TV Drug Ads May Have to Zoom in on Side Effects

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Televised direct-to-consumer drug advertisements may soon be required to provide a toll-free number for patients to report adverse side effects.

(ABCNEWS)

Would consumers get the same warm, fuzzy message from a drug advertisement that promised to lift their mood if it also urged them to report side effects like suicidal thoughts and diarrhea?

Under a proposal regulators will consider Friday, that buyer-be-vigilant message would have to accompany the rosy messages of pharmaceutical promotions.

The Food and Drug Administration is considering requiring TV drug advertisements to carry a toll-free number where patients can report serious problems with their medication. FDA will consult a panel of outside communication experts Friday about whether displaying that language could distract viewers from other important information.

TV promotions have become a cornerstone of the pharmaceutical business since regulators opened the floodgate a decade ago. Companies spent roughly $3.5 billion on spots last year.

But some lawmakers and consumer advocates say the advertisements can encourage over-prescribing of medications before all their side effects are known. By encouraging patients to report negative reactions to FDA, they hope regulators will be able to catch drug safety problems sooner.

"Drugs get approved based on results of a small number of people in clinical trials, but it's really when millions of people start taking them that we see side effects that might not have been known to the company," said Kim Witczak, founder of patient advocacy group WoodyMatters. The group is named for Witczak's husband, Woody, who committed suicide in 2003 while taking Pfizer's antidepressant Zoloft. The following year FDA added warnings about risks of suicidal behavior to all depression drugs.

A Consumer Reports poll published earlier this year found that only 35 percent of consumers knew they could report drug side effects to the government. The group is scheduled to present before FDA on Friday.

Print advertisements already include contact information for the FDA, as required by a law passed last fall. The same legislation ordered FDA to report to Congress by late March whether that information should also be mandatory for TV ads.