1	CDER EXECUTIVE STAFF BRIEFING RAPS Baltimore, MD 10/20/2003 Steven Galson, M.D., M.P.H. Acting Director Center for Drug Evaluation and Research Food and Drug Administration
2	Overview Hot Topics in CDER FDA’s GMP Initiative Shirley Murphy, MD CDER’s Pediatric Therapeutics Program Ajaz Hussain, PhD
3	Hot Topics in CDER Leadership changes CDER Priorities Consolidation with former CBER staff Incorporation of best practices Commissioner’s Innovation Initiative PDUFA III implementation FDA Strategic Plan Addressing challenges of FY 2004 budget
4	Leadership Changes Dr. Janet Woodcock to Office of Commissioner Cross-cutting projects GMP Pharmacogenomics Quality systems Coordination with NIH on harmonized clinical data and adverse event standards Scientific challenges of generic biologics Dr. Mark Goldberger, Acting Deputy Director
5	CDER Priorities Consolidation with former CBER staff Incorporation of best practices Commissioner’s Innovation Initiative PDUFA III implementation FDA Strategic Plan Addressing challenges of FY 2004 budget
6	CBER Consolidation Merger of Biotech Programs Increase of 208 FTEs Increase in CDER's biotech program - adding monoclonal antibodies for therapy and diagnosis; thrombolytics; cytokines; growth factors; and immunomodulators Expands CDER's laboratory research programs Includes 54 approved products and approximately 1500 INDs Focus on Best Practices
7	2003 Accomplishments: CBER Consolidation New Structures to address biotech therapeutic program New Office of Drug Evaluation VI with 3 divisions New Office of Biotechnology Products with 2 laboratory-based review divisions Compliance: new Therapeutic Facilities Review Branch Safety: a new section for statistical support for biologic products
8	CDER Priorities Consolidation with former CBER staff Incorporation of best practices Commissioner’s Innovation Initiative PDUFA III implementation FDA Strategic Plan Addressing challenges of FY 2004 budget
9	Commissioner’s Innovation Initiative Response to falling NME application rates observed world-wide (not unique to FDA) Overall goal: help streamline/facilitate drug development (NOT shorten review times) Root cause analysis – multiple cycles Additional guidances – e.g. pharmacogenomics Quality systems principles in review process
10	Innovation Initiative: Pharmacogenomics (PG) Guidance on filing PG data to INDs and NDAs Work with CDRH on co-development of PG tests and investigational drugs Formation of cross-disciplinary review group Work on standardization
11	Quality Systems Say what you do Do what you say Prove it Improve it
12	Innovation Initiative: Quality Systems (What is it?) Dr. Harry Hertz (Baldridge Award): “You don’t have to be bad to improve” “It’s all about results”
13	Quality Systems Approach Assume organization purpose/goal is to meet/exceed customers needs/expectations Two (maybe three) kinds of customers Internal – you External – public, prescribers, patients, congress, administration, etc. Industry = “constrained customer”
14	Quality Systems Once clear on expectations – assess how processes & work is addressing & if needed Set up metrics for results Audit Continue to improve
15	Quality Systems Lecture series through Fall – telecast across FDA Working group (under product quality initiative) expect to produce a draft framework by Halloween Training course for PDUFA managers being set up
16	CDER Priorities Consolidation with former CBER staff Incorporation of best practices Commissioner’s Innovation Initiative PDUFA III implementation FDA Strategic Plan Addressing challenges of FY 2004 budget
17	PDUFA ‘04 CMA and GRMP Guidances Performance improvement contracts Prospective “root cause analysis” Quality systems Postmarket Guidances IT funding/projects run by CIO’s office
18	PDUFA ’04: CMA and GRMP Guidance's Finalize this Fall Training for all review staff in October Details on email 5 ½ day sessions Aim for consistent implementation
19	CDER Priorities Consolidation with former CBER staff Incorporation of best practices Commissioner’s Innovation Initiative PDUFA III implementation FDA Strategic Plan Addressing challenges of FY 2004 budget
20	Strategic Direction: 2004 Agency Strategic Action Plan
21	Strategic Direction: 2004 Efficient, Science Based Risk Management Patient and Consumer Safety Better Informed Consumers Counterterrorism A Strong FDA
22	Use Science-Based Efficient Risk Management Apply most current scientific knowledge about risk management and quality assurance Pharmaceutical cGMP Initiative Prevent additional review cycles when possible and develop guidances on innovative and cross-cutting product development: Oncology Diabetes Pharmacogenomics Provide high quality, cost-effective oversight of industry manufacturing, processing and distribution to reduce risk
23	Empowering Consumers: Improving Health through Better Information Provide new important information on pediatric labeling to advocacy groups and health care provides Draft guidance on brief summary for direct-to-consumer advertising Better communicate risks of imported prescription drugs Continue Generic Drug Education Educate public and health care providers about antimicrobial resistance Establish joint campaign with CDC
24	Improving Patient and Consumer Safety Work with Industry to improve quality of adverse event information Possibly revise MedWatch data collection methods or form Develop guidance Develop analytical techniques to better understand the sources and degree of product-related risks Data Mining Develop staff expertise to enhance ability to analyze risks Develop reviewer guidance for post-marketing data analysis Enhance design/use of in-house databases to better identify risks Use of population-based databases to better analyze risks Establish a partnership to collect data on medication errors Access databases to complement current available databases
25	Strengthen Capability to Counter Terrorism Threats and Incidents Assess the regulatory status of high priority medical countermeasures Identify what additional countermeasures need to be developed Support appropriate labeling changes for counter terrorism indications Identify medical countermeasure inventories and address potential shortages Identify patterns that indicate a need for increased scrutiny for certain manufacturers, sites and/or products
26	Ensure a World-class Workforce & Effective & Efficient Operations Most actions are led by Office of the Commissioner Implement Shared Services Seeking improved Personnel software (e.g., QuickHire/QuickClass) Improve Agency Financial Management Systems Execute plans for White Oak
27	Agency Strategic Action Plan Over 300 action items total CDER leading over 70 actions Action Plan Monitoring Periodic status updates to Agency Management
28	CDER Priorities Consolidation with former CBER staff Incorporation of best practices Commissioner’s Innovation Initiative PDUFA III implementation FDA Strategic Plan Addressing challenges of FY 2004 budget
29	Budget Prospects – ‘04 Appropriations Committee Markups (House and Senate) completed FDA received an unprecedented $60M cut to base funding $25.7M Management savings $29M IT savings 0.6M Homeland Security Transfer and others
30	Budget Prospects – ‘04 So What does this mean? Very very lean year Targeted increases will not offset losses and yet better performance will be expected Don’t foresee personnel growth in ’04
31	Administrative Changes Administrative Changes: President’s Management Agenda Government-wide Initiatives Strategic Management of Human Capital Competitive Sourcing
32	Administrative Changes Administrative Personnel Reduction Administrative Consolidation A-76 Process
33	Administrative Personnel Reduction Rationale for budget cuts: savings from head count reduction in management/administrative area 7 1/2% Reduction in defined series in ’04 7 1/2% Reduction in ’05
34	Administrative Consolidation: Shared Services Organization and Personnel Shared Services (FDA) IT Infrastructure Shared Services Administrative shared Services: EEO, Real Property, Travel, Contracts/purchasing, Financial Personnel (HHS, pending Congressional agreement) Hiring Classification Promotions
35	Summary Exciting, ambitious plans for coming year Improving and modernizing review process Addressing how FDA can foster/promote innovation in drug development Enhanced focus on special problems (counter-terrorism and pediatrics) Improved methodology for risk management