Project Description
Cover Story
FDA, Chemical Abortion Drugs, and Lawsuit in West Virginia
By Wanda Franz, Ph.D., President
West Virginia Attorney General Patrick Morrisey addresses the audience during Pro-Life Rally Day at the Capitol.
Background
In early January, the Food and Drug Administration (FDA) updated labeling for mifepristone (generic for Mifeprex) that would allow pharmacies to dispense the drug. In issuing the new regulations, the FDA formalized a decision made in 2021 to permanently drop the in-person requirement for the distribution of the abortion pill.
In February, a pair of lawsuits were filed challenging chemical abortion restrictions in North Carolina and West Virginia. North Carolina requires that a physician dispense the drug in-person, and West Virginia bans most abortions.
Previously, the REMS (Risk Evaluation and Mitigation Strategy) required that chemical abortion drugs must be dispensed by the certified providers. Now, the FDA will set up a regulatory system whereby certain pharmacies can become certified to dispense the abortion drugs if a woman has a prescription from a certified provider. The pharmacies would have to agree to a series of compliance and reporting rules, maintaining certain records for every pill they dispense. The drugs can also now be mailed.
In addition, the Biden Administration’s Department of Justice issued an opinion in late December regarding the mailing of abortion drugs. However, the opinion permitting the mailing of drugs does not permit the overriding of state laws in states where abortion is not permitted, nor would it override any state restrictions on the dispensing of chemical abortion drugs.
A group of 22 attorneys general issued a letter in response. This letter was signed by West Virginia Attorney General Morrisey and reads in part: “Though the FDA has abdicated its responsibility to protect women’s health, we have not. …To be crystal clear, you have not negated any of our laws that forbid the remote prescription, administration, and use of abortion-inducing drugs. The health and safety of our citizens—women and children included—is of paramount concern. Nothing in the FDA’s recent changes affects how we will protect our people.”
Lawsuit Attacking West Virginia Ban on Chemical Abortions
West Virginia is being sued by a Nevada-based drugmaker, GenBioPro, because our laws “adversely affect the sale and use of mifepristone within the state.” This company has spent 10 years developing a generic form of mifepristone as its only product, and laws such as those in West Virginia prevent them from realizing their investment.
The lawsuit is filed by Charleston attorney Anthony Majestro. The claim in the lawsuit that the FDA has cleared mifepristone as safe and effective following rigorous testing is highly debatable. The suit fails to mention the many international research studies implicating the drug in deaths and hospitalizations of large numbers of women. In addition, they claim that rules promulgated by the FDA can override laws passed by the people’s representatives in the state legislatures. While this may be true of Federal legislation passed in Congress, it is frightening to think that agencies of the Federal Government can enact rules that override state laws.
The lawyer for GenBioPro has stated that West Virginia was chosen for the suit because our laws have the strongest, most effective ability to prevent chemical abortions. “It speaks well of the people of West Virginia and their elected representatives that they have created some of the most protective laws in the country,” said West Virginians for Life President Wanda Franz. Attorney General Morrisey has stated that he will “defend West Virginia’s new abortion law to the fullest.” He has been quoted as saying: “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.”