WASHINGTON, D.C.— Late yesterday, the U.S. District Court Judge Robert C. Chambers issued a decision GenBioPro, Inc. v. Sorsaia. In the lawsuit, GenBioPro, a chemical abortion drug manufacturer, challenged West Virginia’s Unborn Child Protection Act claiming that it should be found unconstitutional on the basis that Congress gave the Food and Drug Administration (FDA) authority over state laws regarding access to mifepristone, one of two drugs used in a chemical abortion.
Judge Chambers rejected the claim, writing:
There is no disputing that health, medicine, and medical licensure are traditional areas of state authority. Furthermore, the Supreme Court has repeatedly held that the FDCA [Federal Food, Drug, and Cosmetic Act] does not preempt state action in the field of healthcare or medicine, absent a direct conflict.
Yesterday’s decision follows the August 16 decision by a three-judge panel of the Fifth Circuit Court of Appeals, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), which determined that when the FDA loosened regulations in 2016 and 2021 regarding the drug mifepristone, it did so unlawfully, failing to give adequate consideration to demonstrated safety issues with the drug.
The Fifth Circuit Court of Appeals decision will not impact the distribution of the abortion drug Mifeprex (generic: mifepristone) until the U.S. Supreme Court weighs in.
“Yesterday’s District Court decision in West Virginia respects the U.S. Supreme Court’s ruling in Dobbs and affirms a state’s right to protect life,” said Carol Tobias, president of National Right to Life.
“The plaintiff’s argument that the FDA’s authority extends so broadly as to circumvent state law is an overreach,” stated James Bopp, Jr., general counsel for National Right to Life. “The District Court rightly affirmed that a state’s rights cannot be upended by a capricious interpretation of the law.”
In yesterday’s decision, Judge Chambers left open the challenge by GenBioPro regarding telehealth abortions.
According to the Guttmacher Institute, the research organization affiliated with the abortion industry, approximately 54% of all abortions are done using chemical abortion methods like mifepristone and misoprostol.
Mifepristone is used in combination with misoprostol, a prostaglandin, to cause an abortion. Mifepristone blocks progesterone, leading to the death of the unborn baby, while the second drug, misoprostol, causes powerful, painful uterine contractions to expel the dead or dying baby.
The FDA recently weakened the Risk Evaluation and Mitigation Strategy (REMS) requirements for the drug to allow it to be dispensed and even mailed by pharmacies.
Myths regarding mifepristone are addressed in a white paper National Right to Life released on April 5. Addressing Many of the Myths the Media is Repeating about the FDA’s Approval and Management of Mifeprex (Mifepristone) can be accessed here.
The decision by the U.S. District Court for the Southern District Of West Virginia can be accessed here.