# Presentation: 231615

## 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

## Overview	

- Hot Topics in CDER
- FDA’s GMP Initiative
- Shirley Murphy, MD
- CDER’s Pediatric Therapeutics Program
- 	Ajaz Hussain, PhD

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## 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

## Quality Systems

- Say what you do
- Do what you say
- Prove it
- Improve it

## 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”

## 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”

## Quality Systems

- Once clear on expectations – assess how processes & work is addressing &
- 	if needed
- Set up metrics for results
- Audit
- Continue to improve

## 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

## 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

## 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

## PDUFA ’04:  CMA and GRMP Guidance's

- Finalize this Fall
- Training for all review staff in October
- Details on email
- 5 1⁄2 day sessions
- Aim for consistent implementation

## 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

## Strategic Direction: 2004Agency Strategic Action Plan

## Strategic Direction:  2004

- Efficient, Science Based Risk Management
- Patient and Consumer Safety
- Better Informed Consumers
- Counterterrorism
- A Strong FDA

## 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

## 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

## 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

## 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

## 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

## Agency Strategic Action Plan

- Over 300 action items total
- CDER leading over 70 actions
- Action Plan Monitoring
- Periodic status updates to Agency Management

## 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

## 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

## 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

## Administrative Changes

**Administrative Changes: President’s Management Agenda**
**Government-wide Initiatives**
**Strategic Management of Human Capital**
**Competitive Sourcing**

## Administrative Changes

- Administrative Personnel Reduction
- Administrative Consolidation
- A-76 Process

## 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

## 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

## 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