FDA Science Board

Drug Safety Initiative

April 15, 2005Rockville, MD

RADM Steven Galson, MD, MPHActing Director, Center for Drug Evaluation and ResearchFood and Drug Administration

April 15, 2005 FDA SCIENCE BOARD 2

Drug Safety – Change at FDAOutline

Dr. Crawford’s November announcement Secretary Leavitt’s February announcement What’s coming

April 15, 2005 FDA SCIENCE BOARD 3

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

April 15, 2005 FDA SCIENCE BOARD 4

February Drug Safety Announcement – FDA Actions in 4 categoriesOverall goals:

promote a culture of openness and enhanced oversight within the FDA

Specific areas of change:1. More outside expert consultations2. Improve drug safety management practices3. Change how we communicate about emerging

drug risks to improve transparency4. Continue our work to improve scientific methods of

AE signal detection

April 15, 2005 FDA SCIENCE BOARD 5

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.

April 15, 2005 FDA SCIENCE BOARD 6

Drug Safety Initiative New drug safety information outlets

Proposed Drug Watch Program Patient Information Sheets Healthcare Professional Sheets

Drug Safety Oversight Board

April 15, 2005 FDA SCIENCE BOARD 7

Drug Safety Oversight Board 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.

April 15, 2005 FDA SCIENCE BOARD 8

Drug Safety Oversight BoardMembership

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.

April 15, 2005 FDA SCIENCE BOARD 9

Drug Safety Information – new steps Proposed “Drug Watch” web page

List of drugs being watched Patient information sheets Physician information sheets

April 15, 2005 FDA SCIENCE BOARD 13

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