Abortion pill manufacturer GenBioPro sues West Virginia, argues FDA rules preempt state ban

Abortion pill maker GenBioPro sued Wednesday to overturn West Virginia’s ban on abortion because 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 the FDA’s rules on drugs like the abortion pill pre-empt state law under the US Constitution.

Access to the pill, called mifepristone, has become a major legal battleground in the wake of a Supreme Court decision last June that overturned federal abortion rights. A dozen states have banned total abortion, including West Virginia, which basically prohibited the use of mifepristone.

The FDA approved mifepristone 20 years ago as a safe and effective way to end early pregnancy, although the agency placed restrictions on the distribution and administration of the pill.

Mifepristone, when used in combination with misoprostol, is the most common method of terminating pregnancy in the US, accounting for nearly half of all abortions nationwide in 2020.

The FDA has relaxed many of its restrictions to increase access to mifepristone. During the COVID-19 pandemic, the agency allowed patients to receive the pill by mail. Earlier this month, the FDA Retail pharmacies allowed to start dispensing Mifepristone until the first time they get certified to do so.

But restrictions like West Virginia’s 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 typically license the pharmacies that dispense those drugs.

GenBioPro has argued in its lawsuit that West Virginia’s state ban is unconstitutional because it violates the US Constitution’s Supremacy and Commerce Clause, which gives the FDA the power to regulate drugs sold nationwide.

GenBioPro’s attorneys argued, “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 for terminating pregnancy, resulting in the framer’s decision.” Economic fracturing happens.” in the trial.

The company’s lawyers wrote, “A state’s police power does not extend to functionally banning an article of interstate commerce—the Constitution leaves this to Congress.”

On the other hand, anti-abortion activists are Is pushing for the complete removal of mifepristone from the US market, A coalition of physicians opposing abortion has asked a federal court in Texas to overturn the FDA’s more than two-decade-old approval of mifepristone as safe and effective.

A decision can come in this matter in February.