FDA Submits DTC Ad Survey Proposal to OMB
The FDA plans to survey 1,500 adult patients to assess how people perceive prescription drug risks in direct-to-consumer television advertisements.
Under the proposed survey, participants would be asked to watch one of four scenarios of a drug ad — an advertisement with the full risk statement, an ad with an abbreviated risk statement, or one with an abbreviated risk statement that does or does not have a closing statement informing the listener of other potential risks they can research on their own.
The FDA first gave notice of its intent to survey how patients perceive the “major statement” in TV prescription drug ads last February. The question was whether patients need to hear every known risk for a therapy or would do better with an abbreviated statement that noted only serious and actionable adverse reactions and concluded by telling patients that there are other potential risks they can look up.
The final survey proposal, published in the Federal Register, responds to industry concerns about how the survey is conducted.
The FDA rejected PhRMA’s request modified existing advertisements not be used in the survey on grounds that creating entirely new fictitious ads would be too expensive. The group’s comments were among 55 submitted to the FDA.
The agency also rebuffed Pfizer’s request that participants not be asked about ad persuasiveness, saying one of the survey’s goals is to assess how presentation of risk information affects consumer choice. And the FDA turned down Eli Lilly’s recommendation to include a general survey population control group, saying that, too, would be too costly.
Other comments — including concerns that patients may know of other therapies that treat the same condition and the effectiveness of the side effects list — have been incorporated into the survey.
View the Federal Register notice and responses to comments at www.fdanews.com/01-12-15-Direct-Advertisements.pdf. — Bryan Koenig