FDA rethinks its risk communications

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Last month, FDA issued its Strategic Plan for Risk Communication, a 44-page tome 10 years in the making by multiple agency and external committees.

“We are committed to improving communications the public receives about the products we regulate,” said FDA commissioner Margaret Hamburg, MD, in a statement. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being.”

The plan is a hail of bullet points and action items, most of them pretty vague (“Capacity Strategy 1: Streamline and more effectively coordinate the development of communication messages and activities”). But it's an important acknowledgement that the agency doesn't do a great job of communicating information about regulated products, whether to the public or to healthcare professionals, and that that function is central to the agency's mission. It's also an acknowledgment that the terrain has shifted.

“In the past, FDA's communication efforts were largely restricted to overseeing the key vehicle for communicating risk information to the public—the labeling of FDA-regulated products,” the report's authors wrote. “The process of negotiating with product manufacturers about changes to labeling or decisions to recall a product was often lengthy. Now, as the internet and emerging technologies both enable and feed the public's demand for greater transparency and communication frequency, these protracted waiting periods are giving way to communication in real time.”

In the past, the agency has communicated with the public through privileged intermediaries, handing down indecipherably worded labeling to the hoi polloi through priestly classes including physicians, industry and the media, who would then render them into slightly less inscrutable form. Nowadays, any old schmo can pop over to the agency's somewhat retro, vintage looking site and pull up medical hieroglyphics on drugs and devices themselves.

Another key subtext of the plan is a post-Vioxx shift in perception of risk. Where the agency used to deem products safe or not, the agency's understanding of risk is now more nuanced.

“Today, we recognize that education involves more than ensuring the accuracy of product labeling,” says the report. “We must communicate the context of the message so that the words make sense to the audience.” For example, says the agency, when FDA says a product is “safe and effective,” it means that in a very specific legal context—i.e., when used as labeled and intended. Moreover, research assesses risks and benefits for a population, but for individuals, results may vary. These are not caveats that consumers are likely to be mindful of when making medical decisions. And, as the report notes, people are complicated. They don't take drugs as directed, because they don't want to think of themselves as sick and taking them does, or because they start to feel better and think they can discontinue treatment, or because they forget or misread the instructions.

It's encouraging to see the agency taking a more thoughtful and behavioral slant in thinking about communications. It's an impulse industry marketers hope to see more of at the agency's hearings on social media and marketing later this month.

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