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McConnell Applauds FDA Decision on Generic OxyContin

Press Release

Location: Washington, DC

U.S. Senate Republican Leader Mitch McConnell announced today that FDA Commissioner Dr. Margaret Hamburg personally called him regarding her decision to withdraw for sale the original, crushable version of OxyContin for safety or effectiveness reasons, as McConnell requested. This decision will prevent a crushable generic version of OxyContin from coming to the market without an abuse deterrent formulation. During this conversation, Commissioner Hamburg also shared with Senator McConnell that FDA approved the reformulated, non-crushable OxyContin as abuse-deterrent.

OxyContin is particularly potent and was subject to rampant drug abuse prior to the deployment of abuse-deterrent technologies. These technologies prevent addicts from destroying the time release mechanism of the extended release opiates, designed to treat severe pain, by crushing the pills in order for the user to achieve an immediate heroin-like high.

"Given the public health epidemic of prescription drug abuse and the ravaging effects it has on families all across Kentucky, this announcement is great news and will prevent an influx of crushable generic OxyContin from coming to market," Senator McConnell said. "I applaud FDA Commissioner Hamburg for her decision and I look forward to continuing working with her on the issue on behalf of my constituents in Kentucky."

Earlier this week, Senator McConnell joined Senator Tom Coburn in introducing a resolution expressing the Sense of the Senate that the FDA should not approve a generic opioid product without an abuse deterrent formulation if a comparable and existing drug on the market already has this deterrent for misuse and abuse.

Late last year, Senator McConnell contacted the FDA Commissioner to ask that the agency delay these crushable generic drugs coming to market until a workable solution can be found. He followed up on this request and sought additional clarification again in March. Senator McConnell also met with Health and Human Services' Acting General Counsel, Bill Schultz, to emphasize the seriousness of the prescription drug crisis in Kentucky.

Senator McConnell heard from some of Kentucky's top law enforcement and health care providers about their concerns regarding the influx of crushable generic drugs lacking an abuse deterrent technology including: the Kentucky Primary Care Association, Inc., Appalachian Regional Healthcare, Inc., Norton Healthcare, KentuckyOne Health, the Kentucky Narcotic Officers' Association (KNOA), and Operation UNITE.

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