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GAO Hits a Home Run

On July 20, the GAO released its study, “FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of its Resource Needs.”

FDA’s world has changed considerably since the report was requested. Some aspects of the report describe problems that are known and already being addressed. In other important regards, the report is extremely valuable. It will be widely cited and may be instrumental in creating positive changes at FDA.

The GAO started its research using the FY 2008 funding levels as the latest available figures. Subsequently, FDA received a $150M supplemental appropriation in FY 08 and a $325M increase in FY 09. It looks like the agency will get another $295M increase for FY 10. Over this period, the FDA will also have benefitted from a significant increase in user fees.

Therefore, using FY 08 funding levels gives a distorted picture of the FDA situation today.

Further, the new Administration has joined Congress in acknowledging the critical importance of FDA. They have committed to addressing the agency’s many management and programmatic needs. When Congress requested the report, it was looking for GAO to build the case for better management, stronger fiscal controls and higher productivity in the medical product area. In 2009, neither FDA nor Congress need to be persuaded.

If increased funding has changed FDA’s financial and programmatic situation….and the new Administration is already undertaking management initiatives, why is the GAO report so important?

The report’s primary value is that the GAO has:

  • developed the issues list,
  • compiled the data,
  • done the analysis,
  • drawn the conclusions and
  • made the recommendations.

They have been thorough in their work. Their views represent neither an ideological Congress nor a self-serving agency. Never mind that Congress has not been ideological in its concerns about FDA management. And that FDA has not done a good job at being self-serving. To the question “who says,” there is a better, highly credible answer: “GAO does.”

In the process, GAO has boosted some important FDA program needs and inched forward on some more difficult items. For example, FDA needs a major infusion of monies—well beyond what it’s getting—to upgrade and disseminate information technology. The agency may not have enough people to review adverse events reports, but merely hiring more people cannot solve this problem. Only an IT solution can make this labor-intensive work more productive and valuable. Also, the report documents the growing demands on the agency from new legislative mandates and the difficulties in retaining staff.

At the same time, GAO “damns” user fees with faint praise about how it has given the agency flexibility and prevented it from falling further behind. In effect, GAO re-raises the difficult issue of public funding versus user fees. Nothing more is needed to start a debate…if someone wants to have one.

In sum, FDA and Congress are already working on many of the issues and recommendations contained in the new report. GAO’s credibility and thorough analysis will make these efforts more productive and contribute to a stronger and better FDA.


The GAO report can be found at: http://www.gao.gov/new.items/d09581.pdf.


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