FDA Will Study Shorter DTC Risk List

FDA DTC Risk Study

The US Food and Drug Administration (FDA) has announced that it plans to study the impact of shorter DTC risk information. The outcome would demonstrate whether consumers would benefit if direct-to-consumer television advertising listed fewer major side effects, versus the current practice of listing nearly all of them.

Historically, the FDA’s objective has been to provide consumers with easy access to important risk information about drugs or medical devices. However, risk information has evolved into a lengthy, and often confusing list that consumers may not fully understand or simply tune out.

The hypothesis the FDA will test is whether addressing fewer risks may actually help consumers better understand the risks that are presented to them. The study is also testing whether telling consumers to go to other sources for unaddressed risk information, prompts them to do so.

While this study is testing television advertising, the results could mean some sweet relief to medical technology companies struggling to embrace digital marketing, social media in particular.

If you recall, in June of 2014, the FDA issued a draft guidance titled “Internet Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.” It addressed how companies should discuss risk and benefit information on platforms such as Twitter, as well as paid search links on Google where communications are limited to a specific amount of characters.

Read more about the FDA and Social Media and download a PDF Guide on Social Media for Medical Device Companies.

The punch line was: if a company cannot achieve the balance of benefit and risk information within character limits, the FDA proposes it “reconsider using that platform for the intended promotional message.” So basically, “If you can Tweet all the risk information, don’t Tweet at all.”

The problem with this guidance is that it ignores the fact that patients are on digital and social media platforms looking for information. Then, it discourages participation from prescription drug and medical device companies on these platforms. Therefore, information available on any medical device or drug could actually become more limited -- benefit, risk or otherwise -- and not reach the public where they expect to find it. So, in the end, with this guidance, the FDA has inadvertently made risk information harder to find, not easier.

If medical device and drug companies are simply able to tell consumers that risks exist, while driving them to a secondary source (such as their website) to get this risk information, we may finally see medical companies become bigger players in digital marketing. And, who knows, we may even see better educated, more informed patients!

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