GPhA/FDA GPhA/FDA Fall Technical Workshop Janet Woodcock M D - - PowerPoint PPT Presentation

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GPhA/FDA GPhA/FDA Fall Technical Workshop Janet Woodcock M D - - PowerPoint PPT Presentation

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GPhA/FDA GPhA/FDA Fall Technical Workshop Janet Woodcock M D Janet Woodcock, M.D. Director Center for Drug E Evaluation and Research l ti d R h October 20, 2010 Messages Current Status Generic Skepticism Generic Skepticism

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SLIDE 1

GPhA/FDA GPhA/FDA Fall Technical Workshop

Janet Woodcock M D Janet Woodcock, M.D. Director Center for Drug E l ti d R h Evaluation and Research October 20, 2010

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SLIDE 2

Messages

  • Current Status
  • Generic Skepticism

Generic Skepticism

  • Future Developments

GDUFA – GDUFA

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SLIDE 3
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SLIDE 4

ANDA Receipts

766 793 880 830 859 814 900 1000 ns 563 766 793 600 700 800 plication 307 361 449 563 400 500 600

  • f App

307 100 200 300 um ber 100 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 N 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Fiscal Year

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SLIDE 5
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SLIDE 6

Globalization

  • Increasing number of off-shore

manufacturers and facilities

  • More new un-inspected sites

– Impacting approval of some ANDAs – Impacting approval of some ANDAs

  • Increased number of Drug Masterfiles

referenced in each ANDA referenced in each ANDA

– Impacts review time I d h f d fi i i – Increased chances of deficiencies

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SLIDE 7

Product Complexity

  • Complexity of products is increasing

– More complex dosage forms

  • Delayed release, Extended release
  • Transdermal products
  • Inhalational products

Inhalational products

– More complex APIs

  • Oligosaccharides (e.g., enoxaparin)
  • Peptides/proteins (e.g., calcitonin)

– Combination products

  • Drug + inhaler

Drug + inhaler

  • Drug + injection device
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SLIDE 8

Generic Skepticism

FDA approved generic drugs are therapeutically equivalent to the brand p y q name product. However differences can lead to skepticism However, differences can lead to skepticism.

  • Significantly larger tablets

B d t t

  • Bad taste
  • Bad odor
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SLIDE 9

Generic Skepticism

  • Manufacturers need to think beyond

simple therapeutic equivalence and p p q minimal approval standards

– Product presentation Product presentation – Patient perceptions – Meet or exceed patient expectations Meet or exceed patient expectations

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SLIDE 10

Future Developments

  • New OGD Director
  • GDUFA Negotiations

GDUFA Negotiations

  • Quality Management System

I l t ti f M Ki ’

  • Implementation of McKinsey’s

recommendations

  • Question-based Review for QbD
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SLIDE 11

Search for Director

  • Nationwide search to be advertised soon
  • Looking for physician with industrial drug

Looking for physician with industrial drug development experience

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SLIDE 12

GDUFA

  • Initial stages of development
  • Public meeting on September 17th

Public meeting on September 17

– Excellent attendance Valuable input from industry and public – Valuable input from industry and public

  • Public docket for comments

( l d M d 10/18) – (closed Monday 10/18) – Public comment will be reviewed before ti ti t t negotiations start

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SLIDE 13

GDUFA

  • Stable source of supplemental funding
  • Support for the entire generic regulatory

Support for the entire generic regulatory program

  • Fair to all manufacturers (large & small)
  • Fair to all manufacturers (large & small)
  • Straightforward to administer
  • Performance goals that support public

health goals

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SLIDE 14

McKinsey

  • Business-process consultants
  • Assessing composition of ANDA “backlog”

Assessing composition of ANDA backlog

– Pending review vs. awaiting response from sponsor sponsor – Less than 180 days vs. greater that 180 days

  • Assessing review process in OGD
  • Assessing review process in OGD
  • Recommending process improvements
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SLIDE 15

Quality Management System

  • Center-wide Initiative

– Say what you do. Do what you say – Do what you say. – Prove it. – Improve it.

  • OGD has new Quality Management Specialist
  • n board
  • Rapidly moving toward complete set of SOPs for

Rapidly moving toward complete set of SOPs for regulatory processes

  • Developing a Knowledge-Management System

P d i d i i – Precedent-setting decisions

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SLIDE 16

Question-based Review

  • Initiated in 2006
  • Essentially 100% of ANDAs support QbR

Essentially 100% of ANDAs support QbR

  • Fosters consistent & efficient reviews

E l t t i l OGD’ b it

  • Explanatory material on OGD’s website
  • Expanding and revising questions to

support review of ANDAs using QbD paradigm

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SLIDE 17

QbR for QbD

  • Support for implementation thru a

separate contract w/ McKinsey

  • Re-focus questions on:

– Product & Process design – Risk assessment/risk management

  • Recent workshops have targeted

p g refinement of QbD principles for generics

  • Most important for complex products &

p p p dosage forms

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SLIDE 18

Goals for FY-2011

  • Permanent Director for OGD
  • Negotiate User Fee Agreement

Negotiate User Fee Agreement

  • Establish Quality Management System

throughout CDER throughout CDER

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SLIDE 19

Thank you!