Letter to Senator Joe Manchin Urging Him to Investigate FDA’s Decision to Approve Dangerous High-Dose Opioid
March 14, 2014
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Public Citizen commended Senator Manchin for his efforts to (a) overturn the reckless decision by the Food and Drug Administration (FDA) to approve the dangerous, high-dose, non-tamper-resistant opioid drug Zohydro ER; and (b) develop legislation that would target such seriously flawed decision-making by the agency. We also urge him to investigate why newly disclosed information about a tamper-resistant, single-drug hydrocodone product that is in the advanced stages of development failed to sway the FDA against approving Zohydro.