update from the office of generic drugs gary j. buehler, r.ph. director, office of generic drugs...
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Update from theOffice of Generic Drugs
Gary J. Buehler, R.Ph.
Director, Office of Generic DrugsCenter for Drug Evaluation and Research
Food & Drug Administration
March 2, 2004
Generic Pharmaceutical Association
2004 Annual Meeting
Center for Drug Evaluation & Research
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256
230
198
232241
29650
19
68
6269
68
284
89
0
50
100
150
200
250
300
350
400
1997 1998 1999 2000 2001 2002 2003
Fiscal Year
Nu
mb
er o
f A
pp
lica
tio
ns
Office of Generic DrugsFull and Tentative Approvals of ANDAs
(306) (310)(294)(249) (266) (364) (373)
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Office of Generic DrugsMEDIAN Approval Times -- ANDA ORIGINALS
24.2
28.2
24.7
19.618.7
17.3
18.9 18.4 18.317.3
0.0
5.0
10.0
15.0
20.0
25.0
30.0
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003
Fiscal Year
Months
As of September 30, 2003
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4
335346
326 335
307
361
449
0
50
100
150
200
250
300
350
400
450
500
1997 1998 1999 2000 2001 2002 2003
Fiscal Year Totals
Nu
mb
er o
f S
ub
mis
sio
ns
Office of Generic DrugsReceipts of Original ANDA Applications
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Receipts of Original ANDAsBy Month
15
24 22 2225 26
35
62
2319
30
24
30 31 30
22
2926
41
87
36
25
35
29
35 36 37 36
26
38
44
102
55
0
20
40
60
80
100
120
May-01 Jul-01 Sep-01 Nov-01 Jan-02 Mar-02 May-02 Jul-02 Sep-02 Nov-02 Jan-03 Mar-03 May-03 Jul-03 Sep-03 Nov-03 Jan-04
Num
ber
of S
ubm
issi
ons
Office of Generic Drugs
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Office of Generic DrugsControlled Correspondence Documents Received
511
631699
952 972
0
200
400
600
800
1000
1200
2000 2001 2002 2003 2004FISCAL Year
Sub
mis
sion
s of
Cor
resp
onde
nce
*Projected for End of FY 04
*
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Workload Backlog and Staffing
Chemistry FY01 FY02 FY03 FY04
Backlog 140-150days 90-120 days ±100 days
Staffing 60 (at end of FY)
Lost 4
Gained 8
Lost 2
Gained 12Lost 2
Gained 2
Pending 374 395 506 625*
Receipts 307 361 449 239*
*as of 1/31/2004
Center for Drug Evaluation & Research
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New Chemistry Review DivisionChemistry Division 1
Team 1
Team 4
Team 5
Team 2
Chemistry Division 2
Team 6
Team 9
Team 10
Team 7
Team 3 Team 8
Chemistry Division 3
Team 4 Team 6 Team +
Center for Drug Evaluation & Research
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Workload Backlog and Staffing
Microbiology FY01 FY02 FY03 FY04
Backlog (Orig)
210 days 343 days 280 days 86 days*
Staffing 4(at end of FY)
Lost TL
Gained TL +1
Lost 0
Gained 1Lost 0
Gained 1
Backlog (Supp)
209 days 110 days 113 days 90 days*
Pending 121 90 39 72*
Receipts 307 361 449 239*
*as of 1/31/2004
Center for Drug Evaluation & Research
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Workload Backlog and Staffing
Bioequivalence FY01 FY02 FY03 FY04
Backlog ±49 days 118 days 200+ days 226 days*
Staffing 30 (at end of FY)
Lost 4
Gained 0
Lost 2
Gained 5Lost 0
Gained 2
Pending 374 395 506 625*
Receipts 307 361 449 239*
*as of 1/31/2004
Center for Drug Evaluation & Research
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Scientific Staff FY2002
Lawrence Yu
FY2003 FY2004 - projected Robert Lionberger Andre Raw Sam Haider Hyojong Kwon Pradeep Sathe Qian Li
Center for Drug Evaluation & Research
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Clinical Review Staff FY2002
Dena Hixon, MD
FY2003 FY2004 - projected Carol Kim Additional MD Krista Scardina Helen Li (Statistician) Sarah Ho
Center for Drug Evaluation & Research
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Other Activities
Listed Drug Guidance Directed by new law
Drafted; under review
OGD/Office of Chief Counsel (OCC) determining regulation revisions or changes necessitated by new law
OGD/GPhA Communications
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Interaction to Facilitate Efficient Approval of Applications June 11, 2003 - Impurities - Lawrence Yu June 26, 2003 - General discussion - Need for dissolution
database identified September 24, 2003 - Webcast on Impurities October 15, 16, 17, 2003 - Fall Technical Conference November 5 & 6, 2003 - First “ANDA Basics” Workshop February 4 & 5, 2004 - Second “ANDA Basics” Workshop February 10, 2004 - Webcast on cGMP TO COME:
April 20, 2004 – Preparing CTD/eCTD Workshop
Center for Drug Evaluation & Research
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Budget Outlook
FY2004
Not yet finalized
FY2005
Proposed the same as FY2004
Can’t predict what will happen
Center for Drug Evaluation & Research
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Bioequivalence Information Availability Dissolution Methods database
Will be available March 2004 Will be initially populated with older products Newly approved products will be added
incrementally In-Vivo Bioequivalence Recommendations
database being planned
Center for Drug Evaluation & Research
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DRAFT
ben
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Orange Book Revisions
Increased staffing to improve service
Will go to daily patent listings ≈April
2004
New search capability for patent listings
from OB webpage
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CDER Electronic Submission Initiatives
Electronic-Common Technical Document Pilot program has begun
G for I: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions
ANDAs, DMFs, NDAs, BLAs, INDs
Efficient, flexible approach
Uses e-CTD Viewer System (EVS)
Commercial tools available for creating e-CTD
Center for Drug Evaluation & Research
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CDER Electronic Submission Initiatives
E-Labeling Submissions
Implementation of a Structured Drug Label
A repository to house all labels
Develop tools to review and keep labels current
FR, February 5, 2004, Docket No. 2004D-0041
G for I: Providing Regulatory Submissions in
Electronic Format – Content of Labeling
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E-Submissions/E-CTD
Additional information and specifications
www.fda.gov/cder/regulatory/ersr/ectd.htm
CDER/Office of Information Management
ERSR Technical Support:
Center for Drug Evaluation & Research
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For the Future:
Continue to maximize our review efficiency
Continue to focus resources on backlogged review areas
Continue to interact regularly with GPhA to discuss critical issues
Expand the Dissolution Methods database
Create a In-Vivo Bioequivalence Recommendations database
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February 11, 2004 OGD approved 13 applications for
Benazepril or Benazepril/HCTZ 2002 Sales for Lotensin® (the RLD) were
$315 million (ranks 97th)
In one week, the retail price of a month’s supply of Benazepril fell from $44 to $26 (40% decrease)
Approximate annual savings of 100 million dollars
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Final Words...
The generic drug industry has done more to address the spiraling health costs in this country than any other industry
More than 50% of all prescriptions dispensed are supplied by your industry and reviewed by my office
We are making a difference...
Center for Drug Evaluation & Research
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Office of Generic Drugs