Blogs from the Underground

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  • 12/07/2005

Literally. I’m blogging to you from deep beneath L’Enfant Plaza at Day One the FDA’s two-day Part 15 hearing on “Communication of Drug Safety Information.”

In announcing the meeting in the Federal Register, FDA posed six questions about how to better communicate drug safety information, but it really only boils down to one (posed by me, not the FDA): When the agency’s motive (a better informed consumer) is good, but it’s methods (or lack thereof) are bad — what should be done?

In typical government fashion, the answer is “seek comment.” Herewith some of what was presented today:

Ruth Day (Duke University) gave a very good presentation on why FDA’s communications on drug safety issues create (are you ready for a new term?) “Cognitive inaccessibility.” That means the information is disseminated in a way that is not only not understood by consumers but, worse, is misunderstood leading to unintended consequences. She reckons that only 20% of the information put out by FDA is properly comprehended. Her suggestion (among others) is that FDA initially focus on communicating better with health care providers (read “doctors and pharmacists”).

Michael Wolf (Northwestern University) gave a similar presentation. His take-away point was that 90 million adult Americans are functionally health-illiterate, meaning that 90 million adult Americans misunderstand FDA information and this leads to unintended consequences.

Diana Zuckerman (National Research Center for Women & Families) pointed out that FDA’s attempts to communicate safety information is neither clear nor clearly focused to specific user groups with the result being unintended consequences.

Ray Bullman (National Council on Patient Information and Education) spoke to the point that incomplete and emerging information can result in unintended consequences. He also called for the development of an FDA research agenda (with request for comments in the Federal Register) so that the agency can design a communications platform based on sound social science that would drive how they communicates drug safety with and to various constituencies.

When your motives are good and your methods are bad (causing cognitive inaccessibility and unintended consequences) what you should do (beyond “seeking comment”) is “first do no harm.”

It’s gonna take a lot more than just fixing how the FDA uses its website.

PS/I should also add that Sid Wolfe was one of the panelists, but he mumbled his way through his presentation and I wasn’t paying attention.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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