Approving medications, among other items such as foods, additives, medical devices, are the job of the Food and Drug Administration. Classifying of controlled substances that have the potential for abuse or “scheduling” is the responsibility 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 is 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 time-frame for classifying drugs has increased almost fivefold – from 49 to 238 days. One pharmaceutical, Belviq, a weight-loss drug, was classified by DEA 315 days after the FDA gave its blessing..
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.”
The 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.
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