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New restrictions will be placed on prescription of two dozen powerful Schedule II narcotic drugs including OxyContin, methadone and morphine, the New York Times reported Feb. 10.
The new rules could lead to many doctors losing their prescribing rights of extended-release opioids that are addictive and have high potential for overdose and death if misused.
“What we’re talking about is putting in place a program to try to ensure that physicians prescribing these products are properly trained in their safe use, and that only those physicians are prescribing those products,” said John K. Jenkins, director of the drug center at the Food and Drug Administration (FDA). “This is going to be a massive program.”
Jenkins said current FDA regulations have failed to prevent inappropriate prescriptions, overaggressive marketing, and drug misuse that have led to deaths and overdoses. On the other hand, Jenkins noted that the drugs are highly effective in reducing pain. Federal officials will meet with drug makers, consumer advocates and others in March to discuss policy changes.
The announcement may signal a more assertive role in regulating physician prescribing by the FDA, which traditionally has issued warnings but left control over the practice of medicine to state medical boards.
Published
February 2009