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Feature Story

Pain politics

FDA's Hamburg defends Zohydro approval, integrity of science-based regulation

By Steve Usdin
Washington Editor

FDA's approval of Zohydro ER hydrocodone bitartrate from Zogenix Inc. has reignited debates about the best ways to balance the needs of pain patients and concerns about opioid drug addiction, abuse and overdoses. Calls from powerful politicians to reverse FDA's decision to approve Zohydro have also revived concerns about the politicization of drug oversight.

The voices of pain patients have been drowned out by Zohydro's critics, in part because critics of FDA's approval have made extraordinary claims about the drug's potency and abuse potential.

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