March 13, 2014

Manchin Introduces Bill to Ban Zohydro Over FDA Approval

Senator Manchin’s bill would prohibit the FDA from approving similar drugs unless they are formulated to prevent abuse

Washington, D.C. – U.S. Senator Joe Manchin (D-W.Va.) today introduced legislation to withdraw the U.S. Food and Drug Administration’s (FDA) approval of Zohydro ER, a controversial new painkiller.  The FDA approved the powerful and highly addictive opioid drug over the objection of its own Anesthetic and Analgesic Drug Products Advisory Committee, which voted 11-2 against allowing the painkiller to advance in the approval process. Representative Stephen Lynch (D-MA-08) introduced similar legislation in the House, which also prohibits the FDA from approving similar drugs unless they are formulated to prevent abuse.

“I have tried reasoning with the FDA, and I’ve repeatedly requested the agency change its course on this dangerous drug. Their refusal to budge forces me to introduce legislation. Because of this painkiller’s high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country. The prescription drug abuse epidemic has already damaged and destroyed the lives of far too many individuals and families, and hydrocodone is one of the most abused substances out there.  The last thing we need is a drug on the market with ten times the hydrocodone of Vicodin and Lortab, with the capability of killing an individual in just two tablets.  Unless this product is reformulated to prevent abuse, I strongly believe Zohydro will only fuel addiction and death in this nation.  It must be kept off the market for the well-being of our nation, especially our families and our youth.”

To review a copy of the bill, please click here.


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.

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