GenBioPro is suing West Virginia, arguing that the FDA is forestalling a ban

Abortion pill maker GenBioPro sued Wednesday to overturn West Virginia’s abortion ban because it restricts access to a drug approved by the Food and Drug Administration.

The lawsuit, filed in federal court in West Virginia’s Southern District, argues that FDA regulations on drugs such as the abortion pill preempt state laws under the US Constitution.

Access to the pill, called mifepristone, has become a major legal battleground following the Supreme Court ruling overturning federal abortion rights last June. A dozen states, including West Virginia, have adopted near-total abortion bans that outright prohibit the use of mifepristone.

The FDA approved mifepristone as a safe and effective method of terminating an early pregnancy more than 20 years ago, despite the agency placing restrictions on how the pill is distributed and administered.

Mifepristone, when combined with misoprostol, is the most common method used to terminate a pregnancy in the United States, accounting for about half of all abortions nationwide in 2020.

The FDA has eased many of its restrictions to expand access to mifepristone. During the Covid-19 pandemic, the agency allowed patients to receive the pill in the mail. Earlier this month, the FDA allowed retail pharmacies to begin dispensing mifepristone for the first time, so long as they become certified to do so.

However, bans like the one 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 in the U.S. market, states generally license the pharmacies that dispense these drugs.

GenBioPro argues in its lawsuit that the West Virginia state ban is unconstitutional because it violates the primacy and trade clauses of the US Constitution, which give the FDA the power to regulate what drugs are sold across the country.

“The individual government regulation of mifepristone destroys the national common market and conflicts with the strong national interest in ensuring access to a government-approved drug to terminate a pregnancy, resulting in the kind of economic disruption that the Framers intended to prevent by the clause,” argued GenBioPro’s attorneys in the lawsuit.

“A state’s policing authority does not extend to the functional prohibition of an article of interstate commerce — the Constitution leaves that to Congress,” the company’s attorneys wrote.

In another case, a North Carolina doctor on Wednesday asked a federal court to overturn state restrictions on mifepristone because they go beyond FDA regulations. In North Carolina, patients must receive the pill in person from a doctor at a certified facility.

“North Carolina’s imposition of restrictions beyond those that the FDA believes to be warranted as part of its regulatory balance, including restrictions that the FDA has specifically rejected, thwarts the objectives of federal law,” the doctor’s attorneys wrote in the complaint.

Anti-abortion activists, on the other hand, are pushing for mifepristone to be completely removed from the US market. A coalition of anti-abortion doctors has asked a Texas federal court to overturn mifepristone’s more than two-decade-old approval as safe and effective.

A decision in this case could be made as early as February.

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