The FDA recently published their draft guidance for DTC advertising. The document, titled “Presenting Risk Information on Prescription Drug and Medical Device Promotion,” proposes that marketers use a reasonable consumer standard, similar to the FTC standard, to determine whether ads are misleading.

It’s all about the net impression.
In essence, the FDA asks that manufacturers not focus only on individual claims or presentations, but rather on the promotion as a whole. According to the FDA, “the ‘net impression’ of the product after viewing the promotion should not convey a deceptive net impression of the product that could be misleading, even if specific individual claims or presentations are not misleading.”

Is it me or is this a bit vague? What defines misleading? That a product demonstrates value to a potential consumer? That it could solve a problem or unmet need? Should it instead communicate to the consumer that you could take it or leave it? Why then, would we advertise?

What did you say?
The FDA implies that manufacturers try to throw too much at consumers and cite that cognitive research demonstrates that all people, regardless of expertise, are only able to think through and process a limited amount of information at a time.

Cognitive overload — okay I get it, but guys, this isn’t going away. There’s a young generation of multi-taskers (or “multi-slackers” as I like to call them) that are gearing up to conquer the world. They’re not worried about cognitive overload, they want more. They watch TV, blog, chat on the Internet and listen to their iPods all at the same time. Let’s not over-generalize or underestimate people’s abilities to filter information appropriately — the human brain is a remarkable thing.

Volume equality?
The FDA goes on to say that risk information should be presented next to benefits and not just in one place. Additionally, that the volume of risk communicated should be similar to the volume of benefits. Yikes, does that mean that in a 60-second TV commercial, the risk information should take up 30-seconds?

Don’t get me wrong. I support and applaud the need for unbiased, non-misleading information, for transparency and the inclusion of material facts that could influence the decision-making process, to ensure the protection of the consumer from fraud and deception. It is, indeed, a rough world out there.

But what are the possible consequences of over-regulation of the drug industry by the FDA? They are going so far as to art direct — how much white space, how to layout the pages. When will it end? The fact remains that the physician is still the gatekeeper. DTC promotion helps inform the public, but the healthcare professional is responsible for weighing the options and ensuring informed decisions, not the drug makers.

If you are interested in commenting on the FDA’s proposed DTC guidelines, the deadline is August 25, 2009. For more information on submitting comments, click here.