A year after FDA issued its guidance on "Consumer-directed broadcast advertisements," companies are still wrestling to adapt their DTC marketing strategies to FDA's requirements. What does the scorecard show so far? Through September 1998, FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) sent more than 100 warning letters and notices of violations to 50 pharmaceutical companies citing problems with their print and broadcast ads.

Here are some of DDMAC's complaints:

1. Insufficient risk information for the consumer-TV ad refers viewer to illegible and inadequate ad in [magazine].
2. Materials are misleading because they lack fair balance.
3. [Promotional materials] do not present information relating to the side effects, contraindications, and effectiveness.
4. Information not presented in prominent and readable manner.
5. Fails to present information relating side effects and contraindications with a [reasonable] prominence and readability.
6. Lack of reference to risks, adverse effects, and side effects.
7. Claims of safety and efficacy not substantiated by well-controlled studies.
8. Uses confusing language and technical terms often misunderstood by the general public.
9. Does not provide balance between risk and efficacy-uses small type for the risks and large type for efficacy.
10. Risk information is not presented fairly-warnings are in small type, against a dark background.

At the same time FDA is prodding companies to provide adequate information in their DTC messages, consumers are calling for more information to help them make decisions about health care. A recent study by Prevention magazine found, in fact, that providing the required risk information in a DTC message may actually increase consumer confidence in the advertised product.

The point is that instead of minimizing risks, companies may have a better response to their DTC ads if they give consumers greater assurance that they are leveling with them. It is no surprise that a Time Inc. survey this year found that 84 percent of consumers said they want a DTC message that "clearly states all associated risks."

Particularly in today's political climate, consumers have become predisposed to be suspicious of almost everything they hear and read in the media. The savvy consumer will be more likely to respond positively to a DTC ad that provides straightforward, practical information.

Fair Balance
Manufacturers are grappling with how to present the brief summary information on the back of the DTC ad and in other consumer-oriented materials so that it meets FDA fair balance requirements while still being understandable to the consumer. In my July column I suggested that companies eliminate the fine print and complex jargon common to the brief summaries and instead work to present practical information in language consumers can understand.

That prompted a letter from a pharmaceutical company executive who agreed that "...the fine print may be too complex, but it is not the pharmaceutical companies that control this aspect of DTC. FDA requires that if a company makes claims about the benefits of a drug product, then the company must also make a full disclosure about the side effects. This disclosure is accomplished at FDA's insistence by the use of the drug product insert, which was originally designed to provide the health care professional with information...If FDA would change its position on what the consumer needed to be told, the pharmaceutical companies would be more than happy to provide a useable packet of information."

That is a common concern I have heard from a number of pharmaceutical companies. However, having been involved in the development of many Patient Package Inserts (PPIs), I have found that FDA is quite receptive to the "consumerization" of the information in the professional brief summary. As the agency stated in a Federal Register notice in August 1997: "FDA encourages sponsors to write the brief summary in consumer-friendly language. That applies to consumer-directed print advertisements and broadcast advertisements that present a brief summary."

Consumer-Friendly
A company may submit a "consumer-friendly" version of the professional brief summary for FDA approval as a PPI. Most companies submit the PPI pursuant to the labeling section as a supplement to their new-drug application (NDA). Once approved, companies can use the PPI in the DTC ad instead of the professional brief summary. Companies can also use the FDA-approved PPI in other patient-education materials, such as pamphlets, tear-off pads, and videos that health professionals distribute through consumer awareness programs.

Although FDA encourages companies to write the information in language consumers can understand, the agency also critically reviews each "translation" for

1. fair balance in design and content
2. clinically accurate information
3. appropriate behavior-modification techniques to improve compliance
4. patient-friendly language.

FDA does not require that companies include in the PPI every side effect cited in the professional brief summary. It requires companies to present this information in fair balance with adequate warning statements.

In my experience, FDA has also been receptive to the inclusion in the PPI of additional patient-compliance information beyond the information found in the professional brief summary. That could include information to help people better understand their medical conditions, as well as practical tips on how to organize and mange their daily doses.

An effective PPI will also address the patient compliance issues unique to that medication and the patient population being treated. Companies should give special attention to integrating both the content and design with the other patient-education strategies for that product.

Beyond Fair Balance
We are starting to realize that we have an important role to play in our own health care. If we fail to get the information we need, we will suffer the consequences.

Companies should not see the PPI nor the DTC ad as a stand-alone. We need to hear the same "how to manage our medicine" message repeated throughout every stage of our treatment. So when you begin developing the PPI for the back of the DTC ad, take this same message and blend it into all the information you will be giving us as we use your product. That will make your product stand apart from the others-and will help us use your product correctly.

The take-home message for pharmaceutical companies is to learn from the DDMAC experiences and develop DTC messages that consumers can really understand and use.

Dr. Dorothy L. Smith is a consumer education expert and president of Consumer Health Information Corporation. The full-service company specializes in patient labeling, program development, and strategic planning for DTC campaigns.

Do you have a DTC question? E-mail it to dlsmith@consumer-health.com or call (703)734-0650.

Published in Pharmaceutical Executive, November 1998. Copyrighted material; All rights reserved.