The Fiscal year 2013 Budget of the U. S. Government was released by the Office of Management and Budget on February 13. As we are dissatisfied by simplistic journalistic reviews of the Budget in the business press, we urge our readers to review the actual document posted below.

Our readers will be interested in pages 65-70 (Department of Agriculture) and pages 107-115 (Health & Human Services). The FDA FY 2013 Budget can be broken out from the HHS numbers.

For this observer, the Table on page 113 is particularly interesting. With a bit of arithmetic, the diligent student of the Budget can deduce that FDA plans to increase User Fees by 48.5% in FY 2013 as compared with FY 2012. The increase in User Fees for FY 2012 over FY 2011 was a modest 7.54%.

In other words, as the FDA budget grows to $4.486 billion in FY 2013 ($2.517 billion in congressional funding and $1.969 billion in User Fees), all but $11 million of the $654 million increase planned for FDA in FY 2013 will come from increases in User Fees.

It is important to understand that the U. S. Budget, as proposed by OMB, is extraordinarily complex, often deceptive, and essentially a “political” document.

We call the reader’s attention to the following paragraph.

The Budget includes $2.5 billion in budget authority and $4.5 billion in total pro­gram resources for the Food and Drug Adminis­tration (FDA). This includes $10 million in new resources to improve food safety and medical product imports to the United States through a greater FDA presence in foreign countries such as China. The Budget also includes new user fee programs to support implementation of key ele­ments of the Food Safety Modernization Act, and to bring more safe, effective, and affordable ge­neric drugs and generic biologics, also known as biosimilars, to the American public. To better pro­tect public health in response to natural or inten­tional threats, the Administration also invests in FDA’s efforts to advance regulatory science and support the review of new medical countermea­sures for chemical, radiological, biomedical, and nuclear threats. (p. 110)

It seems likely that industry groups will strongly oppose the scale of planned expansion of User Fees for FDA’s FY 2013 budget. We can expect a series of Federal Register Notices of new User Fees and increases in existing User Fees during the year ahead.