FDA Science Board

CDER Drug Safety Update

November 6, 2005

Rockville, MD

Steven Galson, MD, MPHDirector, Center for Drug Evaluation and ResearchFood and Drug Administration

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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

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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

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

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External studies/Investigations Underway

Institute of Medicine

General Accounting Office/ US Congress

Open Congressional Investigations

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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

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Proposed Drug Watch Draft Guidance

Many comments

Support for early communication but unfavorable comments about Watch

Collating/ summarizing

Policy to be revised, as appropriate

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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

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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