Transcript Document 7671092

GPhA Fall Technical Conference
OGD Perspectives
Gary J. Buehler, R.Ph.
Director, Office of Generic Drugs
October 26, 2005
Topics
 Productivity
 Operations Issues
 New Endeavors
 Positive Progress
 Industry Contribution
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Office of Generic Drugs
Comparison of Receipts and Approvals of ANDA Applications
900
Receipts
800
Approvals (Full & Tentative)
766
Number of Submissions
700
600
563
500
400
413
361 364
346
335
300
261
213
249
230
335
326
306
273
200
467
449
373
310
294 307
266
100
0
1995
1996
1997
1998
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1999
2000
2001
Fiscal Year
2002
2003
2004
2005
3
Office of Generic Drugs
30
MEDIAN Approval Times
ANDA ORIGINALS
28.2
24.7
25
19.6
Months
20
18.9
18.7
18.4
18.3
17.3
17.3
16.3
16.3
2004
2005
15
10
5
0
1995
1996
1997
1998
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1999
2000
2001
Fiscal Year
2002
2003
4
Office of Generic Drugs
Pending Original Applications
900
780
800
700
Submissions in Queue
615
600
564
500
417
427
422
374
400
395
300
200
100
0
1998
1999
2000
2001
2002
2003
2004
2005
at Fiscal Year end
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Office of Generic Drugs
Controlled Correspondence Documents Received
1600
1502
Submissions of Correspondence
1400
1200
1116
1000
952
800
685
631
600
511
457
400
200
0
1999
2000
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2001
2002
2003
FISCAL Year
2004
2005
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Operations Issues
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Hiring
On Board
 IO
Change (over FY)
 LPS
37
26
26
19
43
50
+1
+1
-3
+8
+2

201
9
 Chem I
 Chem II
 Chem III
 BioEquiv
TOTAL
Oct 2005
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Hiring Process Delays
 Often takes 6 months or more, from initial
contact, to complete the hiring process
 Has been difficult to hire enough additional
reviewers to address the increase in
submissions
 We continue to fall behind – especially in
Division of Bioequivalence and Microbiology
staffs
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Immediate Office Move
7519 Standish
7500 Standish
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Staff Affected by Move
to 7519 Standish Place
Gary Buehler
Pat Downs
Sam Haidar
Don Hare
Rita Hassall
Hyojong Kwon
Melissa Lamb
LaiMing Lee
Sau Lee
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Robert Lionberger
Patti Littleton
Cecelia Parise
Genie Patrick
Andre Raw
Dave Read
Ruth Warzala
Kristin West
Lawrence Yu
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CDER Offices at White Oak
 Office of Pharmaceutical Science (except OGD)
 Office of Counter Terrorism and Pediatric Drug
Development
 Office of Clinical Pharmacology and
Biopharmaceutics
 Office of New Drugs
 Office of Medical Policy (including DDMAC)
 Office Pharmacoepidemiology and Statistical
Science
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CDER Offices at White Oak
 Effect on OGD

More difficult to communicate with OND and
OPS directly

More time devoted to travel between FDA
buildings

We believe it is critical to maintain face-to-face
contact with these and other offices in CDER
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Review Issues
 Overall review workload as noted
 PEPFAR
 Petitions – actively working on 14
 Emphasis on safety concerns, e.g.,
isotretinoin; transdermals
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New Endeavors – IO Perspective
 Structured Product Labeling (SPL)
 Makes labeling available on Internet via
National Library of Medicine (NLM)
 Review Efficiencies
 Early DMF review
 Cluster reviews – product specialists
 Supplement triaging at team leader level
 DBE Truncated Review
 Question based Review (QbR)
 Will have a very positive impact
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On a Positive Note...
 New resources developed

Dissolution Database

Individual Product Bioequivalence Information
 Encouraged the use of telephone in review
process

Increased the number of 1st cycle approvals

Decreased the total number of review cycles

Total time to approval did not increase in spite
of increased workload
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ben
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This guidance contains an
Internet link to a listing of drug
products, each linked in turn to a
corresponding bioequivalence
recommendation. Clicking on a
product name in that list will
bring up the bioequivalence
recommendations for that specific
product. Recommendations have
been developed for several drugs
that are not yet eligible for generic
competition (i.e., newly approved
products) and some older
products for which information
has previously been provided. As
additional recommendations are
developed, those will be posted on
the Web site. When this guidance
is finalized, the listing will be
available through the Agency’s
Web page.
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OFFICE OF GENERIC DRUGS
TABLE OF BIOEQUIVALENCE RECOMMENDATIONS
Active Ingredient
Potency
Dosage
Form
Almotriptan Malate
12.5 mg
Tablet
Oral
5/16/2005
Alosetron
1 mg
Tablet
Oral
5/31/2005
Atazanavir
200 mg
Capsule
Oral
3/18/2005
Atomoxetine
60 mg
Capsule
Oral
6/13/2005
Cefditoren Pivoxil
200 mg
Tablet
Oral
3/18/2005
Dutasteride
0.5 mg
Capsule
Oral
7/5/2005
Eplerenone
50 mg
Tablet
Oral
3/18/2005
Fosamprenavir Calcium
700 mg
Tablet
Oral
3/18/2005
Memantine
10 mg
Tablet
Oral
7/8/2005
Rosuvastatin
40 mg
Tablet
Oral
3/18/2005
Tadalafil
20 mg
Tablet
Oral
3/18/2005
Vardenafil HCl
20 mg
Tablet
Oral
4/11/2005
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Route of
Administration
Date Finalized
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Industry Contribution
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You Can Help
 Participate in the new initiatives
 Respond quickly
 Utilize available online resources
 Submit applications electronically
 Provide feedback on OGD processes
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You Can Help - Microbiology
 Changes to Container/Closure System

Glass Vials (e.g., change from Type II to Type I,
or vial vendor change)
a) Identical vial opening dimensions: no C/C
integrity validation needed,
b) Non-identical opening dimensions: perform C/C
integrity validation

Stoppers (change in rubber formulation):

Perform C/C integrity validation
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You Can Help - Microbiology
 General Supplement Info:


Note (in cover letter) ANDA/NDA/Supplement
numbers in which the change was previously
submitted/approved
Note (in cover letter) whether the newly
submitted information is identical to or
represents updated information contained in the
initial supplement
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You Can Help - Microbiology
 General Supplement Info – continued:

For minor (“Micro Only”) changes affecting
multiple applications, OGD Micro is amenable to
a single initial supplement filing followed by AR
filing for subsequent reporting of the same
change, provided all affected applications or
products are delineated in the initial supplement.

Otherwise, products not listed in the initial
supplement would require CBE-30/0 supplement
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A Final Word
Emphasis on safety
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Fall Technical Conference
Maintaining
integrity of generic drug review
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Center for Drug Evaluation and Research
Office of Generic Drugs
HFD-600
7500 Standish Place
Rockville, MD 20855
301-827-5845
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