FDA Product Review Fees Would Double Under Trump’s Budget

© Reuters. FILE PHOTO – A view shows the headquarters of the US Food and Drug Administration in Silver Spring

NEW YORK (Reuters) – The cost to healthcare companies of the U.S. regulatory review of their products, including drugs and medical devices, would double under the 2018 budget proposed by the Trump administration.

For 2018, the Trump administration has budgeted more than $ 2 billion in fees that the US Food and Drug Administration will charge the industry, double the amount in 2017, according to budget documents released Thursday.

Citing a tight budget environment, the proposed budget said that industries that benefit from FDA approval “can and should pay 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 to approve drugs, and President Donald Trump told Congress earlier this year that its goal was to speed up drug approval.

The FDA has been charging companies for reviewing their products since 1992. Most user fees collected are for prescription drugs, about $ 866 million estimated in 2017, and generic drugs, about $ 324 million, according to the site. FDA website. The FDA’s budget for 2017 was $ 5.1 billion, the website said.

The budget does not say whether the rate increases would be spread evenly or be directed to a particular area.

The budget did not provide details on what measures to speed up approvals could include.

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