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Abortion pill maker GenBioPro on Wednesday sought to overturn West Virginia’s abortion ban because it restricts access to the drug, which has been approved by the Food and Drug Administration.
The lawsuit, filed in federal court in the Southern District of West Virginia, claims that the FDA’s regulations on drugs like the abortion pill preempt state law under the U.S. Constitution.
Access to the pill, called mifepristone, has become a major legal battleground following a Supreme Court ruling that struck down federal abortion rights last June. A dozen states, including West Virginia, have enacted near-total abortion bans that essentially ban the use of mifepristone.
The FDA approved mifepristone more than 20 years ago as a safe and effective method of terminating early pregnancy, although the agency imposed restrictions on the distribution and administration of the pill.
Mifepristone, when used in combination with misoprostol, is the most common way to terminate a pregnancy in the US, accounting for about half of all abortions nationwide in 2020.
The FDA has relaxed many of its restrictions to expand access to mifepristone. During the covid-19 pandemic, the agency allowed patients to receive pills by mail. Earlier this month, the FDA allowed retail pharmacies to start dispensing mifepristone for the first time, as long as they are certified for it.
But bans like those in West Virginia conflict with FDA regulations on mifepristone, raising the question of whether federal or state laws take precedence. Although the FDA has a congressional mandate to approve drugs for use on the U.S. market, states generally license the pharmacies that dispense these drugs.
In its lawsuit, GenBioPro argues that the state ban in West Virginia is unconstitutional because it violates the Supremacy and Commerce Clauses of the U.S. Constitution, which gives the FDA the power to regulate which drugs are sold nationwide.
“Individual state regulation of mifepristone destroys the nation’s common market and runs counter to a strong national interest in providing access to a federally approved abortion drug, resulting in the type of economic disruption the Framers intended the clause to prevent,” GenBioPro attorneys argued . in the lawsuit.
“The state’s police power does not encompass the Article’s functional prohibition of interstate commerce — the Constitution leaves that to Congress,” the company’s lawyers wrote.
Anti-abortion activists are an effort to completely withdraw mifepristone from the US market. A coalition of doctors opposed to abortion has asked a federal court in Texas to overturn a more than two-decade-old FDA approval of mifepristone as safe and effective.
The decision in this case could be made as early as February.
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