OGD Perspectives Gary J. Buehler, R.Ph. Director, Office of Generic Drugs October 26, 2005 GPhA Fall Technical Conference
Dec 31, 2015
OGD Perspectives
Gary J. Buehler, R.Ph.
Director, Office of Generic Drugs
October 26, 2005
GPhA Fall Technical Conference
FDA/GPhA Fall Technical Conference 2
Topics
ProductivityOperations IssuesNew EndeavorsPositive ProgressIndustry Contribution
FDA/GPhA Fall Technical Conference 3
Comparison of Receipts and Approvals of ANDA Applications
273 261
335 346326 335
449
563
766
213230
306
249266
294 310
373
413
467
307
361 364
0
100
200
300
400
500
600
700
800
900
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Nu
mb
er o
f S
ub
mis
sion
s
Receipts Approvals (Full & Tentative)
Office of Generic Drugs
FDA/GPhA Fall Technical Conference 4
MEDIAN Approval Times ANDA ORIGINALS
28.2
24.7
19.618.7
17.3
18.9 18.4 18.317.3
16.316.3
0
5
10
15
20
25
30
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Fiscal Year
Mon
ths
Office of Generic Drugs
FDA/GPhA Fall Technical Conference 5
Pending Original Applications
417 427 422
374395
564
615
780
0
100
200
300
400
500
600
700
800
900
1998 1999 2000 2001 2002 2003 2004 2005
at Fiscal Year end
Su
bm
issi
ons
in Q
ueu
e
Office of Generic Drugs
FDA/GPhA Fall Technical Conference 6
Controlled Correspondence Documents Received
457511
631685
1116
1502
952
0
200
400
600
800
1000
1200
1400
1600
1999 2000 2001 2002 2003 2004 2005
FISCAL Year
Sub
mis
sion
s of
Cor
resp
onde
nce
Office of Generic Drugs
FDA/GPhA Fall Technical Conference 7
Operations Issues
FDA/GPhA Fall Technical Conference 8
Hiring
IO 37 - Chem I 26 +1 Chem II 26 +1 Chem III 19 - 3 BioEquiv 43 +8 LPS 50 +2
TOTAL 201 9
On Board Change (over FY)
Oct 2005
FDA/GPhA Fall Technical Conference 9
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
FDA/GPhA Fall Technical Conference 10
Immediate Office Move
7519 Standish
7500 Standish
FDA/GPhA Fall Technical Conference 11
Staff Affected by Move
Gary Buehler
Pat Downs
Sam Haidar
Don Hare
Rita Hassall
Hyojong Kwon
Melissa Lamb
LaiMing Lee
Sau Lee
Robert Lionberger
Patti Littleton
Cecelia Parise
Genie Patrick
Andre Raw
Dave Read
Ruth Warzala
Kristin West
Lawrence Yu
to 7519 Standish Place
FDA/GPhA Fall Technical Conference 12
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
FDA/GPhA Fall Technical Conference 13
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
FDA/GPhA Fall Technical Conference 14
Review Issues
Overall review workload as noted
PEPFAR
Petitions – actively working on 14
Emphasis on safety concerns, e.g., isotretinoin; transdermals
FDA/GPhA Fall Technical Conference 15
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
FDA/GPhA Fall Technical Conference 16
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
FDA/GPhA Fall Technical Conference 17
Dissolution Methods for Drug Products New!!
FDA/GPhA Fall Technical Conference 18
ben
FDA/GPhA Fall Technical Conference 19
FDA/GPhA Fall Technical Conference 20
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.
FDA/GPhA Fall Technical Conference 21
OFFICE OF GENERIC DRUGS
TABLE OF BIOEQUIVALENCE RECOMMENDATIONS
Active Ingredient PotencyDosage Form
Route of Administration Date Finalized
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
FDA/GPhA Fall Technical Conference 22
Industry Contribution
FDA/GPhA Fall Technical Conference 23
You Can Help
Participate in the new initiatives
Respond quickly
Utilize available online resources
Submit applications electronically
Provide feedback on OGD processes
FDA/GPhA Fall Technical Conference 24
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
FDA/GPhA Fall Technical Conference 25
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
FDA/GPhA Fall Technical Conference 26
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
FDA/GPhA Fall Technical Conference 27
Emphasis on safetyMaintaining integrity of generic drug review
A Final Word
FDA/GPhA Fall Technical Conference 28
Center for Drug Evaluation and Research
Office of Generic Drugs
HFD-600
7500 Standish Place
Rockville, MD 20855
301-827-5845