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Report: FDA needs to reorganize to better protect food
Thursday - 6/10/2010, 4:24pm EDT
Part of that means taking a serious look at the Food and Drug Administration.
Martha Roberts is a member of the Institute and a former Deputy Commissioner of Agriculture at the Florida Department of Agriculture. She says new statistics from the Centers for Disease Control and Prevention show that food-borne illness has not declined and still poses a major health risk.
The report suggests many things, but one of the most eye-catching has to do with the creation of a new office or agency that would control data about food-borne illnesses and risks for the federal government.
"First of all, we were to look at FDA and FDA's role in enhancing the safety of the U.S. Food supply. There is one thing that we propose that's actually over and above FDA -- it is so strategic that everyone have the ability to access essential data, be able to put it through various modeling, be able to massage that data and to do various predictions -- that we actually propose that there be a risk analysis and data center that's separate from any federal agency."
Part of the problem for the FDA is that it hasn't been able to get ahead of the curve. History shows that, for the most part, it has been reactionary, not proactive, when it comes to problems regarding food in the U.S.
"We want them to be more preventive, more prepared, to be looking at the actual risk involved in our food supply, and approaching those decisions and the use of the resources based on risk. Quite frankly, we all [gather] around the term 'risk-based'. Everyone says they have a risk-based system, but when this group started looking into this and trying to debate the issue, we quickly found there's no acceptable definition. No one has the same idea of what actually constitutes a risk-based system."
This is why the group tries to define what a risk-based system would actual entail -- and this definition is not just for the FDA, but other federal agencies that deal with risk.
One of the biggest parts of mitigating risk successfully has to do with information sharing. Roberts says this just isn't happening often enough within the federal government, or even within federal agencies themselves.
"We don't have the FDA being able to access any of the data that they would need to make a strategic decision as to how to prevent food-borne illness. Within the many recommendations within this report, we actually have three separate areas. We have many specific recommendations that the FDA can do right now with the resources . . . and statutory authority they have available to them. . . . They can do it right now."
So, the first part of solving the problem has to do with reorganization, according to the report.
Roberts says the FDA doesn't necessarily need more funding for its current resources at this time, but it does need to closely evaluate what it has available.
After the evaluation, she explains, then the FDA might have a better idea of where it needs future funding the most.
The report also says that the FDA should explore alternative approaches to the regulation of food safety.
Right now, she says, a manual and processes do exist for how inspections should be carried out, but this is often complicated and time-consuming.
"[It] involves multiple inspectors going in for 8 to 10 hours -- or sometimes two weeks time with 5 and 6 inspectors. . . . We're saying to them, 'You need to step back and review this inspectional procedure'. . . . Quite frankly, at the moment, federal inspectors are responsible for a whole host of divergent areas of responsibility. They're responsible for inspecting drugs, medical devices, food. We recommend that there be a reorganization of the Office of Regulatory Affairs and have dedicated inspectors dedicated to food safety and food inspection."
This wouldn't necessarily cost a lot, either.
Roberts says many states already have their own food inspectors that adhere to standards equivalent to the federal guidelines. The FDA, she adds, needs to leverage and use this data instead of reinventing the wheel.
There are a myriad of other changes suggested in the report, but Roberts says the main issue concerns time -- something should be done sooner rather than later.
"We don't even know what we don't know. In fact, that's where we have to start. We have to ask the right questions."
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