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Compliance In Focus
Posted by John Lehmann on Fri, Jul 25, 2014

Budget Constraints Impacting FDA Strategic Priorities

In an article in The Gray Sheet, FDA Commissioner Margaret Hamburg indicates the FDA needsBudget Constraints Impacting FDA Strategic Priorities more budget predictability to run effectively.  Continued budget constraints will have an impact on the FDA’s strategic decisions in coming years.

The agency does not expect to have the level of funding in coming years for all its needs.  The FDA said in its draft of strategic priorities that “maximizing public health value from each federal dollar has become increasingly important,” especially since new oversight responsibilities do not always come with additional resources.

Agency officials included stewardship – doing more with less – as a priority in its 2014-2018 strategic priorities document, along with regulatory science, globalization, product safety and quality, and smart regulation. This takes a slightly different tone than the 2011-2015 strategic priorities document that did not list stewardship as a cross-cutting priority.

The new language may have been influenced by the recent government shutdown, which limited FDA activities, as well as the budget sequester, which prevented the budget authority and user fee dollars.  Plus, the agency’s fiscal 2015 priorities that are currently stalled in Congress, are asking for less than the White House budget requested.

Beyond the government budgeting process, economic conditions have also influenced some of the FDA goals.  One priority is to improve the predictability of the review process, which has been a long-standing compliant by many in the industry.  The FDA recognizes “predictability” is important because investor funding has become more difficult for sponsors to find.

The FDA indicates in the strategic document that it is looking for ways to “modernize and maximize efficiency.”  The agency said it will continue to prioritize recruiting, developing and retaining high-quality employees, while streamlining its efforts.

What are your thoughts on Commissioner Hamburg’s call for more budget predictability from Congress?  Will the uncertainly impact the FDA moving forward, or has it forced more streamlining and efficiencies?  Let us know what you think.

Photo Credit: Abecedarian Gallery

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Topics: Budget Constraints, Strategic Priorities, Margaret Hamburg, FDA

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