This week, the Fourth Circuit Court of Appeals ruled 2-1 that West Virginia is free to ban the abortion pill Mifepristone under the state’s “traditional right” to protect the health and safety of its citizens. The majority panel said that the Food and Drug Administration’s (FDA) approval of the high-risk drug does not preempt West Virginia’s “Unborn Child Protection Act,” a near-total abortion ban that protects unborn babies and women from dangerous chemical abortion drugs.
The appeals court rejected a legal challenge from a Nevada-based abortion pill manufacturer, GenBioPro, which argued that only the FDA has the “exclusive authority” to regulate access to Mifepristone. According to the ruling, GenBioPro’s chief complaint is that West Virginia’s abortion law “makes it impossible” for the company to sell the drug in the state as it does in other states and criminalizes access to federally-approved drugs.
Writing the majority opinion, U.S. Circuit Judge J. Harvie Wilkinson III cited the U.S. Supreme Court’s 2022 Dobbs decision overturning Roe v. Wade, which returned the ability to regulate abortion back to the states. Judge Wilkinson noted that Dobbs drove a specific point home about how states have traditionally regulated abortion.
“All of the fifty-one state and territorial statutes meticulously analyzed in [Dobbs] prohibited the use of medicine or drugs to accomplish an abortion, just as the state law we deal with here does,” wrote Judge Wilkinson. “The West Virginia law thus fits comfortably within a long history of state regulation of abortion.” The ruling upholds a lower court ruling that the West Virginia law pertains only to restricting abortion, and does not impede the FDA’s mandate to approve drugs.
“The agency’s task has always been to ‘ensure that drugs on the market are safe and effective,’” reads the opinion. “It has never been authorized to ‘regulate the practice of medicine’ or mandate that specific drugs be available.” The majority concluded that the laws governing the FDA do not “create a right” to use “any particular high-risk drug,” and any notion to the contrary would be a “significant intrusion” upon a “state’s traditional authority to protect the health and welfare of its citizens.”
In the court’s view, Judge Wilkinson wrote, Congress has not given the FDA “clear and manifest” authority to supersede state sovereignty or to guarantee nationwide access to Mifepristone, which means states are “free to adopt or diverge from West Virginia’s path.”
“[W]e simply lack authority as a federal court to substitute our policy preferences for those of the West Virginia legislature,” stated the majority. “Litigation was never meant to displace the hard democratic work of persuading the people’s representatives.”
The court also noted that striking down the “Unborn Child Protection Act,” which was enacted for the “express purpose of protecting unborn lives,” would be tantamount to near “defiance” of Dobbs.
“Just after the Supreme Court restored the states’ traditional authority to regulate abortion, GenBioPro would have us wrest it right back,” wrote Judge Wilkinson. “At a time when the rule of law is under blunt assault, disregarding the Supreme Court is not an option.”
From 2016 to 2021, the FDA deregulated Mifepristone so it could be used through the 10th week of pregnancy, rather than only through the 7th week; allowed healthcare providers who are not physicians to prescribe the drugs; relaxed adverse reporting requirements; and allowed the drug to be prescribed online through telehealth appointments and sent through the mail defying the federal Comstock Act that prohibits sending abortion through the mail. The FDA made these changes despite the drug’s questionable safety record. According to data from the pro-abortion Guttmacher Institute, the abortion pill accounts for 63 percent of all abortions in America, which suggests the drugs could potentially cause up to tens of thousands of women going to the ER every year.
Liberty Counsel’s Founder and Chairman Mat Staver said, “The Fourth Circuit’s decision is a tremendous win to help protect the lives of unborn children and women. As there is no right to abortion, there is no right to dangerous abortion drugs. States have the authority to ban drugs that destroy innocent children and harm women. While states may not weaken federal regulations, they can strengthen them to give their citizens even greater protections for their health and welfare. We must make the womb a safe place once again.”
