President Donald Trump's 2018 budget proposal for the U.S. Department of Health and Human Services (HHS) includes a doubling of U.S. Food and Drug Administration (FDA) user fees, putting added strain on small digital health businesses.
The specific section in question states the budget proposal would “recalibrate FDA medical product user fees to over $2 billion in 2018, approximately $1 billion over the 2017 annualized CR level, and replaces the need for new budget authority to cover pre-market review costs. To complement the increase in medical product user fees, the budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products.”
The doubling of such user fees would directly impact small digital health business, many of whom are already struggling to bring products to market.
“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,” said the Alliance for a Stronger FDA in a statement. “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 increase could potentially halt the production of life saving devices, according to the American Medical Informatics Association. By potentially stopping the growth of innovative technologies, the proposal keeps healthcare in the past rather than progressing forward using technology.