Healthy Skepticism Library item: 11973

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E.
Cephalon Will Pay $425M For Off-Label Marketing
Pharmalot 2007 Nov 8
http://www.pharmalot.com/2007/11/cephalon-will-pay-425m-for-off-label-marketing/

Full text:

The drugmaker struck a deal with the US Attorney in Philadelphia, and will sign a corporate integrity agreement after agreeing to a misdemeanor violation of the Food, Drug and Cosmetic Act. The probe reportedly focused on whether Cephalon sales reps were improperly marketing its Provigil narcolepsy drug, which docs have prescribed to treat depression and ADHD.

The settlement doesn’t come as a surprise. Cephalon has been under a microscope for off-label marketing for awhile. Last February, the FDA sent the drugmaker a warning letter ordering an end to promotional material for Provigil that included claims that the drug could be used to treat fatigue, which isn’t an approved use.

Two months ago, Cephalon sent letters to docs this week warning that several deaths have been linked to Fentora, a highly addictive narcotic used to treat acute cancer pain. Here’s the catch – Fentora and its predecessor, Actiq, are approved only for use in cancer patients, but are often prescribed off-label for headaches and back pain.

“We have always taken seriously our responsibility to conduct our business in accordance with both the letter and spirit of the law,” Frank Baldino Jr., Cephalon’s ceo and chairman, says in a statement. “Over the past few years, we have devoted substantial resources to continually enhancing our compliance program and have built a strong foundation for our ongoing compliance efforts.”

Really? Cephalon execs themselves must have suffered from narcolepsy – it appears they were asleep on the job.