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FDA Funding Confronts the “New Normal”

September 9, 2011

Over the last 5 years, FDA has been one of few discretionary programs to receive substantial funding increases. This reflected both Congressional and Executive Branch recognition that the agency was dramatically underfunded for its growing responsibilities in an increasingly complex world. FDA still needs more resources, even though the downward budgetary pressures have become significantly greater.

“Downward budgetary pressure” is, of course, a euphemism. Chairman Kohl, in his opening remarks at the Senate mark-up, was far more direct, referring to the austerity required to reduce the federal deficit and live within our nation’s means. As I believe will be clear as the Congressional “supercommittee” takes up its deficit reduction work … there is no one in either party who thinks that annual federal deficits exceeding $1 trillion are acceptable. Even among those who think the gap should be closed primarily by taxes or entitlements, there is a strong belief that discretionary spending will need to be cut far more deeply.

This is frustrating for the Alliance — we are arguing for funds for an agency whose responsibilities are increasing every year. Some of this comes from important new mandates (e.g., the Food Safety Modernization Act, the new bio-similars approval pathway, advancing medical countermeasures against bioterrorism). However, FDA’s expanding mission is at least equally driven by pressures that are beyond Congress’ ability to control: globalization, increasing scientific complexity, and expansion in the size and activities of the regulated industries.

What we confront is the “new normal” in government spending. Federal programs are going to shrink and some will disappear. Hill staff tell us that “the easy cuts” have already been made. Programs that have survived to this point will continue to be subjected to an often-brutal pruning that will, in effect, determine our national priorities. Every one of the dollars that are cut in FY 12 (and FY 13, FY 14, etc.) will be a dollar that was important to someone, whether we personally agree. There is no alternative to Congress and the federal government but to turn away from important activities that are, nonetheless, too expensive in the aggregate to be continued.

The Alliance’s goal is to have the FDA seen as being in a separate category, one that reflects the centrality and indispensability of the agency to the everyday life of every American. If you consume food (and we all must), then you are dependent on FDA’s activities that make our food supply safer. If you have a chronic or acute medical condition, then you are dependent on FDA to make good judgments about the pre and post-market safety and effectiveness of medical products. These are the FDA’s efforts that receive the most attention, but we are all dependent (as well) on an even broader set of agency responsibilities. These range from vaccines to nutritional supplements, cosmetics to radiation-emitting devices, animal medicines to combating bioterrorism. The Alliance has also documented the enormous economic impact of FDA regulated industries.

As we adjust to the “new normal” in federal spending, we have two important supports for our efforts. First — as was demonstrated in the Senate — policymakers continue to believe in the agency, its mission, and the necessity for increased funding. Second, it is possible to anticipate the severe consequences that would come from underfunding FDA. There is no other government agency to pick up the slack … and for the most part, FDA is performing services that industry itself sees as governmental and not capable of being duplicated in the private sector. FDA standards protect the American people (and, really, people around the world). Those standards also assure a level playing field for companies that want to produce high-quality products.

The “new normal” will mean austerity for FDA. It will mean that the agency will have to find ways to do its job more efficiently. Some programs and activities within the agency will need to be reduced or eliminated. Nonetheless, as an Alliance, we are right to insist that FDA funding must continue to match what it is being asked to do and, therefore, continue to grow. Together, we can make sure that policymakers understand and support the agency

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