Challenges and Threats to FDA Resources: An Update

This week’s Analysis and Commentary is a Q&A on current challenges and threats to FDA resources.Q: With so many issues undecided -- appropriations, budget, debt ceiling, sequestration -- when will FDA know how much money it can spend in FY 18?A: Certainty about spending levels is critical for the FDA. It is much more difficult to spend monies efficiently across an entire year if the amount keeps changing, and especially if the agency has to hold back funds in case there is a decrease.Most likely, FDA will receive $2.76 billion for FY 18, the amount in both the House and Senate appropriations committee bills and the same as in FY 17. As described in last week’s Analysis and Commentary, FDA’s responsibilities keep growing and additional funding and staff are needed. The Alliance continues to advocate for those higher levels. Meantime, there are numerous ways in which FDA may ultimately receive less than the House/Senate proposed levels and these have been have discussed in two recent columns: here and here.Q: What are the resource challenges—large and small—that FDA faces over the next 6 months?A: I count five. There may be more. First, completion of the FY 18 appropriations process. There are a number of possible problems. The top of my list is: lower non-defense budget caps, across-the-board spending cuts, an endless series of short continuing resolutions, and sequestration. Second, passage of FDARA before September 30. This would assure that user fees continue to flow to the agency and that massive de-stabilizing lay-offs will not occur. Third, finding funds to pay for substantial new non-user fee requirements and programming in FDARA.Fourth, the agency needs to fix its recruitment, hiring, and retention. Implementation of 21st Century Cures will help. The key is Commissioner Gottlieb’s initiative to speed up hiring. Fifth, come January 2018, it is very likely that the Administration’s FY 19 request will again propose large decreases in BA funding to be offset by new user fees.Q: If we run into our Senator or Congressman during August recess, what would you like us to tell him/her about FDA?A: First, FDA’s responsibilities are core functions of government. FDA assures vibrant, innovative, and growing markets that provide Americans with safe foods, safe and effective medical products, and many public health and consumer safety benefits. Congress supports the agency's core role, having passed six pieces of legislation since 2009 that expand the FDA’s mission. FDARA will make seven.Second, FDA-regulated industries are world leaders in discovery and innovation in large part because of the stability and oversight provided by FDA. Industry, patients, and consumer are united in supporting the agenda. No other federal regulatory agency enjoys the breadth of support that the FDA does.Third, FDA’s well-trained staff is indispensible. The products overseen by FDA (food and medical products) cannot be evaluated without specialized scientific and technical knowledge. One of the most important reasons for FDA to exist is that the public does not have the needed training or tools to assess whether cantaloupe is contaminated with listeria or a statin is reducing cholesterol.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.