Overcoming the DTC Fear Factor

FDA gets on the “Less is More” bandwagon

The “Less is More” approach is gaining traction in health care. Fear is what often causes people to gird themselves with potentially unnecessary health care interventions: fear of getting it wrong, of missing out, of being criticized, of dying. Atul Gwande details the bravery required to challenge the medical status quo in his recent book Being Mortal. Gwande does a great job of debunking the myth of “more care is better care” when it comes to end of life treatment.

Now “Less is More” is being applied to health care communication. The FDA is overcoming the DTC Fear Factor and casting aside unnecessary risk information with the intent to drive superior patient comprehension. The FDA has issued draft guidelines that require less, not more, risk information in the Consumer Brief Summary portion of DTC print ads. PharmaGuy provides a comprehensive (and as always, entertaining) review of the proposed guidelines in his February Newsletter.

But the FDA is not using the editing pen wily-nilly. Knowledge born of research, is taking the edge off of their DTC Fear Factor. Upcoming research includes a study on the risk information presented in television ads. The objective is to see whether listing only the most actionable risks leads to better comprehension than the usual mind-numbing laundry list.

Certainly the FDA has reason to fear getting the level of risk information wrong. As Daniel Carpenter, a Harvard professor who studies the FDA posits in a Health Affairs article, the FDA is driven by it’s “desire to safeguard its reputation for protecting the public’s health.” The FDA’s “Less is More” approach certainly has its critics. Public Citizen criticized the FDA for its proposed August ’14 guidelines on how pharmaceutical companies should present risk information to physicians

This new “Less is More” approach to risk information demonstrates that the FDA is willing to undergo reputational risk to do the right thing for patients by presenting the information in a way patients can understand and act on. There is substantive evidence that links lack of patient understanding with negative health outcomes.”

So what is the likelihood of pharmaceutical review committees embracing the “Less is More” philosophy regarding risk information? Certainly the new review FDA guidelines will help, but as anybody who has sat through a review committee meeting can tell you, there is wide latitude in how FDA guidelines are interpreted. Many opt for the most conservative approach.

My guess is that review committees won’t get over their DTC Fear Factor anytime soon. There is just too much reputational risk. And it is hard to blame them. The media’s knee-jerk reaction is to attribute any misstep to a nefarious motive on the part of Pharma.

Overcoming the DTC Fear Factor will require Marketing Departments to do the hard work of proving that using fewer and simpler words to describe a product or disease state results in better comprehension. Just as the FDA Researchers helped their Reviewers get over the DTC Fear Factor with data, Pharma marketers will need data to bolster the courage of their Review Committees with solid research.

However, conducting research brings along its own “Fear Factor.” What if the language causes consumers to overestimate the efficacy or underplay the risks of the product? So why bother? In the past, trying to boost outcomes by improving communication comprehension was a “nice-to-have,” despite the compelling health literacy case.

But now, the Affordable Care Act makes reimbursement dependent on outcomes and patient experience. So ensuring patient comprehension is critical to the financial viability of Pharma’s direct customers: physicians, hospital systems and health plans. So follow the dollar. Customers care, so pharma marketers should care too.

Complexity is easy in Pharma communication, just go to the label. Eliminating the DTC Fear Factor in Pharma will take hard work. However, in health care, the “Less is More” train has left the station. Time to put fear aside, join the FDA and jump on the “Less is More” bandwagon.