The FDA Deserves Special Consideration at Budget-Time

Twice in recent months, I have had the opportunity to describe FDA funding to advocates who focus on the budgets of other federal agencies. As we talked, I realized how much FDA was different from other agencies and how that affected the agency’s funding. Here are a few of the items that came up:

• FDA is a staff-intensive organization, with more than 80% of its budget devoted to staff costs (salary, benefits, rent, IT, training, travel, etc.).  Most federal agency budgets include substantial dollars for grants, contracts and transfer payments. NIH (extramural research) and CDC (grants to states) are examples. When there are threats of level-funding or cutbacks, FDA has no cushion between the agency’s budget and its staffing costs. It is with good reason that the Alliance says: the FDA’s workforce is the agency’s most important resource.

• FDA oversees products that are 20% of total consumer spending in the US and that touch every American multiple times per day.  The impact of the agency’s actions are uniquely spread across the country and the economy. One reason is the range of affected products, from food and drugs to medical devices, cosmetics, veterinary medicine, pet foods, dietary supplements, and blood products. The other reason is the aggregate impact on the economy: 1 in 5 consumer dollars are spent on FDA regulated products.

• FDA has a dual mission that combines consumer protection and public health benefits with a mission to support innovative approaches to safe foods and safe and effective medical products. In the context of FDA, it makes sense that one agency is responsible for consumer protection and facilitation of commerce and that the two are intertwined. But it is an awesome responsibility that requires rigorous science to support all decision-making -- from specific products to broad policy. Most well-known federal agencies are bigger than FDA, but few (if any) are challenged as much as FDA by a mandate that leaves so little room for subjective opinion or error.

• Unlike (most) other agencies, FDA has more than one funding source. For most federal agencies, a single number -- total taxpayer-funded (BA) appropriations -- tells almost everything you need to know about the agency’s finances and where it is headed. For FDA, funds are derived from both BA and user fees in a complicated relationship. Among other things, BA is funded annually and supports most agency functions; user fees are set in 5-year cycles and support only a very specific set of activities. For more on the balance between BA and user fee funding (and why the Alliance never includes tobacco funding in talking about agency resources), see here.

The Alliance believes that FDA deserves special consideration at budget-time. Hopefully, this list starts you thinking about the reasons that you and your organization need to help us advocate for increased FDA funding.Editorial note: The Analysis and Commentary Section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.