“Eisai Inc. Sues DEA”
DEA Chronicles 08/21/13 By Larry P. Cote
On Monday, Japanese drug maker Eisai Inc. filed a lawsuit against the DEA in the District of Columbia Court of Appeals. Their complaint? Eisai created a drug, called Fycompa, that the FDA approved last October to treat epileptic seizures. Due to FDA’s scheduling recommendation and the drug’s effect on the central nervous system, the DEA needs to classify Fycompa as a controlled substance before it can be made available to patients in need. Eisai has been waiting seven months for the DEA to initiate the scheduling process. Eisai criticized the scheduling delay, calling it “unreasonable and egregious,” and petitioned the court to order DEA to promptly schedule the epilepsy drug so that it can be made available to patients. Read the story on the Wall Street Journal (subscription required).