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The Short and the Long of FDA Advocacy

August 29, 2014

Recently, my mind has focused a lot on FDA’s standing as a uniquely different and very special federal agency. We have to keep reminding ourselves that, as advocates, we are fully justified in asking for more money for the FDA, even during a time of budgetary stress and cutbacks.

For example, earlier this week, Mike Scott of Calcium USA (which is helping, pro bono, with revision of our Alliance website) reminded Ladd and me about the importance of using video, message pull-outs, graphics, tweets, and other tools to communicate with a minimum of words. This, he reminded us, was essential in an era when attention spans are shortening and there is increasing competition for each individual’s attention. As he said this, I flashed on an assignment I had just completed — reviewing a company’s briefing book in preparation for a pre-IND meeting with FDA. The book was 130 pages plus four appendices — probably fairly average at the pre-IND stage, but a fraction of the material that will be submitted to FDA later in the drug development process.

The world may be increasingly communicating in soundbites, but FDA is the agency that still has to be able to read and understand complex scientific material that often fills hundreds, if not thousands, of pages. I can envision an FDA job posting that stressed: “only applicants with demonstrated reading skills and long attention spans need apply.” Perhaps not a unique insight about FDA, but one I had never thought about and a distinct contrast with the direction our society is taking.

What are some of your ideas about what makes FDA different and special? We have well-rehearsed messages, which we refresh and improve often, about the scope of FDA’s jurisdiction (100% of medical products, 80% of foods, etc.) and how its workload is being increased by legislation, scientific complexity, and globalization. But we can always use new ideas and special insights about why organizations, individuals, and regulated industries view FDA’s mission and character as special. Please share your ideas with me or with Ladd Wiley

Thank you, and have a happy and safe Labor Day weekend.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA

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