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article imageDrug company Eisai sues DEA to expedite drug ‘scheduling’

By W. Mark Dendy     Aug 20, 2013 in Health
Approving medications is just one of the many tasks assigned to the Food and Drug Administration. They also regulate other items such as foods, additives, and medical devices.
Likewise, “scheduling,” defined as the classifying of controlled substances that have the potential for abuse, is just one of the many responsibilities of the Drug Enforcement Agency.
And while most drugs go through years and years of testing and trials before receiving the FDA’s stamp of approval, the DEA can dispense a classification or “schedule” for a drug in a matter of weeks; at least, that’s the way it used to be.
But according to the Aug. 20, Wall Street Journal, a new epilepsy drug, Fycompa, has been waiting a long, long time. The WSJ reports that Eisai Co. Ltd. received FDA approval for Fycompa last October, but is still waiting for DEA to classify the drug that works on the central nervous system.
Eisai has filed a lawsuit to “force the DEA’s hand" on the matter. The pharmaceutical company’s legal counsel told the WSJ that current epilepsy drugs do not effectively treat about “30% of epilepsy patients who suffer the kind of seizures targeted by Fycompa.”
Since the late 1990’s, the DEA’s average timeframe for classifying drugs has increased almost fivefold – from 49 to 238 days. One pharmaceutical, Belviq, a weight-loss drug, was classified by DEA after 315 days.
The Pharmaceutical Research and Manufacturers of America, the industry’s trade group said that such delays “not only negatively impact patient access,” but can also discourage research companies from “pursuing the types of medical innovation that may lead to medicines requiring DEA scheduling.”
There DEA’s lack of expediency leads to one more caveat for drug makers – pharmaceutical companies can enjoy a five year marketing exclusivity period, but that clock starts ticking the day the FDA gives its approval.
More about Epilepsy drug, drug enforcement administration, US Food and Drug Administration
 
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