How to Gloss Over Warnings in TV DTC Ads

Julieta Smith, group strategy director, McCann Humancare -- part of the same healthcare agency that won a Lions Health 2014 GOLD award for Fictional Patient Story (not that that's a good thing compared to a REAL patient story that only won a BRONZE award) -- thinks that the same “generic” warning repeated in all direct-to-consumer (DTC) drug ads would be more effective than SPECIFIC warnings now required by the FDA.

In an article/blog post written for MM&M (here), Smith suggests ALL drug DTC ads on TV just end with this warning message:

“All drugs carry certain risks and should not be used by everyone. These risks can range from inconveniences to the risk of death. You should talk to your doctor to determine your specific risks, reasons you might not be a candidate to use this drug, and any side effects and warnings that may pertain to you personally before you take it. To learn more visit brandx.com.”

Pardon the phrase, but this is an example of “putting lipstick on a pig.” Maybe it's not PC, but I think that's an appropriate analogy.

Smith believes this is a solution to a major problem with TV DTC advertising.

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DTC Print Ads Need Consumer-Friendly Fair Balance Information

The FDA recently published revised draft guidance on "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements." (see "Disclosing Risk in DTC Print Ads: Introducing the 'Consumer Brief Summary'").

The brief summary is the part of direct-to-consumer (DTC) ads that conveys detailed risk information. Typically, this information appears on the back side of the print ad and is sometimes written in small type.

In the original guidance published in 2004, FDA suggested a "less is more" approach (see “FDA Draft Guidance for Print DTCA: Less than Feared”). At that time, FDA said it "believes that exhaustive lists of minor risks detract from and make it difficult to comprehend and retain information on the more important risks." In the revised guidance, FDA suggests specific, more readable formats for the brief summary. As shown in the example below, some DTC print ads have already used these formats in the brief summary section of the ad.

What no one is talking about, however, is the "fair balance" section of the ad. Let's look at a typical Rx drug print ad.

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How Virtually Anyone Can Get an Rx for Amphetamine... Sorry, I Meant to Say Vyvanse

After writing yesterday's blog post about Monica Seles helping Shire promote Vyvanse for Binge Eating Disorder (B.E.D.), which is a new indication for the ADHD drug, I wondered if this would make it easier for young people to obtain prescriptions for Vyvanse, which is a Schedule II controlled substance with a high potential for abuse.

Like overweight college students, I too could use a little "pick me up" pill from time to time.

Since there is no lab test to confirm a B.E.D. diagnosis, all I have to do to get a prescription for Vyvanse is convince a doctor that I meet all of the DSM-5® diagnostic criteria for binge eating disorder, which Shire provides here on the BingeEatingDisorder.com website.


Of course, I have to "certify that [I am] a US health care professional and [I am] opting to receive information about binge eating disorder plus site updates, educational information, patient support resources, and other information from Shire," which anyone can do -- even me, who is definitely NOT a health care professional. No problem, that was easy.

But just in case you are reluctant to pose as a doctor and opt in for email from Shire, you can avoid the DSM and use Shire's handy "Binge Eating Disorder (B.E.D.) Symptom Checklist," which you can find on the "Talking With Your Doctor" page where "Starting the Conversation Is Key."

It's easy to use the Checklist and get a printout (pdf file) to bring to your doctor. Here's how I filled in the Checklist and the advice I got from Shire on "starting the conversation" with my doctor - a surefire way of getting a prescription for Vyvanse and the boost I need during my busy day.

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