Court upholds state’s pro-life law, allowing West Virginia to restrict abortion pill sales

The State of West Virginia can restrict abortion pill sales following a decision by U.S. District Court Judge Robert C. Chambers, which partially dismissed GenBioPro’s challenge to the state’s Unborn Child Protection Act.

GenBioPro, which has claimed to ship a significant portion of abortion pills across the nation, is the generic manufacturer of the mifepristone, approved in 2000 by the Food and Drug Administration as the abortion pill.

Decision Summary

As Reuters noted, “U.S. District Judge Robert Chambers in Huntington… rejected the company’s argument that West Virginia’s ban must be struck down because it conflicts with the federal government’s decision to approve and regulate mifepristone for medication abortion, dismissing most of the company’s lawsuit.”

However, “Chambers did allow GenBioPro’s claims challenging West Virginia’s ban on the use of telemedicine for medication abortion to go forward, finding that that ban conflicted with federal law. The effect of that ruling will likely be limited, however, since West Virginia’s abortion ban contains only narrow exceptions for nonviable pregnancies, medical emergencies or cases of rape that are reported to law enforcement.”

GenBioPro argued that “West Virginia’s new abortion law and a prohibition against telehealth abortion pill prescriptions are unconstitutional and preempted by federal law—that the state cannot enforce a ‘ban’ of a U.S. Food and Drug Administration-approved drug,” West Virginia Attorney General Patrick Morrisey’s office said in a written statement following the August 24, 2023, ruling by the Southern District of West Virginia Huntington Division.

“While the court allowed the telehealth provision challenge to proceed, it concluded that the new pro-life law [Unborn Child Protection Act (UCPA)] was constitutional and not preempted,” the statement added.

Unborn Child Protection Act

West Virginia passed the Unborn Child Protection Act (UCPA) in September 2022, following the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, which overturned Roe v. Wade and essentially granted state’s authority to restrict or expand abortion. However, prior to Dobbs and the passage of the UCPA, West Virginia had provisions in place, which GenBioPro asserted greatly limited the prescription and sale of mifepristone, according to the court document.

“The UCPA expressly includes abortions performed or induced via ‘medicine’ or ‘drug.’ The Act defines the prohibited ‘attempt to perform or induce an abortion’ as ‘an act or the omission of an act that, under the circumstances as the person so acting or omitting to act believes them to be, constitutes a substantial step in a course of conduct intended to culminate in an abortion,” the Court document claimed.

“If a licensed medical professional ‘knowingly and willfully performs, induces, or attempts to perform or induce an abortion’ with the intent to violate the UCPA, ‘the licensing board shall revoke medical professional’s license.’ ‘If a formerly licensed medical professional or any other person ‘knowingly and willfully performs, induces, or attempts to perform or induce an abortion,’ they are guilty of a felony and subject to imprisonment for ‘not less than three nor more than 10 years,” the document added.

Exceptions to the UCPA include instances where the embryo or fetus is considered nonviable, when the pregnancy is ectopic, when a medical emergency exists, and when the pregnancy is the result of sexual assault or incest (and steps are taken to report the assault or incest to law enforcement).

In addition to the UCPA, the state had laid out several restrictions on using the abortion pill (e.g. via telemedicine) before passing the UCPA Act. As such, the court document claimed that GenBioPro argued that these laws “severely constricted the market for mifepristone statewide.”

GenBioPro’s Lawsuit

GenBioPro’s initial lawsuit, filed January 25, 2023, alleged that the “UCPA and prior restrictions violate the Supremacy and Commerce Clauses by limiting the sale of mifepristone in West Virginia,” the most recent court document claimed.

“Federal law,” GenBioPro claimed in their original complaint, “preempts West Virginia’s Ban and Restrictions. These laws impermissibly restrict patients’ access to mifepristone and GenBioPro’s opportunity and ability to market, promote, and sell the medication in the State.” The lawsuit also alleged that “West Virginia’s Ban and Restrictions also burden the healthcare delivery system in violation of the Supremacy Clause of the U.S. Constitution.”

“West Virginia cannot override FDA’s determinations about the appropriate restrictions on a medication that FDA approved for use and Congress subjected to this enhanced regulatory regime,” the company also claimed.

But, in Judge Chambers most recent opinion, he pointed out that “The Supreme Court has made it clear that regulating abortion is a matter of health and safety upon which States may appropriately exercise their police power.”

“Regulation of medical professionals—which the UCPA directly accomplishes—is arguably a field in which the States have an even stronger interest and history of exercising authority,” the Judge, who was appointed to the bench by then-President Bill Clinton (D), wrote.

In other words, according to Alliance Defending Freedom (ADF), “GenBioPro… asked the court to render the state’s pro-life laws unconstitutional, claiming that Congress gave the Food and Drug Administration the power to mandate nationwide access to dangerous chemical abortions—preempting West Virginia’s duly-enacted pro-life laws that protect the lives of the unborn and mothers.”

Judge Chambers’ decision claimed GenBioPro was “not regulated by the UCPA, rather the law only regulated medical professionals” and found that “the UCPA is a restriction on the incidence of abortion, rather than a state directive in direct conflict with the logistical REMS regulations.”

“This Court is compelled to find that federal regulation of medication abortion prescription does not conflict with severe state limitations on abortion… the Court finds that Congress has not expressed an intent to occupy the field of drugs subject to a REMS in a manner which would preempt West Virginia’s abortion restrictions,” Judge Chambers added in his ruling.

Telemedicine Under Dispute

While the most recent decision by Judge Chambers rejected most of GenBioPro’s arguments, ADF contends that, “The only part of the state’s near-total protection for life that the court found could still be challenged is the law ensuring women see a physician in person before receiving chemical abortion drugs. West Virginia had amended its law to prohibit telehealth practitioners from ‘prescribing or dispensing an abortifacient,’ so now the lawsuit will proceed only as it regards that prohibition.”

On April of 2021, under the guise of the COVID-19 pandemic, the Biden administration FDA temporarily enabled abortion pill distribution and expanded the FDA’s safety regulations called REMS to allow limited mail-order pharmacy distribution. By December of 2021, the Biden FDA had further weakened the REMS by eliminating the in-person dispensing requirement and enabling the abortion pill to be permanently shipped by mail. Earlier this month, the Fifth U.S. Circuit Court of Appeals ruled that it was likely the FDA’s pre-2016 changes (which include mail order dispensing of the drug), could be restricted. The case is still being litigated.

“The telemedicine restriction is not ‘upstream’ from the REMS, in the manner of the UCPA,” Judge Chambers wrote. “Rather than indicating what procedures are allowed in West Virginia, the telemedicine restriction dictates the manner in which mifepristone may be prescribed.”

The Judge referred to the “conflict between the REMS and the state statute” as a “kind of impossibility preemption” writing that “a licensed medical professional prescribing mifepristone could not comply with both the access determination made by the FDA and the access determination made by West Virginia as to telehealth.”

In response, Attorney General Morrisey wrote, “While it may not sit well with manufacturers of abortion drugs, the U.S. Supreme Court has made it clear that regulating abortion is a state issue,” the West Virginia AG said. “We look forward to arguing the remaining issue of this lawsuit, and we are confident in the merits of our case.”