Price Wants FDA Reviews ‘100% User Fee Supported’
In a 5/15 letter to Sen. Patty Murray (D-WA), ranking Democrat on the Senate HELP Committee, HHS secretary Tom Price says the administration’s budget blueprint calls for increasing and restructuring the medical product user fee programs at FDA to be 100% user fee supported programs, with no funding triggers that require budget authority financing. “This would replace the need for new budget authority to cover pre-market review costs, while maintaining our commitment to speed the approval of safe and effective medical products,” Price writes. “This will benefit both taxpayers and patients.”
Price says the administration remains committed to the programmatic commitments and objectives outlined in the PDUFA, MDUFA, GDUFA, and BsUFA reauthorization documents, and looks forward to working with Congress toward a timely reauthorization of the programs.
“The administration is committed to improving government performance while reducing the burden on taxpayers to achieve FDA’s mission, a commitment underscored by this policy, so that we might better serve Americans,” Price says. “Therefore, as Congress reauthorizes FDA’s medical product user fee programs, we strongly urge you to include the medical product user fee policy set forth in the president’s budget blueprint so that the industries which benefit from these review processes pay the full cost of FDA’s evaluation activities of their products.”
Meanwhile, Senate HELP Committee ranking member Patty Murray (D-WA) had this to say: “Democrats and Republicans in Congress have worked together on reauthorizing the user fee agreements to ensure the FDA can meet its responsibilities to patients and families across the country — so it is disappointing that President Trump continues to attempt to inject partisanship into an otherwise bipartisan process. Today’s proposal from the Administration would upend our work and if implemented, leave the FDA hamstrung and without the federal investments it relies on to carry out its important public health work. I hope and expect that Republicans and Democrats alike will reject it.” Committee chair Lamar Alexander (R-TN) told Politico that the administration’s request “can be considered the next time the FDA negotiates the user fee agreements with the manufacturers of drugs and devices, but it is way too late to have an impact on this year’s agreements.”