1. FDA Science Board CDER Drug Safety Update November 6, 2005 Rockville, MD Steven Galson, MD, MPH Director, Center for Drug Evaluation and Research Food and Drug Administration

2. November 6, 20052 Outline Review of last spring Science Board mtg External studies/Investigations underway Internal policy changes & development Drug Watch guidance and comments Involving the public and expert peer reviewers Drug safety budget, personnel and organization DSOB and early communication examples – Dr. Throckmorton Q & A

3. November 6, 20053 Spring 2005 Science Board Briefing on Drug Safety Pre-Market Drug Safety: Labeling and Electronic Initiatives: Drug Safety Initiatives: Post-Market Drug Safety: Drug Safety Resources: Applying New Science to Drug Safety: Committee Questions and Discussion

4. November 6, 20054 Key Points from Spring Meeting 50 % of CDER resources spent on drug safety – every office, most activities Many new initiatives underway to improve: pre and post-market analysis & communication Fundamental progress in drug safety will be made only with continued scientific investments and scientific progress

5. November 6, 2005 Example: New Technologies for Personalized Medicine Genomic, proteomic, metabolomic markers Status in patients with serious side effects vs those without? Study in prospective trials and from MedWatch reports Develop ability to avoid high risk patients or monitor for development before overt toxicity occurs

6. November 6, 20056 External studies/Investigations Underway Institute of Medicine General Accounting Office/ US Congress Open Congressional Investigations

7. November 6, 20057 Progress Underway: Internal policy changes & development SOPs on interactions between CDER units Quality Systems implementation and process improvements New communications paradigms – DT DSOB, “sheets”, adverse events newsletter

8. November 6, 20058 Proposed Drug Watch Draft Guidance Many comments Support for early communication but unfavorable comments about Watch Collating/ summarizing Policy to be revised, as appropriate

9. November 6, 20059 Public comment & expert peer review “Part 15” Hearings: Risk Communication and Direct-to-Consumer Advertising Survey of physicians preferences on risk communications Drug Safety and Risk Management Advisory Committee: May 18-19, 2005 Discuss drugs safety issues including Risk assessment program for marketed drugs Advantages/Disadvantages of current system

10. November 6, 200510 Advisory Committee Meetings Anti-viral: HIV, chronic hepatitis B Arthritis: severe rheumatoid arthritis Cardiovascular: treatment of heart failure Dermatologic/Opthalmic with Nonprescription: Rx to OTC switch of corticosteroids Endocrinologic and Metabolic: type II diabetes mellitus Nonprescription: benefits/risks of antibacterial soaps

11. November 6, 200511 Advisory Committee Meetings Oncologic: transfusion dependent anemia, leukemia, prostate cancer Pediatric: discussed pediatric post-marketing studies for products for cancer indications Peripheral and Central Nervous System: migraines Pharmaceutical Science: assessment of research programs, quality by design Psychopharmacologic: major depressive disorder, need for longer term efficacy data Pulmonary-Allergy: asthma, COPD, preventing rejection of lung transplant

12. November 6, 200512 Drug Safety Budget, Personnel and Organization FY 2006 House/Senate Conference Report: House proposes additional $5M for drug safety activities over original $5M drug safety increase request (for total of $10M) New Director of Office of Drug Safety – Gerald DalPan, MD, MHS New Reorganization Plan for CDER

13. November 6, 200513 Reorganization: Goals Reflect the commitment of CDER to sustained, multi-disciplinary, cross-Center approach to drug safety Placement in organization must reflect level of commitment Need focus and consistency and improvement in communication about drug risks and benefits Need focus for cross-center policy development Locus for Critical Path Activities

14. November 6, 200514 Reorganization: Proposal New Associate Center Director – drug safety policy and risk communication focus Consolidate certain communications activities Elevated organizational status unit responsible for epidemiology and surveillance (current Office of Drug Safety) Report to Center Director New “super-office” combining OCPB, OB, responsible for CP projects and other cross-cuttting science activities

15. November 6, 200515 Summary Continued high level of focus on improving drug safety and risk communications activities in CDER while outside evaluations conclude with recommendations

16. November 6, 200516 Drug Safety Oversight Board Update Doug Throckmorton, MD