and safety of their citizens. They found that the West Virginia law and the FDAAA operate in different fields, distinguishing abortion from medication safety, and explained that the FDAAA doesn’t guarantee nationwide access to mifepristone or other high-risk drugs. The majority also saw the lawsuit as a thinly veiled attack on the Supreme Court’s decision to return authority over abortion to the states. They suggested that accepting the preemption arguments would essentially amount to disregarding that decision.
The implications of this ruling could extend beyond abortion. It might encourage some states to tighten restrictions on access to vaccines, contraceptives, and other medical interventions approved by the FDA.
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