Enough with the inexplicable delays, lawmakers and health advocates said Tuesday as they discussed a bill that would force the Drug Enforcement Administration (DEA) to schedule new drugs in a predictable, more timely manner.
Currently, the DEA takes an average of 237 days to schedule a controlled drug following FDA approval, up from about 49 days less than 20 years ago, the Epilepsy Foundation's Nathan Fountain testified before a House subcommittee. In the worst delay, the DEA dragged its feet for more than a year in scheduling Eisai Inc.'s epilepsy drug Fycompa (perampanel), depriving the drugmaker of valuable patent and market exclusivity time. (See BioWorld Today, Aug. 13, 2013.)
Besides squelching innovation, DEA delays are needlessly costing lives, Fountain said, especially since the FDA has already determined the drugs are safe and effective and the DEA has yet to change an FDA scheduling recommendation.
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