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Friday, December 27, 2013

Attorneys General Urging FDA Mandate Drug Abuse-Deterrent Features

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The prescription drug epidemic in the United States has been exacerbated by drug companies who fail to create products with abuse deterrents because of the costs associated with doing so. While a number of brand-name prescription opioid painkillers makers have incorporated abuse-deterrent features, there is a concern that companies who produce generics will not.

The U.S. Food and Drug Administration (FDA) is being urged by Attorneys General from 42 U.S. states and territories to mandate prescription drug makers producing generic opioids to incorporate abuse-deterrent features. The attorneys general said they are concerned about generic versions of opioids lacking abuse-deterrent features because of the cost, the Lexington Herald-Leader reports.

The Attorneys General wrote a letter to FDA Commissioner Margaret Hamburg, where they said, we “respectfully request that the FDA provide clear and fair regulatory standards for the incorporation of abuse-deterrent technologies into generic opioids.”

“Requiring abuse-deterrent formulations for generic opioids is a common sense improvement that provides us another important tool to help fight this epidemic,” Kentucky Attorney General Jack Conway said in a news release.

What’s more, the Attorneys General from 28 states would like the FDA to reassess its decision to approve a pure form of the painkiller hydrocodone - Zohydro ER (extended release). They said in a letter to Commissioner Hamburg, the attorneys general believe the approval of Zohydro ER “has the potential to exacerbate our nation’s prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly five to ten times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties.”
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