CHARLESTON — West Virginia Attorney General Patrick Morrisey’s office wants a lawsuit filed by a company that makes a generic version of the abortion pill mifepristone to be dismissed.
In its federal lawsuit filed February 1, GenBioPro says West Virginia’s new abortion law violates several laws and that the state cannot enforce a ban of a U.S. Food and Drug Administration-approved drug. It’s asking the court to find the state’s abortion law unconstitutional.
But Morrisey’s office says mifepristone is not banned under the law, which is also called the Unborn Child Protection Act. Morrisey’s office says the pill can be used in cases where legal abortion can take place in compliance with state law. The act prohibits abortions except in cases of rape or incest or to protect the life of the mother.
“The lawsuit this company filed does not have a legal leg to stand on — they’re trying to do an end-run around valid state laws,” Morrisey said in a press release. “We put forth very strong arguments in our motion to dismiss and believe the court should see this case the way we do.
“As I have said before, 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.”
In the motion filed February 21, the AG’s office says there is nothing in the federal Food, Drug and Cosmetic Act that gave the FDA such extraordinary power, there is nothing in the FDCA that preempts state law regulating abortion and there is nothing to suggest Congress empowered the FDA to do so by simply evaluating the safety and efficacy of a particular drug.
“The Supreme Court was not ignorant of the FDA’s regulatory role when it overturned Roe v. Wade,” Morrisey said. “The Supreme Court’s decision is very clear: the issue of abortion is left up to the states and their elected representatives.”
Alliance Defending Freedom Senior Counsel Denise Harle, who is co-counsel with members of Morrisey’s staff, agreed.
“West Virginia has a strong and compelling interest in protecting unborn life, maternal health and safety, and the integrity of the medical profession; and thanks to the state’s pro-life laws, it can do just that,” said Harle, who also is director of the ADF Center for Life. “It is no surprise that the manufacturer of this dangerous chemical abortion drug would seek to put profit over the lives of pregnant women and their unborn children.
“Simply put, the FDA does not have the authority to set national abortion policy, and we urge the court to reject this baseless attempt by GenBioPro to market, promote, and sell harmful drugs to vulnerable women and girls in West Virginia.”
In its complaint filed January 25 in federal court in Huntington, GenBioPro says the state’s abortion ban restricts access to the FDA-approved drug. It names Morrisey and Putnam County Prosecuting Attorney Mark Socsaia as defendants. 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.”
“I believe if abortion is illegal, then no responsible medical provider will be doing them,” the complaint quotes Sorsaia.
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. The AG’s office is being represented by Chief Deputy AG Douglas P. Huffington II and Deputy AG Curtis R.A. Capehart as well as Denise M. Harle and Erin M. Hawley of Alliance Defending Freedom.
“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 last month, 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
