Device, drug makers would pay $1 billion extra to FDA under Trump budget

Included in President Donald Trump’s budget proposal for fiscal year 2018 is a big increase in what the medical device and pharmaceutical industries would pay the Food and Drug Administration (FDA) to cover the costs of reviewing their products.

Under the plan, companies would collectively pay an extra $1 billion ($2 billion total) in “medical product user fees,” doubling the amount from the continuing budget resolution for the current fiscal year.

“In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share,” the blueprint said.

In return, the proposal said there will be unspecified administrative changes made to “achieve regulatory efficiency and speed the development of safe and effective medical products.”

Overall, the proposal would cut 18 percent, or $15.1 billion from HHS and its associated agencies, reducing its overall funding level to its lowest mark since 2002.

The blueprint doesn’t offer specifics in many different areas, making its overall impact on medical technology hard to ascertain. On the innovation side, research would be cut deeply, with Trump proposing a $5.8 billion reduction for the National Institutes of Health (NIH). This would erase the $2 billion boost given to the agency in 2015 and include a “major restructuring” of the institutes and centers under its umbrella.

One area supposedly untouched by the Trump administration’s budget axe would be additional funding for the 21st Century Cures Act. That law included $4.8 billion for NIH to advance the precision medicine initiative among other health IT-friendly measures