The mandate for protecting the public’s health at FDA has expanded dramatically, especially last year when the Food Safety Modernization Act (FSMA) was passed and signed into law, giving the FDA new authorities to inspect and initiate recalls of food – particularly imports. This summer, E. coli breakouts in Europe sickened thousands and caused many deaths.
Yet ironically, as noted in an interview here on Eye on FDA with Congressman Jack Kingston, some in Congress do not see the need to fund the FSMA. And while the agency and the administration were seeking increases for FDA in the coming fiscal year, in May, the House Appropriations Agriculture Subcommittee (headed by Congressman Kingston) cut FDA spending by 11.5 percent. There remained among many the hopes that FDA funding might be restored through the course of the process vis a vis the Senate. Even more ironically, in July the House moved to curb funding for the Microbiological Data Program that screens U.S. produce for E. coli.
Enter the debt ceiling crisis where the cuts being contemplated now measure in the trillions – either 2 or 4 over a 10 year period depending on the mood of the negotiators and their propensity for walking out of discussions – and you have to ask yourself – what would a $4 trillion cut look like? Well, no matter what way you cut it, it doesn’t look like an increase for agencies like the FDA, does it? And yet the debt ceiling talks have made clear – the notion of cuts this deep are no longer a theoretical possibility, they are a practical probability.
The potential consequences are important to consider and one hopes that FDA is thinking about them. And they are not limited to food safety. For months now, the agency has been lumbering over the creation of a regulatory pathway for biosimilars in this country. New candidates for treatment approvals are increasingly complex. Risk management systems are more elaborate and need tracking. In short, the more complex our environment – from food to medicine – the greater the risks and the greater the risks, the more the agency grows.
But no matter what way one cuts this pie, at some point, there is going to be a shrinking budget for FDA. Not only that, as seen from the period of May when the agency was asking for more funds to July when draconian cuts are proposed across the board, the situation is highly fluid and rapidly changing. And so one hopes that somewhere in the bowels of the vast agency, someone is sitting down to consider how the FDA will be able to do more with less. There are a number of ways to accomplish that goal, but it will not be easy and will require careful strategic planning. The agency is not known for its quick action, saddled with some antique methodologies to consider change – the guidance system being a case on point.
The mandate for the agency to protect the public’s health has never been greater. It may be that the appetite for funding that mandate has never been less. With that kind of equation, effective alternative planning is essential.