The FDA plans to interview more than 1,500 consumers to decide whether DTC TV ads should urge patients to report side effects, theAssociated Press writes. However, some critics argue the toll-free number could distract viewers from other important safety info about prescription drugs.
Print ads already include contact info for the FDA, as required by a law passed last September. The legislation ordered the FDA to report to Congress by late March whether that info should also be mandatory for TV ads. But the agency requested more time to complete its work and is expected to soon begin a formal study - more than a year after the safety legislation was signed into law (back story here and here).
The agency has now made plans for a large-scale study to assess whether adding instructions about reporting side effects would overwhelm viewers who are already being bombarded by medical info. The "ads are already quite dense when compared with ads for other products," the agency states in documents posted online. "The risk information should not be compromised by the addition of the toll-free statement."
For its study, the FDA will show ads for a fictitious blood-pressure drug to 1,600 consumers, who would then be interviewed to see how much of the info they understood. Specifically, researchers will assess how the placement, time and wording of the statements affects comprehension. The FDA did not indicate when it would launch the study, but will accept comments for the next two months.
PhRMA has not taken a stance, but did support adding the language about side effects to print ads. However, some lawmakers and consumer advocates say ads can encourage over-prescribing before all side effects are known. By encouraging patients to report negative reactions to FDA, they hope regulators will be able to catch safety problems sooner, the AP writes.
By the time the FDA completes its study of the toll-free number, however, lawmakers may have already moved ahead with even stricter regulations. Rosa DeLauro, a Connecticut Democrat, introduced a bill in the House last spring that would ban consumer-directed advertisements during the three years after a new drug's launch, the AP continues. What do you think?
Should TV Ads Carry Toll-Free Numbers?
- Yes (71%, 60 Votes)
- No (29%, 25 Votes)
Total Voters: 85