March 26, 2012 – Note to Industry Leaders

The Coalition for Healthcare Communication needs your input on a study FDA is planning to conduct regarding corrective DTC television advertising. In the recent past, FDA has used this enforcement tool only sparingly, most notably as part of a Warning Letter involving contraceptives. Our primary concern is that FDA may be fielding this study to support more extensive use of this extraordinary remedy.

FDA has asked for comments on the following corrective advertising study issues:

• Whether the study is necessary
• Whether the cost estimates are accurate
• Ways to enhance the study
• Ways to reduce the cost

To inform the Coalition comment to FDA, we would like to hear from you on the impact of corrective ads, especially on whether or not corrective ads achieve the intended goals of the FDA and whether or not they may be counterproductive. We would like to include data supporting our comments and recommendations wherever possible.

Background

Corrective advertising was born in the 1970s as a hypothetical remedy for deceptive advertising. The Federal Trade Commission requires it only in extraordinary cases because it is controversial and is subject to limits under the First Amendment. At FDA, corrective advertising has been used in both professional and consumer advertising, but there exist very limited public data on its impact.

FDA’s Stated Objective

To examine how variations in corrective advertising may impact consumer understanding.

Study Design

FDA proposes to use an Internet panel asking questions online. There would be two phases:

• Phase 1 – Examination of the impact of exposure to combinations of the original and corrective ad.
• Phase 2 – Examination of how the similarity of the original and the corrective ads and the time between their use impact the ability to correct misinformation.

FDA says that there will be no capital or operating and maintenance costs associated with this collection of information.

What You Can Do

If you want more details on the plan, go to the Federal Register/Vol. 77, No. 40 published Feb. 29, 2012. You may wish to pass this message along to those in your organization who focus on market research, requesting comments and suggestions.

Agencies and publishers may choose to comment individually, as well as to support the Coalition comment.

For our part, we are seeking data and information from communication professionals on just how FDA’s use of

corrective advertising action might impact consumer perception and behavior. The FDA would be especially interested in data that demonstrate the limits and possible unintended consequences of requiring corrective advertising in its enforcement actions.

Deadline

Comments must be filed with FDA by April 29, 2012. We would like your views and suggestions by April 6^th so we can consolidate and prepare our final comments. Interested members should contact Jack Angel at jeangel@cohealthcom.org or 203-661-3314.

In addition, you will soon receive a similar request to support Coalition comments on the recently released draft guidance on pre-review of DTC advertising. That comment is due May 15.

Jack Angel & John Kamp
Coalition for Healthcare Communication