Maker of generic abortion pill sues to keep drug on the market

[April 20, 2023]  By Brendan Pierson

(Reuters) -GenBioPro Inc, maker of the only U.S. generic version of the abortion pill mifepristone, on Wednesday filed a lawsuit seeking to ensure that it can continue selling its pill amid ongoing legal challenges.

The lawsuit, filed in federal court in Baltimore, comes as the U.S. Supreme Court is poised to decide by 11:59 p.m. ET on Friday whether to block a lower court order stemming from a separate lawsuit by anti-abortion activists that would effectively ban GenBioPro's generic.

Privately held, Nevada-based GenBioPro currently supplies a majority of the mifepristone used for medication abortion in the United States. Its only products are mifepristone and misoprostol, which are used together for medication abortion.

The company sued the U.S. Food and Drug Administration to ask the Baltimore court to order the agency to keep the drug on the market.

GenBioPro argues that the FDA cannot simply suspend approval for its drug without a normal process in which it has a chance to be heard, "regardless of external attempts to interfere."

The company said a court order against the FDA was needed because the agency has not provided any assurance it would not take any enforcement action without following the normal process.

"With the specter of criminal prosecution looming, GenBioPro may be obligated to undertake recalls, cancel contracted manufacturing and hold or destroy perishable inventory," the company said.

It added that it was "suffering irreparable financial and reputational harm, severely threatening its core business model and commercial viability."

The FDA, in response to the anti-abortion groups' lawsuit, has said mifepristone is safe and effective, and that its approvals of GenBioPro's generic and Danco Laboratories' earlier brand-name version should stand. It declined to comment on GenBioPro's lawsuit.

Used boxes of Mifepristone pills, the first drug used in a medical abortion, fill a trash at Alamo Women's Clinic in Albuquerque, New Mexico, U.S., January 11, 2023. REUTERS/Evleyn Hockstein

Anti-abortion groups and doctors led by the recently formed organization Alliance for Hippocratic Medicine last year sued the FDA in Amarillo, Texas, seeking to pull mifepristone from the market.

They said the agency failed to consider the drug's safety adequately and that it used an improper legal procedure when it first approved the drug in 2000. The claims have been strongly disputed by the FDA as well as mainstream U.S. medical associations.

U.S. District Judge Matthew Kacsmaryk earlier this month suspended mifepristone's approval in a preliminary order, but the New Orleans-based 5th U.S. Circuit Court of Appeals partly overruled him. The appeals court allowed only Danco's version of the drug to be sold, with significant new restrictions, while the lawsuit proceeds.

That order will take effect on Saturday at midnight if the Supreme Court does not block it. The FDA and Danco have urged the Supreme Court to do so, arguing that the restrictions could halt access to mifepristone for months while Danco works to comply with them.

GenBioPro has also submitted a brief urging the Supreme Court to block the new restrictions.

A spokesperson for lawyers representing the anti-abortion plaintiffs did not immediately comment on GenBioPro's lawsuit.

(Reporting by Brendan Pierson and Susan Heavey; Editing by Alexia Garamfalvi and Bill Berkrot)

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