Does this sound like off-label marketing?

The drugmaker was handed a warning letter by the FDA for talking up Provigil, a pill used to treat excessive sleepiness, such as narcolepsy and shift work sleep disorder, as a salve for run-of-the-mill insomnia and fatigue that can be found in patients with MS, ADHD, Parkinson’s, depression and Chronic Fatigue Syndrome.

The violation was found in a handout that was distributed by a consulting doctor at a presentation to the Maryland health department committee, which was considering the pill for its formulary. The brochure, which somehow omitted the usual risk information, was never submitted to the normally sleepy FDA. Remarkable oversight, isn’t it?

Moreover, the handout implied that Provigil could help prevent trucking accidents due to driver fatigue, even though the drug’s product labeling specifically cautions about driving a vehicle while taking the pill. Wait a second - Provigil can prevent the kind of accident it may cause?

A Cephalon spokeswoman says the handout was never authorized, but the company takes responsibility and is conducting an internal investigation. However, she was unable to say whether Cephalon continues to have a relationship with the doctor, Harry Kerasidis, who didn’t return a call for comment.

If the warning letter isn’t enough of a wake-up call, maybe Frank Baldino, Cephalon’s ceo, should take some of his own medicine.

[tags]Cephalon, Provigil, Sleeping Disorders, Warning Letters[/tags]