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 • Future Developments – GDUFA GDUFA
ANDA Receipts 1000 880 859 ns 900 830 814 793 793 plication 766 766 800 700 563 563 600 600 of App 449 500 361 400 307 307 um ber 300 200 100 100 N 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Fiscal Year
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 – Increased chances of deficiencies I d h f d fi i i
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
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 • Bad taste B d t t • Bad odor
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
Future Developments • New OGD Director • GDUFA Negotiations GDUFA Negotiations • Quality Management System • Implementation of McKinsey’s I l t ti f M Ki ’ recommendations • Question-based Review for QbD
Search for Director • Nationwide search to be advertised soon • Looking for physician with industrial drug Looking for physician with industrial drug development experience
GDUFA • Initial stages of development • Public meeting on September 17 th Public meeting on September 17 – Excellent attendance – Valuable input from industry and public Valuable input from industry and public • Public docket for comments – (closed Monday 10/18) ( l d M d 10/18) – Public comment will be reviewed before negotiations start ti ti t t
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
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
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 on board • Rapidly moving toward complete set of SOPs for Rapidly moving toward complete set of SOPs for regulatory processes • Developing a Knowledge-Management System – Precedent-setting decisions P d i d i i
Question-based Review • Initiated in 2006 • Essentially 100% of ANDAs support QbR Essentially 100% of ANDAs support QbR • Fosters consistent & efficient reviews • Explanatory material on OGD’s website E l t t i l OGD’ b it • Expanding and revising questions to support review of ANDAs using QbD paradigm
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
Goals for FY-2011 • Permanent Director for OGD • Negotiate User Fee Agreement Negotiate User Fee Agreement • Establish Quality Management System throughout CDER throughout CDER
Thank you!
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