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Attorney General Bill Sorrell Urges FDA To Require Abuse Deterrent Formulations Of Generic Prescription Pain Killers

CONTACT: Bessie Weiss, Assistant Attorney General, (802) 652-2092

December 26, 2013

Attorney General Bill Sorrell joined 42 other state and territorial attorneys general in sending a letter today to the U.S. Food and Drug Administration (FDA) urging it to require manufacturers of generic prescription pain relievers to develop tamper-resistant versions of their products. Sorrell was also part of a coalition of attorneys generals that requested the FDA reconsider its recent approval of Zohydro ER, a high dose narcotic painkiller.

Prescription drug abuse has reached epidemic levels in many states and requiring abuse-deterrent pain killing prescription drugs (opioids) is a commonsense improvement that provides yet another important tool in the fight against this epidemic. “Vermont is working hard to combat the problem through the Vermont Prescription Monitoring Program and comprehensive substance abuse treatment like Vermont’s Hub and Spoke initiative,” said Sorrell. “The FDA needs to continue to support the States in their efforts and do what it can to prevent the scourge of prescription drug abuse from worsening.”

In their letters, the attorneys general thanked the FDA for their recent efforts to require abuse-deterrent formulations for branded opioid drugs and urged that the reformulation of Zohydro ER be accomplished as soon as possible if FDA refuses to revoke its approval of the drug. The FDA was also encouraged to go even further by ensuring that generic opioids, like their branded counterparts, have abuse-deterrent properties. The FDA was asked to provide “clear and fair regulatory standards for the incorporation of abuse-deterrent technologies into generic opioids.” The letters can be found here.
Letter 1 and Letter 2.

"With the growing opioid addiction problem, we must take the public health approach and put all possible safeguards in place," said Vermont's Health Commissioner Harry Chen, MD. "We rely on our federal partners at the FDA to require abuse-deterrent formulations and labeling, and tamper-resistant packaging for pain relief products."

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