FDA Posts Draft Strategic Plan for 2014-18
The Food and Drug Administration posted a draft version of its strategic priorities for 2014-18. Just as it had in its 2011-15 strategic plan, FDA’s draft plan for the next four years emphasizes the importance of the globalization of supply chains for FDA-regulated products. It calls for cooperation between regulators worldwide. Other agency goals for the next four years include improved oversight of FDA-regulated products; improved and safer access to FDA-regulated products to benefit health; better informed patients, consumers and professionals; and improved internal organization and accountability. Comments on the draft strategic plan are due July 31, said FDA (here).
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Overall, FDA’s draft strategic plan lists globalization as its second priority, just after improving regulatory science. It calls for “close partnership with our foreign counterparts,” including by assembling “global coalitions of regulators” for sharing of data. For example, FDA says it plans to work with foreign regulators to identify critical data elements like unique facility identifiers that would standardize reporting and facilitate data exchanges. FDA also says it plans to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics. Besides improved regulatory science and globalization, other overarching priorities include “safety and quality,” “smart regulation,” and “stewardship.”
The strategic plan also lists specific goals and objectives that must be met to achieve those goals. These goals include the following:
- Enhanced oversight of FDA-regulated products through increased use of regulatory science; a reduction of risks in manufacturing, production and distribution of FDA regulated products; strengthened detection and surveillance; and improved response to identified problems.
- Improved and safer access to FDA-regulated products through increased regulatory science capacity to evaluate products; an improved product development process; and improved predictability, consistency, transparency, and efficiency of the review process.
- Better informed decisions about FDA-regulated products through better social and behavioral science; improved information for patients and providers; and improved safety and health information for the public.
- Strengthened organizational health and accountability through recruiting, developing, retaining and managing “a world-class workforce”; improved overall effectiveness of FDA; and investment in infrastructure.