sources of risk from drug products
DESCRIPTION
Sources of Risk from Drug Products. Known side effects. Medication errors. Product quality defects. Unavoidable. Avoidable. Preventable adverse events. Remaining uncertainties Unexpected side effects Unstudied uses Unstudied populations. Injury or death. Modular. - PowerPoint PPT PresentationTRANSCRIPT
Source: CDER Report to the Nation 2001
Standard NDA ApprovalsMedian times, approvals
12
.0
12
.0
12
.0
12
.0
16
.2
15
.1
14
.7
12
.0
17
.8
18
.7
14
.0
13
.8
12
.0
15
.0
56
78
55
65
102
67
101
0
12
24
1995 1996 1997 1998 1999 2000 2001
Calendar Year
Mo
nth
s
0
60
120
Ap
pro
va
ls
Median FDA review time Median total approval time Number approved
Source: CDER Report to the Nation 2001
Standard NDAsActions, filings*, approval percentages
22
5
19
7
15
3
18
5
14
3
14
7
20
0
92
90
92
87
10
1
87
91
36%45%
42% 37% 40% 39%
51%
0
150
300
1995 1996 1997 1998 1999 2000 2001
Calendar year*A filing in one year may lead to several actions or an approval in subsequent years.
Nu
mb
er
0%
50%
100%
Pe
rce
nt
Actions Filings Percent of actions that are approvals
Source: CDER Report to the Nation 2001
Priority NDA ApprovalsMedian times, approvals
6.1
6.0
6.2
6.0
6.0
7.8
6.2
6.4
7.8
6.0
6.0
6.1
6.0
6.4
10
20
28
2529
15
20
0
12
24
1995 1996 1997 1998 1999 2000 2001
Calendar Year
Mo
nth
s
0
15
30
Nu
mb
er
Median FDA review time Median total approval time Number approved
Source: CDER Report to the Nation 2001
Priority NDAsActions, filings*, approval percentages
35
43
27
31
46
41
44
621
31
27
32
26
24
57%
37%
49%
65%54%
66%48%
0
25
50
1995 1996 1997 1998 1999 2000 2001
Calendar year*A filing in one year may lead to several actions or an approval in subsequent years.
Nu
mb
er
0%
50%
100%
Pe
rce
nt
Actions Filings Percent of actions that are approvals
Source: CDER Report to the Nation 2001
Standard NME ApprovalsMedian times, approvals
12
.3
15
.7
15
.4
14
.4
15
.9
14
.0
14
.6
13
.4
19
.0
19
.9
15
.0
16
.3
15
.1
17
.8
1718
30
19
35
1416
0.0
12.0
24.0
1995 1996 1997 1998 1999 2000 2001
Calendar Year
Mo
nth
s
0
20
40
Nu
mb
er
Median FDA review time Median total approval time Number approved
Source: CDER Report to the Nation 2001
Standard NMEsFilings*
34
29
24
28
22
15
26
0
20
40
1995 1996 1997 1998 1999 2000 2001
Calendar year*A filing in one year may lead to several actions or an approval in subsequent years.
Nu
mb
er
Filings
Source: CDER Report to the Nation 2001
Priority NME ApprovalsMedian times, approvals
6.2
6.0
6.4
6.0
6.3
7.7
6.2
6.0
6.7
6.9
9.6
6.0
999
18
16 19
0.0
12.0
24.0
1995 1996 1997 1998 1999 2000
Calendar Year
Mo
nth
s
0
10
20
Nu
mb
er
Median FDA review time Median total approval time Number approved
Source: CDER Report to the Nation 2001
Priority NMEsFilings*
16
16
18
15
16
15
4
0
12
24
1995 1996 1997 1998 1999 2000 2001
Calendar year*A filing in one year may lead to several actions or an approval in subsequent years.
Nu
mb
er
Filings
Source: CDER Report to the Nation 2001
New or Expanded Use ApprovalsMedian times, approvals
12
.3
11
.9
11
.9
11
.7
10
.2
10
.0
10
.1
14
.2
16
.0
10
.4
10
.0
11
.3
11
.8
13
.969
108
124118
97134
91
0
12
24
1995 1996 1997 1998 1999 2000 2001
Calendar year
Mo
nth
s
0
70
140
Ap
pro
va
ls
Median FDA review time Median total approval time Number approved
Source: CDER Report to the Nation 2001
New or Expanded UsesActions, approval percentages
18
5
19
6
18
9
17
3
18
4
20
5
21
3
60%
72%
53% 65%57%
37%43%
0
125
250
1995 1996 1997 1998 1999 2000 2001
Calendar year
Ac
tio
ns
0%
50%
100%
Pe
rce
nt
Actions Percentage of actions that are approvals
Source: CDER Report to the Nation 2001
OTC New Approvals & New Uses
81 720
8 69 5 3 11 3
0
12
24
1996 1997 1998 1999 2000 2001
Calendar year
Nu
mb
er
New approvals or Rx-to-OTC switches New uses
Source: CDER Report to the Nation 2001
Generic Drug ApprovalsMedian times, approvals
19
.3
27
.0
18
.0
18
.2
23
.0
18
.6
18
.1
207 212
273
225
186
244234
0
12
24
36
1995 1996 1997 1998 1999 2000 2001
Calendar year
Mo
nth
s
0
100
200
300
Ap
pro
va
ls
Median approval times Number of generic approvals
Source: CDER Report to the Nation 2001
Generic DrugsSubmissions*
29
6
36
5
32
0
33
0
30
7
28
3
34
50
200
400
1995 1996 1997 1998 1999 2000 2001
Calendar year*Submissions = workload in subsequent years
Nu
mb
er
Submissions
Source: CDER Report to the Nation 2001
NDA Manufacturing Supplement ApprovalsMedian times, approvals
5.1
4.5
4.0
5.4
5.9
5.2
4.0
1,3941,3451,419
1,375
1,178
1,4221,024
0
6
12
1995 1996 1997 1998 1999 2000 2001
Calendar year
Mo
nth
s
0
320
640
960
1,280
1,600
Ap
pro
vals
Median total approval time Number approved
Source: CDER Report to the Nation 2001
NDA Manufacturing SupplementsActions, approval percentages
1,6
05
1,7
47
1,6
59
1,6
30
1,7
82
1,6
74
1,7
20
80%
83% 81% 84%72%
61%
81%
0
1,000
2,000
1995 1996 1997 1998 1999 2000 2001
Calendar year
Nu
mb
er
0%
50%
100%
Nu
mb
er
Actions Percent of actions that are approvals
Source: CDER Report to the Nation 2001
Generic Drug Manufacturing SupplementsApprovals, receipts
2,3
33
1,9
69
2,2
84
1,9
03
2,3
14
2,453
2,1182,370
3,036
2,522
0
2,000
4,000
1997 1998 1999 2000 2001
Calendar year
Nu
mb
er
Number of supplements approved Number of supplements received
Source: CDER Report to the Nation 2001
Inspections of Clinical Research
312
28 40 42 64 61 49 38143
184
191
139
4 7 1 4 10 28246
293
296
258
297
393
170
158
155
28
0
250
500
1995 1996 1997 1998 1999 2000 2001
Calendar year
Nu
mb
er
U.S. clinical investigators Foreign clinical investigators
Institutional review boards Sponsors, monitors, CROs
Source: CDER Report to the Nation 2001
Sources of Risk from Drug Products
Known side effects
Unavoidable Avoidable
Medicationerrors
Product qualitydefects
Preventableadverseevents
Injuryor death
Remaininguncertainties
• Unexpected side effects• Unstudied uses• Unstudied populations
Source: CDER Report to the Nation 2001
Post-Marketing Adverse Event Reports
156,477
191,865212,843
247,604
278,143 266,991
286,755
0
150,000
300,000
1995 1996 1997 1998 1999 2000 2001
Calendar year
Nu
mb
er
Direct (MedWatch) 15-day Nonserious periodic Periodic
Source: CDER Report to the Nation 2001
Drug Promotion Review
12
9
53
9
27
6
77
3
51
5
59
7
22
0
24
5
10
5
11
7
17
1
23
7
35
0
39
9
17
8
41
7
55
8
0
400
800
1995 1996 1997 1998 1999 2000 2001
Fiscal year
Nu
mb
er
Regulatory actions Launch campaigns Other letters
Source: CDER Report to the Nation 2001
Drug Recalls
19
1
22
6
24
8
35
2
60
53
34
88
72
15
6
24
8
31
6
17
7
72
0
200
400
1995 1996 1997 1998 1999 2000 2001
Fiscal year
Nu
mb
er
Prescription Over-the-counter
Source: CDER Report to the Nation 2001
Safety-Based NME WithdrawalsBased on year of approval
2.7%2.7%0.0%
1.5%
3.0%
Pre-PDUFA(13)
PDUFA(7)
Approval periods (number withdrawn as of April 30, 2002)
Pe
rce
nta
ge
Percentage withdrawn
Source: CDER Report to the Nation 2001
FDA Inspections of Manufacturing Plants
77
3
1,1
44
82
2
1,7
75
1,0
85
1,2
68
1,8
44
1,4
36
1,4
97
0
1,000
2,000
1999 2000 2001
Fiscal year
Nu
mb
er
New drug preapproval Generic preapproval Current good manufacturing practice
Source: CDER Report to the Nation 2001
Export Certificates Issued
1,74
7
4,49
9
4,37
8
4,38
2
3,97
3
4,19
7
4,54
2
0
2,500
5,000
1995 1996 1997 1998 1999 2000 2001
Fiscal Year
Nu
mb
er
Export certificates issued
Source: CDER Report to the Nation 2001
Modular Structure of Common Technical Doc ument
Nonclinical written and tabulated
summaries
Module I Administrative
and prescribing information
(not harmonized)
Module II General introduction and overall summaries of quality, nonclinical
and clinical information
Clinical written and tabulated
summaries
Module IV Nonclinical
study reports
Module III Quality
data
Module V Clinical
study reports
Source: CDER Report to the Nation 2001
Average Monthly Use of CDER Internet Site
7232156 226 406 549
0.5
1.3
3.12.5
6.7
9.3
0
500
1,000
1996 1997 1998 1999 2000 2001
Calendar year
Vis
ito
rs (
tho
usa
nds)
0
5
10
Hit
s (
mill
ions
)
Visitors (thousands) Hits (millions)