Abortion pill maker GenBioPro on Wednesday sued to overturn West Virginia’s abortion ban because it limits access to drugs approved by the Food and Drug Administration.
The lawsuit, filed in federal court in the southern district of West Virginia, says FDA regulations on drugs such as the abortion pill preempt state law under the U.S. Constitution.
Access to the pill, called mifepristone, has become a major legal battleground after the Supreme Court’s ruling that overturned federal abortion rights last June. Dozens of states, including West Virginia, have enacted total abortion bans that generally prohibit the use of mifepristone.
The FDA approved mifepristone more than 20 years ago as a safe and effective way to end early pregnancy, although the agency placed restrictions on how it was distributed and administered.
Mifepristone, when used in combination with misoprostol, is the most common way to end a pregnancy in the US, accounting for about half of all abortions nationwide in 2020.
The FDA has lifted many restrictions to expand access to mifepristone. During the Covid-19 pandemic, the agency allowed patients to receive the pill by mail. Earlier this month, the FDA allowed retail pharmacies to begin dispensing mifepristone for the first time in the course of obtaining certification.
But bans such as the one in West Virginia conflict with FDA regulations on mifepristone, raising the question of whether federal or state law should take precedence. Although the FDA has a congressional mandate to approve drugs for use on the US market, most states license pharmacies that dispense these drugs.
GenBioPro, in its lawsuit, argued that West Virginia’s state ban was unconstitutional because it violated the supremacy and commerce clause of the U.S. constitution, which gives the FDA the power to regulate drugs sold across the country.
“Individual state regulation of mifepristone undermines the national common market and conflicts with a strong national interest in ensuring access to a federally approved drug to terminate pregnancy, causing the economic fracture that the Framers intended to prevent the clause,” said GenBioPro attorneys. in a lawsuit.
“The state’s police power does not extend beyond the function of prohibiting articles of interstate commerce — the Constitution leaves that to Congress,” the company’s lawyers wrote.
Anti-abortion activists, on the other hand, are pushing for mifepristone to be pulled from the US market. A coalition of doctors opposed to abortion is asking a federal court in Texas to overturn mifepristone’s more than two-decade-old FDA approval as safe and effective.
A decision in the case could come as early as February.