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Opportunities and Tools May Change … But Challenges Remain

February 7, 2014

The last two Analysis and Commentary columns have discussed why the Alliance sees the FY 15 budget cycle as an opportunity for FDA. With the ceiling for FY 15 spending already set by the December 2013 budget agreement, we continue to believe that the plan for “regular order appropriations” this year provides us with a deliberative process in which there will be time and interest in the case we can make for increased FDA appropriations.

That said, our view is not entirely optimistic. There are still many obstacles to the completion of a full deliberative appropriations cycle. It is more proper to say that we anticipate such a process, rather than that we are certain of it.

Further, we face what might be called “the NIH doubling problem.” In what was probably the most significant appropriations action in the history of U.S. public health, Congress increased NIH funding from approximately $14 billion to $28 billion in a 5-year period. Once accomplished, Congress’ attitude toward NIH funding might best be described as “You got yours, now there are other priorities for increasingly scarce funds.” In year six, and for several years thereafter, the NIH went from clearly the most favored federal agency — perhaps in the entire government — to a largely flat trajectory. It is possible to be a victim of one’s own success.

FDA potentially faces the same situation. This past week, a Member of Congress even asked why the doubling of the food safety budget over the last decade isn’t sufficient to support full implementation of the Food Safety Modernization Act. The answer we would give with regard to food … is the same answer we would give with regard to all of FDA:

  • FDA was massively underfunded at the time, 7 years ago, when the agency started receiving increased appropriations.
  • The responsibilities of the FDA have increased by multiples through Congressional mandates, including FDASIA, FSMA, generics, tobacco, drug compounding, and medical product quality and safety.
  • The size of the FDA’s job has also increased significantly during this period because of the massive shift in globalization and the increasing complexity of science.
  • The industries that FDA regulates are also growing — something which is good for the economy and good for consumers — but which requires more manpower.
  • FDA continues to provides major public health and economic opportunities that can only be realized by additional investment.

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A final, unrelated, thought. In John Milton Cooper’s biography of President Woodrow Wilson (1913 to 1920), he describes Wilson as the last great Presidential orator and observes that

Soon new media — first radio, then newsreels, and finally television — would vastly expand politicians’ reach, but at the price of shorter exposures that offered fewer chances for education and more for exhortation and manipulation.

As advocates, this seems a particularly pointed reminder that the challenges of persuasive communications endure, even as the tools change.

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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