North Carolina obstetrician and gynaecologist Dr. Amy Bryant Wednesday challenged state laws restricting the prescription and use of medication abortion drug mifepristone.
Bryant argues that state laws cannot frustrate the objectives of federal law. As the Federal Food, Drug and Cosmetic Act (FDCA) allows the Food and Drug Administration (FDA) to regulate medication, Bryant contends that additional restrictions imposed on the prescription of mifepristone by North Carolina are in conflict with the FDCA.
Under recently amended FDA rules, mifepristone must be prescribed by a certified prescriber but can now be dispensed by certified retail pharmacies. Under the new rules, health care providers no longer need to see patients in person and can prescribe the medication via telehealth. However, North Carolina law requires a 72-hour waiting period, counseling and an ultrasound, in some instances, prior to the use of abortion medications.
Bryant stated:
For North Carolina to impose restrictions that go beyond those FDA deemed warranted as part of its regulatory balancing, including restrictions that FDA specifically rejected, frustrates the objectives of federal law… Simply put, North Carolina cannot stand in the shoes of FDA to impose restrictions on medication access that FDA determined are not appropriate…
Pharmaceutical company and mifepristone manufacturer GenBioProLegal also launched action over abortion medication on Wednesday. The GenBioPro lawsuit alleges that West Virginia law restricting the prescription of mifepristone also conflicts with FDA rules. Although abortion is banned in West Virginia, the suit alleges that if the ban is deemed unconstitutional, mifepristone restrictions will be in force once more.