By now, you know the winners and the losers in the Trump budget: Defense and homeland security get a huuuuge boost; almost everything else has cuts, some of them very deep, indeed. Healthcare research and, in particular, the National Institutes of Health, face “targeted reductions,” as does the medical device industry, via a doubling of FDA user fees. The budget would double those fees, from around $1 billion to $2 billion next year.
The Alliance for a Stronger FDA, which includes consumer advocates, health professionals and trade associations among its members, issued the following statement in response:
“The President’s proposed funding mechanism — cutting more than a third of the agency’s appropriation and offsetting it with an enormous increase in medical product industry user fees—is neither wise nor realistic. Not wise because FDA’s core responsibilities—safe and effective medical products and safe foods—need to be supported in large measure by the public, who is the primary beneficiary. Not realistic because the drug and device industries have recently completed user fee agreement negotiations with FDA, concurring upon an appropriate amount of industry fees to support agency improvements. User fees have always been intended to supplement the agency’s appropriation, never to replace it.”
The administration justified the proposal by saying that “in a constrained budget environment, industries that benefit from FDA’s approval can and should pay their share.”
One potential upside for industry, notes sister brand Qmed, is that "the plan also calls for new administrative actions designed to achieve regulatory efficiency, and speed the development of medical products. Cutting some of FDA's red tape to improve approval times is expected to be a focus of Scott Gottlieb's, if he is confirmed as the new FDA commissioner.”
Of course, as an NPR reporter noted, the presidential budget always “lands with a thud.” What really matters is what happens in Congress, and it’s already clear that many of the planks face serious obstacles.