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FDA “Exceptionalism” at the Funding Crossroads

The 15-month long battle over the nation’s fiscal year (FY) 2011 budget was finally resolved on April 16, just before Congress recessed. Despite broad pressures for program cuts and deficit reduction, the FDA received a $107 million increase, one of the few winners among domestic federal agencies.

Congress returns at the beginning of May to start the FY 12 appropriations process. Downward pressure on federal spending will intensify. If, despite this, the FDA receives another increase, then it will move closer to establishing itself as an exception to the budget cutting process. Thus, FDA Matters sees the coming funding battle as a crossroads for FDA.

There are two primary considerations that drive FDA’s fate in the FY 12 funding battles:

  • The US government is in a fiscal situation that can’t be resolved without unpopular actions. There is no avoiding the “iron triangle” of deficit reduction: discretionary spending cuts, entitlement changes and net increases in tax revenues. While there is hope that a comprehensive, multi-year resolution can pass Congress this year, it will still take at least a decade before the deficit crisis is fully behind us.


  • FDA has been chronically underfunded for more than 25 years. Congress has chosen to give FDA new responsibilities without commensurate increases in appropriations. Even without these mandates, the FDA has needed to grow because of globalization, increasingly complex science, and significant growth in the industries it oversees. After several years of substantial increases, the agency is in better financial shape, but still resource-restricted in fulfilling its mission.

Advocacy by the Alliance for a Stronger FDA and others (especially Commissioner Hamburg) undoubtedly helped in achieving an increase for FDA this year. Also of significant help to FDA was the half-billion dollars in “saving” that the agriculture appropriations subcommittees derived from lower FY 11 cost estimates for the nearly $7 billion Women’s, Infant and Children (WIC) nutrition program. Behind the scenes, we know that Members of Congress spoke on behalf of FDA’s funding needs.  

The FDA budget, along with the rest of federal spending, is going to be under significant pressure for at least the next 10 years. Surviving the first year is an accomplishment, but not a trend. Nor can it be treated as a sign that FDA will have it easier in the FY 12 funding battles.

Yet, FDA has a strong case for why it should be an exception to budget-cutting. Here are a few of the points that should resonate this year:

Congress is interested in creating more jobs and stimulating the US economy. FDA is part of the solution.  FDA-regulated products represent nearly 25 cents out of every consumer dollar spent in the US.  There are millions of jobs in the food, drug, device and cosmetics industries that FDA oversees. These are also industries that are growing and are major exporters of US products.

Congress is concerned that regulatory agencies, in particular, are an impediment to innovation and the growth of US companies. Yet, all the major trade associations favor increased FDA funding. Every company whose products are regulated by FDA probably wishes for at least a few changes in agency rules and regulations. However, they recognize that no federal regulatory agency is more willing to engage in dialogue and consider changes. Further, industry understands that their problems are likely to get worse, not better, if FDA is underfunded.

Congress wants to protect the health and well-being of the American people. FDA has a unique role in achieving this. If FDA cannot do its job, there is no organization or persons to pick up the slack. No one else can assure that our food is safe. No one else can evaluate the safety and efficacy of drugs, devices, biopharmaceuticals, and vaccines prior to market. The agency also has a unique role in preventing agro-terrorism and developing medical countermeasures that will lessen the casualties from a terrorist attack.

There are many more reasons why FDA should be an exception to Congressional budget-cutting. The main advocate for this cause is the Alliance for a Stronger FDA, the only multi-stakeholder group devoted to increasing the appropriated resources available to FDA. I urge you to contact me and consider joining.  


For purposes of disclosure: I am one of the founders and serve as Deputy Executive Director of the Alliance for a Stronger FDA. Members include patient and consumer groups, professional societies, research advocacy groups, associations, companies, consultants and individuals. For more information about the Alliance, go to www.StrengthenFDA.org or write to me at sgrossman@StrengthenFDA.org.

FDA and Its Regulated Industries: A Cornerstone of America’s Economic Future       March 7th, 2011


On March 7, the Alliance for a Stronger FDA released a white paper on the far-reaching and positive economic impact of a strong FDA and the industries it oversees. The report is intended to provide interested parties, including Congress and Executive Branch policymakers, with information on FDA’s role in economic growth. A number of groups–consumers, patient advocates and industry–provided comments to the Alliance on the impact of FDA on the American economy.


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