FDA fees for product review would more than double under Trump budget

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By Caroline Humer | NEW YORK

NEW YORK 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 Thursday.

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

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.

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.



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