Abortion pill manufacturer GenBioPro on Wednesday sued to overturn West Virginia’s ban on abortion since it restricts access to a medicine approved by the Food and Drug Administration.
The lawsuit, filed in federal court in West Virginia’s southern district, argues that FDA regulations on medications equivalent to the abortion pill preempt state law under the U.S. Structure.
Access to the pill, called mifepristone, has develop into a significant legal battleground within the wake of the Supreme Court ruling that overturned federal abortion rights last June. A dozen states, including West Virginia, have implemented near total abortion bans that principally outlaw using mifepristone.
The FDA approved mifepristone greater than 20 years ago as a protected and effective method to terminate an early pregnancy, though the agency imposed restrictions on how the pill was distributed and administered.
Mifepristone, when used together with misoprostol, is probably the most common solution to end a pregnancy within the U.S., accounting for about half of all abortions nationwide in 2020.
The FDA has eased a lot of its restrictions to expand access to mifepristone. Throughout the Covid-19 pandemic, the agency allowed patients to receive the pill by mail. Earlier this month, the FDA allowed retail pharmacies to start out dishing out mifepristone for the primary time as long as they get certified to achieve this.
But bans equivalent to those in West Virginia conflict with FDA regulations on mifepristone, raising the query of whether federal or state laws take precedence. Although the FDA has a congressional mandate to approve drugs to be used within the U.S. market, the states generally license the pharmacies that dispense those medications.
GenBioPro, in its lawsuit, argues that West Virginia’s state ban is unconstitutional since it violates the supremacy and commerce clauses of the U.S. Structure, which provides the FDA power to manage which drugs are sold in across the country.
“Individual state regulation of mifepristone destroys the national common market and conflict with the strong national interest in ensuring access to a federally approved medication to finish a pregnancy, leading to the form of economic fracturing the Framers intended the Clause to preclude,” GenBioPro’s lawyers argued within the lawsuit.
“A State’s police power doesn’t extend to functionally banning an article of interstate commerce — the Structure leaves that to Congress,” the corporate’s lawyers wrote.
In one other case, a health care provider in North Carolina asked a federal court Wednesday to toss out the state’s restrictions on mifepristone because they transcend the FDA’s rules. North Carolina requires patients to acquire the pill in person from a physician in an authorized facility.
“For North Carolina to impose restrictions that transcend those FDA deemed warranted as a part of its regulatory balancing, including restrictions that FDA specifically rejected, frustrates the objectives of federal law,” the doctor’s lawyers wrote within the criticism.
Anti-abortion activists, alternatively, are pushing to have mifepristone completely pulled from the U.S. market. A coalition of physicians who oppose abortion have asked a federal court in Texas to overturn the FDA’s greater than two-decade-old approval of mifepristone as protected and effective.
A choice in that case could come as soon as February.