"Bad Ad" Fad Unclad

In the immortal words of Theodore Roosevelt, “When you are in a hole, stop digging.”

I refer, of course, to the FDA’s embarrassing “Bad Ad” program.  After the initial rollout last year in which 33,000 health-care providers were informed about the program, an aggressive agency media effort, brochures, and medical meeting outreach the initiative has resulted in some skin in the game … one letter … for “Derma Smoothe Body Oil.” 

At best this effort isn’t, um, cost effective.

At worst, it’s compliance through secret commination. Anonymous e-mails from people who may or not be physicians denouncing ads and sales presentations to a FDA star chamber?  Really?  Whatever became of transparency.  What’s next? Anonymous adverse event reporting?

The “Bad Ad” program is a bad idea for so many reasons – not the least of which is that it seeks to deputize people who don’t understand the law.  In the Old West this was more generally referred to as a posse, or worse – a lynch mob.

Secret e-mails are nothing short of electronic lettres de cachet and have no place in official FDA policy. A smart move by the FDA would have been to allow the program to quietly wither away.

Instead, the agency is going on the offensive – making a bad idea even worse by holding it up for broader public scrutiny that will, undoubtedly further embarrass the agency and attract Congressional scrutiny.

Witness this media alert (I am not making this up):

FDA CONSUMER HEALTH INFORMATION – April 28 Webinar: Bad Ads Program

The pharmaceutical industry spends nearly three times as much on advertising to health care professionals as it does on advertising to consumers.

Responsible promotional efforts can give health care professionals valuable information about the latest drug treatments. But not all promotions are accurate and balanced.

Through its Bad Ads Program, the Food and Drug Administration (FDA) asks health care professionals for help in making sure the promotion of prescription drugs is not false or misleading.

Learn how the Bad Ads Program helps protect the public during a 30-minute webinar.

An opportunity to ask questions will follow the presentation.

When:   Thursday, April 28, 12:00 p.m. (ET)

Length: 30 minutes

Where:  To join the webinar, see the instructions at

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm249817.htm

Host: Division of Drug Marketing, Advertising, and Communication within FDA's Center for Drug Evaluation and Research

Featured speaker: Catherine Gray, Pharm.D., of the Division of Drug Marketing, Advertising, and Communication within FDA's Center for Drug Evaluation and Research.

This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.

If you want a more detailed discussion of the “Bad Ad” program’s failure, have a look at the article, “FDA's 'Bad Ad' Program Generates One Warning Letter in First Year” in the current edition of Advertising Age.

Here’s how the article begins, “Nearly a year into the Food and Drug Administration's "Bad Ad" program, only one pharmaceutical company has received a warning letter that stemmed from the initiative and the recipient called it a "joke."

The complete article can be found here.