FDA fees for product review would more
than double under Trump budget
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[March 16, 2017]
NEW YORK (Reuters) - The cost to
healthcare companies for U.S. regulatory review of their products,
including drugs and medical devices, would more than double under the
Trump administration's proposed 2018 budget.
For 2018, the Trump administration has budgeted over $2 billion in fees
to be collected by the U.S. Food and Drug Administration from industry,
twice as much as in 2017, according to budget documents released on
Citing a constrained budget environment, the proposed budget said
industries that benefit from the FDA's approval "can and should pay for
In return, the budget said it also offered measures that would help
speed up the approval process for new drugs and other products.
The FDA has been criticized by lawmakers for not being quick enough at
approving drugs, and President Donald Trump told Congress earlier this
year that he aimed to speed up the approval of drugs.
The FDA has been charging companies to review their products since 1992.
Most of the user fees collected are for prescription drugs - around $866
million estimated in 2017 - and generic drugs - around $324 million,
according to the FDA website. The FDA's 2017 budget was $5.1 billion,
the website said.
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A view shows the U.S. Food and Drug Administration (FDA)
headquarters in Silver Spring, Maryland August 14, 2012.
REUTERS/Jason Reed/File Photo
The budget does not say if the fee increases would be evenly spread
or directed in a particular area.
The budget did not provide specifics on what measures to speed up
approvals might include.
(Reporting by Caroline Humer; Editing by Leslie Adler)
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