Hunting for the Wheat in the Chaff of Hyperbole

This is the Alliance’s tenth President’s budget request and we have learned a few things along the way.Notably, it is important to distinguish between the “headline” numbers and the reality of what the President is actually recommending. Last year, the President’s budget was touted as providing FDA with

$4.9 billion, an overall increase of nine percent or $424.8 million compared to the FY 2015 Enacted level.

That sounded wonderful and was widely and inaccurately touted in the media as demonstrating a significant funding commitment to FDA by the President (“nearly $5 billion”).The reality? The headline number included several hundred million dollars in proposed user fees, none of which had a chance of becoming law. It also included inflation-adjustments to user fees. Altogether, two-thirds of the proposed FY 16 increases involved industry rather than taxpayer funds.The actual proposed increase for FDA funding from the federal budget and from taxpayers amounted to about $145 million or 5.5% above the $2.6 billion appropriated in FY15. Ironically, this was actually a fairly good budget request, just not what was publicized as the President’s request.In the same vein, adding together appropriations and user fee income tends to distort the picture. User fee monies are collected for very specific purposes and cannot be used to plug holes when priorities and needs shift. This is not to be in the least critical of user fees -- they have clearly benefited patients, companies and FDA -- but rather to point out that a user fee dollar is not available for just any need. In addition, of the nearly $2 billion in user fees, more than $500 million of the user fees are for the tobacco center. Those dollars may be providing great value for the American people, but they are not available for FDA’s traditional responsibilities for safe foods and safe and effective medical products.The Alliance will publicize the actual appropriations numbers as soon as we can find them in the welter of data and other information contained in the President’s request. Hopefully, they will reflect the FDA’s many pressing needs for additional funding. Not only would this be good in its own right, but will definitely help with the Congressional appropriations process because the President’s proposals are used as a baseline when the subcommittees’ mark-up. The President’s request is also important because it is hard to get Congress to spend more money on FDA than the President requested.So, next Tuesday is a big day with powerful implications for FDA’s future. We will keep you informed.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.