FDA Struggles To Be Both Fast and Right, Will it Ever be Both?
As the FDA launches its pilot program related to tracking high-risk foods, we are once again reminded of the ongoing difficulties FDA experiences when it comes to choosing between acting quickly and acting thoughtfully. Think back to 2011’s food safety crises involving salmonella and E. coli. On numerous occasions, FDA was last to comment, often because they didn’t want to speak out of turn and provide inaccurate information. At other times, however, they were simply scooped by the world’s mass media who, with the advent of the 24-hour news cycle, were not incentivized to focus on high degrees of accuracy. In the cases where FDA was not the first to speak, wild speculation was broadcast on almost every news channel in existence. What is the FDA to do? Should they speed up their enforcement actions and risk an increase in errors? Or should they maintain silence until they have a high degree of confidence in the accuracy of their information, even while the news networks engage in non-stop speculation and conjecture?
In a recent Food Navigator article, an FDA senior advisor demonstrates the paradox of such agency communication decisions in a simple (but loaded) statement: “We need to be fast, but we also need to be right.” While it is, of course, desirable to be both fast and right, this statement ignores the third factor in any proper analysis: the cost. You cannot increase both speed and quality without increasing cost.
The recent Food Safety Modernization Act (“FSMA”) has heightened this paradoxical pressure on FDA by mandating unrealistic increased speed and accuracy while not providing a corresponding increase in budget. It attempts to offset the lack of funding by suggesting various increases in efficiency in relation to food safety communication in a few different ways.
- Increased planning/working with the private sector so that some of the cost is born by industry
- Increased leveraging of technology as a pre-curser to strategic communication
- Establishing communication streams that are socially integrated (grocery stores, media)
While ideas such as leveraging technology, partnering with industry, and crowdsourcing information distribution are, at their base, good ideas, one must ask if the goal of being “fast and right” is realistically obtainable under any existing cost structure. The answer is “No.” FDA will continue to have to choose – probably in a chaotic and inconsistent manner – between being right and being fast.
We have already seen examples of what choice FDA will make. FDA caused a panic with its recent sprint to talk about the orange juice/carbendazim issue before they even reflected properly upon the lack of any risk to consumers. In addition to causing sales of OJ to drop by over 15% and retail prices to rise by 6.7% in the four weeks following FDA’s announcement, FDA also refused multiple entries of orange products, thus harming specific importers and growers. This is just one clear example of how the pressures created by things like the FSMA will result in FDA choosing “fast” over “right” with increasing frequency, causing unneeded panic and damage to not only industries as a whole, but to specific industry participants.