The U.S. Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services, is requesting nearly $2.4 billion to protect and promote public health as part of the President's fiscal year (FY) 2009 budget - a 5.7 percent increase over the budget submitted to Congress last year. The budget proposal includes proposed key budget increases to protect America's Food Supply and to improve Medical Product Safety and Development. As FDA Commissioner Andrew C. von Eschenbach said, “The FDA Congressional Justification contains a performance budget request that supports public health priorities and reflects the goals and objectives in the Department of Health and Human Service and the FDA Strategic Plans.”

A +$17.4 million for a total investment of $887 million and 8 FTEs are requested for medical product safety and development. This initiative allows the FDA to improve the safety of medical products, including human tissues, blood and blood products, human drugs, medical devices, and animal drugs.

As pointed out by the agency, the investment will strengthen the FDA's ability to effectively monitor the safety of medical products, including imported products.

Examples of activities the Initiative supports are:
 

• Biologics Programme:

  • Strengthen essential infrastructure to prevent, detect, and respond to emerging safety threats in blood and blood products.

  • Strengthen medical and microbiologic review and acquire greater epidemiologic expertise to conduct adverse event analysis and safety investigations.

  • Improve tissue safety by conducting workshops to educate industry about tissue processing and tissue safety technologies.
     

• Human Drugs Programme:

  • Improve import safety by conducting import investigations of criminal drug activity.

• Device and Radiological Health Program:

  • Strengthen import safety by working together with Customs and Border Protection and other agencies

  • Leverage information from other sources to conduct stronger risk-based entry review of medical devices.
     

• Animal Drugs and Feed Programme:

  • Provide grants to stimulate development of new animal drugs

The FY 2009 budget also captures the productivity savings (-$8.9 million, -11 FTEs) generated by recent FDA investments and reinvests the savings in priority food safety and medical product programs.

More details about the FY 2009 request, which covers the period of Oct. 1, 20089 through Sept. 30, 2009, can be found here:
http://www.fda.gov/oc/oms/ofm/budget/documentation.htm

 

Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)