Has risk information run rampant?

In an era when many patients prefer a conversation over a commercial, and as the FDA considers revisions to the "brief summary," how much risk information is necessary in DTC ads and why?

Joan Wildemuth
EVP, global creative director, JUICE Pharma Worldwide

In today's multiscreen environment, we need to take a radically different approach to delivering risk information to align with how people expect to interact with each medium.

Traditional DTC ads are teasers, conversation starters. Is all that upfront risk information doing anything but turning off those who could benefit?

However, online, when people are in research mode, risk messages should be robust and treated with respect and love.

How about point of prescription? If ever there was a time to serve up risk in an inviting, friendly way, this is it. But is this happening?

Perhaps there's a more important question than how much risk information is ­necessary and that is, when in the decision-making process does presenting that information make the most sense?

Andy McAfee
Creative director, AbelsonTaylor

A shorter Major Statement would be a major improvement. The litany in current broadcast ads dilutes focus on important and actionable risks.

And why drive consumers to the anachronistic “Book of Record” for the details? I'm not sure I would know where to find Redbook if I really wanted to “See our ad in Redbook.” With internet access near 100%, wouldn't it make sense to exclusively drive people online?

Branded websites already include safety info. But why not create a separate URL that focuses on risks in a truly patient-friendly manner: simplify the language; include FAQs; offer video for those who prefer it; make it easy to navigate.

A shorter Major Statement is a great start. Using technology, we can create a truly meaningful presentation of risks.

Deborah Dick-Rath
President, Epic Proportions

Patients may prefer an individual conversation, but they will need to search for it—and that takes effort. A TV commercial can still be a big advantage for a DTC marketer because it can quickly generate awareness across a wide swath of population. The trick is to use it within an integrated campaign that uses every channel to its advantage. We are more than ready for revisions to the brief summary! The warnings and risks in DTC can scare patients and actually make them non-compliant.

As long as a physician's prescription is required, the FDA should ease up on the risks info. I always think about the prospects of how FDA-style regs could be applied in other advertised categories. My favorite image: a pair of skinny jeans with the voiceover warning that they may not actually appear this way on everyone.

Michael Byrnes
VP, Rx EDGE Pharmacy Networks

The brief summaries often are taken from the risk-related section of the product label, generally intended for HCPs and containing detailed medical information. There are often unexplained medical terms and extensive clinical research data included that most patients do not understand. This can discourage, rather than inspire, patient action. The risk information in DTC ads should include only the drug's most serious and common risks, communicated in language suitable for lay readers. Doing so would give patients the critical information they need and support meaningful dialogue with the healthcare professionals in charge of their care.


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