Generic abortion pill maker sues FDA to keep drug on market

GenBioPro seeks to ensure pill sales can continue amid legal challenges
FDA: Mifepristone is safe; approval of the generic version should stand
The company currently supplies a majority of mifepristone in the U.S.

Updated: Apr 20, 2023 / 11:40 AM CDT

(NewsNation) — The maker of the only U.S. generic version of the abortion pill mifepristone has filed a lawsuit seeking to ensure that it can continue selling its pill amid ongoing legal challenges.

The lawsuit, filed Wednesday by GenBioPro Inc, comes as the Supreme Court decided to extend a stay that prohibits restrictions on the abortion drug mifepristone from going into effect. The stay will now be extended through Friday.

It’s a move that comes after a legal battle in Texas, as abortion opponents sought to remove FDA approval for mifepristone, the most common drug used in medication abortions in the U.S. A federal judge ruled to remove FDA approval of the drug, but a federal appeals court reversed the decision, with restrictions on using mifepristone.

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

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

In response to the lawsuit, the FDA 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.

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.

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.

Reuters contributed to this story.