FDA Warns Eli Lily on Strattera Ad.

by Pete Quily on June 18, 2005 · 0 comments

The US FDA sent Lily a warning letter over it’s direct to consumer ad “videogame”

The TV ad is false or misleading because it inadequately communicates the indication for Strattera and minimizes the risks associated with Strattera. …This ad is concerning from a public health perspective because by failing to adequately communicate the Attention-Deficit Disorder (ADD) indication for Strattera, it potentially broadens the use of the drug beyond the indicated patient population, while also minimizing the serious risks associated with the drug.

Lily pulled the ad

Lily rep Jennifer Bunselmayer said

We’re complying with the FDA’s request not to air it, but it had run its course for our media buy about a month ago. Right now, we’re just reviewing what’s been sent to us and complying with the FDA request…Lilly stands behind the ad and feels that we appropriately portray the safety information. The ad does not minimize the safety risk.

Anyone seen the ad? If you did, what did you think of it?

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