OGD Perspectives

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


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


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



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



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



Operations Issues


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


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


Immediate Office Move

7519 Standish

7500 Standish


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


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


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


Review Issues

Overall review workload as noted

PEPFAR

Petitions – actively working on 14

Emphasis on safety concerns, e.g., isotretinoin; transdermals


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


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


Dissolution Methods for Drug Products New!!


ben



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.


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


Industry Contribution


You Can Help

Participate in the new initiatives

Respond quickly

Utilize available online resources

Submit applications electronically

Provide feedback on OGD processes


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



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



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


Emphasis on safetyMaintaining integrity of generic drug review

A Final Word


Center for Drug Evaluation and Research


HFD-600

7500 Standish Place

Rockville, MD 20855

301-827-5845