GenBioPro Sues FDA to Keep Generic Mifepristone on the Market

“Once a drug has been through the rigorous FDA review process and received approval, federal law protects the right to market the drug,” said GenBioPro CEO Evan Massingill. “GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers.”

the U.S. Food and Drug Administration on Wednesday, April 19, in Maryland federal court, where the agency is headquartered. The suit seeks an order to compel the FDA to allow GenBioPro to continue to sell the medication in the United States. GenBioPro estimates their generic medication comprises two-thirds of the mifepristone in the United States.in a Texas case that attempt to remove the medication from the market.

GenBioPro argued the company has the right to preserve the drug’s availability under the federal Food, Drug and Cosmetic Act , the FDA’s regulations and the company’s constitutional rights guaranteed by the Fifth Amendment of the United States Constitution.

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