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Making the Case: The Alliance’s “Ask” for FY 19

March 3, 2018

Last year, the President’s request for  FY 18 proposed an overall increase for FDA funding. However, it did so by proposing new, never-discussed, never-negotiated user fees and using them to replace a large chunk (about $700 million) worth of BA (taxpayer) funding. So, despite the increased total, last year’s request was a threat to the agency because it undercut our belief that the American public, not industry, is the primary beneficiary of FDA activities.

This year’s request from the President for FY 19 is completely different and altogether better. This year’s budget also proposes an overall increase in funding, but it differs because it is entirely focused on a $473 million investment in the agency that will be funded by BA (taxpayer) funding. While the new budget request does include $190 million in increased user fee funding, virtually none of it is controversial and almost all of it is automatic annual workload adjustments already built into the user fee programs.

Since the Administration has only released the budget-in-brief, which has a minimum of details, what we know about the proposed $473 million increase is contained in Commissioner Gottlieb’s statement. It describes the medical products initiatives that would be funded under the  President’s request. We are very encouraged by the new initiatives, which represent cutting-edge opportunities to make the agency more efficient and more effective. Accordingly, the Alliance has stated:

The Alliance supports the President’s proposed medical products increases to strengthen the systems that guide and support agency decision-making and stimulate innovation. Among the items proposed: improvements in drug and device manufacturing, advances in the use of real world evidence in medical product development, revisions to the regulatory framework for digital health technology, enhancements to research on rare diseases, and new systems that could speed the introduction of cost-saving generic drugs.

On the other hand, the Alliance is  concerned that opportunities are being missed in the food safety area, which needs investments that cannot be funded from its current budget. Among areas that deserve attention are extensive training needs for both regulated and regulators, additional State support and assuring that domestic producers are not at a competitive disadvantage relative to imported foods. Accordingly, the Alliance has stated:

Since enactment of FSMA in 2011, FDA has worked collaboratively with the states, as well as consumer, public health, and food industry stakeholders to advance implementation centered around seven foundational rules and the need for imported and domestic foods to be held to the same safety standards.  The National Association of State Departments of Agriculture and others confirm that the agency will need increased baseline resources to meet state funding requirements in FY 19. Additionally, import safety remains a particularly high priority, as do the tools and training needed by regulated stakeholders to comply with the new federal standards. 

The Alliance’s request of $50 million in additional FY 19 food safety funding will enable FDA to meet the expanded scope of state partnerships, while also strengthening other key FSMA implementation priorities, particularly import safety and training.

When we see the budget-in-detail, we will be able to flesh out these recommendations with more observations and details. In the meantime, the Alliance will be disseminating its “ask” widely and urges Alliance member organizations to do the same.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.

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