First Impressions and Key Priorities on the Hill

The first Hill meetings each year help us to judge where FDA and its funding needs stand with Congress. My first impression: staff was very knowledgeable and interested in FDA and that Dr. Gottlieb was drawing high marks from both Republican and Democratic offices. We give thanks to Alliance members who participated and urge more of you to let us know your willingness to participate in Hill meetings.All of the staffers knew that the President had proposed a substantial increase in FDA funding for FY 19. However, not all of them had read Commissioner Gottlieb’s statement that describes the FDA initiatives that would be funded under the  President’s request. While each meeting had its own focus, the core presentation to staff had four messages:First, we are very encouraged by the new initiatives in medical products, which represent cutting-edge opportunities to make the agency more efficient and more effective. Congress always asks for detailed plans for spending money, rather than general requests. The budget request for FDA will be fully responsive to this. While we are waiting for more information that will be in the budget-in-detail and looking for Alliance member input on aspects of the President’s plan, we anticipate endorsing its direction and general parameters.Second, we are concerned that an opportunity is being missed in the food safety area, which also 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 support for State departments of agriculture that have a critical role under the law, and program adjustments to assure that domestic producers are not at a competitive disadvantage relative to imported foods.Third, we emphasized the importance of a well-trained expert staff at FDA. More than 80% of the FDA’s budget is devoted to people-costs (salaries, benefits, rent, IT, training, travel, etc.) It is possible that there may be proposals affecting federal employees generally that would be inappropriate and destructive for the FDA’s need for expertise.Fourth and finally, we need staff who lived through last year’s FDA budget fight to understand that this year’s issues are completely different. Last year was about whether new user fees (that had no chance of being adopted) should replace taxpayer dollars that are vital to the agency and reinforce that the primary beneficiary of FDA’s work is the American public. This year’s budget is about investments that should appropriately be funded by BA (taxpayer) funding. While the new budget request includes $190 million in increased user fee funding, almost the entirety is non-controversial renewals of existing programs and workload adjustment factors that allow for automatic increases in years 2 through 5 of the user fee agreements.More meetings are coming. Please join us. ... FDA is a truly worthy cause and our advocacy makes a difference.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.