While the current bill reauthorizing US FDA user fees seems to be a done deal in Congress, the Trump White House continues to insist medical products industries pick up the entire tab for reviewing drugs, biosimilars and devices.
On July 12, the House passed the FDA Reauthorization Act or FDARA, which includes user fee authorizations for drugs, biosimilars and medical devices as well as several riders addressing medical device accessories, device facility inspections and other issues. The bill is now on its way to the Senate for approval and has strong bipartisan support, as well as support from industries and FDA. (Also see "US FDA User-Fee Bill Swiftly Passes US House, Now Moves To Senate" - Medtech Insight, 12 Jul, 2017.)
While the White House says they are in support of the bill, the Trump administration is still insisting medical product makers pay more. In fact, the administration states medical product companies should fund the full cost of FDA premarket reviews, complaining that the House bill continues to require taxpayers to invest a significant portion of the cost of the reviews.
"The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs," said the White House in a July 13 statement. "In an era of renewed fiscal restraint, industries that benefit directly from FDA's work should pay for it."
The administration's demand is consistent with their initial budget proposal earlier this year to greatly increase user fees collected from industry. (Also see "Trump Budget: FDA-Regulated Firms Should Pay 'Their Share' In User Fees" - Medtech Insight, 16 Mar, 2017.)
Raising user fees was a thorny subject during the initial conversations between FDA and medical device lobby groups when negotiating MDUFA IV. Industry voiced concern the Obama administration was moving to push more burden of the review costs onto industry and emphasized the importance that the agency continue to be paid for by taxpayer-funded appropriations. After a year of negotiations device-makers accepted a $300m-plus increase in user fees over five years, associated with guarantees of improved review times and other metrics.
Senators on the Health, Education, Labor and Pensions Committee have already made it clear they are unwilling to re-open negotiations to raise user fees. (Also see "Senators To Trump Administration: 'Way Too Late' To Change US FDA Budget Structure Now" - Medtech Insight, 19 May, 2017.)
Sources following the user fee bill and how it is being received on the Hill say they are a bit flummoxed by the White House's insistence on raising fees.
The bill has strong bipartisan support and FDA still stands by the deal they negotiated during the previous administration. One source Medtech Insight spoke to said they suspect the continued push to raise user fees is likely coming from other entities inside the White House and potentially from the Office of Management and Budget in a bid to cut federal spending. Another potential explanation is it is part of the larger narrative the administration has been pushing that the cost of drugs are too high and pharmaceutical companies are making too much profit.