In the wake of the most recent financial crisis – a question has emerged – inspired by our nation's banks, but now spilling over into the vernacular – too big to fail? It seems reasonable, therefore, to ponder the other side of the coin. Can some institutions become too big to succeed?
As we often hear, the FDA regulates about one-quarter of the economy – from your dogfood to your lipstick to your purchase of game meat to tracking down food borne illnesses to drugs to biologics and assuring the safety of the entire production chain from simple commodities such as tomatoes to complex manufacturing chains such as occur in the production of medicines like heparin. They are responsible for overseeing communications vis a vis medical products and patients. They are charged with collecting information about products that are consumed and issuing warnings when there are public health concerns. They oversee the labeling of products. They license and approve new products.
And, the job is growing. Recently the FDA was given new authority over the regulation of tobacco products and the recently passed health care reform legislation created a number of matters that the agency will need to address in order to implement the legislation, including the development of an infrastructure and approach to the consideration of biosimilars.
There is more. In the 1990s the priority enunciated by public sentiment was one for expanded access – we wanted the faster approval of drugs more quickly and we wanted greater access to foods in season and out. There was a public policy response – the creation of accelerated approval and fast track status for drugs and the globalization of trade that meant food and ingredients came from all over the globe. That means that the FDA we have today has a whole host of much more complex issues and breadth and depth to its responsibilities that did not exist even 15 years ago. There are more products, more product areas and more responsibilities than ever before.
But is there more ability to deal with them?
The Alliance for a Stronger FDA had an excellent posting last week along these lines concerning the possibility that new proposed legislation on food safety might become law and add another layer of responsibility. The Alliance makes the point that the CBO has estimated that the potential cost of expanded regulatory capacity would have a cost that approximates a billion dollars by year 5, doubling the current food safety allocation in FY2010. Yet, as the Alliance also makes clear, we are also facing a domestic budget reality that means that domestic spending will likely be reduced in coming years, not expanded.
With or without the food safety legislation, one thing becomes clear. We are expecting more and putting in less, which is a set up for failure. The areas of responsibility for the agency are proliferating. The budget for the agency will not. That means that regulatory oversight of one-fourth of the economy will have to do more with less. If it cannot, that means that the agency itself, under current circumstances, may not be sustainable – it is a race where one is destined to be always behind. That may be a reality to plan for sooner rather than later.