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March 14, 2014

Public Citizen Calls for Congressional Investigation on the Approval of Zohydro, Supercharged Opioid

Newly Disclosed Information Raises Questions About Why the FDA Approved a Needlessly Dangerous Medication When Safer Option Soon Will Be Available

WASHINGTON, D.C. – In a letter to U.S. Sen. Joe Manchin (D-W.Va), Public Citizen today called for a congressional investigation to find out who at the U.S. Food and Drug Administration (FDA) knew about the status of a tamper-resistant hydrocodone product that had already been developed, when they knew it and why that knowledge failed to lead to a decision to reject the dangerous, high-dose, non-tamper-resistant opioid, Zohydro ER.

The FDA approved Zohydro, made by Zogenix, in October 2013 against the advice of its own advisory committee, which voted 11-2 against allowing Zohydro to be sold. It is the first single-ingredient form of this medication ever to be approved and is so powerful that one capsule of the highest dose could kill a child.

News reports on Wednesday disclosed that Purdue Pharma, a manufacturer testing a tamper-resistant form of hydrocodone, got FDA approval to conduct clinical trials that began in 2011 and were completed in the late summer of 2013. This new information shows that officials who were involved in the review and approval of Zohydro should have been aware that another manufacturer’s version of the drug was far advanced in the development pipeline, when the agency decided to approve Zohydro.

Furthermore, the FDA has made statements to the media indicating that that agency was inclined to remove Zohydro from the market once a safer alternative was approved – a clear acknowledgement that non-tamper-resistant Zohydro is less safe than a tamper-resistant form would be. Questions remain as to why the FDA has allowed Zohydro to be marketed when Purdue Pharma has projected that its tamper-resistant product will be approved by mid-2015.

“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.”

On March 10, Manchin sent a letter to U.S. Health and Human Services Secretary Kathleen Sebelius urging her to overturn the FDA’s approval of Zohydro. He reportedly plans to introduce legislation that would push back against the FDA’s approval of this dangerous medication. Public Citizen applauds Manchin’s efforts and urges him to initiate an investigation to find out how much the FDA knew about the new tamper-resistant drug before approving Zohydro.

“Zogenix reportedly began shipping Zohydro to pharmacies last week so the FDA has no time to waste. It is urgent that the FDA withdraws its approval,” said Carome. “The public deserves to know whether the FDA is working to protect the public health or helping to line the pockets of pharmaceutical companies.”

Read the letter.

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