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FDA Urges Studies on Safer Formulations of Narcotic Painkillers
Date:1/10/2013

ng to the agency.

"Our decision-making will be based on the scientific data that are submitted to us," Throckmorton said. "The FDA intends to take a flexible approach to the evaluation and labeling of these products as the new science evolves."

The FDA is looking for public comments on the draft guidance, and will make its final recommendations later in the year.

"Drug companies are looking at new ways to make it very hard to use a drug [in ways other] than what is intended," said Peter Delany, director of the Center for Behavioral Health Statistics and Quality at the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).

It will take a combined effort from federal and state governments, doctors and other health care professionals to stop the misuse of these drugs, Delany said.

SAMHSA recently released a report that highlights the extent of the prescription-drug-abuse problem state by state. According to that report, some 22 million Americans abused prescription painkillers in 2002.

Pooled data from 2010 and 2011 shows the rates of prescription painkiller abuse for those aged 12 or older ranged from 3.6 percent in Iowa to 6.4 percent in Oregon.

More information

For more on prescription drug abuse, visit the U.S. National Library of Medicine.

SOURCES: Peter Delany, Ph.D., director, Center for Behavioral Health Statistics and Quality, U.S. Substance Abuse and Mental Health Services Administration; Jan. 9, 2013, press conference with Douglas Throckmorton, M.D., deputy director, regulatory programs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


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