rue to its word, the Trump administration released its 2018 budget that includes a notable change for drug and device makers — they would face a stiff increase in so-called user fees that industry pays for to fund product reviews conducted by the Food and Drug Administration. And the higher fees, which are slated to nearly double to $2.4 billion, would be used to cover the entire cost of those reviews (see page 39).

The notion was widely anticipated after a May 15 letter, which written by US Health and Human Services Secretary Tom Price to the Senate Health, Education, Labor, and Pensions Committee, leaked out. The administration, he wrote, “is seeking to recalibrate how the FDA finances its medical product review work in order to better serve the American people.”

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