Drugmakers Combat Misuse of Painkillers

by: Prince, Glover & Hayes Monday, December 21st, 2009

Drugmakers being prodded by federal regulators to curb misuse of potent prescription painkillers on Friday offered proposals for improving consumer and physician education, but bureaucratic barriers have complicated efforts to manage risks associated with the medications.

One key proposal would require that physicians be trained in the use of the painkillers and be certified by the Drug Enforcement Administration. But giving the DEA the power to issue such certification would require legislative action.

The FDA could, in the meantime, institute and voluntary education program for physicians, said Dr. John Jenkins, head of the FDA’s Office of New Drugs. But Jenkins acknowledged that if the requirements are too burdensome, doctors would opt out and their patients would be denied access to the drugs, which though dangerous in certain circumstance, are important tools in pain management.

Jenkins also noted that another proposal, for information guides for consumers, would tax FDA resources by requiring the agency to review separate versions for at least 18 versions of opioid.

Jenkins said the FDA will consider industry proposals and submit its safety guidelines for public comment and review by an advisory committee of experts in the spring.

-McClatchy- Tribune News Services


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