The FDA's Proposed New Budget

by Patricia Green, published on 2/7/07 by MedsAbroad.com

The FDA sent a proposed 2008 budget to congress, asking for $2.1 billion. This is a 5% increase over the 2007 budget. Increases are included in the following areas:

• $10.6 million for "Strengthening food safety," which means that they want to spend money to find ways to pinpoint food poisoning outbreaks more closely, perhaps prevent new outbreaks by putting more manpower on the task.
• $11.2 million for "Modernizing drug safety," by increasing their employees who track drug safety, and work to "develop an electronic drug safety tracking system."
• $7.2 million for "Improving medical device safety and review," by which they mean they will hire more people to devote to the entire life-cycle of medical device products, including product recalls.
• $5.6 million in tax-payer funds plus $15.7 million in user fees for generic drug reviews. As brand-name drugs lose their patents, more and more generics come on to the market. The FDA is responsible for approving applications for these generics. The user fee is a new idea, and is, perhaps mis-named. It does not take fees from generic drug users but rather charges a fee to generic drug manufacturers, to pay for the cost of pushing them through the FDA approval process.
• $27 million for "Other New User Fees," which are: (1) the Reinspection User Fee, which is charged to labs and facilities who have failed an official inspection. This will pay for the re-inspection. (2) The Export Certification user fee, which will be charged to food product exporters for the cost of issuing export certificates which are required by some foreign governments.
• $21.8 million for "Cost of Living Pay Increase." Last year's COL increase was 2.2% for the FDA's employees. This 2008 amount also appears to be about a 2.2% increase. Average civil service pay rose about 3.5% in 2006.
• $13.3 million for the "White Oak Consolidation." FDA has been progressively moving to a new location in White Oak, MD, where they hope to have all of their offices. Right now, their offices are located in 20 different sites across the region.

It is not unreasonable for the FDA to increase its budgetary request as the scope of its work increases. People don't work for free, after all. The 2.2% salary increase doesn't even cover the cost of inflation, which is trending upward, with an inflation rate (average) of about 3.5% in 2006.

We would like to see the FDA get better organized with the funds it gets, providing more efficient services within its proposed budget. The recent change in leadership, as well as the move to White Oak, ought to solve some of these internal bureaucratic problems.

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