Price increases in the FDA could mean that submitting a news drug application could cost twice as much as last year.
US President Donald Trump and his administration have released a financial plan of action called “America First: A Budget Blueprint to Make America Great Again.”
In it, among a number of other changes, are proposed alterations to the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
The plan “recalibrates” FDA medical product user fees to more than $2bn in 2018, about $1bn higher than in 2017. This is intended to “replace[s] the need for new budget authority to cover pre-market review costs.”
In a constrained budget environment, industries that benefit from FDA’s approval should pay for their share.
“In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share,” claims the document.
The proposed changes also reduce the NIH's spending by $5.8bn, from about $25.9bn – a cut of around 20%.
The Budget includes: “a major reorganization of NIH’s Institutes and Centers to help focus resources on the highest priority research and training activities...”
This includes, among other things, eliminating the Fogarty International Center and consolidating the Agency for Healthcare Research and Quality within NIH.
The Budget also “rebalance[s] Federal contributions to research funding.”
