Tracking FDA Drug Review Performance€¦ · Some Therapeutic Areas Still Need Improvement Despite...
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Some Therapeutic Areas Still Need Improvement Despite consistent decreases in average approval times, endocrine, gastrointestinal and CNS therapies have lagged behind in recent years. Breakthrough Designation Pharmaceutical and biotechnology innovators seek the breakthrough designation because it provides a faster path to patients. Since its inception, breakthrough therapies have been concentrated in oncology, rare diseases and infectious conditions. That said, 2015 marks an increase in the diversity of breakthrough designated approvals. The FDA has an important and difficult job: Ensuring timely and efficient drug review processes while maintaining rigorous scientific and safety standards. Overall, agency performance has improved markedly, a reflection of the work by FDA leadership, industry, Congress and other stakeholders. Refinements, such as the most recent user fee legislation (the 2012 FDA Safety and Innovation Act) and the breakthrough therapy mechanism, have accelerated approvals. Still, there are wide variations across therapeutic areas, with some indications, such as oncology and infectious disease (e.g., Hepatitis C), benefiting more than others. As we approach the next user fee reauthorization and recognize the differences across therapeutic areas, there is a real opportunity to identify managerial, procedural and other practices that will promote more consistency across the agency. Tracking FDA Drug Review Performance Improved Review Times… Since 2009, FDA review times have steadily declined. …With a Caveat Over the last ~15 years the fastest reviews have been in oncology, infectious and rare diseases (although the gap has significantly narrowed over the last 5 years). View online: CALifeSciences.org/2016FDADrugReport @CALifeSciences SUBMISSION APPROVALS Difference from average approval time, FY 2008-2015 Gastrointestinal Musculoskeletal Anti-infective Dermotological Endocrine CNS Oncology & Immunomod SUBMISSIONS -6 -3 -12 -9 0 6 3 Months difference from average approval time of 12.7 months 3 8 21 4 10 17 52 33% 0% 76% 0% 0% 29% 58% # % Expedited* *Includes Priority, BTD, Priority + BTD and Orphan designated drugs together Conclusion The FDA has worked diligently to improve overall drug review times and processes — a success to be applauded. As Congress, the agency and the biopharmaceutical industry look toward the next user fee round, we have a great opportunity to replicate those improvements across all therapeutic areas. More than 2 years 1-2 years Less than 1 year Estimated review time (incl. in-process) Review time (approved Rx only) DRUG APPROVAL TIMES Estimated review time to approval for NME/NBE submission cohorts, FY 2000-2015 Percent of approvals 100% 75% 50% 25% 0% ’13 ’12* ’11 ’10 ’09* ’08* ’07 ’06 ’05 ’04 ’03 ’02 ’01 U.S. Submission Cohorts (FY) *Includes estimates of approval times for drugs still in process ’00 ’14 ’15* Lighter shades indicate projections for drugs in-process Months 24 18 12 6 0 21 21 17 20 15 12 13 13 21 21 15 13 12 11 9 10 BREAKTHROUGH DESIGNATIONS BY THERAPEUTIC AREA As of March 14, 2016 Hematology Ophthalmology Rare disease Respiratory Infectous disease Oncology BREAKTHROUGH DESIGNATED APPROVALS 2013-2015 100 80 60 40 20 0 Publically available BT Dermatology Gastroenterology Cardiovascular Sensory Immunology Blood Respiratory Neurology Rare disease Infectous disease Oncology TOTAL: 107 52 14 1 1 3 3 4 4 6 6 13 2013 2 1 3 2014 7 2 3 1 13 2015 9 3 3 3 2 1 21 1 SUBMISSIONS VS. APPROVAL TIMES Breakdown of expedited and standard approvals, FY 2000-2015 0 6 12 3 9 15 21 18 24 80 70 60 50 40 30 20 10 0 Average U.S. review time, in months Number of submissions Blood Gastrointestinal Musculoskeletal Genitourinary Anti-infective Other Cardiovascular Endocrine CNS Oncology & Immunomod Expedited (includes Priority, BTD, Priority + BTD and Orphan designated drugs together) Standard Oncology submissions are the most numerous and achieve quickest review SOURCES: BCG analysis based on FDA data, EvaluatePharma, literature reviews and press releases Data supplied by Boston Consulting Group, Feb. 2016 Graphics by PAUL HORN / Special to CLSA © 2016 California Life Sciences Association. All rights reserved.
Transcript of Tracking FDA Drug Review Performance€¦ · Some Therapeutic Areas Still Need Improvement Despite...
Some Therapeutic Areas Still Need ImprovementDespite consistent decreases in average approval times, endocrine, gastrointestinaland CNS therapies have lagged behind in recent years.
Breakthrough DesignationPharmaceutical and biotechnology innovatorsseek the breakthrough designation because it providesa faster path to patients. Since its inception, breakthroughtherapies have been concentrated in oncology, rare diseasesand infectious conditions. That said, 2015 marks an increasein the diversity of breakthrough designated approvals.
The FDA has an important and difficult job:Ensuring timely and efficient drug reviewprocesses while maintaining rigorous scientificand safety standards. Overall, agencyperformance has improved markedly, areflection of the work by FDA leadership,industry, Congress and other stakeholders.Refinements, such as the most recent user feelegislation (the 2012 FDA Safety and InnovationAct) and the breakthrough therapy mechanism,
have accelerated approvals. Still, there arewide variations across therapeutic areas, withsome indications, such as oncology andinfectious disease (e.g., Hepatitis C), benefitingmore than others. As we approach the next userfee reauthorization and recognize thedifferences across therapeutic areas, there is areal opportunity to identify managerial,procedural and other practices that willpromote more consistency across the agency.
Tracking FDA DrugReview Performance
Improved Review Times…Since 2009, FDA review times have steadily declined.
…With a CaveatOver the last ~15 years the fastest reviews have been in oncology, infectious andrare diseases (although the gap has significantly narrowed over the last 5 years).
View online:CALifeSciences.org/2016FDADrugReport
@CALifeSciences
SUBMISSION APPROVALSDifference from average approval time, FY 2008-2015
Gastrointestinal
Musculoskeletal
Anti-infective
Dermotological
Endocrine
CNS
Oncology & Immunomod
SUBMISSIONS
-6 -3-12 -9 0 63Months difference from average approval time of 12.7 months
3
8
21
4
10
17
52
33%
0%
76%
0%
0%
29%
58%
#%
Expedited*
*Includes Priority, BTD, Priority + BTD and Orphan designated drugs together
ConclusionThe FDA has worked diligently to improve overall drugreview times and processes — a success to be applauded.As Congress, the agency and the biopharmaceutical industrylook toward the next user fee round, we have a greatopportunity to replicate those improvements across alltherapeutic areas.
More than 2 years1-2 yearsLess than 1 year
Estimated review time (incl. in-process)Review time (approved Rx only)
DRUG APPROVAL TIMESEstimated review time to approval for NME/NBE submission cohorts, FY 2000-2015
Perc
ent o
f app
rova
ls
100%
75%
50%
25%
0%’13’12*’11’10’09*’08*’07’06’05’04’03’02’01
U.S. Submission Cohorts (FY)
*Includes estimates of approval times for drugs still in process
’00 ’14 ’15*
Lighter shades indicate projections for drugs in-processM
onth
s24
18
12
6
0
21 2117
20
1512 13 13
21 21
1513
12 119 10
BREAKTHROUGH DESIGNATIONS BY THERAPEUTIC AREAAs of March 14, 2016
HematologyOphthalmologyRare diseaseRespiratoryInfectous diseaseOncology
BREAKTHROUGHDESIGNATED APPROVALS2013-2015
100
80
60
40
20
0
Publically available BT
DermatologyGastroenterologyCardiovascularSensoryImmunologyBloodRespiratoryNeurologyRare diseaseInfectous diseaseOncology
TOTAL: 107
52
14
113
34
4
6
6
13
20132
1
3
2014
7
23
1
13
2015
9
333
21
21
1
SUBMISSIONS VS. APPROVAL TIMESBreakdown of expedited and standard approvals, FY 2000-2015
0 6 123 9 15 2118 24
80
70
60
50
40
30
20
10
0
Average U.S. review time, in months
Num
ber o
f sub
mis
sion
s
Blood
GastrointestinalMusculoskeletal
Genitourinary
Anti-infective
Other
Cardiovascular
Endocrine
CNS
Oncology & Immunomod
Expedited(includes Priority, BTD, Priority + BTD and Orphan designated drugs together)Standard
Oncology submissions are the mostnumerous and achieve quickest review
SOURCES: BCG analysis based on FDA data, EvaluatePharma, literature reviews andpress releases
Data supplied by Boston Consulting Group, Feb. 2016
Graphics by PAUL HORN / Special to CLSA
© 2016 California Life Sciences Association. All rights reserved.
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