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Regulatory News | 17 May 2017 | By Zachary Brennan
Secretary of Health and Human Services (HHS) Tom Price is continuing to push the Senate to further increase the industry fees paid to the US Food and Drug Administration (FDA), which would upend the agreed-to amounts negotiated by FDA and industry for the next five years, and allow for further cuts to the agency’s congressional appropriations.
Last week, the Senate Health, Education, Labor & Pensions (HELP) committee advanced a bill reauthorizing the user fee programs for prescription drug, medical device, generic drug and biosimilar industries without the additional fees that President Donald Trump requested in his budget blueprint for the next fiscal year.
The fees included in the bill were what both sides negotiated for PDUFA VI, MDUFA IV, GDUFA II and BsUFA II.
But Price wrote in a letter on Monday to Sen. Patty Murray (D-WA), the ranking member of the HELP committee: "To ensure the FDA has the critical resources needed to keep pace with this field, the President's Budget Blueprint proposes to increase and restructure the medical product user fee programs at FDA to be 100 percent user fee supported programs, with no funding triggers that require budget authority financing."
The call to restructure the user fee programs so that FDA appropriations from Congress can be further slashed comes just months before the reauthorizations must be passed and signed into law before FDA staff are laid off. All four of the deals also followed years of negotiation between the agency, industry and other stakeholders on what the next five-year agreements should contain.
Murray said in a statement on Tuesday: "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."
HELP committee chairman Sen. Lamar Alexander (R-TN) told Politico that Price'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."
As the Senate looks to vote on the bill in the coming weeks, the House is also moving forward with the agreed-to user fee amounts and the Energy & Commerce Committee will discuss the reauthorization bill on Thursday.
Secretary Price Letter
Tags: Tom Price, MDUFA IV, BsUFA II, PDUFA VI, GDUFA, user fees