FDA Chief Defends Approval of Controversial Painkiller

The Food and Drug Administration Commissioner Dr. Margaret Hamburg on Thursday defended her agency's decision to approve the much-debated painkiller Zohydro, saying it fills an "important and unique niche" for treating pain, NBC News reported. She dismissed demands that the agency wait for a version of the drug -- which went on the market at the beginning of this month-- that would be harder to abuse, saying there really isn’t a good abuse-proof formulation yet. “I would love if we had abuse-deterrent formulation regulations that were actually effective,” Hamburg told a hearing of the Senate's Health, Education, Labor and Pensions Committee. “It does not do any good to label something as abuse-deterrent if it is not actually abuse-deterrent.” Consumer advocates and law enforcement officials protested when the FDA approved Zohydro last October, noting that the agency’s own advisers had voted overwhelmingly against approval.

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