Abortion pill maker GenBioPro is suing West Virginia, alleging FDA rules ahead of state ban


Abortion pill maker GenBioPro filed a lawsuit Wednesday to overturn West Virginia’s ban on abortion, alleging it restricts access to a drug approved by the Food and Drug Administration.

The lawsuit, filed in federal court in the Southern District of West Virginia, argues that FDA regulations on drugs such as the abortion pill pre-empt state law under the U.S. Constitution.

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

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The FDA approved mifepristone more than 20 years ago as a safe and effective method of terminating an early pregnancy, even though 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 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 the pill by mail. Earlier this month, the FDA allowed pharmacies to dispense mifepristone for the first time, as long as they are certified to do so.

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But bans like those in West Virginia violate 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, the states generally give permission to the pharmacies that dispense these drugs.

GenBioPro argues in its lawsuit that West Virginia’s state ban is unconstitutional because it violates the supremacy and trade clauses of the U.S. Constitution, which gives the FDA the authority to regulate which drugs are sold nationwide.

“Individual state regulation of mifepristone destroys the national common market and conflicts with the strong national interest in ensuring access to a federally approved drug to terminate a pregnancy, resulting in the kind of economic rupture the Framers wanted with the clause prevent,” argued GenBioPro’s lawyers. in the lawsuit.

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“A state’s police force does not extend to functionally prohibiting an article of interstate commerce — the Constitution leaves that to Congress,” the company’s lawyers wrote.

In contrast, anti-abortion activists are pushing for mifepristone to be completely withdrawn from the US market. A coalition of anti-abortion doctors has asked a Texas federal court to overturn the more than two-decade-old FDA approval of mifepristone as safe and effective.

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



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