President Donald Trump's FY 2018 budget proposal for the FDA, released this week, sets up a battle with Congress as the proposal seeks to reduce funding for the FDA while further increasing industry user fees and also reduces science-based research funding.
Medical product safety investments in the FY 2018 proposed budget total $3.2 billion at the program level, which is $505 million above the spending appropriated under the annualized level of the FY 2017 Continuing Resolution (CR). This total includes $648 million in budget authority and more than $2.4 billion in industry user fees. The President’s proposed budget recalibrates medical product user fees to more than $2.4 billion in 2018, approximately $1.2 billion over the 2017 annualized CR level.
The President budget proposes to increase medical product user fees to finance the full cost of FDA premarket review and replace the need for new appropriated budget authority. Currently, medical product user fees cover an average of 60% of FDA premarket review costs, ranging from 30% for animal drug review to 70% for prescription drugs. The President’s proposed budget reflects a decrease in budget authority for the FDA of $321 million for prescription drugs, $121 million for generic drugs, and $32 million for biosimilars.
In a bipartisan measure, in mid-April 2017, members of the US House and Representatives and the US Senate proposed a discussion draft, The FDA Reauthorization Act of 2017, under which the base user fee would increase from $718.7 million in fiscal year (FY) 2017 to $878.6 million in FY 2018 for prescription drugs; would rise from $299 million in FY 2017 to $493.6 million in FY 2018 for generic drugs; and would increase from $20 million in FY 2017 to $45 million in FY 2018 for biosimilars.
Since then, the US Senate Health, Education, Labor and Pensions Committee voted on May 11, 2017 to move forward a bill (S. 934) for reauthorization of user fees with certain amendments for consideration for the full Senate. The Health Subcommittee of the US House Energy and Commerce Committee moved forward its bill (H.R. 2430) for reauthorization of user fees, with certain amendments, to the full House committee on May 18, 2017,
Meanwhile, scientific associations point to reduce funding for scientific research in the proposed budget: For instance, the proposal calls for reductions in science and technology programs, including 11% from the National Science Foundation, which champions basic scientific research across all fields except medical topics; 22% from the National Institutes of Health, the world’s largest biomedical research agency; and 44% from the Environmental Protection Agency’s science and technology programs.
“Slashing funding of critically important federal agencies threatens our nation’s ability to advance cures for disease, develop new energy technologies, improve public health, train the next generation of scientists and engineers and grow the American economy,” said Rush Holt, CEO of the American Association for the Advancement of Science (AAAS), in a statement.
Source: President's FY 2017 Budget Proposal, 2018 President’s Budget for HHS and the AAAS.