Eisai Loses Lawsuit Against DEA Over Scheduling Epilepsy Pill

In a setback to Eisai that also raises questions for the pharmaceutical industry, a federal appeals court has dismissed a lawsuit the drugmaker filed against the US Drug Enforcement Agency for failing to schedule its Fycompa epilepsy pill as a controlled substance. Eisai charged the DEA with “unreasonably” and “egregiously” delaying what “historically, has been a straightforward, relatively simple task.” As we noted at the time the lawsuit was filed last August, the pill was approved by the FDA a year ago and a scheduling recommendation was sent in January. The delay meant not only lost sales, but Eisai also maintained that there is an unmet medical need for patients who suffer partial onset seizures. Fycompa was approved for those 12 years and older. And as written previously, Eisai argued in its lawsuit that the DEA scheduling process not only lacks transparency, but is taking longer than ever before. The scheduling process for new chemical entities, or NCEs, has jumped to an average of 237 days between 2009 and 2013, compared with 49 days between 1997 and 1999, according to data the drugmaker filed in its petition to the court. The protracted scheduling is “part of a trend of ever-worsening DEA delay in scheduling NCEs, which harms patients and pharmaceutical companies, which effectively reduces the incentives for companies to invest the considerable resources necessary to develop new medicines that are likely to be scheduled as controlled substances,” the ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs