FDA’s 2018 Strategic Policy Roadmap, Part 1

In January, FDA’s Commissioner announced the release of “Health Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap” that provides a detailed overview of priorities for the agency within a relatively short timeframe. FDA and the various centers that make up the agency have long submitted strategic outlines to the public, but they have had a slightly different character. In the document on FDA Strategic Priorities 2014-2018, then Commissioner Margaret Hamburg laid out priorities in broad brushstrokes – Enhancing Oversight of FDA Regulated Products, Improve and Safeguard Access to FDA Regulated Products to Improve Health were two of the goals outlined in that report, for example. 

In the document issued by Commissioner Gottlieb, however, the priority areas of concentration are a little less broad and encompass four categories:

  1. Reducing the burden of addiction crises that are threatening American families;
  2. Leverage innovation and competition to improve healthcare, broaden access and advance public health goals;
  3. Empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease; and 
  4. Strengthen FDA’s scientific workforce and its tools for efficient risk management. 

While an outline for the coming year, there is little question that there have already been efforts within each of these priorities, some of which begin to signal for stakeholders in each just where the agency is going and how that is going to impact stakeholder interests. 

Often documents like this are issued and then never heard about again. While that is not likely the case, given the new approach to communications out of FDA this past year, it seemed then like a good idea to begin an occasional series that looks at each of these priorities and tries to shed some light on where we are, where we want to go, and how we are doing at getting there.  We will look at each of the four categories – examine what is being targeted, what has been done and what potentially may be done with some effort at assessing impact on stakeholders. 

The next installment in this series will look a the first priority in some depth, followed by the other 3 in coming posts. 

Photo by Nadine Shaabana on Unsplash


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