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W.Va. AG, others seek tamper-resistant generic opioids

By John O'Brien | Mar 12, 2013

WASHINGTON - West Virginia Attorney General Patrick Morrisey has joined 47 colleagues in a letter sent to the U.S. Food and Drug Administration over prescription drug abuse.

The letter, sent March 11, asks the FDA to ensure that generic manufacturers of opioid prescription drugs use tamper-resistant and abuse-resistant formulations. The lead authors are Luther Strange of Alabama, Pam Bondi of Florida, Jack Conway of Kentucky and Roy Cooper of North Carolina.

"(T)he development of tamper-resistant drugs provides an opportunity," says the letter, which was sent to Commissioner of Food and Drugs Margaret A. Hamburg.

"Adding new physical and chemical features to prescription opioids to deter abuse could reduce misuse of these drugs and the sometimes early consequences."

The attorneys general say they are concerned with the possibility that generic versions of extended-release opioid prescription drugs and other non-tamper-resistant products may soon reach the market.

They also applaud the FDA for proposing guidelines to establish clear standards for manufacturers who develop and market tamper- and abuse-resistant opioid products and consider incentives for companies that undertake the research and development necessary to bring those products to market.

Morrisey noted that research from the Centers for Disease Control shows West Virginia had one of the highest rates of drug overdose in 2008 in the nation - more than 25 deaths per 100,000 people.

"That is a very sad and scary statistic that is made all the worse when you think of the families and lives forever changed by this plague," Morrisey said.

"We joined in with other states and territories in the hope that if pharmaceutical manufacturers can make all prescription opioid-based pain relievers tamper-resistant and abuse-resistant, it will help to address one part of the prescription drug abuse problem."

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