A consumer group says newly disclosed information raises questions about why the FDA approved a powerful painkiller. Public Citizen is calling for a congressional investigation to determine who at the agency knew that a safer alternative had already been developed.
The FDA approved Zohydro against the advice of its own advisory committee last October. According to Public Citizen, new information shows officials involved in the approval of Zydro should have known that a tamper resistant form of the drug was in the pipeline.
"From a public health and clinical standpoint, there was absolutely no need to have non-tamper-resistant Zohydro on the market between now and 2015," said Dr. Michael Carome, Director of Public Citizen's Health Research Group. "the FDA failed miserably in its primary public health mission by approving Zohydro."
The potentially safer pain killer from Purdue Pharma is expected to be on the market next year.
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