OGD Perspectives

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OGD Perspectives
GPhA Fall Technical Conference

• Gary J. Buehler, R.Ph.
• Director, Office of Generic Drugs
• October 26, 2005

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Topics

• Productivity
• Operations Issues
• New Endeavors
• Positive Progress
• Industry Contribution

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Office of Generic Drugs
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Operations Issues
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Hiring
On Board Change (over
FY)

• IO 37 -
• Chem I 26 1
• Chem II 26 1
• Chem III 19 - 3
• BioEquiv 43 8
• LPS 50 2
• TOTAL 201 9

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
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Staff Affected by Move
to 7519 Standish Place
Robert Lionberger Patti Littleton Cecelia
Parise Genie Patrick Andre Raw Dave Read Ruth
Warzala Kristin West Lawrence Yu

• Gary Buehler
• Pat Downs
• Sam Haidar
• Don Hare
• Rita Hassall
• Hyojong Kwon
• Melissa Lamb
• LaiMing Lee
• Sau Lee

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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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• 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 Agencys Web page.

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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 safetyMaintaining integrity of
generic drug review
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Center for Drug Evaluation and ResearchOffice
of Generic Drugs
HFD-600 7500 Standish Place Rockville, MD
20855 301-827-5845