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Lou Morris is president of Louis A. Morris & Associates, which specializes in regulatory research and consulting. Morris spent 23 years at FDA and is currently a member of FDA?s Drug Safety and Risk Management Advisory Committee. He can be reached at email@example.com or (631) 385-1172.
Arguments over DTC have become more sophisticated, and there is much more middle ground.
Sitting at fda's hearings on DTC promotion, one question kept resounding in my head: What's the problem? The more I heard critics and proponents discuss proposed solutions, the more uncertain I became of what the problem actually is.
Researchers suggested that DTC broadcast ads lacked fair balance: They contain fewer risk words, while distracting messages of benefit compete for viewers' attention. Although true, it is not clear that the intent of the fair-balance requirement is to have equal risk and benefit messages. Fair balance is intended to ensure truthful ads, by requiring companies to disclose material facts regarding a drug's risks. FDA has never expressed any other rationale for the fair-balance requirement in DTC ads.
Research doesn't support the idea that risks and benefits should be fully communicated in broadcast ads. And expecting patients to become experts simply by viewing a commercial doesn't make a lot of sense. I don't advocate standardized warning messages. But I am in favor of giving people tools to use drugs safely. DTC should generate interest, not attempt to fully educate patients.
At the hearings, people cited many of the same benefits and criticisms of DTC that we heard over a decade ago. But these arguments have become more sophisticated, supported by various studies, and there is much more middle ground in the debate. Even some of the fiercest opponents seek a moratorium rather than a ban, while some of the strongest proponents see risks and limitations.
During the past decade there have been a number of research studies—not just periodic surveys, but real experiments—that provide insights into how variations of DTC promotion influence consumers. Yet, at the hearings, there was no scholarly summary of the research presented. Opponents and proponents cited the same studies to support their conclusions. An independent review would have been useful.
The most profound effect of DTC isn't consumers' knowledge about a single drug. Rather, it's what they think about medicines in general. This type of cultural impact—the trivialization of medicines— has led to battered confidence in the safety of drugs and the institution that regulates them. What role did DTC have in the process? And further, what changes in DTC could restore confidence?
Among opponents at the hearings were those who believed that DTC raised the cost of drugs. Some managed care representatives produced studies suggesting that DTC led to the violation of guidelines regarding the use of medicines. There were also poignant stories from individuals whose loved ones were victims of suicides, which they believed were caused from taking certain medicines.
The most convincing supporter of DTC was a representative from Pfizer, who presented ways in which the company is improving risk and benefit information, especially to low literacy patients.
At the end, we heard a number of suggestions about how to improve DTC. The recently issued PhRMA Guidelines were among the solutions offered. The guidelines are intended to improve the image of pharma companies and diminish some practices that have been the subject of controversy, such as ED drug ads in prime time and reminder ads that confuse people. PhRMA hopes to instill more confidence in the industry by having all ads previewed by FDA.
Other solutions were suggested. The American Society of Health-System Pharmacists suggested delaying DTC ads until post-marketing data are collected. However, delay in promoting a useful drug could slow the adoption of medicines that some truly need. Peter Pitts, former associate commissioner at FDA, suggested better use of social science and the formation of a health communications advisory committee. Social science-based evidence (like what is used by the FTC) should be included in FDA decisions to a greater degree. Still, this suggestion only affects the process—not the structure of DTC itself.
Where does that leave us? FDA gave no clues about the future direction of DTC regulation, nor did it indicate clearly where it would help industry to mend its ways. Will the PhRMA Guidelines head off any real change? Will FDA ban DTC for certain drugs, like Symlin (pramlintide) and Forteo (teriparatide)? Will there be a more systematic review of individual ads? Or, will FDA permit greater experimentation? Like always, we hope for a wise FDA.
Questions Left Unanswered Despite FDA holding hearings, and PhRMA issuing guidelines to help diminish controversial promotional activity, it remains unclear what specific problem needs to be addressed in order to improve industry's use of direct-to-consumer marketing.
Lou Morris is president of Louis A. Morris & Associates. He can be reached at firstname.lastname@example.org