HUNTINGTON – The manufacturer of an abortion pill has sued to overturn West Virginia’s ban on abortion, saying it restricts access to a drug approved by the federal Food and Drug Administration.
GenBioPro filed the complaint January 25 in federal court against West Virginia Attorney General Patrick Morrisey and Putnam County Prosecuting Attorney Mark Sorsaia. The company argues that federal regulations on medications such as mifepristone supersede state law, according to the U.S. Constitution.
The complaint says Morrisey recently signed a letter calling FDA decisions about the drug “illegal and dangerous” It says Sorsaia has said he and other prosecutors “have a clear obligation to enforce the laws of our state.”
Morrisey
“I believe if abortion is illegal, then no responsible medical provider will be doing them,” the complaint quotes Sorsaia.
Morrisey says his office will fight the lawsuit.
“We are prepared to defend West Virginia’s new abortion law to the fullest,” Morrisey said in a press release. “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.
“I will stand strong for the life of the unborn and will not relent in our defense of this clearly constitutional law.”
Access to mifepristone has become an issue in a dozen states, including West Virginia, since those states implemented new restrictive laws regarding abortions after the United States ruled in June in Dobbs to overturn Roe v. Wade and federal abortion rights. West Virginia and the other states’ near total abortion bans essentially outlaw the use of mifepristone, a medication approved more than 20 years ago by the FDA as a safe and effective method to terminate an early pregnancy. The FDA did impose restrictions on how the pill was distributed and administered.
“Congress subjected (mifepristone) to a substantial and detailed federal regulatory program with which West Virginia law interferes. That state law must give way to the comprehensive federal regime Congress enacted and the Food and Drug Administration implemented,” the complaint states, noting that West Virginia’s ban and restrictions “impermissibly restrict patients’ access to mifepristone and GenBioPro’s opportunity and ability to market, promote, and sell the medication in the state.”
When used with another drug called misoprostol, mifepristone accounted for almost half of all abortions in the United States in 2020.
The FDA also has relaxed restrictions on the medication. During the COVID-19 pandemic, it allowed patients to receive the pill by mail. And this month, the FDA approved retail pharmacy dispensing of the drug with a certificate.
In its complaint, GenBioPro says West Virginia’s ban is unconstitutional and violates the supremacy and commerce clauses of the U.S. Constitution, noting that the FDA has congressional authority to approve drugs for use in the United States.
“GenBioPro was founded out of a deep conviction that all people, regardless of income level, race, sex, or geography are entitled to the benefits of evidence-based medicine and state-of-the- art medication,” GenBioPro CEO Evan Masingill said in a press release. “We have sought to make mifepristone more accessible through commercializing the first FDA-approved generic version of the medication.
“And, consistent with our commitment, we are challenging laws in the state of West Virginia that in effect ban mifepristone, a drug that is safe and effective and which Congress and FDA have subjected to a specific regulatory regime.”
West Virginia’s law bans most abortions. There are exceptions for rape and incest victims as well as in cases of life-threatening medical emergencies and nonviable pregnancies.
“Individual state regulation of mifepristone destroys the national common market and conflict with the strong national interest in ensuring access to a federally approved medication to end a pregnancy, resulting in the kind of economic fracturing the framers intended the clause to preclude,” the complaint states. “A state’s police power does not extend to functionally banning an article of interstate commerce — the Constitution leaves that to Congress. …
“The ban and restrictions make it impossible for GenBioPro to market and distribute mifepristone in West Virginia in accordance with FDA’s requirements.”
GenBioPro is being represented by Anthony Majestro and Christina Smith of Powell & Majestro in Charleston as well as by David C. Frederick, Ariela M. Migdal, Eliana Margo Pfeffer and Mary Charlotte Y. Carroll of Kellogg Hansen Todd Figel & Frederick in Washington, John P. Elwood, Daphne O’Connor and Robert J. Katerberg of Arnold & Porter Kaye Scholer in Washington and by Skye L. Perryman and Kristen Miller of Democracy Forward Foundation in Washington.
“West Virginia’s decision to step in where Congress has granted FDA the authority to regulate mifepristone is harmful and unlawful,” Majestro said. “We look forward to representing the company in enforcing protections afforded by the U.S. Constitution.”
Also Wednesday, a North Carolina obstetrician-gynecologist filed a federal lawsuit saying state requirements placed on obtaining abortion pills go against federal law.
U.S. District Court for the Southern District of West Virginia case number 3:23-cv-00058