FDA Launches Online DTC Primer for Consumers

Consumers pondering whether a drug ad they came across in the latest issue of their favorite magazine crosses any legal or regulatory boundaries now have somewhere to turn for answers. Last week, FDA unveiled a new Web site dedicated to educating consumers about appropriate consumer advertising.

“Be Smart About Prescription Drug Advertising: A Guide for Consumers” offers side-by-side comparisons of different types of DTC ads, frequently asked questions, and definitions of terminology used in consumer marketing. The agency was approached by online marketing troupe EthicAd in 2001 to help build the site, but it took a green light from Center for Drug Evaluation and Research Director Janet Woodcock, and a half decade of designing and planning, to get the site up and running. 

“It’s one of these hybrid sites because parts of it are geared toward consumers, and parts of it are geared toward industry,” said Nancy Ostrove, senior advisor for risk communications, FDA. “We tried to get it at a level that reasonably educated consumers could understand.”

The site contains fake examples of correct and incorrect ads to demonstrate the kinds of ads that are permissible and those that are not permissible in prescription drug advertising. Another page lists questions patients should ask themselves if they see a drug ad that might have a medication of interest to them.

Ostrove said that one thing the Web site would not be is a place to lambaste pharma companies that have been caught with inappropriate ads. “We are not trying to punish industry,” she told Pharm Exec on Monday. “The purpose is to educate public, so that when someone looks at an ad, they can tell the difference between whether it is a reminder ad versus an ad that tells you what a product does, or whether it is a health information ad.”

FDA intends to expand the site to include examples of broadcast ads, as well as more interactive features such as quizzes and surveys. “There is more that can be done,” Ostrove said. “There are a lot of straits to be navigated because everything we put up must be 508 compliant, such as Flash video-that’s problematic.”

Ostrove made it clear that this site has nothing to do with the risk/distraction study being done using mock ads to gather information about how people view ads and risk/benefit information. That study will also use fake advertising to reach the end goal, but it will be more of a fact-finding mission rather than an educational program.

The big question, however, is whether or not the regular consumer really needs a Web site like this or whether it will give DTC opponents another thing to complain about.

“The site was created as an answer to customer complaints for more DTC information,” Ostrove said. “There are going to be people out there that think DTC advertising is bad, and that we should ban it. But the people we are trying to reach are those that are confused about what they are seeing and are willing to look for the information that will get them out of that area of confusion.”