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From Health Law Daily, May 19, 2017

FDA user fee legislation moves forward while Trump Administration throws curve ball

By Bryant Storm, J.D.

The House Energy and Commerce Subcommittee on Health advanced the Food and Drug Administration Reauthorization Act of 2017 on May 18, 2017, making four amendments to the bill (H.R. 2430) in a markup session. On May 15, 2017, the Trump Administration announced a plan for the user fee structure which would deviate dramatically from the status quo, and the proposed legislation, by turning the FDA’s medical product user fee programs into 100 percent user fee programs. Sen. Patty Murray (D-Wash), ranking member of the Health, Education, Labor and Pensions Committee, responded to the announcement by criticizing President Trump for unnecessarily injecting partisanship into a previously bipartisan process. She noted, the “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.”

Price Letter. HHS Secretary Tom Price announced the Trump Administration’s budgetary approach to a new user fee structure in a May 15, 2017, letter to Murray. The letter said, “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 Administration’s proposal would significantly alter the current user fee structure. Although user fees account for more than one-fourth of all FDA funding—or about $8 to $9 billion over a five-year period—user fees represent only a fraction of the agency’s total medical product review budget (see HELP committee advances FDA user fee agreements to Senate floor , May 12, 2017).

House. Despite the Administration’s announcement, the House Energy and Commerce Subcommittee on Health moved forward with H.R. 2430, adding amendments for the regulation of over the counter hearing aids, risk-based inspections for device establishments, protections for the drug supply chain, and enhancements for generic competition. Full committee chairman Greg Walden (R-Ore) said: “Let me be clear: if we do not have this bill to the President’s desk in July, not only will thousands of FDA employees be seeking new employment, but desperately needed treatments and cures will not reach patients.”

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