Litany of side effects in DTC ads 'a waste of time' for patients, top FDA official says

Momentum is building at the FDA for an overhaul of DTC advertising. That familiar--and often lampooned--recitation of side effects is looking more and more like an endangered species.

Richard Pazdur

In fact, none other than Richard Pazdur, who heads up the agency's oncology apparatus, is the latest to take shots at the current DTC rules on risk disclosure. He went so far as to call that breathless voice-over of side effects "a waste of time" for patients.

"When they give the adverse events, or adverse reactions, it's this litany of complaints--death, or 'Don't use if you have MAE1,'" Pazdur said at a Friends of Cancer meeting Tuesday (as quoted by Bloomberg). "What patient knows what MAE1 is? It's just a waste of time."

Pazdur didn't specifically say that the DTC rules should be changed. He did "encourage" the agency "to look at this whole advertising issue in a much more innovative approach."

The FDA's ad police are trying to do just that. For more than a year, the agency has been discussing the prospect of whittling down the risk disclosures in ads to focus on the most serious and common side effects. That way, instead of blurring together in one long list--or a page full of eye-numbing fine print in a magazine--the risks would be more evident and understandable. And potential patients might actually listen (or read them).

Drugmakers cheered the idea during a comment period last April, as the FDA prepared for a study that would assess how patients perceive abbreviated disclosures versus the current, long-form style. Pfizer ($PFE), for instance, called the study "much needed," and said it could provide "serious benefits" to consumers.

Earlier this year, the FDA actually told drugmakers they could scrap the fine print in magazine and newspaper ads, by using a variety of different disclosure methods--info boxes, what have you. An official format might be next. So might some new rules for TV commercials, if Pazdur's comments are any indication.

- see the Bloomberg news

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