The feds are warning you: No off-label marketing, or else! Coming on the heels of two big settlements related to alleged off-label promos--Eli Lilly's $1.4 billion on Zyprexa marketing and Pfizer's $2.3 billion on Bextra--this warning appears to have teeth.

According to BNet Pharma (which picked up on an op-ed in the Philadelphia Inquirer), the acting U.S. attorney for Pennsylvania's Eastern District is promising consequences for drugmakers that fail to heed the rules against pushing meds for uses not approved by the FDA.

"These cases should send a clear message to the entire pharmaceutical industry: This conduct must stop," wrote Laurie Magid. "Off-label marketing is a sales strategy that ignores the basic purpose of the federal drug-regulatory program, which is to protect the consumer."

Magid lambastes Lilly's "Viva Zyprexa" campaign, and she took Cephalon to task for targeting primary-care docs with the cancer painkiller Actiq. It's not easy to prosecute off-label marketing cases like these, she writes, promising, "But we will keep bringing them until this practice stops."

- read the post [1] at BNet
- check out the Inquirer column [2]

Related Articles:
Did Lilly chief support off-label promos? [3]
Cephalon finalizes $425M off-label settlement [4]
FDA flubs off-label enforcement [5]
Pro/Con on FDA off-label proposal [6]
Should off-label journal promos be OK? [7]