Side effects in FDA Rx rules

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The disclosure-heavy rules that govern prescription drug marketing are again having their peculiar impact, this time on a new campaign for Hoffman-La Roche's Xenical weight-loss drug. There's no likelihood this will end until the U.S. Food & Drug Administration rethinks some of its fundamental notions about the roles of advertising and labeling.

As the FDA sees it, advertising and labeling for prescription items are little different from one another. What appears on labels should, in some form, appear in ads, too. In today's world, the FDA's stand has produced a conundrum: Drug marketers can advertise a product by name but they can't say what it's for unless they are willing to talk about side effects (often in vivid detail). So, many name a product but are silent on its purpose. Or they give no product name but say there are marvelous new options for treating (name the condition), so ask your doctor. It's a poor substitute for more informative ads.

Strategists for Xenical, and other drugs, are getting savvy about how to play this game. New ads for Xenical from WPP Group's Y&R Advertising no longer primarily seek to build recognition of the product as a weight-loss medicine (avoiding disclosure requirements). Some don't mention the Xenical name at all but simply urge consumers to talk with physicians about new options for weight control.

Consumers need accurate, accessible information about the prescription products they are considering. That's why the physician serves as the gatekeeper between the drug product and patient. Advertising should play a role in this information system, but not the same role as product labels, physicians or pharmacists.

Prescription drug ads will be a more effective partner in this process when the FDA's rules focus on actually communicating a select few things (such as effective general warnings about the need to understand side effects) and focus less on forcing labels into ads.

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