An Inspector General’s report came out this week in which the agency made public their concerns that the FDA is too slow in managing of recalls. From that, we can clearly deduce that the OIG is not benefiting from the speed at which the FDA does or does not move. Having run a food safety system, I thought now would be a good to time to offer some much needed perspective.
Like all issues involving government agencies, the politics drowns out the logic of why our system functions the way it does. Those opposed to the existence of government hold it up to prove the ineffectiveness of government, while those in favor of strong regulator action hold it up to prove…the ineffectiveness of government. Somewhere of to the side is the fact that the government is actually quite effective in many important regards. To understand the FDA, my suggestion is get a mirror and look into it.
That’s right, the FDA is us.
They represent us, and our relationship to food in all our glory and our failings as individuals and as a nation. They also represent the “private public partnership” and all that means for commerce across all fifty states and the territories. They are staffed by some of the most exceptional hard working people you could ever hope to meet, and they also have employees who just skate by, just like the business you work(ed) in. They employee cutting edge science to solve mysterious, incredibly complex biological interactions, and they also succumb to the limitations of existing in a business-first country, just like everybody else. If you want to anticipate how the FDA is or is not going to react to a given food crisis, all you need to do is examine the approximate bottom line of the businesses involved in that given crisis and work backwards from there.
I am a very big fan of the FDA, and I am enthusiastic in my hopes for the changes the Food Safety Modernization Act will entail when it is fully implemented later this year. But I also know that like every government agency, they are made up of real live human beings who have quite a number of contradicting motivations playing out in real time when one of these 90-car-pile-up food emergencies show up at a grocery store near you.
Any off the shelf recall, whether it be food related or not, by definition is going to be composed of a series of complicated investigations, financial reimbursements, insurance claims and potential lawsuits or criminal probes. The vast majority of these recalls are handled by the private businesses involved, and in the case of food and drugs, the FDA is going to monitor the situation and be kept up to speed on the progress of finalizing the situation by the private businesses (and not for profits) involved. They ask for proof of the recall being dealt with, and they step in if things look fishy, or if companies cannot provide adequate proof that they are working quickly towards resolution. If they are satisfied that the involved entities have dealt with the situation adequately, they will stay on the sidelines.
With that in mind, anyone who has managed a food safety program (with or without an attending recall) has had some level of anxiety of the FDA or their state’s Department of Agriculture showing up unannounced to take a look around. The FDA is no joke, and they can and will shut a business down if that business is on the wrong side of FDA or state regulations. When the FDA shows up to your facility on a complaint, they are the police, and they do enforce the law with all of the accoutrements the powerful use to get compliance. Folks with FDA run ins often emphasis the scariness of that encounter. On the other side of that, the FDA is known to be somewhat reluctant to fully use their powers, especially the untested ones (i.e. new regulations), due to our particular and peculiar system of government in which a local, state or federal judge can strip the FDA, partially or in full, of their power in any given case. With all of the political turmoil surround the judiciary in this country, is it any surprise that an executive agency like the FDA would be careful not to stick themselves out far enough to get into a dispute with a district court judge in Sioux Falls or an Eight Circuit judge in St. Louis (let alone the supreme court) that might imperil their ability to oversee interstate transactions?
At a more granular level, in my own professional conversations with government regulators, I have found that not an insignificant number hold negative views about the government in general very similar to your average private citizens. I once did a facility finished a walk through with a very nice inspector who was open and honest about their basic distain for government oversight, while at the same that person was printing out my final government oversight form. The last thing that person did before leaving was thank me for having a nice facility that did not require the agent from having a late start to their planned weekend vacation. Life is just like that, sometimes.
As far how the FDA chooses to enforce the law, it’s the same way most enforcement entities do. The less powerful and essential get full enforcement, and the powerful get treated just a little bit different. Affluenza, it’s not just about one family in Texas. Remember that the only people who went to jail after the deregulation scandal of 2002 were a couple of guys from Enron (after that company went broke, not coincidentally) and Martha Stewart. The only major entities who went to jail after the crash of 2008 was Bernie Madoff and Allan Sanford (again, after both went broke). That’s part of our country, and the world. We are scandalized when it is put in front of us, but the wheel always gets just enough grease to spin, and food safety is no exception.
In the vast majority of their actions, the FDA is performing wonderful work, and they keep us remarkably safe from food born illness (11 million food illnesses out of 320 or so million people is not that bad considering all but the poorest of the 320 million people in this country eat three or more meals a day, plus snacks). I cannot say enough that they are on the side of the consumer, and they are exceptionally effective with limited resources.
But they are also on the side of the consumer, and you want to buy all that food you wanted to buy, correct? It would be upsetting to go to the trouble of seeking out a monetary transaction of your choosing only to find that the government has made that impossible by removing said item of your desire from the shelf just because they weren’t absolutely sure it was safe, would it not? It would be even more troubling if a major corporation saw its quarterly profits impacted by adverse government regulation, and that would be infinitely more troubling if you owned stock in that particular business and watched your return on investment suffer, no?
When a company finds that they must issue a recall, the very first thought goes to how much money is about to be lost, and if it is possible to recoup that money. Next comes the thought towards the fear that some will become ill or die, if that has not already happened. They want to recall the minimum amount of effected goods, and they want to get back to full production as quickly as possible. More than full production, really, since they are going to need to replace all of the product that had to be thrown away, plus the normal scheduled quantity of production. The FDA is going to give some leeway to the company to determine what needs to be recalled (and the company gets a pretty good amount of time to figure that out), and they are going to let the company have a first crack at figuring out when the situation is under control. That is why there are so many second and third waves of recalls. The cynic would have recalled the whole of the potentially contaminated lot or lots to save the time and energy of continuously expanding the recall over a period of weeks and months, but then the cynic’s money is not on the line in those situations.
When the FDA is at their most powerful, they are the police, with all the rights and privileges accorded to law enforcement. They produce warrants, they bring forfeitures and seize assets, and they throw guilty parties in jail in some cases. In short, they make sure the system functions properly.
When they are faced with a recall involving a multinational corporation, the FDA is referee. A referee much like a frat brother referee’s his house’s wet t-shirt contest. They do have a whistle, and they can step in if thing get out of hand. But really, they’re there to make sure that cash is made and that the whole event goes off without too much of hitch (the wet t-shirt contest is you and me by the way, buying food in the grocery store). In short, they make sure the system functions properly.
So does the FDA move too slowly? How much skin do you have in the game when the FDA get involved with a crisis?