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DEA Loses A Round


Control Over Painkiller Approval To Return To FDA

A potentially significant shift in federal pain management and drug control policy occurred in early November 2005. The Washington Post reported Nov. 5, 2005 ( "Drug Enforcement Agency Stripped Of Role On New Painkillers") that "A House-Senate conference committee yesterday dropped a controversial provision that gave the Drug Enforcement Administration authority to review, and potentially block, the sale of all new prescription narcotics. The legislation, promoted by Rep. Frank R. Wolf (R-Va.) and attached to a multi-department appropriations bill, passed last year with little notice. But this year the Food and Drug Administration, many drug makers and doctors who treat pain patients objected to renewing it, and the provision was stripped from the bill. Opponents said the provision was an unwarranted intrusion by a law enforcement agency into the FDA's drug-review system. Pain specialists also said the DEA reviews could jeopardize development of new drugs needed by patients with chronic pain."

According to the Post, "John Scofield, spokesman for the House Appropriations Committee, said the provision was dropped at the request of the Senate, which did not include it in its version of the appropriations bill. The dispute over the measure, and the almost $50 million in additional DEA funding attached to it, reflect a wider debate over the DEA's proper role in monitoring the use of prescription painkillers. The agency has arrested scores of doctors, pharmacists and other health-care workers accused of negligence or willful diversion in dispensing prescription narcotics that were later abused. Pain doctors complained that, as a result, many physicians have stopped prescribing needed painkillers."

Previously ( "DEA Is Opposed On Painkiller Approval") the Post reported that "The provision, included in H.R. 2862, says no new drug containing controlled substances such as morphine, oxycodone and hydrocodone will be allowed on the market unless the DEA has 'reviewed and provided public comments on labeling, promotion, risk management plans, and any other documents' related to the drug. Before the provision was passed last year, the DEA's role with prescription drugs was primarily to decide how much of a controlled drug each company got to make, and then to monitor the use of those drugs on the market. Now, however, the DEA must sign off on any new FDA-approved medications containing controlled substances before they can be sold. In its report on the bill, the House Appropriations Committee expressed concern that 'drugs more powerful than OxyContin will be approved with similar risk management and labeling plans as OxyContin. . . . The Federal government must ensure that new high-risk drugs do not become easily available to illegal drug dealers and abusers.' The new bill gives the DEA $201 million to spend on preventing prescription drug diversion, an increase of more than $47 million from last year."


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