This is about food, but also about medicine.
This week the markup of the House Appropriations Agriculture Subcommittee was posted to the Committee’s Website revealing that the FDA was getting a $285 million dollar cut from last year’s budget and $571 million below fiscal year 2012 request put in by the Administration. In fact, there were cuts nearly across the entire package. Overall the spending package was cut by 13.4% while the FDA’s cut amounted to 11.5% less.
Presumably, the large chunk of requested funding that is going to be unfunded is the implementation of the Food Safety Modernization Act (FSMA) passed in the 111th Congress that would, among other things, step up foreign inspections to ensure food safety. The passage of that act was in part fueled by the many food safety problems that grabbed headlines in 2007 and again in 2008 – perhaps most notably the melamine contamination of several food products prompting widespread recalls of multiple products and multiple brands. If the FSMA had been in place then, would those recalls have been averted? We may never know. But clearly there is a cost to implementation that is identifiable in dollars and cents – the cost of not implementing may be much more, but is also more elusive as a fiscal concept.
If these appropriations become reality, FDA is at a crossroads. There have been statements made that there are provisions of the FSMA that can be implemented without the broad funding, but without much in the way of specifics. What elements of FSMA won’t be implemented as a result? (It should be noted that the Food Safety Inspection Service also received a cut of $35 million.)
And on the medical product side of the equation, the cuts will force the agency to assess the status quo and decide what will be different for the future. The agency will have to look to cut waste, redundancy and to become more efficient, which is what appropriators have in mind.
Of course, FDA can’t enunciate at this stage of the proceedings how it will work to implement FSMA without funding for doing so would signal that they can do without it. One hopes, however, that there are plans on the drawing board. Because once a final corner is turned on FSMA, FDA will have to state with clarity for all its stakeholders on both the food and drug side of the house, how it intends to accomplish more with less.