US FDA against drug makers pursuing gaming tactics to delay generic competition

No patients should be priced out of medicines they need to support their health. As stressed by the President and Secretary Azar last week, one of the Administration’s highest priorities is advancing policies that increase competition as a way to help make drugs more affordable and improve access.

There isn’t one single action that’s going to solve this issue. We will achieve these public health goals through the coordinated effort of different federal agencies working in partnership with industry and other stakeholders. At the FDA, we’re taking steps across a broad range of areas to improve new and generic drug competition as a way to improve access and affordability. Among these efforts, we’re especially focused on addressing tactics we sometimes hear of branded companies pursuing as a way to forestall expected generic entry.



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