Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
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).
FDA's notice said that researchers and policymakers “currently lack empirical literature regarding the various influences of corrective [direct-to-consumer] ads on prescription drug consumers.” The agency said its project will examine the influence of corrective messages in the realm of consumer-directed prescription drug advertising.
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.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)