FDA Science Board

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
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

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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
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

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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

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External studies/Investigations Underway

• Institute of Medicine
• General Accounting Office/ US Congress
• Open Congressional Investigations

7
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
Proposed Drug Watch Draft Guidance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
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

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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

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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
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

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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

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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

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Summary

• Continued high level of focus on improving drug
  safety and risk communications activities in CDER
  while outside evaluations conclude with
  recommendations

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Drug Safety Oversight BoardUpdate

• Doug Throckmorton, MD