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FDA will publicly scold drug companies that try to derail generics

Joe Mont | May 17, 2018

The Food and Drug Administration’s latest tactic for driving down prescription drug costs: publicly naming and shaming prescription drug makers that try to block generic equivalents of their products.

FDA Commissioner Scott Gottlieb announced the FDA’s new strategy to encourage generic drugs on Thursday, describing efforts to shine light “on situations where drug makers may be pursuing gaming tactics to delay generic competition.”

The move, he said, is part of a broader strategy of “advancing policies that increase competition to help make drugs more affordable and improve access.” Among these efforts is focusing “on addressing tactics we sometimes hear of branded companies pursuing to forestall expected generic entry.”

Gottlieb described one common scenario for how companies create obstacles for generic developers that involves purchasing samples of their brand drugs.

Generic drug developers need samples of the brand drug to develop their alternative...

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