Innovation Today for Better Healthcare Tomorrow How is the User Fee Process Working? December 3, 2003 (November 18, 2004) MDUFMA Stakeholder Meeting Mark.

Slides:

Advertisements

Similar presentations

The Federal Budget and R&D Funding in 2007 Kei Koizumi AAAS Board of Directors October 27, 2006 AAAS R&D Budget and Policy Program

Advertisements

1 AIAA Delta Forum AIAA Public Policy A CRISIS IN AERONAUTICS The NASA Landscape Aerospace Sciences Meeting January 8, 2001 Carol A. Cash, Chair Aeronautics.

The State of ADAPs Update on the ADAP Crisis and the ADAP Crisis Task Force Murray Penner National Alliance of State & Territorial AIDS Directors April.

Senate Finance Committee Tuition And Fees At Virginia Public Institutions Dan Hix SCHEV Finance Policy Director June 17, 2010.

Unemployment Insurance & Employment Service Reform A New Balance.

Revised FY 2007 & Proposed FY 2008 Operating & Capital Budgets Retail Rates Committee January 4, 2007.

Louisiana Hospital Association The Budget Challenge of Healthcare

Georgia Budget Crisis: The Hole Gets Deeper Alan Essig Executive Director Georgia Budget & Policy Institute November 13, 2009.

COMMUNITY COLLEGE LEGISLATIVE PRIORITIES APRIL, 2015 David Baime AACC Senior Vice President, Government Relations and Policy Analysis Jee Hang Lee ACCT.

Medical Device User Fee Reauthorization & FDA Update Roadmap to a Successful 510(K) Submission For Your Medical Device August 22, 2012.

Experiences from Denmark: Action Plan and Legislation on CSR by Carsten Ingerslev Danish Government Center for CSR Brussels, 23rd February 2010.

Preparing our Future Workforce: What Americans Need from Nurses in the 21 st Century NM 6/3/09 Brenda L Cleary, PhD, RN, FAAN Director, Center to Champion.

1 SIX SIGMA "Delivering Tomorrow's Performance Today" AIR CDRE ABDUL WAHAB.

1 FNGATSWG-Initial Observations Financing the Next Generation Air Transportation System Working Group (FNGATSWG) July 27, 2005.

FDA MDUFMA Stakeholder Meeting AMDR Presentation November 17, 2005 Gaithersburg, MD.

National Institute of Standards and Technology U.S. Department of Commerce TheTechnology Innovation Program (TIP) Standard Presentation of TIP Marc G.

Copyright Course Technology Chapter 16: Closing.

Presented by: Terry Glasscock, Senior Project Consultant, Capital Link Health Choice Network Of Florida June 2014 Capital Financing: Strategies and Tools.

Presentation to the RDLA April 23, Alliance for a Stronger FDA Nearly 200 members Patient and consumer groups Health professional and research advocacy.

Early Budget Preparation Chesapeake School Board Meeting November 29, 2010.

THE COMMONWEALTH FUND Developing Innovative Payment Approaches: Finding the Path to High Performance Stuart Guterman Assistant Vice President and Director,

COH PENSION SYSTEMS STATUS UPDATE BUDGET & FISCAL AFFAIRS COMMITTEE December 7, 2010 Craig Mason Chief Pension Executive.

Environmental Quality Restricted Account (EQRA) Path Forward Discussion Bill Sinclair Deputy Director Utah Department of Environmental Quality July 30,

Financial Aspects of MDUFMA Presentation at Public Meeting by Frank Claunts November 18, 2004.

Beyond the Crossroads National Conference on Transportation Infrastructure and Regulatory Policy May 27, Denver, CO Future Infrastructure Needs,

ORGANIZATIONS Education HEGN Board of Directors Policy Comm. C4/PAC (Political) Executive Committee Appoints a Majority of CCT/SCI Boards Board of CCT.

Copyright Course Technology 1999

The Minnesota State Colleges and Universities system is an Equal Opportunity employer and educator. Minnesota State Colleges and Universities

PENSION REFORM: LACERS TIER II P RESENTATION TO L ABOR O RGANIZATIONS Office of the City Administrative Officer City of Los Angeles September 6, 2012.

Confronting the challenges of responding to rising demand for higher education and research CAUBO June 20, 2005.

AHRQ’s Patient Safety and Medical Liability Initiative James B. Battles, Ph.D. Agency for Healthcare Research and Quality Center for Quality Improvement.

Education Funding in Oklahoma Are our children a priority ? Updated December 12, 2012 Megan Benn Oklahoma Policy Institute

Financial Challenges in FY 2014 All Information Provided by House Fiscal Staff and/or OK SDE.

Environmental Quality Restricted Account (EQRA) Background Bill Sinclair Acting Executive Director Utah Department of Environmental Quality May 28, 2009.

Summary of NAST Major Accomplishments Dollars in Millions National Coalition White Paper NAST Congressional Testimony $54.5M RAND $2M Wind Tunnel Study.

1 Medical Device User Fee and Modernization Act (MDUFMA II) Legislative Recommendations April 30, 2007.

#NPS15 MAKING “CENTS” OF THE FEDERAL FUNDING DEBATE Mitch Coppes Legislative and Regulatory Affairs Manager.

March 2, 2011 Status of the Patent Budget. 2 Steps in the Budget Process Strategic Planning – long term Budget Formulation and Performance Planning -

Ready or Not? Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism Jeff Levi, PhD Executive Director Trust for America’s Health.

OCFO - Financial Status of USPTO May 7, FY 2010 Status Authorized level of $1,887.0 million Mid-year Budget Execution Review currently underway.

Status Report on ILC Project in Japan Seiichi SHIMASAKI Director, Office for Particle and Nuclear Research Promotion June 19, 2015.

1 Effectiveness and Efficiency Project Report to the House Appropriations Sub-Committee on Education and Economic Development January 25, 2005.

Community Budget Forum FY 2015 Budget Development Dr. Patrick K. Murphy, Superintendent Deirdra McLaughlin, Assistant Superintendent, Finance & Management.

1 Operation of the Prescription Drug User Fee Program Janet Woodcock, M.D. Deputy Commissioner for Operations November 14, 2005.

American Fisheries Society Incoming Governing Board Breakfast Scott Rayder Chief of Staff National Oceanic and Atmospheric Administration September 15,

State Fiscal Outlook New England Board of Higher Education Boston, MA December 5, 2008 Brian Sigritz Staff Associate National Association of State Budget.

FY 2010 and FY 2011 Budget and Fee Collection Update March 3, 2010.

FY 2010 and FY 2011 USPTO Financial Report Trademark Public Advisory Committee Meeting February 25, 2010.

Budget and Caseload Update Policy and Fiscal Committee January 3, 2011.

Funding Outlook for the Housing Choice Voucher Program Barbara Sard Forum on Impact of Sequestration November 1, 2013.

1 Use of Emergency Department Services by Medical Assistance Recipients Legislative Audit Bureau Legislative Audit Bureau June 2004.

Superintendent Workshop Lake Chelan, May 4, 2015.

Provisions Regarding Economic Development  Title IV, Section 409: Congressional Task Force on Economic Growth in Puerto Rico  Title V: Puerto Rico Infrastructure.

Education Funding: How Much is Enough?

Lessons in Ophthalmology Advocacy from Frankfort to D.C.

Strategic Framework in Action:

Property Tax Reform The League of Oregon Cities is committed to assisting with the passage of legislation that will enhance local decision-making, provide.

RDLA's July Legislative Webinar

Presentation Title Your company information.

Presentation Title Your company information.

U.S. Global Health Funding: Global Malaria, FY FY 2013*

Douglas E. Hill, Executive Director

The Land and Water Conservation Fund What is Happening, Why It Matters, and What Land Trusts Can Do To Help Presented By: Graham Chisholm, Conservation.

George Bearpaw, Director

FPP Legislative Update

U.S. Global Health Funding: The Global Fund, FY FY 2013*

U.S. Funding for Global Health Security, FY 2006 – FY 2019 Request

Updates to the PhRMA Code on Interactions with Healthcare Professionals National Pharma Audioconference August 5, 2008.

Presentation transcript:

Innovation Today for Better Healthcare Tomorrow How is the User Fee Process Working? December 3, 2003 (November 18, 2004) MDUFMA Stakeholder Meeting Mark B. Leahey, Esq. Executive Director, MDMA

Innovation Today for Better Healthcare Tomorrow Title 1 of MDUFMA-User Fees The impact of user fees on smaller companies and innovation has been controversial for years The impact of user fees on smaller companies and innovation has been controversial for years The issue isn’t whether CDRH need additional resources, it does The issue isn’t whether CDRH need additional resources, it does Bill had three critical components: industry user fees, Congressional appropriations and FDA performance Bill had three critical components: industry user fees, Congressional appropriations and FDA performance

Innovation Today for Better Healthcare Tomorrow One Year Later-Where Are (Were) We? Average 35% increase in fees Average 35% increase in fees Appropriations shortfall of $11 million in 2003 Appropriations shortfall of $11 million in 2003 Improved Performance? Improved Performance?

Innovation Today for Better Healthcare Tomorrow Next year and beyond Appropriations shortfall between $20-$27 million expected in 2004 Appropriations shortfall between $20-$27 million expected in 2004 FDA is projecting decreased submissions in 2004 which will result in increased fees in 2005 FDA is projecting decreased submissions in 2004 which will result in increased fees in 2005 Smaller companies cannot sustain continued dramatic spikes in fees Smaller companies cannot sustain continued dramatic spikes in fees

Innovation Today for Better Healthcare Tomorrow Two Years Later-Where Are We? Fees have gone up over 55% in just two years Fees have gone up over 55% in just two years $4.8 million industry shortfall will result in another 15% fee increase $4.8 million industry shortfall will result in another 15% fee increase Appropriations shortfall of $20 million in FY04 Appropriations shortfall of $20 million in FY04 Optimistic for full funding in FY05, but this will not address the $30+ million appropriations shortfall from FY03 & FY04 Optimistic for full funding in FY05, but this will not address the $30+ million appropriations shortfall from FY03 & FY04 Improved Performance? Improved Performance?

Innovation Today for Better Healthcare Tomorrow Reforms Needed to Ensure a Strong, Viable User Fee Program that Fosters Innovation (2003) If there is an appropriations shortfall, Congress will be forced to revisit MDUFMA in 2004(5) If there is an appropriations shortfall, Congress will be forced to revisit MDUFMA in 2004(5) 3 rd Party Audit: What money does FDA need and where does it go? 3 rd Party Audit: What money does FDA need and where does it go? Eliminate workload and compensating adjustments (only allow increase for inflation) Eliminate workload and compensating adjustments (only allow increase for inflation)

Innovation Today for Better Healthcare Tomorrow Reforms Needed to Ensure a Strong, Viable User Fee Program that Fosters Innovation (2004) Any legislation to “forgive” Congress for the appropriations shortfall must be accompanied by: Full funding for FDA in FY05; Full funding for FDA in FY05; Forgiveness of the industry’s shortfall; Forgiveness of the industry’s shortfall; Fee increases for inflation only (elimination of the workload and compensating adjustments); Fee increases for inflation only (elimination of the workload and compensating adjustments); Revisiting the performance goals and enhancing where appropriate; and Revisiting the performance goals and enhancing where appropriate; and 3 rd Party Audit: What money does FDA need and where does it go? 3 rd Party Audit: What money does FDA need and where does it go?