March 13, 2014

Manchin Confronts FDA Approval of Zohydro and Pay-to-Play Scheme with FDA Commissioner Hamburg Prior to Committee Hearing

Washington, D.C. – Today, U.S. Senator Joe Manchin (D-W.Va.), after months of receiving insufficient answers from the Federal Drug Administration (FDA), attended the Senate Health Education Labor and Pensions (HELP) Committee hearing, of which he is not a member, to meet FDA Commissioner Margaret Hamburg and discuss his serious concerns over the FDA’s approval of the powerful and highly addictive opioid drug, Zohydro Extended Release (ER), and the unsettling pay-to-play allegations surrounding FDA conferences.

“I am pleased that Commissioner Hamburg personally guaranteed that she would respond to our letters and further discuss with me the deeply troubling pay-to-play allegations and the FDA’s approval of Zohydro over its own advisory panel’s recommendations,” said Senator Manchin. “Americans are abusing, and many cases dying, at an alarming rate from highly addictive pain medicine, and it is shameful that the FDA would ignore its own experts to approve this drug. Zohydro is ten times more addictive than any hydrocodone painkiller, and lacks any abuse-deterrent features. It cannot be released to the market, and I am concerned it was approved for all the wrong reasons. Americans and West Virginias need to have confidence that their government is acting in their best interests and not allowing special interests to buy a seat at the table to push their own financial agenda. The pay-to-pay allegations call into question whom the FDA is working for and the American people deserve to know the truth.”


Senator Manchin sent several letters to FDA Commissioner Margaret Hamburg, as well as to the U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, expressing concerns about the FDA’s authorization process of highly addictive drugs, including the approval of Zohydro. He strongly believes that the FDA should not compromise patient safety for financial gain.

Below are the links to Senator Manchin’s previous letters:

March 10, 2014 Letter to HHS Secretary Sebelius

March 10, 2014 Letter to Request Investigation into Pay-to-Play Allegations

February 26, 2014 Letter to Request Answers to FDA Involvement in Latest Pay-to-Play Allegations and Zohydro Approval

December 6, 2013 Letter to Express Concern On FDA Approval of Zohydro Despite Advisory Board Opposition
October 9, 2013 Letter to Call for Full Investigation of FDA & Personnel After Reports of ‘Pay To Play’ Between Pain Medicine Companies and Agency