From time to time on this blog, I have raised the question about whether the growth trajectory of the FDA is sustainable. Already overseeing the regulation of over one-quarter of the economy, within the past few years, the mandate of the agency has expanded like a balloon. One thing, however, that has become certain is that while growth has been steady, the atmospheric pressure has also changing – and not in a way that is conducive to expansion.
A recent spate of legislative advancements – health care reform, the stimulus package, the passage of the Food Safety Modernization Act and the Family Smoking Prevention Tobacco Control Act have all added considerable heft to FDA’s plate. The agency must figure out how it will deal with biosimilars and comparative effectiveness; and there is a whole new set of authorities unsupported by user fees in food safety.
With regard to specific appropriations, funding for the Food Safety Modernization Act is certainly no sure thing, and has its own specific detractors on the Appropriations Committee such as Congressman Jack Kingston. But generally speaking, there are funding issues as well.
How they will impact the FDA is being closely followed by the Alliance for a Stronger FDA. As they recently noted, “FDA’s FY 11 funding level has not been set. The agency’s actual number will be set by the House Agriculture appropriations subcommittee as they decide how to find $3.2 billion in savings (below FY 10) for the current fiscal year.”
That subcommittee is headed by Congressman Kingston. During my interview with him on the second day of the new Congress, it was clear that the Congressman was intent on cutting spending. He also was a great proponent of industry’s ability to police itself.
It is reality that domestic agencies, presumably FDA included, are going to face a cash drain. What impact is that going to have at FDA? Will there be a decision to move ahead with new programs that are not funded by user fees or to keep investing in the enforcement renaissance that has been underway at the agency (also, I believe, not funded by user fees)? Does there need to be such a choice?
Only time will tell. But the uptick, for example, to 52 regulatory action letters issued by DDMAC during 2010, while a near doubling of actions over just a few years ago, is still a far cry from enforcement levels of a decade ago, when the agency and its mandate were smaller. At this point, exactly what the impact of budget cuts will be may be hard to discern – but what is not difficult to anticipate is that cuts will happen, and FDA is quite likely to be included.