Abortion pill maker seeks to keep challenge to W. Va. abortion ban alive

[May 24, 2023]  By Daniel Wiessner

(Reuters) - Lawyers for abortion pill maker GenBioPro Inc on Tuesday urged a West Virginia federal judge to allow them to proceed with their challenge to the state's near-total abortion ban, claiming it is invalid because it interferes with the federal government's approval of mifepristone.

U.S. District Judge Robert Chambers at a hearing in Huntington, West Virginia at times seemed skeptical of claims by the state's lawyer, Jennifer Scragg Karr, that West Virginia has the power to regulate potentially dangerous drugs beyond what is required by the U.S. Food and Drug Administration.

"That's what the FDA is charged with determining," Chambers said to Karr.

Karr replied that West Virginia's law merely complements FDA regulation and does not conflict with it, and that the state has the power to protect unborn life and maternal health.

GenBioPro in its January lawsuit claims the state's ban on virtually all abortions violates the U.S. Constitution by blocking interstate sales of mifepristone despite its approval more than two decades ago by the FDA.

Mifepristone is part of a two-drug regimen with misoprostol used for medication abortions, which account for more than half of U.S. abortions.

Nevada-based GenBioPro makes the only generic version of mifepristone and currently supplies a majority of the drug used in the U.S. Numerous medical studies have concluded that the drug is safe and effective.

Chambers on Tuesday also seemed leery of the company's claim that it was impossible to reconcile the FDA's goal of ensuring nationwide access to abortion pills with West Virginia's "functional ban" on the drug.

"You're able to sell it to a point but not as much as you'd like," Chambers said to David Frederick, the company's lawyer. Chambers noted that West Virginia's abortion law does not ban mifepristone and allows it to be prescribed in cases involving rape, incest and medical emergencies.

Frederick said the narrow exceptions to the state's abortion ban go far beyond restrictions set by the FDA.

A box containing a Mifepristone tablet is seen at Blue Mountain Clinic in Missoula, Montana, U.S. February 28, 2023. REUTERS/Callaghan O'Hare

Chambers said it would likely be several weeks before he issues a ruling.

The hearing came as anti-abortion groups are challenging mifepristone's approval in a separate case in Texas, with potentially far-reaching consequences for abortion access across the country. A U.S. appeals court last week appeared skeptical of the government's appeal of a federal judge's April ruling in that case essentially suspending the FDA's approval of the drug.

Mifepristone remains available for now, due to an emergency order from the U.S. Supreme Court preserving the status quo during the appeal.

The cases are among several in a heated nationwide legal battle over access to mifepristone that emerged after the Supreme Court last year overturned its landmark Roe v. Wade ruling that had established a constitutional right to have an abortion.

GenBioPro last month filed a separate lawsuit seeking to force the FDA to keep the drug on the market, while Democrat-led states and abortion clinics have filed similar lawsuits against the agency.

In the states' lawsuit, a federal judge in Washington last month blocked the FDA from altering access to mifepristone as the states' lawsuit proceeds, in a ruling that conflicted with the one out of Texas.

The case is GenBioPro Inc v. Sorsaia, U.S. District Court for the Southern District of West Virginia, No. 3:23-cv-00058.

For GenBioPro: David Frederick of Kellogg, Hansen, Todd, Figel & Frederick

For the state: Jennifer Scragg Karr of the Putnam County Prosecuting Attorney's Office

[© 2023 Thomson Reuters. All rights reserved.]This material may not be published, broadcast, rewritten or redistributed.  Thompson Reuters is solely responsible for this content.