GenBioPro sues West Virginia, argues FDA prevents ban


Abortion pill maker GenBioPro filed a lawsuit on Wednesday to overturn West Virginia’s abortion ban because it restricted access to a Food and Drug Administration-approved drug.

The lawsuit, filed in federal court in the Southern District of West Virginia, argues that FDA regulations on drugs such as the abortion pill take precedence over state law under the US Constitution.

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Access to the pill, called mifepristone, has become a major legal battleground following the Supreme Court’s decision that struck down federal abortion rights last June. A dozen states, including West Virginia, have implemented near-total abortion bans that essentially outlaw the use of mifepristone.

The FDA approved mifepristone more than 20 years ago as a safe and effective method for terminating early pregnancy, although the agency placed restrictions on how the pill was distributed and administered.

Mifepristone, when used in combination with misoprostol, is the most common way to end a pregnancy in the United States, 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 the pill by mail. Earlier this month, the FDA allowed retail pharmacies to begin dispensing mifepristone for the first time, provided they are certified to do so.

But bans such as 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 in the US market, states generally license pharmacies that dispense these drugs.

GenBioPro, in its lawsuit, argues that the West Virginia state ban is unconstitutional because it violates the Supremacy and Commerce Clauses of the US Constitution, which gives the FDA the power to regulate drugs sold in any the country.

“Individual state regulation of mifepristone destroys the national common market and conflicts with the strong national interest to ensure access to a federally approved drug to terminate a pregnancy, resulting in the kind of economic fracturing that the drafters wanted the clause to prevent,” GenBioPro’s attorneys argued. in the trial.

“A state’s policing power does not extend to functionally prohibiting 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 rules. North Carolina requires patients to obtain the pill in person from a physician at an approved facility.

“For North Carolina, imposing restrictions that go beyond those deemed justified by the FDA as part of its regulatory balancing, including restrictions that the FDA has specifically rejected, defeats the purposes of the federal law,” the doctor’s attorneys wrote in the lawsuit.

Anti-abortion activists, meanwhile, are pushing for mifepristone to be removed from the US market altogether. A coalition of doctors who oppose abortion have asked a Texas federal court to overturn the more than two-decade-old FDA approval of mifepristone as safe and effective.

A decision in this case could come as early as February.


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