FDA CITES CEPHALON FOR OFF-LABEL PROMOTION OF PROVIGIL

The FDA recently warned Cephalon for off-label promotion of its wakefulness-promoting agent Provigil.

The warning letter cites the firm for marketing the product for unapproved indications in a promotional piece disseminated to the Maryland Department of Health and Mental Hygiene's Pharmacy and Therapeutics Committee. The therapeutic areas cited include "various disorders associated with fatigue, sleepiness or inattentiveness," the FDA wrote.

Provigil (modafinil) is indicated "to improve wakefulness in patients with excess sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder," according to physician labeling.

The promotional piece was part of a presentation consultant Harry Kerasidis of Chesapeake Neurology Associates delivered to the committee on behalf of the company Aug. 17, 2006. Cephalon said that the document was independently created by Kerasidis and was not reviewed by the firm or its medical directors.

In concurring with the FDA's assessment of the piece, Cephalon said the presentation was "egregious," and that the company's medical directors were not aware of the content in the presentation.

The agency is requesting a complete, written response to the warning letter by March 12 and is also asking for a comprehensive action plan for the dissemination of accurate promotional materials in the future. Cephalon said it is completing an investigation into the matter and plans to respond to the FDA shortly.

The warning letter can be viewed at www.fda.gov/cder/warn/2007/Provigil-wl.pdf ( http://www.fda.gov/cder/warn/2007/Provigil-wl.pdf ).