Mifepristone manufacturer GenBioPro Inc. Wednesday filed a lawsuit against the state of West Virginia, challenging the state’s restrictions on medication abortions. Mifepristone is a generic medication abortion pill approved by the US Food and Drug Administration (FDA) to be used up to ten weeks of pregnancy.
GenBioPro alleges that West Virginia’s Unborn Child Protection Act is unconstitutional because the FDA approval of mifepristone preempts the state’s restrictions. Additionally, GenBioPro claims that West Virginia’s act violates the Commerce Clause of the US Constitution. The company argues that “the elements FDA determined are necessary to ensure mifepristone’s safety are the only restrictions that may be imposed on a patient’s access to, and the healthcare delivery system’s distribution of, mifepristone.” Thus, GenBioPro requests that the Southern District of West Virginia declare the Unborn Child Protection Act invalid and enjoin its enforcement.
In its complaint, GenBioPro also states that despite authority granted by Congress and the FDA to sell mifepristone nationally, West Virginia’s abortion legislation makes it “impossible for GenBioPro to promote and market its product in West Virginia as it does in other states.” These restrictions, it claims, “have caused significant, ongoing economic injury to GenBioPro in the form of lost sales, customers, and revenue.”
The Unborn Child Protection Act, signed into law in September of 2022, states that “[a]n abortion may not be performed or induced or be attempted to be performed or induced unless in the reasonable medical judgment of a licensed medical professional: (1) The embryo or fetus is nonviable; (2) The pregnancy is ectopic; or (3) A medical emergency exists.” Additionally, the act’s definition of abortion includes the use of abortifacients.
GenBioPrio filed a similar challenge against Mississippi in October 2020 but dropped the lawsuit after the US Supreme Court ruled that there is no federal constitutional right to abortion. However, the FDA has begun loosening its restrictions on access to mifepristone and has publicly supported continued access to the drug. The Biden administration released guidance warning pharmacies that failing to fill prescriptions for medication abortions could violate a range of federal civil rights laws, and the Department of Justice has stated that merely mailing abortifacients “to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.”
The FDA’s most recent rule, allowing mifepristone prescriptions to be dispensed by mail or from specially certified pharmacies rather than directly from a physician, led to attorneys general from 22 states, including West Virginia, to pen an open letter to FDA Commissioner Dr. Robert Califf, calling the FDA’s decision “illegal and dangerous.”
