At FDA, science rules. Decisions are based on facts. But even facts require interpretation, and that task is done with verve,
excellence, and dedication by the agency's world-class experts. But what about social science? How does the Division of Drug
Marketing, Advertising, and Communications (DDMAC) engage social science to interpret vague concepts such as "fair balance"
and "adequate provision"? The answer is that they know it when they see it—on a case-by-case basis. In common parlance, this
is known as "judgment."
Claude DeBussy said, "Music is between the notes," and this is as true for new drug applications as it is for communications
oversight. But the same techniques used to judge clinical trials cannot be applied to communications. Current DTC policy is
not based on a scientific analysis of the consumers it targets. This raises a crucial question—where are the social science
metrics, indeed the rules, driving the expert review of pharmaceutical advertising to consumers?
That was the key question posed by FDA in its February 2004 draft guidance on the brief summary—summed up by Commissioner
Mark McClellan who said that, when it comes to the brief summary, less risk information may, indeed, be more. But that conditional
"may" is crucial. And that's a question, as FDA is fond of saying, that requires comment. But the kind of comment required
is scientifically defensible research into how consumers best understand and retain risk/benefit information.
Consider the Facts
In FDA's 1999 study, 56 percent of the people who saw a DTC print ad said they read the brief summary "not at all" or "a little."
In 2002, that number jumped to 73 percent (a 30 percent increase). During that same three-year span, those saying they read
"almost all" or "all" fell from 26 percent to 16 percent—a substantial decline.
How much of the summary do you read?
In the wake of this public health disconnect (and in my role as FDA's associate commissioner for external relations), I toured
the country speaking with advocacy groups, physicians, consumers, pharmas, and communications professionals about how DTC
advertising could be made better. And by "better" I meant in ways that actually advance the public health. Specifically, how
could marketers more clearly and meaningfully communicate the risk/ benefit equation of advertised drugs?
What I heard time and again was that FDA needed a solid benchmark study to serve as a foundation for the agency's final policy
decision—a social-scientific protocol, a quantitative research project composed of structured, closed-ended questions and
a sample size representative of the US population with regard to geography, race, gender, age, and the treatment/disease of
interest. A study armed with questions that would provide insight into the most effective ways to communicate risks so they
are understood by the reader. A study that would provide a social science-based regulatory framework, potential templates,
and metrics, and, most important, one that would add predictability to the DDMAC review process.
Although face-to-face discussions and conferences held by thoughtful third parties such as Parade magazine and Good Housekeeping focused on forward-thinking ways to make the regulatory system better, the "official" comments submitted to FDA detailed
what the agency didn't know and, in several instances, argued for preservation of the status quo. But the status quo isn't
a viable option because, as FDA's own research shows, the current brief summary requirement is a poor public health tool.
That being the case, can it really be a good business tool? "In compliance" and "user friendly" should not be mutually exclusive—a
lesson learned earlier and practiced more energetically by the public relations side of healthcare communications.