Impact of the Prescription Drug of New Drug Development

Impact of the Prescription Drug
User Fee Act of 1992 on the Speed
of New Drug Development
Kenneth I Kaitin, Ph.D.
Director, Tufts Center for the Study of Drug Development
FDA Public Hearing on PDUFA
Washington, D.C., September 15, 2000
Regulatory Initiatives to Speed
Availability of High Priority Drugs
Subpart E Procedures (1988)
Accelerated Approval Regulations (1993)
Cancer Initiatives (1996)
Tufts
Development Times for Accelerated,
Subpart E, and Other NCE Approvals,
1995-99
84
Other NCES (n=151)
73.9
Accelerated (n=19)
Subpart E (n=8)
72
60
MONTHS
49.7
48
45.6
36
24
17.2
10.1
12
5.7
0
Clinical Phase
Source: Tufts CSDD Approved NCE Database, 2000
Approval Phase
Tufts
Mean Clinical and Approval Phases
by Therapeutic Class, 1995-1999
8.5
Endocrine
Anesthetic/Analgesic
0.8
7.1
CNS
1.5
Cardiovascular
6.3
1.6
Anticancer
6.4
1.4
Respiratory
4.8
Antiinfectives
4.8
AIDS Antivirals
3.4
0
2.7
8.1
7.9
7.8
7.5
6.3
1.5
3.8
0.4
2
8.4
1.3
6.6
9.3
4
6
8
YEARS
Clinical
Source: Tufts CSDD Approved NCE Database, 2000
Approval
Tufts
10
NCE Approvals in 2 or More Years, 1 Year
or Less, and 6 Months or Less, 1990-1999
PDUFA
70
PERCENTAGE
60
1 Year or Less
2 Years or More
50
40
30
6 Months or Less
20
10
0
1990
1991
1992
1993
1994
Source: Kaitin & DiMasi, Drug Inf J 2000;34:673-80
1995
1996
1997
1998
Tufts
1999
Approval Phases for NCEs and
Biopharmaceuticals
36
33.8
32.2
30.5
23.3
23.1
MONTHS
20.7
16.7
15.1
12.0
10.4
0
NCEs
FY 81-85
Source: Tufts CSDD, 2000
Biopharmaceuticals
FY 86-89
FY 90-93
FY 94-96
FY 97-98
Tufts
User Fee Review Phases for NCEs by
FY Cohort
24
20.3
18.0
17.1
MONTHS
13.9
12.4
11.8
11.0
9.8
12.8
10.6
9.9
7.8
0
Time to 1st Action
FY 93
Source: Tufts CSDD, 2000
FY 94
Total Approval Phase
FY 95
FY 96
FY 97
FY 98
Tufts
User Fee Review Phases for
Biopharmaceuticals by FY Cohort
24
23.1
19.6
MONTHS
14.3
12.9
12.9
12.2
11.0
9.3
9.1
7.0
6.0
5.6
0
Time to 1st Action
FY 93
Source: Tufts CSDD, 2000
FY 94
Total Approval Phase
FY 95
FY 96
FY 97
FY 98
Tufts
User Fee Review Phases for Standard
and Priority NCEs, FYs 97-98
18
15.3
13.6
12.1
11.8
MONTHS
10.7
7.5
6.3
6.0
0
Time to 1st Action
FY 97-S
Source: Tufts CSDD, 2000
Total Approval Phase
FY 97-P
FY 98-S
FY 98-P
Tufts
Prior, Foreign Marketing of New
Drugs Approved in the US, 1996-1998
U.S. 1st
market, 47%
<1 yr prior
mktg, 31%
1-5 yrs prior
mktg, 14%
Source: Kaitin & Healy, Drug Inf J 2000;34:1-14
>10 yrs prior
mktg, 4%
6-10 yrs prior
mktg, 5%
Tufts
Prior, Foreign Marketing of New
Drugs Approved in the US, 1991-1995
<1 yr prior
mktg, 12%
1-5 yrs prior
mktg, 37%
U.S. 1st
market, 31%
>10 yrs prior
mktg, 9%
6-10 yrs prior
mktg, 10%
Source: Tufts CSDD Approved NCE Database, 1999
Tufts
New Drug Approvals and
Withdrawals 1990-1999
60
53
Approvals (total=526)
Withdrawals* (total=10)
NUM BER
39
27
30
28
33
30
26
22
21 20
20
30
28
25
23 23
22
14
12
1
1
1
2
1
2
2
0
80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99
* Withdrawals indicated by year of drug approval
Source: Tufts CSDD, 2000
Tufts
Current Status of Pharmaceutical
Innovation in the United States
Collegial FDA-sponsor relationship
Large number of NCE approvals
Faster approval times
Focus on development times
More drugs approved first in the U.S.
Tufts
Conclusions
PDUFA - most significant piece of drug
legislation since 1962 Amendments
Overwhelming success in speeding drug
review process and changing the
relationship between agency and sponsors
Public ultimately benefits from faster
access to important new drugs
Tufts