GenBioPro Inc., US maker of the generic version of the abortion pill mifepristone, Wednesday filed a lawsuit in a Maryland federal court to ensure continued access to its product. The move comes only a day after the US Supreme Court extended access to the branded version of mifepristone, Mifeprex, while the court reviews a legal battle over a North Texas ruling.
The drug company argued that recent court cases involving Mifeprex “have purported to dramatically alter the landscape” of the Food and Drug Administration’s (FDA) regulation of mifepristone. As a result, GenBioPro filed a lawsuit against the FDA seeking to preserve consumer access to their generic version of mifepristone. Specifically, GenBioPro asked the court to prevent the FDA from revoking their approval “without first following the statutory and regulatory procedures for suspension.”
To support their claims, GenBioPro cited both the US Constitution’s Fifth Amendment and the Federal Food, Drug, and Cosmetic Act (FDCA), which they argued protect GenBioPro’s due process rights. An April 12 ruling from the US Court of Appeals for the Fifth Circuit would stay the FDA approval of GenBioPro’s mifepristone in addition to altering access to Mifeprex. GenBioPro argued the ruling is “unprecedented” since “no court in history has ever ‘stayed’ or ‘suspended’ a longstanding FDA approval.” If the stay were to go into effect, the FDA would have to classify GenBioPro’s generic mifepristone as misbranded, effectively revoking their FDA approval and access to the drug.
The FDA approved GenBioPro’s generic version of mifepristone in 2019, while the FDA approved Mifeprex in 2000. GenBioPro argued that to stay access to one while allowing (but curbing) access to another would be “chaos.” GenBioPro pointed out that FDA approval for both drugs rests on identical scientific bases.
After repeated failed attempts to obtain reassurance over access to the drug from the FDA, GenBioPro said it was forced to file the lawsuit.
On April 7, two federal district courts issued conflicting rulings regarding FDA approval of mifepristone. The US District Court for the Northern District of Texas suspended the FDA approval, while the US District Court for the Eastern District of Washington ruled the drug safe and effective. On April 12, the US Court of Appeals for the Fifth Circuit took up the North Texas court ruling and granted partial access to the drug but imposed new restrictions on its approval. Since then, Supreme Court took up the case for review. Both the Biden administration and Congressional Republicans have weighed in on the issue.
As of now, access to mifepristone is uncertain. The Supreme Court is set to hand down a decision on the case by Friday.