US Senate Committee on Health, Education, Labor, & Pensions

McConnell, Coburn, Alexander Push for FDA Accountability on its Approval of Powerful Pure Hydrocodone Product

Wednesday, February 12, 2014Liz Wolgemuth 202-228-4729

WASHINGTON, DC – U.S. Senate Republican Leader Mitch McConnell (R-KY) and Senators Tom Coburn (R-OK) and Lamar Alexander (R-TN) wrote to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg today to hold the agency accountable for decisions it makes that have the potential to negatively affect prescription drug overdose rates, misuse, abuse, and diversion.

In 2010, drug overdose was the leading cause of injury-related death in the United States, largely driven by opioids. The FDA has an important role to play in approving safe and effective prescription drugs, including opiates. The Senators requested information on the recent approval of a powerful extended-release, pure hydrocodone product that has the potential to worsen the drug abuse epidemic. 

In the letter to Commissioner Hamburg, the Senators wrote: “We believe the approval of pure hydrocodone products without methods to prevent abuse, misuse, and diversion, including abuse-deterrent formulations, poses a significant danger to our constituents, as it could worsen the drug abuse epidemic in our country.” They went on to say, “We would like to know what safeguards FDA mandated for the product and we… look forward to hearing about your systematic approach to balancing the risks and benefits associated with access to innovative pain medication and any associated potential abuse, misuse, and diversion.”

The text of the letter is HERE.

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