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…