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. The 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.
Warning of possible risks
"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 the 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.
An agency spokeswoman said it submitted an interim study to lawmakers but is still working on the final report.
The Pharmaceutical Research and Manufacturers of America has not yet taken a stance on the issue. However, the group — which represents Merck & Co. Inc., Wyeth and other drugmakers — supported adding the language about side effects to print advertisements.
Witczak, who is scheduled to speak Friday, argues that "if it's good enough for print, it's good enough for TV."
"Any warning of a possible risk is better than not publicizing that information until it's too late for someone," said Witczak.
Stepped up oversight
Friday's meeting is the latest example of Washington stepping up oversight of the drug industry's $5 billion-a-year consumer marketing push.
Last year the FDA announced it would study whether TV ads paint an overwhelmingly positive impression of pharmaceuticals, despite audio warnings about potential side effects. And just last week Democrats in Congress held a hearing on the issue titled: "Direct-to-Consumer Advertising: Marketing, Education or Deception?"
At the hearing, Duke University professor Ruth Day told House lawmakers that advertisers often use faster voice-overs and distracting visuals when describing drug side effects during the commercial.
She cited Schering Plough Corp.'s spots for allergy drug Nasonex, in which a bee buzzes around the screen when side effects are mentioned, but stays put while the drug's benefits are touted.
In her research, Day found that 80 percent of viewers can recall benefits mentioned in TV drug ads, while only 20 percent successfully recall side effects.