1. FDA Science Board Drug Safety Initiative April 15, 2005 Rockville, MD RADM Steven Galson, MD, MPH Acting Director, Center for Drug Evaluation and Research Food and Drug Administration

2. April 15, 2005FDA SCIENCE BOARD2 Drug Safety – Change at FDA Outline Dr. Crawford’s November announcement Secretary Leavitt’s February announcement What’s coming

3. April 15, 2005FDA SCIENCE BOARD3 Drug Safety – Specific Actions Acting Commissioner Crawford’s 5-Point Plan Announced in November Sponsor an Institute of Medicine (IOM) Study of the Drug Safety System Implement a Program for Adjudicating Differences of Professional Opinion Appoint Director, Office of Drug Safety Conduct Drug Safety/Risk Management Consultations Publish Risk Management Guidances

4. April 15, 2005FDA SCIENCE BOARD4 February Drug Safety Announcement – FDA Actions in 4 categories Overall goals: promote a culture of openness and enhanced oversight within the FDA Specific areas of change: 1. More outside expert consultations 2. Improve drug safety management practices 3. Change how we communicate about emerging drug risks to improve transparency 4. Continue our work to improve scientific methods of AE signal detection

5. April 15, 2005FDA SCIENCE BOARD5 Drug Safety Initiative The initiative will: Give patients, healthcare professionals and other consumers quick and easy access to the most up-to-date and accurate information on medicines. Make FDA’s drug review, approval, and monitoring programs as transparent as possible.

6. April 15, 2005FDA SCIENCE BOARD6 Drug Safety Initiative New drug safety information outlets Proposed Drug Watch Program Patient Information Sheets Healthcare Professional Sheets Drug Safety Oversight Board

7. April 15, 2005FDA SCIENCE BOARD7 Drug Safety Oversight Board Will provide independent oversight and advice to the CDER Center Director on management of: Important drug safety issues and policies. Dissemination of certain safety information through FDA’s website to healthcare professionals and patients.

8. April 15, 2005FDA SCIENCE BOARD8 Drug Safety Oversight Board Membership Chair – Deputy Director, CDER Executive Director – Dr. Susan Cummins Membership - representatives from relevant CDER offices, CBER, CDRH, NIH, VA. Consumer or patient representatives and advisory committee members as consultants. CDER is will make operating procedures available explaining the Board in more detail very soon.

9. April 15, 2005FDA SCIENCE BOARD9 Drug Safety Information – new steps Proposed “Drug Watch” web page List of drugs being watched Patient information sheets Physician information sheets

13. April 15, 2005FDA SCIENCE BOARD13 Summary FDA responsive to concerns about drug safety decision making and communication While comprehensive review underway, we will implement important changes to improve public knowledge, internal management and outside involvement Changes will not be free of controversy and may raise important new issues for resolution