Agency officials said in interviews
that Dr. Joshua Sharfstein — the administration’s choice to lead the
agency while Dr. Margaret Hamburg goes through the confirmation process
to become commissioner — sought to avoid the agency’s cautious,
step-by-step actions in the recent peanut recall. More than a month
passed between the initial recall of a few lots of peanut butter and a
decision to recall years of production from the Georgia and Texas plants
of the Peanut Corporation of America.
officials have long been reluctant to seek broad food recalls unless
contamination has been proved, and such gradually expanding recalls have
been a common feature of F.D.A. food actions for decades. Last week, Dr.
Sharfstein told agency officials to act boldly far earlier, officials
Sharfstein speeded the agency’s decision making by getting as many as 40
agency officials to talk to one another in weekend conference calls. Dr.
Sharfstein “wanted to drive it hard and drive it fast,” Dr. Acheson said.
So the question that should be fairly
asked is a simple one: Has the FDA’s aggressive action increased food
safety? The answer is that this is unlikely. The powers that be at FDA
are either well intentioned but incorrect in their analysis, or they are
more concerned with burnishing FDA’s reputation for enhancing food safety
than with actually enhancing food safety.
Here is the problem. The particular
firm implicated in this food safety investigation has a good reputation.
We quickly get calls when things like this break, from ex-employees,
competitors, etc., telling us if the management of a company is sleazy.
That is why if you check out past editions of the Pundit you will find no
pieces defending the management of Peanut Corporation of America — we
heard from too many people of too many problematic decisions.
We are not getting that feedback on this
Now what about the FDA’s alleged
finding of salmonella in the plant in California… doesn’t that, you may
ask, prove that the FDA acted prudently and, in fact, enhanced food
safety by getting this product out of the system? Especially since the
FDA simultaneously identified some imperfect production practices?
No it does not. In order to enhance
food safety, the FDA would have to know that the product from this one
plant is more likely to have pathogens on it than the average product
being turned out by alternative sources.
Yet the methodology the FDA is using is
simply not designed to prove anything like that.
In this case, the FDA dove in to the
implicated plant, did hundreds of tests, a super thorough evaluation and
found some things that were problematic.
We have absolutely no issue with its
efforts and, indeed, think the plant should correct them and produce
safer food. We have no indication — from the FDA or anyone else — that
the company is unwilling to do so.
But if we did hundreds of tests and
super-thorough inspections of all other pistachio facilities, how do we
know all of them would be flawless in design and execution and without a
pathogen to be found? And if we don’t know that, then how can we possibly
know whether we are helping or hurting food safety?
If the implicated plant is imperfect
but less imperfect than its competitors, then restricting its sales but
not those of its competitors simply makes the food supply more dangerous
— not safer.
It is the failure of FDA to present
rational arguments for its actions or to even indicate its awareness of
these dilemmas that make us feel its executives are more concerned with
enhancing the institutional reputation of FDA than they are with
enhancing food safety.