Friday, June 13, 2008

The FDA blows off the GAO

Typically, when the Government Accounting Office says that a government agency should do something, it does so with the best interests of the American people in mind. The Food and Drug Administration (FDA) typically blows them off and does whatever it wants. Which is usually nothing.

The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply, including $417 billion worth of domestic food and $49 billion in imported food annually. Changing demographics and consumption patterns along with an increase in imports have presented challenges to FDA. At the same time, recent outbreaks, such as E. coli from spinach and Salmonella from tomatoes, have undermined consumer confidence in the safety of the food supply.

In November 2007, FDA released its Food Protection Plan, which articulates a framework for improving food safety oversight.

In January 2008, GAO expressed concerns about FDA's capacity to implement the Food Protection Plan and noted that more specific information about the strategies and resources needed to implement the plan would facilitate congressional oversight. This testimony focuses on

(1) FDA's progress in implementing the Food Protection Plan,
(2) FDA's proposal to focus inspections based on risk, and
(3) FDA's implementation of previously issued GAO recommendations intended to improve food safety oversight.

To address these issues, GAO reviewed FDA documents, such as FDA's operations plan, and FDA data related to the plan. GAO also interviewed FDA officials regarding the progress made. GAO also analyzed FDA data on domestic and foreign food firm inspections. GAO also analyzed the status of past recommendations.

So that all sounds well and good, doesn't it? Hundreds of people have been sickened this past week--and the US tomato industry is collapsing.
What is the FDA doing to comply? To protect American citizens?

Since FDA's Food Protection Plan was first released in November 2007, FDA has added few details on the resources and strategies required to implement the plan. FDA plans to spend about $90 million over fiscal years 2008 and 2009 to implement several key actions, such as identifying food vulnerabilities and risk. From the information GAO has obtained on the Food Protection Plan, however, it is unclear what FDA's overall resource need is for implementing the plan, which could be significant.

For example, based on FDA estimates, if FDA were to inspect each of the approximately 65,500 domestic food firms regulated by FDA once, the total cost would be approximately $524 million. In addition, timelines for implementing the various strategies in the plan are also unclear, although a senior level FDA official estimated that the overall plan will take 5 years to complete.

Importantly, GAO has noted that public reporting is the means through which the federal government communicates the results of its work to the Congress and the American people. FDA officials told GAO that they had prepared a draft report on progress made in implementing the Food Protection Plan, but as of June 4, 2008, FDA told GAO that the Department of Health and Human Services had not cleared the report for release. The Food Protection Plan identifies the need to focus safety inspections based on risk, which is particularly important as the numbers of food firms have increased while inspections have decreased.

For example, between 2001 and 2007, the number of domestic firms under FDA's jurisdiction increased from about 51,000 to more than 65,500, while the number of firms inspected declined slightly, from 14,721 to 14,566. Thus, conducting safety inspections based on risk has the potential to be an efficient and effective approach for FDA to target scarce resources based on relative vulnerability and risk. FDA has implemented few of GAO's past recommendations to leverage its resources and improve food safety oversight.

Since 2004, GAO has made a total of 34 food safety related recommendations to FDA, and as of May 2008, FDA has implemented 7 of these recommendations.

Yep--the FDA is in compliance with about 21% of what the GAO recommends. That's a great track record. But--when all is said and done--it's a great metaphor for where we stand today. The American people are in danger because this administration cannot protect them from bad food supply issues that have already been identified and have already been submitted to them as recommendations. We're not talking about unknown threats, variables no one can anticipate or obscure issues that only affect a handful of people. We are talking about major problems facing millions of consumers that have been identified by the GAO.

And, sadly, that's the Bush administration--21% in the approval ratings, and 21% in the compliance ratings.

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