Generic Abortion Pill Maker Sues FDA to Keep Drug Available.

GenBioPro, the US manufacturer of the generic version of a medication abortion drug, has sued the FDA, alleging that the agency has violated the Constitution’s Due Process Clause and other laws in how it has responded to recent court orders halting the approval of the generic version of the drug, mifepristone. The company is seeking a court order that would require the FDA to go through certain procedural steps laid out under federal law before declaring its mifepristone product unapproved. The Supreme Court is currently considering whether to freeze the court orders that emerged from a separate lawsuit, filed by anti-abortion activists in Texas, that would undo the 2019 approval of the generic version of the drug and reverse other steps the FDA has taken in recent years to make abortion pills easier to obtain.
- Generic abortion pill maker GenBioPro sues FDA over its response to orders halting drug's approval CNN
- Abortion Pill Maker Sues F.D.A. to Protect Drug if a Court Orders It Off the Market The New York Times
- In fight over mifepristone, generic abortion pill maker sues FDA NPR
- Abortion pill maker sues FDA to preserve access POLITICO
- Abortion pill manufacturer sues FDA to keep drug on the market Axios
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