The manufacturer of the generic version of a major abortion pill has asked to join a federal lawsuit over the pill’s future, marking a new step forward in litigation that could rewrite US abortion access.
The manufacturer, GenBioPro, filed court papers on Monday to become a defendant in the lawsuit over mifepristone, one of two drugs typically used in a US medication abortion. That lawsuit, which was brought by the Republican attorneys general of Idaho, Missouri and Kansas, seeks to reverse FDA regulations that dramatically expanded access to the pill, such as provisions that permit providers to prescribe it through telehealth.
Medication abortions account for more than 60% of US abortions. Last year, tens of thousands of them were provided through telehealth, including to women living in states with abortion bans, according to #WeCount, a research project by the Society of Family Planning.
“Despite the overwhelming majority of Americans – including constituents of these attorneys general – supporting the legal right to abortion, these politicians remain determined to severely restrict access to a critical drug that women across America depend on,” Skye Perryman, the president and CEO of Democracy Forward, said in a statement. Lawyers from Democracy Forward are serving on GenBioPro’s legal team.
Perryman continued: “Their baseless attacks not only jeopardize the availability of mifepristone, but also threaten the integrity of our nation’s drug regulation system.”
The lawsuit is a continuation of a case that reached the US supreme court last year. It was first brought by an anti-abortion coalition known as the Alliance for Hippocratic Medicine. In a 9-0 ruling, the justices found that the coalition lacked the legal standing to bring the case and sent it back to a lower court.
However, Judge Matthew Kacsmaryk of the northern district of Texas, ruled in January that the attorneys general from Idaho, Missouri and Kansas could continue the case for now. Kacsmaryk, who was appointed by Donald Trump, had in the earlier version of the case issued a court order that would yank mifepristone from the market entirely. That order was frozen by higher courts.
Under Joe Biden, the FDA defended itself against the lawsuit and argued in favor of maintaining the FDA’s current regulation of the drug. Under Trump, however, the FDA is widely expected to drop out of the case.
Danco Laboratories, which manufactures mifepristone under the brand name Mifeprex, is already a defendant in the suit.
More than 100 studies, conducted across decades and dozens of countries, have found that mifepristone and misoprostol, the second drug normally used in US abortions, are safe.
Other states, meanwhile, are taking aim at providers’ ability to dispense abortion pills across state lines. Texas has filed a civil lawsuit against a New York doctor who allegedly prescribed pills to a woman in Texas, while Louisiana is pursuing a criminal case against the same doctor. New York, which has a shield law in place to protect abortion providers who operate in other states, has declined to sign Louisiana’s extradition order.
