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FDA Commissioner defends decision to approve Zohydro before Congress

FDA Commissioner Dr. Margaret Hamburg
FDA Commissioner Dr. Margaret Hamburg
FDA

FDA Commissioner Dr. Margaret Hamburg is defending her Agency’s decision to approve the powerful new painkiller Zohydro, despite attempts by West Virginia Senator Joe Manchin (D) to introduce a bill to force it from the marketplace.

Zohydro, which contains “up to 5 times more of the narcotic than Vicodin (and similar drugs) is the first single-ingredient hydrocodone drug to ever be cleared for patients in the US.

While Hamburg told members of Congress that “Zohydro fills an important and unique niche for treating chronic pain,” Manchin followed by telling his colleagues on Capital Hill that. “I have tried reasoning with the FDA and I have repeatedly requested that they change course on this drug because of the high potential for misuse and abuse due to its lack of tamper-proof design, and thus poses a dangerous threat to communities across our country.”

Note: The CDC reports that hydrocodone is the “most frequently abused prescription drug in the United States. They also noted that it and other prescription opiates are blamed for 16,660 fatalities in 2010 alone.