Hydrocodone Up-scheduling: FDA Faces Philosophical Toss-Up After Advisory Cmte.
Two-thirds of FDA’s Drug Safety and Risk Management Advisory Committee say the combination products have a similar abuse profile as drugs already on Schedule II, but others note there is no guarantee drug abuse will decline with reclassification, which will adversely affect pain patients’ access to the drugs.
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Prescriber training courses to be provided through continuing medical education venues are to be available by March 1, 2013. Changes from the draft are subtle, but indicate FDA’s focus on preventing incorrect use of the high-dosage narcotics and protecting patients.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.