user fees and the fda · 2011-09-26 · current fda picture • fda’s total budget - $3.4b -...
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User Fees and the FDA
William K. Hubbard National Health Policy Forum
September 23, 2011
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SUMMARY
• The Setting – 1980s • The Breakthrough – ca. 1991 • The Effects • The Growth • What Next • Is the attention to fees a diversion from the
real problem?
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Current FDA Picture
• FDA’s Total Budget - $3.4B - Appropriations - $2.4B - User Fees - $1B • Staffing – 12,381 FTEs - From appropriations – 9,368 - From user fees – 3,013
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DRUG REVIEW - BACKGROUND
• U.S. pharmaceutical industry grew up with an FDA
• Limited pharmaceutical presence 1st 3rd of 20th century
• FDA drug review begun in 1938 • Efficacy requirement in 1962 • Drug “lag” with Europe by 1972
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Climate by Late 1980s
• FDA a “Black Hole” • R&D moving to Europe • Reviewers arrogant laggards (and not very
bright either) • Sponsors cynical • “Box up the data, ship it to FDA, and wait
three years”
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Early 1990s • Increasing demand for “reforms” • Fast Tracking • Lower efficacy standard • “Deemed approved” after set time
• Success with cancer & AIDS - High reviewer ratio = <year • FDA Proposal to industry - Support from VCs
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The Fix
PDUFA • Congressional imprimatur that speed
matters • Review timeframes in return for sufficient
reviewers • Run it like a business • Project management, deadlines, much
increased collaboration • Move from Black Hole to Certainty
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The Result
• 90% of truly new drugs – 6 months • 90% of standard applications – 10 months • Over 1500 new drugs/biologics approved • Average time to approval dropped 60% • Average development time dropped 10% • First-cycle approval rates - 46% to 63%
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The Result
12
PDUFA Fees Enabled Increased Staffing and Improved Systems for Drug Review
History of PDUFA Total Process and User Fee Funded FTEs
0
500
1000
1500
2000
2500
3000
1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
FTEs
TotalProcessFTEsUser FeeFTEs
Non-UserFee FTEs
FTE = Full Time Equivalent staffing
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FDA Staffing Declines Food 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
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
Fiscal Year
FTE
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 Justification 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
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THE RESULT
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The Result
• Inflation and workload adjustments • Good review practices • More collaboration, increase in app quality • Guidance on innovative trial design • Better AER reporting/analysis • Risk management tools • Review deadlines • Better predictability & certainty
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FDA Approves Drugs Faster than EMA
23 new cancer drugs were approved by both FDA & EMA
• Of 23 new cancer drugs approved by both FDA and EMA, FDA approved 21 first
• All 23 came to the U.S. market before they reached the European market
21
2
23
00
5
10
15
20
25
First to Approve First to Market
FDA
EMU
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FDA vs. EMA Review Times
261
373
050
100150200250300350400
Median Number of Days toApprove New Oncology Drugs
FDA
EMA
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01-Jan-06
01-Jan-07
01-Jan-08
31-Dec-08
31-Dec-09
31-Dec-10
01-Jan-06 01-Jan-07 01-Jan-08 31-Dec-08 31-Dec-09 31-Dec-10
FDA Approval Date
Priority NMEs/NBEs Standard NMEs/NBEs Line of identity
43 Approved by FDA First
14 Approved by EMA First
57 New Drugs Approved by FDA & EMA (2006-2010)
2 out of 3 new applications were approved by FDA first
Eur
opea
n C
omm
issi
on
Aut
hori
zatio
n D
ate
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Fee payments / fee funding have increased significantly
(Fee funding in thousands)
$0
$100,000
$200,000
$300,000
$400,000
$500,000
$600,000
199319941995199619971998199920002001200220032004200520062007200820092010
PDUFA FeesSupportingHuman DrugReview
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Has PDUFA Affected Safety?
Withdrawal Rates
• 1970s – 1980s (Pre-PDUFA) - 3%
• 1990s – Present (Post-PDUFA) - 3%
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Medical Devices
• Next user fee program • Analogous goals - e.g., 90% of 510(k)s in
90 days • Lower fee structure than PDUFA • More complicated results • Thus, less buy-in by industry
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MDUFA II 510(k) Tier 1 Performance
9194
919191
76777579
84
65
70
75
80
85
90
95
100
2000 2001 2002 2003 2004 2005 2006 2007** 2008** 2009**Fiscal Year (Receipt Cohort)
Per
cent
With
in 9
0 D
ays
.
**Cohorts still open as of Sept. 30, 2010, FY 2009 data may change *SE and NSE decisions only
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CDRH Average Time to Decision
9297 100 97 10193
106118 122
148
76 79 77 7460 58 64 67 68
77
22 21 2027 33 35
4252 53
71
0
20
40
60
80
100
120
140
160
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Fiscal Year (Decision Cohort)
Day
s
Total FDA Submitter *SE and NSE decisions only; times may not add to total due to rounding
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Generic Drug Fees
• Enacting legislation highly possible • Highly cooperative negotiation process • Facility & application fees (<$PDUFA) • $299M/yr $1.5B/5 years • 10 mo. Application review/reduced cycling • Eliminate application backlog over 5 yrs • Parity in foreign/domestic inspections • Proposal to Congress in January
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Other Enacted Fees
• Family Smoking Prevention and Tobacco Control Act ($477M in FY12, $712M in FY 19 and beyond)
• Animal Drugs - $17M (FY 11) • Animal Generic Drugs - $5M (FY11) • Mammography - $19M (FY11) • Color Certification - $8M (FY11) • Biosimilars – FDA directed to create
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Enacted Fees, continued
• Foods (newly authorized) – Food Reinspection ($15M) – Export Certification ($1.3M) – Voluntary Qualified Importer Program ($71M) – Recall ($12M)
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New Fees?
• Foods • To implement FSMA • Substantial need - $400-500M • New standards, preventive controls,
inspections, import surveillance, science capacity, Federal-state integration, outbreak response
• Facility Registration
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WHERE ARE WE IN 2011?
• Difficult to imagine FDA without fees • Future appropriations uncertain • Triggers may help protect against cuts • Fees likely to be increasing % of agency • Concerns about consequences, e.g., over-
reliance on industry • Does debate on user fees cloud more important
issues?
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Recent declines in NME submissions and consequent NME approvals raise questions
about the drug pipeline CDER CY New Molecular Filings and Approvals
(1993 - 2008)
0
10
20
30
40
50
60
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004* 2005* 2006* 2007* 2008*
Calendar YearNew Molecular Entity Approvals New Molecular Entity Filings
*beginning in 2004 these f igures include BLAs for therapuetic biologics
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Ebb in Drug Pipeline Worldwide But US Share Has Increased
0
50
100
150
200
250
300
1983-1987
1988-1992
1993-1997
1998-2002
2003-2007
Year of NAS Cohort
Tota
l NA
Ss
Non-USAUSA
Source: Scrip NCE Review/Scrip Yearbook/Scrip Magazine (1983 -2005), PharmaProjects R&D Annual Review (2006/2007)
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US Still Dominates As Region of Launch for NMEs 1st
Marketed
2002
2003
2004
2005
2006
2002
2003
2004
2005
2006
2002
2003
2004
2005
2006
0
10
20
30
40
50
60
70
80
90
100
2002
2003
2004
2005
2006
USA Europe Japan Rest of World
CMR International /2007 Pharmaceutical R&D Factbook
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Looking Forward: A Growing Number of Commercial Investigational New Drugs (INDs)
Under Active Development
Commercial INDs with Activity*
38824090 4227 4164 4321
45324732 4836
5123 5209 53805598
59636369 6426
0
1000
2000
3000
4000
5000
6000
7000
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
Year
Num
ber
*CDER and CBER INDs
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The “Cliff” for Brand Name Drugs
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FDA Review is a Small Part of Drug Development
3
The Drug Development Process
* The full patent term is 20 years from the date a patent is filed.** Average total elapsed time. Source: Tufts Center for the Study of Drug Development; (includes the cost of failures)
Basic
ResearchDiscovery Preclinical Phase 1
(safety)
Phase 2
(efficacy)
Phase 3
(side effects)
Clinical Development NDA filing/
FDA review
Phase 4 Studies
Safety Surveillance
Patent Expiry *
Generic competition
3.2 years** 6.6 years** 1.4 years**
Average Total Time: 11.2 years**
Average total cost-per-success in bringing new chemical entity to market: $930 M ($2006)**
Pre-Market Post-Market
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A “Golden Age” for Biomedical Discovery
• Sequencing of human genome reveals new candidate targets
• Combinatorial chemistry, high throughput screening, biosynthesis provide thousands of candidate drugs
• Electronics innovations, nanotechnology, materials science drive device innovation
• Transgenic animals, new technologies (e.g., RNAi) for evaluating activity
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BUT
• Current methods of testing safety and efficacy are decades old and have poor predictiveness
• Leading to costly late-phase failures • Phase III failure rate now 50%, vs. 20% 10
years ago • New compounds entering Phase I have
8% chance of reaching market, vs. 15% 15 years ago
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SO
• FDA has halved review times since Pre-PDUFA days
- 6 and 10 months may be essentially the limit for review times
- Recent NDA contains 10 gigabytes
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SO
• If FDA has halved review times since Pre-PDUFA days
- 6 and 10 months may be essentially the limit for review times
o And R&D funding is providing the basic research, then,
O What’s Missing?
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Biomedical Discoveries Not Effectively Translated
• Investment in biomedical science far surpasses investment in medical product development process
• The development process is becoming a bottleneck to delivery of new products
• We are using evaluation tools and infrastructure of the last century to develop this century’s advances
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Opportunities for Modernization
O Biomarkers/surrogate endpoints O Genetic markers to predict adverse
reactions O Computer modeling O Clinical trial modernization O Bioinformatics O Pediatrics
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The Opportunity for Industry
• FDA willing to step beyond its traditional drug “review” role and promote drug development and innovation
• Enormous potential payoff - More predictable process - Increased % of compounds entering
Phase I reaching market - Reduced Phase III failure rate - Lower drug development costs
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And for Patients?
• Larger treatment effects via more targeted therapy
• Avoidance of side effects and injury • Better/earlier drug availability • Higher quality health care • Lower health care costs