Washington, DC – The manufacturer of a generic version of a major abortion pill has taken a significant step in a federal lawsuit that could impact abortion access in the United States. GenBioPro has requested to join a lawsuit concerning the future of mifepristone, a key medication used in abortions. This legal action, initiated by Republican attorneys general from Idaho, Missouri, and Kansas, aims to challenge FDA regulations that have expanded the availability of the pill. These regulations include provisions allowing healthcare providers to prescribe mifepristone through telehealth services.
Medication abortions, which rely on mifepristone, make up more than 60% of all abortion procedures in the US. A substantial number of these abortions were conducted via telehealth last year, offering crucial access to women in states with restrictive abortion laws. Despite widespread public support for abortion rights, the attorneys general involved in the lawsuit are pushing to limit access to this essential medication, according to Skye Perryman, the president and CEO of Democracy Forward. Perryman emphasized the potential threats to both mifepristone availability and the nation’s drug regulation system.
The legal battle over mifepristone has been ongoing and previously reached the US Supreme Court, where it was ultimately sent back to a lower court for further review. Judge Matthew Kacsmaryk of the northern district of Texas, appointed by former President Donald Trump, allowed the lawsuit to proceed. Under the Biden administration, the FDA has defended its current regulations on mifepristone. However, it is anticipated that the FDA may shift its stance under a different administration.
Danco Laboratories, the manufacturer of Mifeprex (the branded version of mifepristone), is already a defendant in the lawsuit. While more than 100 studies have confirmed the safety of mifepristone and misoprostol, another drug used in medication abortions, some states are targeting providers who dispense these medications across state lines. Texas has filed a civil lawsuit against a New York doctor for prescribing abortion pills to a Texas resident, while Louisiana is pursuing criminal charges against the same doctor. New York, which protects abortion providers operating in other states through a shield law, has refused to comply with Louisiana’s extradition request.