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Three Questions For FDA

After listening to last week’s press conferences by the FDA and CDC, three questions came to mind:

1) Why does the FDA establish policies that don’t make sense?

For example, in the early days of this outbreak the FDA’s recommendation against consuming various types of tomatoes only applied to New Mexico and Texas. Yet one didn’t have to be a food safety expert to realize that if the problem was a tomato from Mexico that entered the US in Texas, merely driving it through Texas and New Mexico to Arizona would not make it a safe tomato. The recommendation was illogical.

Now the FDA was at pains last week to make clear that it did not know if the problem was on a farm or that it could have been somewhere else in the packing and distribution chain. In fact, specific reference was made to searching for a facility where tomatoes from Mexico and Florida might have “come together” and looking for a facility where something dangerous “may have been going on or is continuing to go on.”

Of course, if the danger came from a repacking facility or other such facility where a dangerous activity may be “continuing to go on,” what is the point of publishing that list of states and countries not associated with the outbreak? If the problem is in a repacking facility, then the fact that those states weren’t producing at the time of the outbreak is meaningless.

2) Don’t they ever speak to people who know the subject?

To parody some old movies, when a situation such as this arises here is what you do: First, you find people who really know the business. We’ll pick on Jay Taylor since he just got out of the business. Second, a few marines show up surrounding Jay and tell him the President really needs his help and he should pack his belongings. Then he heroically boards the Marine helicopter to save his country.

The press conferences are filled with evidence that FDA knows little about the industry and hasn’t tried to learn much. When asked if there is one big facility in the US where tomatoes from Florida and Mexico are comingled and then redistributed — the answer given is that the traceback will determine if this is so.

Traceback is fine, but you don’t have to begin traceback in a state of total ignorance. This can all be sped up with a little expertise on board.

3) How does the FDA do resource allocation?

Dr. David Acheson, M.D., FDA’s Associate Commissioner For Foods, clearly said of outbreaks that “Just because it is large doesn’t mean we put more horses on it at FDA,” and then he went on to explain they don’t want even one person to get sick.

Well nobody wants anyone to get sick, but since we do not have unlimited resources, don’t we have to look at the upside and downside of any investment? Of course, size of outbreak isn’t the only criteria; some are more deadly than others, some more inscrutable, etc. But, still and all, isn’t it possible that this failure to allocate resources rationally could help explain why FDA says it always needs more money?

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