Abortion pill maker enters legal battle over FDA rules

The Hill

26-02-2025

The country's only manufacturer of generic abortion medication asked to be a part of the first legal fight over the procedure since President Donald Trump returned to office.
The company, GenBioPro, filed a motion on Tuesday in the United States District Court for the Northern District of Texas, Amarillo Division, asking to be added to the list of defendants in a case seeking to restrict access to the abortion drug mifepristone.
If a judge grants the company its request, it means the company would be allowed to lead the case's defense.
The case, called Missouri et al v. FDA, is a revamped version of a lawsuit filed by anti-abortion groups and doctors in 2023 seeking to block the Food and Drug Administration's (FDA) approval of the abortion medication.
After the Supreme Court decided to uphold access to mifepristone last year, the challenge was revived by conservative attorneys general in Missouri, Kansas and Idaho, directly challenging GenBioPro's approval of its generic version of mifepristone.
Those states want the FDA to ban telehealth prescriptions for mifepristone, ban the drug's use after seven weeks of pregnancy and prevent pharmacies from dispensing the drug.
'We remain concerned about extremists and special interests' attempts to undermine the US Food and Drug Administration's regulatory authority,' said GenBioPro CEO Evan Masingill in a statement.
'All people have a right to access safe, affordable, evidence-based health care, and GenBioPro remains committed to using all legal and regulatory tools to protect mifepristone for millions of patients and providers across the country,' he continued.
'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 Americans depend on,' said Skye Perryman, president and CEO of Democracy Forward which is representing GenBioPro in its case along with lawyers from Arnold & Porter.
'Their baseless attacks not only jeopardize the availability of mifepristone, but also threaten the integrity of our nation's drug regulation system,' Perryman added.
Medication abortions typically require the use of two drugs: mifepristone, which blocks the hormone needed for a pregnancy to continue and misoprostol, which induces contractions in the uterus to empty it.
Most abortions in the U.S. are medication abortions with the method making up 63 percent of all abortions in the country in 2023, according to reproductive health research group The Guttmacher Institute.
The FDA approved BioGenPro's generic form of mifepristone, mifepristone tablets 200 mg, in 2019.