TRUMP WANTS TO DOUBLE DEVICE USER FEES (Orthopedics This Week)
President Trump wants the medical device and pharmaceutical industries to pay the full cost to push devices and drugs through the FDA.
His budget proposal released on May 23, 2017, will basically double medical product user fees to finance the full cost of FDA pre-market review and replace the need for new appropriated budget authority. Currently, medical product user fees cover an average of 60% of FDA premarket review costs. That would push user fees to over $2.4 billion for 2018, up $1.2 billion from 2017.
"Industries that directly benefit from FDA's medical product premarket approval and administrative actions can and should pay more to support FDA's continued capacity," stated the proposal.
More Money for FDA
Overall, the budget would cut the agency's congressional funding from $2.74 billion to $1.89 billion. But when adding in the extra fees collected from industry, the agency's entire budget would increase by over $400 million.
Scott Whitaker, president & CEO of AdvaMed, told MassDevice.com via email that the group is seeking further details on the proposal from the White House “before we can assess its impac...
