AGs send FDA second letter over opioid containers

By Bryan Cohen | Dec 30, 2013


COLUMBUS, Ohio (Legal Newsline) – Ohio Attorney General Mike DeWine urged the U.S. Food and Drug Administration on Dec. 16 to require manufacturers of generic prescription pain relievers to develop tamper-resistant versions of the medications.

DeWine joined 41 other state and territorial attorneys general, including West Virginia's Patrick Morrisey, in sending the FDA a second letter requesting the change. Forty-eight attorneys general sent a similar letter to the FDA in March.

“Adding new physical and chemical features to prescription opioids can deter abuse and reduce misuse and accidental death,” DeWine said. “By making the generic versions of prescription pain pills harder to abuse, we can prevent addiction and save lives.”

The attorneys general praised the FDA for recent efforts to require abuse-deterrent formulations for brand name opioid drugs. The letter urged the FDA to ensure that generic opioids contain the same abuse-deterrent properties.

According to the FDA, abuse-deterrent formulations of drugs target the anticipated routes of abuse, such as crushing or dissolving, for the specific substance in the formulation. The letter requested that the FDA allow for the incorporation of the deterrent formulations into generic opioids.

The attorneys general signing the letter included representatives from Wisconsin, Washington, Vermont, Utah, Texas, South Dakota, South Carolina, Rhode Island, Pennsylvania, Oregon, North Dakota, North Carolina, New Mexico, New Jersey, New Hampshire, Nevada, Nebraska, Montana, Missouri, Mississippi, Minnesota, Michigan, Massachusetts, Maryland, Maine, Louisiana, Kentucky, Iowa, Indiana, Illinois, Idaho, Hawaii, Guam, Georgia, Florida, Delaware, Colorado, Arkansas, Arizona and Alabama.

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