The stated aim is to assist FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) in its efforts to deter promotional activities. DDMAC examines promotional pieces submitted to the agency, scans ads and TV commercials informally, and monitors drug company exhibits and programs at medical meetings. An important source of information is all the complaints the division receives are from industry competitors who see another company getting away with off-label promotion or unfair comparisons. It’s impossible for DDMAC to catch everything, and certainly not what’s said in meetings between doctors and sales reps or at sponsored dinner programs.

To kick off the Bad Ad program, which was announced last month, DDMAC staffers will give talks and distribute educational materials to providers at medical conventions and society meetings. A brochure advises doctors on how to recognize misleading promos: omitting risks, overstating effectiveness, promoting off-label uses, or making misleading comparative claims. FDA is making it easy for doctors to squeal about objectionable messages by establishing a special call-in number and email address.

It’s not yet clear if the campaign will generate a lot of finger-pointing—or if it does, how DDMAC will deal reports that are vague and undocumented (anonymous calls are okay). Marketers fear that doctors will file complaints based on misunderstandings and personal prejudices. Supporters of the program anticipate that marketers and sales reps will modify their pitches if they think that their audience is taking a much closer look at what they say. But free-speech advocates like the Washington Legal Foundation fear it will chill open exchange of health information, which can be useful.

The Bad Ad campaign fits FDA’s effort to step up enforcement, as Commissioner Margaret Hamburg promised a year ago. The agency has issued 186 warning letters so far this year, putting it on track to meet last year’s record of 570 enforcement missives, according to BNet Pharma. And more of those are coming from DDMAC, which doubled its warning-letter rate to 41 in 2009, vs. 21 the year before. Many recent letters challenge Internet marketing, an activity that remains on FDA’s radar screen. In April, DDMAC sent a long warning letter to Novartis challenging the company’s use of Web sites to promote unapproved uses and to make unsubstantiated claims for Gleevec. FDA plans to develop guidelines on Internet promotion and use of social media by drug marketers, but it’s proving to be a complicated business.

When 5,742 physicians opt in voting for their favorite medical journal ads over utilizing spare time that never comes, you know it’s a big deal. And yesterday at The Doctor’s Choice awards luncheon sponsored by the Association of Medical Media (AMM), their input was not only showcased on a most refined level but also indicative of what they want pharma marketing to deliver.

It became quite clear to me early in the ceremony that physicians weren’t selecting ads based on how fun and fancy they were, but rather on how they delivered a message straight and to the point. William Castagnoli, director of The Doctor’s Choice awards, echoed my thoughts.

“Doctors are looking for information and they very often are not impressed by what we would think is a bright clever headline or photo,” he said. “There were a lot of ads this year that were atypical.”

Despite a lack of fluorescent colors with flashy themes, most ads did present more text and fewer frills. Dusa’s Clindareach launch ad combined, what I thought, the right mix of amusement and information for doctors. In fact, Topin & Associates, the agency that created the ad, walked away with the most awards – highest scoring specialty ad, the four-page and over, and dermatologicals categories.

“Clearly this is a concept that’s been proven to deliver impact,” said Alan Topin, president and founder of Topin & Associates. “I’m proud of our experienced team that developed this award-winning work,” he added.

Companies close behind taking two awards were Merck, Lilly, Alcon, Pfizer, and Salix.

For the first time in history, Lilly’s four-page Cymbalta ad created by GSW Worldwide won in two product categories: diabetes therapy and neurologicals. Again, we saw tons of text going on in this ad but the clincher here was the patient who tells a story.

Kris McGlosson, vice president creative director for GSW Worldwide said that Cymbalta targets endocrinologists and neurologists because it effectively communicates both diabetes and pain. She also pointed out that the key was casting somebody who could play the role of a diabetic.

“I think doctors in their educational progress are data driven so when you ask their response to communication they say show me the data,” said Dean Tepper, senior vice president group creative director, GSW Worldwide. “They digest communication in an emotional way and if they can become a hero they will respond.”

Click here and here for a full list of winners