FDA to Branded Drugmakers: Play Fair, We’re Watching

Industry advice from the Food and Drug Administration is pushing branded drugmakers to play fair with generic drug developers and dissuade them from gaming its approval system for generics.

Before a generic drug can be sold, the FDA usually requires generic drug makers to negotiate with branded drug companies on how they’ll use the same administrative systems, like databases, to share drug information among manufacturers, doctors, and pharmacies. Scott Gottlieb, head of the FDA, has long accused branded drug companies of dragging out these negotiations, which delay generic drugs from coming to the market.

The agency’s Risk Evaluation and Mitigation ...