Several times this year, I have been told: FDA’s food activities have been getting most of the new monies at the expense of human drugs (CDER) and biologics (CBER). But is it true that food activities (mostly CFSAN, the Center for Food Science and Applied Nutrition) are receiving preferred treatment?

FDA Matters ran the numbers to see. We conclude that center-envy is bad in its own right, but even worse when it is based on misinformation and misperceptions.

Here is a chart providing relevant comparisons over nine fiscal years, including the current one.

Center, field activities and user fees combined. These are the number across the two rows marked “total.” In FY 2002, the FDA’s food budget was 72% of the amount allocated to human drugs/biologics received.

In FY 2007, it had declined to 61% and rebounded slightly to 66% in FY 10. Thus, over this 9 year period (8 appropriations cycles), funding for food activities has actually declined slightly compared to CDER/CBER.

Excluding field activities from funding available for Center activities. “Field activities” is FDA-speak for investigations and enforcement. The funds supporting field activities are in each Center’s budget, but are transferred to the Office of Regulatory Affairs (ORA). These funds do not support core Center activities.

If field activities in ORA are excluded over the nine year period, CFSAN grew by 60%. CDER and CBER (including user fees) grew by more than 150%. Thus, it is possible to conclude that the core functions of CDER and CBER have done far better than the core functions of CFSAN.

The pace has changed over the last 3 years. During this period, CFSAN grew by 67% compared to CDER and CBER’s growth (including user fees) of 62%. Funding for drugs and biologics, which grew enormously through the mid-2000’s, is now growing at a rate comparable to foods. However, for foods this means an increase of $78 million, while CDER/CBER grew by $384 million over the three years.

Excluding User Fees, as well as field activities. Core appropriated funding for the centers grew at about the same rate over both the longer and shorter period. For the nine years (eight appropriations cycles), CFSAN grew by 60%, CDER/CBER by 57%. For the last three years, CFSAN has grown by 67% compared to 69% for human drugs and biologics. In effect, the food and drugs centers have been treated almost identically, with user fees tilting the comparison dramatically in favor of CDER and CBER.

Bottom-line: Increases in CFSAN have gotten a lot of attention, but CDER and CBER budgets have grown by far more over the last nine years if user fees are included. If user fees are excluded, then CFSAN and CDER/CBER have grown at comparable rates over the nine year period and also over the last three years.

PS: In the President’s FY 11 request, the proposed appropriations increase for CFSAN is larger than for CDER and CBER combined. However, all of the differential is in 87 people and $40 million that is being proposed for new food inspectors. If ORA is excluded, as well as user fees, the food increase and the drug/biologics increases are about equal on a percentage basis.

Steven

Two past columns have discussed the Office of Regulatory Affairs and a recent column urged less reliance on user fees to fund CDER.

The Uncrowned Prince of FDA
September 15th, 2009

Which FDA line manager has the most appropriated resources to work with in FY 09? Is it Janet Woodcock, head of the drug center or Stephen Sundlof, head of the food center? The correct answer: neither. Read the rest of this entry »

Commissioner Hamburg’s Most Important Personnel Decision
February 21st, 2010

With due respect to the many fine individuals that Commissioner Hamburg has recruited, FDA Matters thinks the most important appointment so far has been Michael Taylor to be Deputy Commissioner for Foods. An even more important decision needs to be made soon: choosing the right person to be Associate Commissioner for Regulatory Affairs. Read the rest of this entry »

Wrestling for the Soul of FDA
March 17th, 2010

User fees are a bad way to fund FDA, a public health regulatory agency that oversees nearly a quarter of all consumer spending. It’s not that user fees are corrupting. FDA is capable of making good and bad decisions without regard to where the money comes from. But user fees have the potential to erode public confidence in the agency. Read the rest of this entry »

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