GenBioPro sues West Virginia, alleging FDA anticipates state ban

Abortion pill maker GenBioPro filed a lawsuit on 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 for the Southern District of West Virginia, alleges that FDA rules on drugs such as abortion pills take precedence over state law under the US Constitution.

Access to a birth control pill called mifepristone has become a major legal battlefield following a Supreme Court decision that struck down federal abortion rights last June. A dozen states, including West Virginia, have implemented a near total ban on abortion, effectively banning the use of mifepristone.

The FDA approved mifepristone over 20 years ago as a safe and effective method of terminating early pregnancy, although the agency placed restrictions on the distribution and administration of the pills.

Mifepristone in combination with misoprostol is the most common method of abortion in the US, accounting for about half of all abortions in the country in 2020.

The FDA has loosened 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, provided they were certified.

But bans like those in West Virginia go against the FDA’s rules for mifepristone, raising the question of whether federal or state laws take precedence. While the FDA has a congressional mandate to approve drugs for use in the US market, states typically license pharmacies that dispense these drugs.

GenBioPro, in its lawsuit, argues that the West Virginia ban is unconstitutional because it violates the Rule and Commerce clauses of the U.S. constitution, which give the FDA the power to regulate which drugs are sold nationwide.

“Individual government regulation of mifepristone disrupts the overall national market and runs counter to a strong national interest in providing access to a federally approved abortion drug, leading to some of the economic rift that the makers wanted to prevent with this clause,” lawyers at GenBioPro argued. in the trial.

“The power of the state police does not extend to a functional prohibition of interstate commerce – the Constitution leaves this to the discretion of Congress,” the company’s lawyers wrote.

Anti-abortion activists, on the other hand, are pushing for the complete removal of mifepristone from the US market. A coalition of pro-life doctors has petitioned a Texas federal court to overturn the FDA’s approval more than two decades ago for mifepristone as safe and effective.

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

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