The Food and Drug Administration outlined in a Dec. 26, 2012, notice its plans to study the impact of corrective television ads that aim to remedy incorrect information in direct-to-consumer pharmaceutical advertising.
The agency published a notice in the Federal Register (77 Fed. Reg. 76,046) that solicits comment on what it calls an experimental study with the title, “Examination of Corrective Direct-to-Consumer Television Advertising.”
The agency said its regulations require prescription drug ads “to contain accurate information about the benefits and risks of the drug advertised. When this is not the case, corrective advertising is designed to dissipate or correct erroneous beliefs resulting from a false claim.”
The agency gave as an example of corrective advertising the ad produced by Bayer HealthCare Pharmaceuticals in 2009 for Yaz, a birth control product, after a warning about misleading claims.
Another recent instance of corrective advertising is the Oregon attorney general's December announcement that Pfizer will run corrective advertising on television about the company's EpiPen product, an injectable form of epinephrine used to stop allergic reactions. An assurance of voluntary compliance approved by an Oregon state court describes the corrective advertising (see related item in this issue).
The agency said it will conduct the study over the internet, with an expected total of 6,650 interviews. Asthma and weight loss will be the two conditions for the drug treatments in the ads.
The first phase of the study will look at how the exposure to a combination of the original TV ad and the corrective TV ad affects message recall and concentration as well as intention to use the drug. FDA will compare those who see the original and corrective ads with those who see only the original ad, only the corrective ad, and neither ad. The second phase will examine the similarity of the original and corrective ads, as well as the time lag between viewing the two versions.
The participants will be assigned randomly to watch one version of a DTC ad for a prescription drug. Then, after watching the ad, the participants will answer questions about their recall and understanding of the benefit and risk information, their perception of the benefits and risks, and their intent to ask a doctor about the drug.
FDA's Dec. 26 notice follows a Feb. 29 notice (77 Fed. Reg. 12,307) in which the agency asked for public comment on the proposed collection of information. The agency received comments, and provided responses in the new notice.
Among the responses to comments, FDA said it changed the study design to add a longer, six-month delay element, which is a more realistic approach to original and corrective message exposure. The Feb. 29 notice said one month would be the longest delay between the two versions of DTC ads.
The Dec. 26 FDA notice is a collection of information submitted to the White House Office of Management and Budget. FDA said that written comments on the collection of information should be faxed by Jan. 25 to the Office of Management and Budget's Office of Information and Regulatory Affairs (202) 395-7285. They also can be submitted to email@example.com. The docket is FDA-2012-N-0176.
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