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Sustaining FDA Remains a National Priority

July 15, 2012

Tough decision this week: write more about the macro-budgetary situation or write more about the needs and plight the US Food and Drug Administration. So, I am going to write a bit about each.

Macro-budgetary Situation. My best guess is that we are done with appropriations bills until after Election Day. There is still an occasional rumor that the full House will consider the FY 13 Agriculture-FDA appropriations bill before August recess. If so, that would be the last gasp.

The impossibility of more action (at this time) rests on the fundamental and irreconcilable difference between the Senate and House positions. The Senate bills, taken collectively, spend $1.047 trillion on discretionary programs, consistent with the Budget Control Act of 2011. The House bills, taken collectively, spend $1.028 trillion on discretionary programs, consistent with the FY 13 House Budget Resolution. Further, the bills spend significantly different amounts on defense programs, which further exaggerate the differences for all non-defense programs.

After the election, the Congress will have its plate full dealing with a series of interlocking budgetary decisions. In addition to resolving FY 13 appropriations, they will have to decide what to do about the sequester (across-the-board cut) planned for January 2, 2013 (also part of the Budget Control Act of 2011); and whether to extend all or part of the Bush tax cuts, the temporary payroll tax cut, and the extended unemployment insurance provisions. In addition, sometime soon into the new calendar year (estimates vary), we will again run into the need to extend the federal debt ceiling.

Congress will either have to resolve these in the post-election session or “kick the can down the road” again, possibly for as little as one month or as long as a year. There is talk that a grand deal is possible ($3 to $ 4 trillion in deficit reduction, including spending cuts, entitlement changes and some new revenue (although it might be called something else). There is also talk of how much would be needed in deficit reduction (maybe $120 billion?) to put off the sequester for a year.

FDA’s Situation. FDA’s case for additional resources is very strong and the Alliance has been instrumental in gaining Congressional consensus on this point. If we could keep the discussion just about FDA, then we could focus all our energies on answering the question: how much more does the agency need in FY 13?

It is the macro-budgetary situation that threatens FDA, particularly the large across-the-board sequester cuts that are indiscriminate rather than assure funding for national priorities, such as FDA. But even initial FY 13 appropriations are representative of the difficult overall situation: the Senate provides a little more money in FY 13 than FY 12; the House a little less.

We appreciate that Members of Congress care, but there is always the larger picture of FDA’s role that needs to be continuously reinforced:

  • Americans use FDA-regulated products multiple times each day, assured that the agency is committed to safe foods and safe and effective medical products.
  • These are services that the American people cannot do without. If FDA cannot perform these services, nobody else will.
  • An adequately funded FDA is in everybody’s interests, including consumers, patients and industry. Everybody benefits when the agency has the resources to provide clear, timely, consistent and reliable science-based guidance.

FDA is a part of those government operations that differentiate society from chaos. It is not too strong to say that FDA needs to be sustained with the same priority as national defense and air traffic controllers. Don’t hesitate to say this out loud; it is true.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.

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