Presentation to the fda alumni association april 11 2007 bill hubbard steven grossman
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Presentation to the FDA Alumni Association April 11, 2007 Bill HubbardSteven Grossman. The FDA Alliance www.StrengthenFDA.org. FDA Budget Basics. FDA’s budget is relatively small: $1.5B appropriated; $400M in user fees

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Presentation to the FDA Alumni Association April 11, 2007 Bill HubbardSteven Grossman

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Presentation to the fda alumni association april 11 2007 bill hubbard steven grossman

Presentation to the FDA Alumni Association

April 11, 2007

Bill HubbardSteven Grossman

The FDA Alliance

www.StrengthenFDA.org


Fda budget basics

FDA Budget Basics

  • FDA’s budget is relatively small: $1.5B appropriated; $400M in user fees

  • 83% of FDA costs are staff-related: salary, benefits, rent, supplies, telecom, travel, etc.

  • FDA’s appropriation must increase $80 to $100 million per year to “stay even” with increased costs

  • User fees, user fee triggers, earmarks, and counterterrorism grow, while FDA’s base erodes

  • Need for a multi-year public effort to ensure FDA has sufficient resources, and to maintain and build public confidence and trust in FDA


Fda stakeholders responding

FDA Stakeholders Responding

  • FDA Alliance formed in April, 2006 at urging of patient and research advocacy groups

  • More than 100 members, including seven former commissioners and a broad range of patient, consumer and industry interests

  • Coalition for a Stronger FDA formed in September, 2006 by BIO, GMA and three former HHS Secretaries

  • Broad membership representing consumers, patients, trade associations, and companies


A common goal

A Common Goal

  • Two coalitions, two voices, one goal:

    Increased Appropriations for FDA

  • Both organizations have campaigns underway to educate and persuade Congress, Administration, media, general public

  • Model: Multiple advocates contributed to doubling of the NIH budget

  • FDA’s budget problems are so great and the stakes so high, there cannot be too many voices!


Budget environment difficult but congress is listening

Budget Environment Difficult, But Congress is Listening

  • Most federal agencies will get the same dollars in FY 2007 (current year) as they did in FY 2006

  • FDA received $90M more in FY 2007 than in FY 2006 (+$65M appropriation; +$25M in user fees)

  • President’s FY 2008 budget request calls for further increases (in appropriation and user fees)

  • Alliance/Coalition urging Congressional focus on adding appropriated dollars to meet FDA mission

  • Members/staff encouraging; hard fight still ahead


What are we telling congress

What are we telling Congress?

  • New product submission flat, drug development too long

  • Uninspected food imports skyrocketing

  • Foodborne disease outbreaks increasing

  • New therapies/devices for major diseases and conditions could be seriously slowed

  • Public confidence in drug safety sinking

  • Scientist turnover double that of NIH, CDC

  • Europe investing $250M/yr. in “critical path”

  • Food bioterrorism a realistic threat, few countermeasures

  • Demands to shift resources to counterterrorism from food additives, international harmonization, etc.


Public confidence plummeting

Public Confidence Plummeting

Harris Poll:

Fair/poor jobExcellent/good job

  • 37% 61%

  • 47% 56%

    2006 58% 36%


Appropriations dropping as percentage of fda s total costs

Appropriations dropping as percentage of FDA’s total costs

$1.78 M

$1.68 M

$1.64 M

Counterterrorism

$1.54 M

Payroll Shortfall

$1.28 M

User Fees

User Fee Triggers

Earmarks

Facilities

Core Functions

$ Thousands of Current Dollars


Fda staffing

FDA Staffing


Congress keeps adding responsibilities 60 since 1994

1994 - Animal Medicinal Drug Use Clarification Act

1994 - Dietary Supplement Health and Education Act

1995 - Federal Reports Elimination and Sunset Act

1995 - Unfunded Mandates Reform Act

1995 - The Paperwork Reduction Act

1996 - Freedom of Information Act (FOIA)

1996 - Safe Drinking Water Act Amendments

1996 - Animal Drug Availability Act

1996 - Food Quality Protection Act

1996 - Economic Espionage Act of 1996

1996 - Electronic Freedom of Information Improvement Act

1996 - Comprehensive Methamphetamine Control Act

1996 - Health Insurance Portability and Accountability Act

1996 - Drug-Induced Rape Prevention Punishment Act

1997 - Food & Drug Administration Modernization Act (FDAMA)

1997 - Better Pharmaceuticals for Children Act

1997 - PDUFA II

1998 - Antimicrobial Regulation Technical Corrections Act

1998 - Sec. 615 Ag. Research, Extension and Education Reform Act

1998 - MQSA Reauthorization

1998 - Sec. 654, Omnibus Approps. (Family Impact Assessments)

1999 - Government Employees Training Act

1999 - Fed. Financial Assistance Management Improvement Act

2000 - Responsible for Clinical Laboratory Improvement Amendments (CLIA)

2000 - Approps Act (FDA) - FY 2001

2000 - Medicine Equity and Drug Safety Act

2000 - Prescription Drug Import Fairness Act

2000 - Approps. Act (HHS), Sec. 516, HPV-Condom Labeling Review

Congress Keeps Adding Responsibilities—60 since 1994

2000 - Ryan White AIDS Care Act

2000 - Date Rape Drug Prohibition Act

2000 - Children’s Health Act

2000 - Technology Transfer Commercialization Act

2001 - Animal Disease Risk Assessment

2002 - Medical Device User Fee and Modernization Act (MDUFMA)

2002 - Hatch-Waxman-Amendments

2002 - Drug Importation Report

2002 - Farm Security & Rural Investment Act

2002 - Bioterrorism Act

2002 - PDUFA III

2002 - Best Pharmaceuticals for Children Act

2002 - Rare Diseases – Orphan Product Development

2002 - E-Government Act

2003 - Mosquito Abatement for Safety and Health Act

2003 - Animal Drug User Fee Act

2003 - Pediatric Research Equity Act (PREA)

2003 - Medicare Prescription Drug and Modernization Act

2004 - Minor Use and Minor Species Animal Health Act

2004 - Food Allergen Labeling and Consumer Protection Act

2004 - Medical Devices Technical Corrections Act

2004 - National Defense Authorization Act

2004 - AIDS (PEPFAR)

2004 - Project BioShield

2004 - Anabolic Steroid Control Act

2004 - MQSA Reauthorization

2004 - Homeland Security Pres. Directive (HSPD) #12, ID Standard

2005 - Protecting America in the War on Terror Act

2005 - Patient Safety & Quality Improvement Act

2005 - Medical Device User Fee Stabilization Act (MDUFSA)

2005 - Stem Cell Therapeutic and Research Act

2006 - Combat Meth Act


Volume of adverse event reports becoming unmanageable

Volume of Adverse Event Reports Becoming Unmanageable


Presentation to the fda alumni association april 11 2007 bill hubbard steven grossman

Imports of FDA-regulated products

19.8 MILLION


Ora field budget history ftes

ORA Field Budget History - FTEs


Presentation to the fda alumni association april 11 2007 bill hubbard steven grossman

Has FDA Been Given Enough Resources?

FDA Funding Has Lagged Other Public Health Agencies


Has fda been given enough resources fda funding comparable to local school systems

Has FDA Been Given Enough Resources?FDA Funding Comparable to Local School Systems

FY 06FY07CR FY08

Proposed

Fairfax County (VA) $1.89B$2.1B$2.2B

Montgomery County (MD) $1.72B$1.85B$1.98B

FDA (appropriated funds) $1.48B$1.55B (Pres. Request $1.64B)

Prince George's County (MD) $1.35B$1.49B$1.66B


Annual appropriations

Annual Appropriations...

  • Never include the full cost to FDA of the increased costs of pay and benefit increases

  • Never include increases for increased non-pay costs

  • Almost always include reductions in FDA’s budget under a variety of headings

    • –Administrative Savings

    • –IT Consolidation

    • –Strategic Redeployment, etc….


What would fda look like

What would FDA look like?

What would FDA’s budget look like today if it had gotten the full costs of these inflation increases?

  • Assume 2003 starting point

  • 5.8% Inflation increases

  • Budgeted program increases also increased at same rate in future years

  • No annual budget cuts


Total fda appropriations

Total FDA Appropriations


The need

The Need

  • Renewed public commitment to the FDA

  • Recognition that FDA cannot keep up without a concerted, bipartisan, multi-stakeholder commitment

    • Administration

    • Congress

    • Patient Groups

    • Consumer Groups

    • Industry

  • Multi-year effort to:

    • Ensure FDA has sufficient resources, and

    • Maintain and build public confidence and trust in FDA


Success will have broad benefits

Success Will Have Broad Benefits

  • Increased public health protection

    • Longer, healthier lives

    • Reduced health care costs

  • Safer food supply, less vulnerable to bioterrorism

  • Greater public confidence in FDA decisions and the products it regulates

  • Improved patient access to new therapies

  • FDA leadership in promoting science-based standards nationally and internationally to improve American competitiveness


For more information

Steven Grossman

Executive Director

FDA Alliance

PO Box 4305

Silver Spring, MD

20914-4305

[email protected]

www.StrengthenFDA.org

Bill Hubbard,

Senior Advisor

Coalition for a Stronger FDA

1333 New Hampshire Ave., NW,

Suite 429

Washington DC, 20036

[email protected]

www.FDAcoalition.org

For More Information

The FDA Alliance

www.StrengthenFDA.org


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