There have been a lot of changes at the FDA in the past few weeks – changes in personnel and changes in approach. Today the New York Times reports that Dr. Joshua Sharfstein, who has taken the reigns as Acting Commissioner until Dr. Margaret Hamburg is confirmed, pushed the agency to be far more aggressive than in the past with respect to the current recall involving pistachios. For a long time now, people have been trying to read the tea leaves to ascertain what the new Administration would bring in the way of differences at FDA. This New York Times article provides some worthy insight.
If one remembers back to the painful episode of the tomato recall during the spring/summer of 2008 and the never-ending peanut recall – decisions were made that were in response to where the evidence, or indications of evidence, pointed. That resulted in long delays between the time of reports of illness and actual action by the agency and stretched out the recall situation over a lengthy period of time which, in turn, can certainly shake public confidence. According to today's New York Times report, however, Dr. Sharfstein encouraged far quicker action, and a recall was underway before there were any reports of illness.
During the recording of a podcast that I did with Dr. David Acheson, Assistant Commissioner for Food Safety at FDA back in September 2008, he outlined the anatomy of a food recall, that included reactions to CDC reports of illness outbreaks. It would seem apparent that this methodology may be a thing of the past as the Administration begins to position on more sure footing in response to consumer protections. In other words, the evidence of conditions that could make people ill are going to become the basis for action, rather than evidence of illness itself. That may not sound like much of a change, but it is. It means that food manufacturers are going to be held to a higher standard than before to ensure and provide proof that their manufacturing methods are air tight and that products do not have the potential to cause harm. It also means that large-scale recalls may be undertaken with more frequency in the future.
These actions are bound to bolster consumer confidence in the FDA. It would be logical to assume that a similar outlook may apply to the approval and monitoring of drugs and biologics. And if this same standard is to be applied to drug delivery as well as food, it may mean that we see an increase in Complete Response Letters as manufacturers are told to go back to the drawing board and more thoroughly demonstrate that risks presented by pharmaceutical and biologic treatments do not have the potential for causing harm, particularly in outliers, or that risks have been addressed through effective management programs. At what level that standard is set remains to be seen, but it certainly seems reasonable to begin thinking now of higher, more state of the art and much more involved risk management efforts than seen in the past. It won't be your father's risk management program.
