Testimony presented by Peter J. Pitts NEW

Director, Center for Medicines in the Public Interest
Senior Fellow, Pacific Research Institute
November 2, 2005

Winston Churchill said that Americans always strive do the right thing – after they have tried everything else. Today we have the opportunity to devise a system – we must design a system -- wherein DTC advertising is designed in equal parts as savvy marketing strategy and powerful public health tool – because these are not mutually exclusive concepts.We must learn from our mistakes. While industry’s errors have been, in many instances, sins of commission, mistakes literally aired in public, so too has the FDA erred, mostly through sins of omission. Specifically, using personal judgment rather than social science to decide what “in compliance” means. This lack of predictability has lead to an absence of direction and an abdication of leadership. And the result is advertising that isn’t as potent a public health tool as it otherwise might be. With that as my point of departure, let me ask a question: what do we want pharmaceutical direct-to-consumer advertising to be when it grows up?

A recent consumer survey in Europe asked people in Great Britain, the Czech Republic, France, Germany, Italy, the Netherlands, Spain and Sweden what reforms would most likely increase their quality of care. In every nation, by a large margin, the answer was “giving patients more information about their illness.” Here at home 96.7 million consumers go on-line and 65% of them seek information about their health.

Health care information is the consumer’s Rosetta Stone, and public policy institutes, pharmaceutical firms, communications professionals, health care providers, disease organizations, patient advocates, and academics along with the FDA must be allied and aligned conduits.

That being said, how can the FDA help calibrate the proper balance without overstepping its regulatory authority? Is the answer to ramp up the volume of NOVs? I don’t think so. More letters do not result in better, more public health driven communications. Industry, by and large, strives to be in compliance. But when the rules are vague and fluid and an ad or a promotional brochure that is okayed by DDMAC one day can be ruled out of compliance the next sends ominous signals to both industry and consumers alike. And it’s like red meat for some members of Congress.

We need better DTC advertising – and the way to get there is to apply sound social science to better communicating medical science. Claude DeBussy said that, “Music is between the notes,” and this is as true for NDAs 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 target subject – the consumer. And this raises a crucial question -- where are the social science metrics driving the expert review of pharmaceutical advertising?

Specifically, how could marketers more clearly and meaningfully communicate the risk/benefit equation of advertised drugs by following more useful directions from the Food and Drug Administration?

FDA needs a solid benchmark study to serve as a foundation for the agency’s regulatory oversight of direct-to-consumer advertising; a social-scientific protocol, a quantitative research project composed of structured, closed-ended questions and a sample size representative of the U.S. 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 in ways that are understood by the average consumer. A study that would provide a social science-based regulatory framework, potential templates, metrics and, most importantly, add predictability to the DDMAC review process.

I do not believe that the status quo is a viable option because, as FDA’s own research shows, the current brief summary requirement is a poor public health tool. “In compliance” and “user-friendly” should not be mutually exclusive. In our post-Vioxx world we can no longer afford to allow risk information to remain hidden in plain view. As far as the public health is concerned, it is not “adequate provision.”

The status quo is a nonstarter because it is antithetical to public health. If “an educated consumer is our best customer,” then industry needs an evidencebased regulatory framework that provides predictable standards for their communications efforts with consumers. Perhaps it’s time for a standing advisory committee on health care communications. FDA cannot continue to regulate vague concepts such as fair balance and adequate provision on a caseby- case basis. Instead, the FDA, with input from the pharmaceutical industry, consumers, communications professionals, and academia, must develop an evidence-based, predictable framework for DTC marketing. . And there must be options, because the same rules cannot equally apply to an allergy medicine on the one hand and an anti-depressant on the other. FDA must take the next steps required to put the “science” back in social science. To paraphrase Jerry McGuire, “Show me the metrics.”

Thank you. 
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