fda’s budget challenge august 22, 2007 wayne pines
DESCRIPTION
FDA’s Budget Challenge August 22, 2007 Wayne Pines. The FDA Alliance www.StrengthenFDA.org. FDA Budget Basics. FDA’s 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. - PowerPoint PPT PresentationTRANSCRIPT
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FDA’s Budget Challenge
August 22, 2007
Wayne Pines
The FDA Alliancewww.StrengthenFDA.or
g
2
FDA Budget Basics• FDA’s 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.
• FDA’s appropriation must increase $80 to $100 million per year to “stay even” with increased costs
• FDA’s 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
2004 56% 37%
2006 36% 58% (after Vioxx, stents)
2007 45% 49% (May 22-24)
8
FDA StaffingFood and Drug Administration
Full Time Permanent (FTP) Positions / Full Time Equivalents (FTEs)
5,000
6,000
7,000
8,000
9,000
10,000
11,000
Fiscal Year
FT
E
USER FEES****
FDA S&E*,**,***
* Prior to 1980, FDA counted each federal employee as a Full Time Permanent (FTP) position.
** Listed are program level FTPs or FTEs only. User Fees, Revolving Fund for Certification and Other Services, Advances & Reimbursable, and Parklawn Computer Center FTPs or FTEs are NOT included in the FDA S&E column.
*** Source: DHHS/FDA J ustification of Estimates for Appropriations Committees
**** Source: FDA's data submission to Bio and PhRMA PDUFA IV information request; Source: MDUFMA Industry Chart; Source: ADUFA Industry Chart
Since 2003 “bump:” overall staff levels have declined;
user fees pay for an increasing proportion of staff
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Congress Keeps Adding Responsibilities—60 since 19941994 - Animal Medicinal Drug Use Clarification Act1994 - Dietary Supplement Health and Education Act1995 - Federal Reports Elimination and Sunset Act1995 - Unfunded Mandates Reform Act1995 - The Paperwork Reduction Act1996 - Freedom of Information Act (FOIA)1996 - Safe Drinking Water Act Amendments1996 - Animal Drug Availability Act1996 - Food Quality Protection Act1996 - Economic Espionage Act of 1996 1996 - Electronic Freedom of Information Improvement Act1996 - Comprehensive Methamphetamine Control Act1996 - Health Insurance Portability and Accountability Act1996 - Drug-Induced Rape Prevention Punishment Act1997 - Food & Drug Administration Modernization Act
(FDAMA)1997 - Better Pharmaceuticals for Children Act1997 - PDUFA II1998 - Antimicrobial Regulation Technical Corrections Act1998 - Sec. 615 Ag. Research, Extension and Education
Reform Act1998 - MQSA Reauthorization1998 - Sec. 654, Omnibus Approps. (Family Impact
Assessments)1999 - Government Employees Training Act1999 - Fed. Financial Assistance Management
Improvement Act2000 - Responsible for Clinical Laboratory
Improvement Amendments (CLIA)2000 - Approps Act (FDA) - FY 20012000 - Medicine Equity and Drug Safety Act2000 - Prescription Drug Import Fairness Act2000 - Approps. Act (HHS), Sec. 516, HPV-Condom
Labeling Review
2000 - Ryan White AIDS Care Act2000 - Date Rape Drug Prohibition Act2000 - Children’s Health Act 2000 - Technology Transfer Commercialization Act2001 - Animal Disease Risk Assessment 2002 - Medical Device User Fee and Modernization Act (MDUFMA)2002 - Hatch-Waxman-Amendments2002 - Drug Importation Report 2002 - Farm Security & Rural Investment Act2002 - Bioterrorism Act2002 - PDUFA III2002 - Best Pharmaceuticals for Children Act2002 - Rare Diseases – Orphan Product Development 2002 - E-Government Act2003 - Mosquito Abatement for Safety and Health Act2003 - Animal Drug User Fee Act2003 - Pediatric Research Equity Act (PREA)2003 - Medicare Prescription Drug and Modernization Act2004 - Minor Use and Minor Species Animal Health Act2004 - Food Allergen Labeling and Consumer Protection Act2004 - Medical Devices Technical Corrections Act2004 - National Defense Authorization Act2004 - AIDS (PEPFAR)2004 - Project BioShield2004 - Anabolic Steroid Control Act2004 - MQSA Reauthorization 2004 - Homeland Security Pres. Directive (HSPD) #12, ID Standard2005 - Protecting America in the War on Terror Act2005 - Patient Safety & Quality Improvement Act 2005 - Medical Device User Fee Stabilization Act (MDUFSA)2005 - Stem Cell Therapeutic and Research Act 2006 - Combat Meth Act
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0
20,000
40,000
60,000
80,000
100,000
120,000
140,000
160,000
180,000
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
Year
Ind
ivid
ual
Saf
ety
Rep
ort
s R
ecei
ved
MFR 15-day
Volume of Adverse Event Reports Becoming Unmanageable
11
0
4,000
8,000
12,000
16,000
20,000
24,000
1993 1995 1997 1999 2001 2003 2005 2007 est
FISCAL YEAR
IMPORT LINES (000)
19.8 MILLION import lines
Imports of FDA-regulated food products
Imported food lines subject to FDA review has quadrupled since 1999
12
ORA Field Budget History - FTEs
3493 3488 3488
3633
38724003
2002 2003 2004 2005 2006 2007
Fiscal Year
FT
Es
FTE Level
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FDA Funding Has Lagged Other Public Health Agencies
$0
$5,000,000
$10,000,000
$15,000,000
$20,000,000
$25,000,000
$30,000,000
19
86
19
88
19
90
19
92
19
94
19
96
19
98
20
00
20
02
20
04
20
06
Th
ou
san
ds
of
Do
lla
rs
FDA CDC NIH
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Congressional Appropriations to FDA and Other Agencies
42.17%
72.78%
83.93%92.28%
109.69%
147.42%
0.00%
20.00%
40.00%
60.00%
80.00%
100.00%
120.00%
140.00%
160.00%
USDA FoodSafety
FDA (withoutuser fees)
HRSA NIH Alcoholand DrugInstitutes
NIH CDC
Agencies
Pe
rce
nta
ge
Gro
wth
(1
99
8 t
o 2
00
6)
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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President’s 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 FDA’s budget under a variety of headings– –Administrative Savings– –IT Consolidation– –Strategic Redeployment, etc….
• Usually proposes new priorities without adding enough new money
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Congress is Listening to Us
• FDA Alliance has held about 80 meetings with Congressional staff and members themselves
• Alliance’s “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
PRELIMINARY ANALYSIS BY THE FDA ALLIANCE--UPDATED JULY 26, 2007
Center/Major Function
FY 2007 Appropriat
ion (budget
authority w/o user
fees)
House Committee
Recommend.FY2008
HouseFY2008 increase
overFY2007
Senate CommitteeRecommen
d.FY2008
Senate FY2008 increase
over FY 2007
FDA Alliance : Recommendations on
Budget Authority/Appropriations
FY 2008
Increase over FY 2007
Foods $457,105,000
$475,726,000
# +28,000,000
+$47 million
$ 522,453,00
0
+$ 65 million
$597,105,000
+$140 million
Drugs $315,138,000
## $348,438,00
0
+33 million
$ 354,706,00
0
+$ 40 million
$413,138,000
+$ 98 million
Biologics $144,547,000
$155,073,00
0
+11 million
$ 158,588,00
0
+$ 14 million
$191,547,000
+$ 47 million
Animal Drugs& Feed
$94,749,000
$ 94,809,000
none $ 98,513,00
0
+$ 4 million $124,749,000
+$ 30 million
Devices & Radiol. Health
$230,683,000
$240,122,00
0
+$ 9 million
$ 243,255,00
0
+$ 13 million
$302,683,000
+$ 72 million
NCTR $42,056,000
$36,455,000
($6 million)
$ 46,104,00
0
+$ 4 million
$55,056,000
+$ 13 million
Other Activities 90,541,000 $89,577,000
($1 million)
$ 102,007,00
0
+$ 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 & RelatedFacility Costs ###
$194,425,000
$229,509,00
0
+$35 million
$ 229,509,00
0
+$ 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
22
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 GrossmanExecutive Director
FDA AlliancePO Box 4305
Silver Spring, MD 20914-4305
[email protected] www.StrengthenFDA.org
301-879-9800
The FDA Alliancewww.StrengthenFDA.
org