
An injunction barring further marketing of the generic drug Repronex, recently approved by the Food and Drug Administration, was issued by a U.S. District Court July 25. Although this is the first time that a court has ruled against an FDA determination of generic equivalence in numerous lawsuits brought by manufacturers of reference brand products, it is not the first time that Sporkin has decided against a federal agency. Sporkin wrote, "the FDA cannot selectively choose to reinterpret the FFDCA (Federal Food Drug and Cosmetic Act) and its own implementing regulations in such an arbitrary manner. 'Same' means 'identical,' just as the agency's own regulation say and an agency must follow its own regulations and not arbitrarily reinterpret those regulations."