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FDA Science Board

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. Outline. Review of last spring Science Board mtg External studies/Investigations underway

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FDA Science Board

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  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

  3. 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

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 Proposed Drug Watch Draft Guidance • Many comments • Support for early communication but unfavorable comments about Watch • Collating/ summarizing • Policy to be revised, as appropriate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

  10. 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. 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

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

  16. Drug Safety Oversight BoardUpdate • Doug Throckmorton, MD

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