Resources

ALLIANCE WHITE PAPERS

• The U. S. Food and Drug Administration: A Cornerstone of America’s Economic Future (issued March 7, 2011)

FDA BUDGET AUTHORITY APPROPRIATION SUMMARIES

• Alliance’s formal request for FY 13 budget appropriation for FDA
• Graph showing FDA funding increases: FY 01 – FY 12
• Chart comparing President’s budget request for FY 13 for FDA to approved appropriations for FY 10 – FY 12
• Chart comparing FDA FY 12 appropriations to FY 10 and FY 11
• FDA budget authority appropriations, FY 08 – FY 10

TESTIMONY and DATA PRESENTED BY THE ALLIANCE

• Written testimony of the Alliance for a Stronger FDA to the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies regarding FY2011 appropriations for the US Food and Drug Administration
• Written testimony of the Alliance for a Stronger FDA to the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies regarding FY2011 appropriations for the US Food and Drug Administration
• One-page explanation and chart used by Alliance staff in Hill briefings, March 2012
• Slides used by Alliance staff in Hill briefings, March 2012

VIDEO OF APPROPRIATIONS HEARINGS

• Senate Appropriations Committee hearing on the FDA budget for 2012, inclusive of testimony from Commissioner Hamburg (held March 17, 2011)
• Senate Appropriations Committee hearing on the FDA budget for 2011, inclusive of testimony from Commissioner Hamburg (held March 9, 2010)

STATEMENTS BY THE COMMISSIONER OF THE FDA

• Commissioner Hamburg’s statement to the Senate Appropriations Committee hearing on the FDA budget for FY 12 (given March 17, 2011)
• Commissioner Hamburg’s statement to the House Appropriations Committee hearing on the FDA budget for FY 12 (given March 11, 2011)
• Commissioner Hamburg’s statement to the House Appropriations Committee hearing on the FDA budget for FY 11 (given March 10, 2010)
• Commissioner Hamburg’s statement to the Senate Appropriations Committee hearing on the FDA budget for FY 11 (given March 9, 2010)
• Commissioner Hamburg’s new year memorandum to all FDA staff (issued January 7, 2010)

KEY REPORTS ON THE FDA’S RESOURCE NEEDS

• Hamburg MA, Sharfstein JM. The FDA as a public health agency. New Engl J Med. 2009;360:2493-2495
• U.S. Government Accountability Office. Section on “Protecting public health through enhanced oversight of medical products,” in High Risk Series: An Update. Report no. GAO 09-271. U.S. Government Accountability Office, Washington, DC, 2009, pp. 15-21.
• U.S. Government Accountability Office. Federal Oversight of Food Safety: FDA’s Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical. Report no. GAO-08-435T. U.S. Government Accountability Office, Washington, DC, 2008.
• U.S. Government Accountability Office. Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections. Report no. GAO-08-428T. U.S. Government Accountability Office, Washington, DC, 2008.
• U.S. Food and Drug Administration. FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology, prepared for the FDA Science Board. U.S. Food and Drug Administration. Rockville, MD, 2007.
• Institute of Medicine (Baciu A, Stratton K, Burke SP, Eds). The Future of Drug Safety: Promoting and Protecting the Health of the Public. National Academies Press, Washington, DC, 2007.

OTHER FDA-RELATED RESOURCES

• Autor, D. Globalization and the FDA. Slides from a presentation given to membership of the Alliance for a Stronger FDA, February 8, 2012
• Corrigan, D. Office of Regulatory Affairs. Slides from a presentation given to membership of the Alliance for a Stronger FDA, July 26, 2011.
• Lumpkin M. Viewing the world through the FDA international lens: Advancing domestic public health through international engagement. Slides from presentation given to membership of the Alliance for a Stronger FDA, April 26, 2011.