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FDA to Study Reducing Risk Disclosure on TV

Less is more goes the common saying. FDA, announced 2/18 in the Federal Register, that they are going to study having less risks read in TV ads. Their hypothesis is the litany of risks and warnings make it harder for the consumer to remember the most important ones. I have advocated, as have many advertising experts, that consumers would be better served airing only the most serious or most likely risks/side effects.

FDA logo sign

?Consumers would be better served by shorter ads?? - Bob Ehrlich

Consumers are now subject to up to two minute ads, in many cases the fair balance runs longer than the selling points of a drug. Xarelto runs such a two minute ad, with the majority discussing the warnings and side effects. Do consumers change the channel, zone out, or minimize that whole section? FDA wants to see what happens when they test an ad as it would air today versus a shorter version. In that shorter version they will add a general statement that other side effects and risks occur and consumers should talk to their doctor and refer to the full prescribing statement for those.

Consumers want to know what is the worst that can happen as well as what is most likely to happen.
Minor side effects or those so rare add very little to consumer decisions to take a drug. I think consumers also need to know the odds of major side effect or risk but this is not being studied. Commercials often use terms like rare to describe a serious side effect but that is a very vague term. To some consumers rare is 1 in a 100, for others it may be 1 in a 100,000. Risks and side effects need to be put in some real world context.

In this study, FDA is doing something I wish they had done when DTC ads were first aired on TV in 1997. Still it is better late than never so I am pleased they are doing it. What consumers need are actionable, clear, and relevant data. That helps in the discussion with the doctor. The litany version of warnings, risks and side effects in many ads does not educate or highlight what consumers need to consider.

Advertising copy writers know consumers can only remember a few key points from an ad. This applies to both the benefits and risks. Most consumers would be better served by shorter ads, even just 30 seconds. Can this be done for most drugs? Of course it can. Even Xarelto can probably cut at least 45 seconds from their ad if only the major benefits and risks were discussed.

Of course, the television networks might lose some ad sales if those 120?s became 60?s and 60?s became 30?s or 45?s. On the other hand, more drugs might advertise if the price of entry was lower or they might run spots more frequently. It would also help the smaller drug companies do DTC ads if they could run 30?s.

FDA has been doing a good job testing DTC advertising hypotheses with its limited human and financial resources. Of the many studies they have done or are planning, this is one of the most important to all DTC constituencies. If drug companies advertise then we need to make sure consumers understand what is being said. With so much detailed benefit and risk information available to consumers, television ads are merely one of the first steps in the process of drug education and selection. Recognizing that role, requiring less detail seems like a logical and positive step.

Bob Ehrlich
Chairman & Chief Executive Officer at DTC Perspectives
Bob Ehrlich has over 20 years marketing experience in pharmaceutical and consumer products. Bob is the CEO of DTC Perspectives, Inc., a DTC services company founded in 2000. DTC Perspectives, Inc. developed the DTC National Conference, the largest DTC conference in the industry. DTC Perspectives, Inc. also publishes DTC Perspectives, a quarterly journal dedicated to DTC issues and practices. In addition DTC Perspectives, Inc. does DTC consulting for established and emerging companies, and provides DTC marketing plans for pharmaceutical companies.

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