Resources

ALLIANCE WHITE PAPERS

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

OMB REPORT ON IMPACT OF SEQUESTRATION

• OMB Report Pursuant to the Sequestration Transparency Act of 2012 (P. L. 112–155) (issued September 14, 2012)

ALLIANCE ANALYSIS OF IMPACT OF SEQUESTRATION

• FDA: Sequesterable Funding by Center/User Fee — a Preliminary Analysis (issued as of October 17, 2012)

FDA BUDGET AUTHORITY APPROPRIATION SUMMARIES

• Alliance’s formal request for FY 13 budget appropriation for FDA
• Graph showing FDA funding increases: FY 04 – 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
• FDA Final FY 13 appropriations numbers (compiled by the Alliance as of March 22, 2013)

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
• One-page explanation and chart used by Alliance staff in Hill briefings, March 2013
• One-page explanation and chart used by Alliance staff in Hill briefings re FY 14 appropriation, May 2013
• Slides used by Alliance staff in Hill briefings, March 2012
• Slides used by Alliance staff in Hill briefings, March 2013
• Written testimony of the President, Alliance for a Stronger FDA, before the Science Board of the U.S. Food and Drug Administration (presented February 27, 2013)
• Written testimony of the President, Alliance for a Stronger FDA, before the U.S. House Appropriations Committee Subcommittee on Agriculture, Rural Development, FDA and Related Agencies regarding FY2014 appropriations for the US Food and Drug Administration (presented March 20, 2013)
• Written testimony of the President, Alliance for a Stronger FDA to the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies regarding FY2014 appropriations for the US Food and Drug Administration (presented April 26, 2013)

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.
• Perakslis E. (and many others). FDA IT and informatics transformation. Slides from a presentation used by Dr. Perakslis in a meeting with members of the Alliance for a Stronger FDA in August 2012.
• Harris W. and Taylor J. FDA operational strategies and budget priorities. Slides from a presentation given to membership of the Alliance for a Stronger FDA, April 30, 2013.
• Slides from a presentation given by senior leadership of CDER to the Alliance for a Stronger FDA on Friday, August 9, 2013.
• Slides from a presentation given by senior leadership of CBER to the Alliance for a Stronger FDA on Friday, August 9, 2013.