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Apr 17 2013

Coburn and Upton Issue Statement on FDA Opioid Drug Application Ruling

(WASHINGTON, D.C.) – U.S. Senator Tom Coburn, M.D. (R-OK), Ranking Member on the Homeland Security and Governmental Affairs Committee, and House Energy and Commerce Committee Chairman Fred Upton (R-MI) issued the following statement regarding the Food and Drug Administration’s ruling to not approve opioid drug applications reliant upon previous approvals which did not require abuse-deterrent properties: 

“We applaud FDA Commissioner Hamburg’s announcement that the FDA will not approve any abbreviated new drug applications that rely upon the approval of original OxyContin which did not have abuse-deterrent properties. With more than 16,000 Americans dying from opioid drug overdoses each year, FDA Commissioner Hamburg’s announcement is a significant step forward in the federal government’s effort to reduce opioid drug abuse and protect consumers.

“For too long, drug abusers have been able to crush or dissolve opioid drug products in order to defeat their time-release mechanisms for snorting or injecting the drugs.  This drug abuse has wreaked a terrible human and economic toll on our country’s patients, families, and health care system. However, the FDA recognized the merits of certain abuse-deterrent formulations and has also stated the Agency can require future generic opioid drugs to also have abuse-deterrent properties.

“It is clear that Commissioner Hamburg and her staff carefully reviewed the available scientific data to make a regulatory decision in the best interest of patients. We believe this decision will help protect patients and consumers while thwarting abuse.  Our hope is that FDA builds upon this decision to promote patient safety and prevent further abuse of opioids.”

Coburn and Upton have been working to keep non-abuse-deterrent prescription drugs from hitting the market:

A copy of Upton’s and Coburn’s December 21, 2012, letter can be found here.

FDA Commissioner Hamburg’s January 8, 2013, response to can be found here. 

A copy of Upton and Coburn’s March 5, 2013, letter can be found here.

FDA Commissioner Hamburg’s April 16, 2013, response can be found here.  

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