FDA product review fees may double or more
Higher FDA fees for product review under Trump budget
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.
(Reporting by Caroline Humer; Editing by Leslie Adler)