Healthy Skepticism Library item: 18217

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: Electronic Source

Edwards J
FDA Caught Napping at the Wheel When It Comes to Sleeping Pill Advertising
BNet 2010 Jun 21
http://industry.bnet.com/pharma/10008663/fda-caught-napping-at-the-wheel-when-it-comes-to-sleeping-pill-advertising/

Full text:

The FDA’s failure to stop a misleading TV ad by Sepracor for its Lunesta sleeping pill underlines everyone’s concerns about underfunding the agency. Everyone?* Yes, both consumer groups and the drug industry’s corporate lobbyists want the FDA’s resources increased. Consumer activists want the agency take police actions faster; the industry wants it to make decisions such as new drug approvals faster.

The FDA’s current lack of speed was writ large in its warning letter to Sepracor over a commercial titled “boxing bed.” In the ad, a woman tosses and turns all night in a bed surrounding by boxing ring ropes. If only she’d taken Lunesta, which keeps you asleep all night, the ad concludes. The FDA wrote that the ad was misleading because it made an unsubstantiated superiority claim over other drugs.

At first, the letter seems to imply that the system is working perfectly. The FDA’s letter is based on a review of a storyboard for the ad – Sepracor appears to have done the right thing by submitting its marketing materials for FDA review at the beginning of the advertising process.

But note the date on the storyboards: Nov. 19, 2009. The ad was on the air for seven months before the FDA put printer ink to paper: Horse, meet unbolted barn door.

The FDA’s budget has increased from $1.86 billion in 2006 to $4 billion for 2011. A lot of that budget comes from fees levied on drug companies. It’s a conflict of interest, of course – the companies are paying for their own regulation – but if the agency cannot stop offenses before or as they’re being committed, then the budget for that conflict may not be enough.

*OK, not everyone: conservatives to the right of Bill O’Reilly believe the FDA should be reduced or abolished.