FDA

1

• FDAs Budget Challenge
• August 22, 2007
• Wayne Pines

2
FDA Budget Basics

• FDAs relatively small 1.57B appropriated in FY
  2007 plus 400M in user fees
• 83 of FDA costs are staff-related salary,
  benefits, rent, supplies, telecom, travel, etc.
• FDAs appropriation must increase 80 to 100
  million per year to stay even with increased
  costs
• FDAs crunch
• more responsibilities more complex task ,
  small budget increases eroding credibility
• E.g., could not complete analysis of diabetes
  drug data before Avandia adcom July 30

3
Two Groups Formed

• FDA Alliance formed in April, 2006 at urging of
  patient and research advocacy groups
• More than 100 members, including six 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

4
A Common Goal

• Two coalitions, two voices, one goal
• Increased Appropriations for FDA
• Both organizations have campaigned to educate and
  persuade Congress, Administration, media, general
  public
• Model Multiple advocates contributed to doubling
  of the NIH budget

5
Basic Messages

• FDA touches every American, every day
• FDA needs more resources to assure safety
  foster innovation and ensure that the United
  States remains the gold standard for food,
  drug, device and cosmetic regulation.
• A strong FDA benefits both public health and the
  U.S. economy
• All FDA stakeholders consumers, patients,
  professional societies, and industry support
  increased funding

6
Consequences of Underfunding FDA

• New therapies/devices for major diseases and
  conditions could be seriously slowed
• Public confidence in drug safety wavering
• Europe forging ahead, investing 250M/yr. in
  critical path
• Scientist turnover double that of NIH, CDC
• Public confidence in food safety sinking
• Uninspected food imports skyrocketing
• Foodborne disease outbreaks increasing
• Food bioterrorism a realistic threat, few
  countermeasures

7
Wavering Public Confidence in FDA

• Harris Poll How well does FDA ensure safety and
  efficacy of new Rx drugs?
• Positive Negative
• 56 37
• 2006 36 58 (after Vioxx,
  stents)
• 2007 45 49 (May 22-24)

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FDA Staffing
Since 2003 bump overall staff levels have
declined user fees pay for an increasing
proportion of staff
9
Congress Keeps Adding Responsibilities60 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

2000 - Ryan White AIDS Care Act 2000 - Date Rape
Drug Prohibition Act 2000 - Childrens 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
10
Volume of Adverse Event Reports Becoming
Unmanageable
11
Imports of FDA-regulated food productsImported
food lines subject to FDA review has quadrupled
since 1999
19.8 MILLION import lines
12
ORA Field Budget History - FTEs
13
FDA Funding Has Lagged Other Public Health
Agencies
14
Congressional Appropriations Grow Quicker in
Grant-Centered Agencies Compared to FDA and Other
Salary-Intensive Agencies
15
FDA Funding Compared To Local School Systems

• FY 06 FY07CR 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 1.57B
  (Pres. Request
  1.64B)
• Prince George's County (MD) 1.35B 1.49B 1.66B

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Presidents Annual Appropriations Request for FDA

• Never includes the full cost to FDA of the
  increased costs of pay and benefit increases
• Never includes increases for increased non-pay
  costs
• Almost always include reductions in FDAs budget
  under a variety of headings
• Administrative Savings
• IT Consolidation
• Strategic Redeployment, etc.
• Usually proposes new priorities without adding
  enough new money

18
Congress is Listening to Us

• FDA Alliance has held about 80 meetings with
  Congressional staff and members themselves
• Alliances ask is for 2 billion in FY 2008
  plus user fees (about another 500 million)
• This would restore FDA to its FY 2003 operating
  level
• Congressional reception has been excellent but
  committees must deal with competing demands
• Plus controversies have undermined FDA
• E.g., story about bonuses to senior officials

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The Outcome

• Senate appropriators raised FDA budget to 1.755B
• increase of 186 million, 12 more than FY07 and
  almost as many new dollars as in last three years
  combined
• House appropriators raised FDA budget to 1.697B
• increase of 128 million, 7.7, but nearly 60M
  below Senate
• Schedule compromise numbers will be worked out
  by House/Senate in mid-to-late September
• Impacted by Bush threat to veto appropriations
  bills

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• FY07 Appropriations vs. House, Senate FY08 Levels
  and Alliance Recommendations

Recommended FY 2008 Budget Authority Appropriations Increases, by Total and by Center for the FDA Recommended FY 2008 Budget Authority Appropriations Increases, by Total and by Center for the FDA Recommended FY 2008 Budget Authority Appropriations Increases, by Total and by Center for the FDA Recommended FY 2008 Budget Authority Appropriations Increases, by Total and by Center for the FDA Recommended FY 2008 Budget Authority Appropriations Increases, by Total and by Center for the FDA Recommended FY 2008 Budget Authority Appropriations Increases, by Total and by Center for the FDA Recommended FY 2008 Budget Authority Appropriations Increases, by Total and by Center for the FDA Recommended FY 2008 Budget Authority Appropriations Increases, by Total and by Center for the FDA
PRELIMINARY ANALYSIS BY THE FDA ALLIANCE--UPDATED JULY 26, 2007 PRELIMINARY ANALYSIS BY THE FDA ALLIANCE--UPDATED JULY 26, 2007 PRELIMINARY ANALYSIS BY THE FDA ALLIANCE--UPDATED JULY 26, 2007 PRELIMINARY ANALYSIS BY THE FDA ALLIANCE--UPDATED JULY 26, 2007 PRELIMINARY ANALYSIS BY THE FDA ALLIANCE--UPDATED JULY 26, 2007 PRELIMINARY ANALYSIS BY THE FDA ALLIANCE--UPDATED JULY 26, 2007 PRELIMINARY ANALYSIS BY THE FDA ALLIANCE--UPDATED JULY 26, 2007 PRELIMINARY ANALYSIS BY THE FDA ALLIANCE--UPDATED JULY 26, 2007
Center/ Major Function FY 2007 Appropriation (budget authority w/o user fees) House Committee Recommend. FY2008 House FY2008 increase over FY2007 Senate Committee Recommend. FY2008 Senate FY2008 increase over FY 2007 FDA Alliance Recommendations on Budget Authority/Appropriations FDA Alliance Recommendations on Budget Authority/Appropriations
Center/ Major Function FY 2007 Appropriation (budget authority w/o user fees) House Committee Recommend. FY2008 House FY2008 increase over FY2007 Senate Committee Recommend. FY2008 Senate FY2008 increase over FY 2007 FY 2008 Increase over FY 2007
Foods 457,105,000  475,726,000 28,000,000 47 million 522,453,000 65 million 597,105,000 140 million
Drugs 315,138,000 348,438,000 33 million 354,706,000 40 million 413,138,000 98 million
Biologics 144,547,000   155,073,000 11 million 158,588,000 14 million 191,547,000  47 million
Animal Drugs Feed 94,749,000     94,809,000 none   98,513,000   4 million 124,749,000  30 million
Devices Radiol. Health 230,683,000   240,122,000 9 million 243,255,000 13 million 302,683,000  72 million
NCTR 42,056,000    36,455,000 (6 million)   46,104,000   4 million 55,056,000  13 million
Other Activities 90,541,000    89,577,000 (1 million) 102,007,000 11 million 120,541,000 30 million
SUBTOTAL 1,374,819,000 1,468,200,000 93 million 1,525,626,000 151 million 1,804,819,000 430 million
Rent Related Facility Costs 194,425,000   229,509,000 35 million   229,509,000 35 million 219,375,000 20 million
TOTAL 1,569,244,000 1,697,709,000 128 million 1,755,135,000 186 million 2,024,194,000 450 million
Funds made available by the House for July
1, 2008 to September 30, 2009, conditional on
committee approval of a food safety plan from
FDA Of which 6.25 million is an increase
for review of DTC ads, in lieu of funds that
would come from a new user fee for review of DTC
television advertisements contained in
authorizing legislation that is likely to pass
Congress shortly. FDA receives 4.95
million for buildings and facilities repair
every year. It is sometimes included in summation
charts, but is not reflected in these charts,
which are the numbers being reported by the
Committees as their totals and include only
salary and expenses. Note FDA Alliance
recommendations and allocations do not include
any new authorities that may result from pending
legislation and do not include user fee revenue.
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How FDA Will Use Money

• Up to FDA, OMB and Congress
• Both groups advocated for overall spending, not
  specific program needs
• Largest immediate needs
• IT
• Inspectors
• Usable adverse events data bases for foods, drugs
  and devices
• User fees in PDUFA will ease pressures in
  drug/device review divisions and drug safety
  initiatives food will be most in need of new
  funds

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Appropriations Committees Report Language
Priorities for FDA

• Senate
• Assuring resources for Critical Path
• Drug safety
• Improve MedGuides
• Speeding generic drug reviews
• Medical device unique identifies
• Food safety and import inspections
• No closure of FDA Labs
• House
• Upgrade FDA field force, enforcement, no closure
  of labs
• Funds DTC review without new user fees
• Postmarketing studies
• Sunscreen monograph
• Microbial resistance

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For More Information

• Steven Grossman
• Executive Director
• FDA Alliance
• PO Box 4305
• Silver Spring, MD 20914-4305
• info_at_StrengthenFDA.org www.StrengthenFDA.org
• 301-879-9800