GenBioPro, the only domestic manufacturer of mifepristone, filed a lawsuit Wednesday against the Food and Drug Administration in an attempt to block the agency from taking the drug off the market.
GenBioPro brought the case against FDA in U.S. District Court in Maryland after orders by a federal court judge in Texas and a Court of Appeals this month required the agency to take generic mifepristone off the market. The company cited court filings in which FDA indicated that, barring a stay by the Supreme Court, it would comply with the rulings by deeming GenBioPro’s mifepristone “misbranded,” which means the drug would have to be removed from the market.
The FDA declined to comment. It already is caught in the middle of competing lawsuits and court orders over abortion pills. A District Court judge in Washington stateThe convenience of medication abortions has made them the preferred choice for many doctors and patients. They now account for more than 50 percent of all abortions in the country.
GenBioPro’s complaint puts a spotlight on the unprecedented nature of the rulings by the Kacsmaryk and 5th Circuit courts.
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