Eisai Files Petition Against DEA - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Eisai Files Petition Against DEA



Eisai has filed a petition with the US Court of Appeals for the District of Columbia asking the court to direct the Drug Enforcement Agency (DEA) to schedule the company's anti-epilepsy drug.

Fycompa (perampanel), a new chemical entity, approved by FDA in October 2012 as an adjunctive therapy for the treatment of partial onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older. FDA sent its scheduling recommendation for Fycompa to the DEA in January 2013, but the DEA has not yet begun the scheduling process, according to Eisai.

In its petition for a writ of mandamus, Eisai asserted that the DEA has "unreasonably" and "egregiously" delayed the scheduling of Fycompa. The petition also challenges the justification for the delay and highlights the lack of a timetable, predictability, or transparency related to the DEA's scheduling process. In addition, Eisai asserts that the DEA's delay also continues to harm Eisai by preventing it from launching Fycompa in the United States even though Eisai demonstrated to the satisfaction of FDA that the drug is safe and effective when prescribed in accordance with its labeling.

FDA requires that sponsors of drugs that FDA recommends for scheduling wait until the scheduling process is finished before commercially distributing the product.

Source: Eisai

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Click here