Right now, that call won't go through, butan FDA advisory committee will meet tomorrow to discuss the possibility of including in televised DTC ads a statement encouraging consumers to report negative side effects to MedWatch. Right now, such statements are only required for DTC print ads.
The meeting comes amid ongoing debate over DTC ads. A growing chorus of critics say that risks are regularly minimized in favor of feel-good messages that can lead to over-prescribing. Some lawmakers and consumer advocates want toll-free phone numbers placed in the ads in hopes of helping the FDA spot warning signs sooner.
A recent Consumers Union poll found that 81 percent of Americans reported seeing or hearing an ad within 30 days of being questioned. The same poll found that one in six Americans who have ever taken a prescription drug experienced a side effect serious enough to send them to a doc or hospital, but only 35 percent were aware side effects can be reported to the FDA.
Two months ago, the FDA was supposed to have given Congress a report on mandatory contact info in TV ads, but an agency spokeswoman tells the Associated Press that a final version is still being worked on. PhRMA hasn't taken a stance, but supported adding the side-effect language in print ads.
"If it's good enough for print, it's good enough for TV," Kim Witczak, founder of the WoodyMatters advocacy group, tells the AP. Her husband, Woody, committed suicide while on Pfizer's antidepressant Zoloft. The following year FDA added warnings about risks of suicidal behavior to all depression drugs.
Last year, the FDA announced plans to study whether TV ads paint an overwhelmingly positive impression, despite audio warnings about potential side effects. And week a House committtee held a hearing about DTC ads.
At the hearing, Duke University professor and linguist Ruth Day testified that advertisers often use faster voice overs and distracting visuals when describing drug side effects during the commercial. She cited Schering Plough ads for the Nasonex allergy med in which a bee buzzes around the screen when side effects are mentioned, but stays put while the 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. She also noted the benefits can be understood by anyone with a sixth-grade education, but a ninth-grade education is required for side effect info.