GenBioPro, the manufacturer of the abortion pill, filed a lawsuit on Wednesday seeking to overturn West Virginia’s abortion ban, arguing that it obstructs access to a medication approved by the FDA.
The lawsuit, lodged in federal court in West Virginia’s southern district, contends that FDA regulations on drugs like the abortion pill preempt state laws under the U.S. Constitution.
Access to the pill, known as mifepristone, has become a significant legal battleground following last June’s Supreme Court decision overturning federal abortion rights.
Twelve states, including West Virginia, have enacted nearly complete abortion bans effectively prohibiting the use of mifepristone.
The FDA sanctioned mifepristone over two decades ago as a safe and effective method for terminating early pregnancies, albeit with restrictions on its distribution and administration.
Mifepristone, in combination with misoprostol, is the predominant method for ending pregnancies in the U.S., accounting for approximately half of all abortions nationwide in 2020.
The FDA has relaxed many of its restrictions to broaden access to mifepristone.
During the Covid-19 pandemic, the agency permitted patients to receive the pill by mail. Earlier this month, the FDA authorized retail pharmacies to begin dispensing mifepristone for the first time, provided they obtain certification.
However, bans such as West Virginia’s conflict with FDA regulations on mifepristone, prompting questions about whether federal or state laws hold precedence.
While the FDA is mandated by Congress to approve drugs for U.S. market use, states typically license the pharmacies that dispense these medications.
In its lawsuit, GenBioPro argues that West Virginia’s ban violates the U.S. Constitution’s supremacy and commerce clauses, which empower the FDA to regulate drug sales nationwide.
“Individual state regulation of mifepristone undermines the national common market and contradicts the significant national interest in ensuring access to a federally approved medication for terminating pregnancies, resulting in economic fragmentation that the Framers intended to prevent,” GenBioPro’s attorneys asserted in the lawsuit.
“A state’s police power does not extend to functionally banning an item of interstate commerce — Congress is tasked with that under the Constitution,” the company’s legal team emphasized.
In a separate case, a physician in North Carolina petitioned a federal court on Wednesday to invalidate the state’s mifepristone restrictions for exceeding FDA regulations. North Carolina mandates that patients obtain the pill in person from a physician at a certified facility.
“For North Carolina to impose restrictions beyond what the FDA deemed necessary as part of its regulatory balance, including restrictions that the FDA explicitly rejected, undermines the goals of federal law,” the doctor’s lawyers argued in their complaint.
Conversely, anti-abortion activists are advocating for the complete removal of mifepristone from the U.S. market.
A coalition of abortion-opposing physicians has urged a federal court in Texas to overturn the FDA’s more than two-decade-old approval of mifepristone as safe and effective.
A ruling in that case could be issued as early as February.
