FDA's upcoming draft guidances on direct-to-consumer advertising will encourage more use of disease awareness ads, Associate Commissioner for External Relations Peter Pitts said in a Jan. 23 speech to the advocacy group Families USA in Washington, D.C.

"One of the things that we want to drive with our direct-to-consumer guidances...[is] more disease advertising on television and in print," Pitts said. "We feel it is under-used and is absolutely in the best interest of the public health."

FDA is expected to release three DTC draft guidances in the next few weeks.

The guidances are understood to cover disease awareness ads, the brief summary and medical device broadcast advertising.

Guidance on the brief summary was expected before the end of 2003. FDA has frequently acknowledged the shortcomings of the brief summary requirement and repeated the need for alternatives at a September public meeting (¹ [A#00650390022], p. 30).

Pitts highlighted the most frequently cited criticism of the brief summary: the current design emphasizes compliance over consumer use.

"Risk information is hidden in plain view and benefits are communicated broadly. It's not a question of fault. It's a question of fact," he said.

"Currently, the brief summary is neither designed nor delivered to be user friendly. It's designed and delivered to be in compliance while benefits are written with the boldest pen and painted with the broadest and brightest brush. That needs to change."

"Our goal is to provide clear guidance on how to communicate better and to use the bully pulpit to encourage patients to seek earlier detection and appropriate treatment of illness because earlier detection saves lives and saves money," he said.

Pitts described the DTC guidances as part of what he sees as an evolution of FDA's mission - from just "protecting America's health" to both "protecting and advancing America's health".

"We must work together as colleagues to address these serious issues: making our medicines safer and more affordable, getting better information to consumers. If we can do that, then I'm confident we can even more powerfully protect and advance America's health," Pitts said.

Providing better consumer information is one of five elements of FDA's strategic plan under Commissioner McClellan (² Also see "FDA Strategic Plan: Milestones Will Be Unveiled In June" - Pink Sheet, 28 April, 2003., p. 6).

"According to research presented by academics...DTC advertising is indeed advancing America's public health, most specifically by getting more people to visit their doctors," he said.

"Advertising legitimizes. More specifically, it helps to de-stigmatize certain diseases and encourage people to talk to their doctors about problems previously considered taboo, such as depression," Pitts said.

One therapeutic category that may have once been considered "taboo" before being discussed in TV ads by famous politicians and athletes is erectile dysfunction (see ³ Also see "Lilly Cialis Ads Ready For Super Bowl Showdown With Levitra" - Pink Sheet, 26 January, 2004. ).

Pitts also cited research demonstrating little or no correlation between a brand's DTC spend and its cost.

"It is an extraordinarily high-profile thing for pharmaceutical companies to do, to almost flaunt in the face of the American public that these drugs are available and expensive. One has to assume they do it because it works."

"But on the other hand, I also think that the pharmaceutical industry is doing an extraordinarily poor job in explaining to the American public why drugs cost as much as they do," Pitts said.

The associate commissioner also cited data collected from a physician survey suggesting that physicians are split on whether DTC advertising has positively or adversely affected the doctor/patient relationship (⁴ Also see "FDA Readies Report On DTC, Says Physician Survey Supports Current Policy" - Pink Sheet, 20 January, 2003., p. 3).

FDA To Release Three DTC Draft Guidances: Disease Awareness Is One Focus

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