You've seen the drug ad spoofs: Those fake TV commercials that show patients skipping through the tulips, grinning crazily, while a voice-over lists frightening side effects at rapid fire. Well, the FDA apparently watches Saturday Night Live and YouTube, too. And the agency wants those parodies to be instantly outdated.
FDA is now advising drugmakers to avoid trying to distract viewers from side effects, either via images or sound effects. And the agency says drugmakers should make sure to use similar voice-over and type styles for a product's risks as they do for its benefits. Quick scene changes, auctioneer-style side-effects discussion, et al, aren't kosher, the draft guidelines state. So when agency reviewers look at DTC ads, they'll consider the "net impression" of a promo piece. And even if the sum of the parts add up, regulation-wise, the total may not.
The guidelines also take a sidelong swipe at online promotions. The rules apply regardless of medium, the agency states. (Exact wording: "The principles set forth below apply to all promotional pieces, regardless of the medium used or the target audience.") That blanket reference isn't likely to satisfy the folks advocating for clear-and-precise guidance on social media, search ads, and other forms of internet marketing. But at least they got a mention.
- read the Reuters story
- check out the draft guidance from FDA (.pdf)