OT FDA Science and Mission at Risk

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FDA Science and Mission at Risk

Report of the Subcommittee on Science and Technology

PREPARED FOR

FDA Science Board

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%

20Report%20on%20Science%20and%20Technology.pdf

FDA Science and Mission at Risk Report of the Subcommittee on

Science and Technology

Table of Contents

FDA Mission

Statement............................................................

..........iii

1.0 Executive

Summary..............................................................

......1

1.1

Overview.............................................................

......................1

1.2 Major

Findings.............................................................

..............3

1.2.1 The FDA cannot fulfill its mission because its scientific base

has eroded and its scientific organizational structure is

weak.........3

1.2.2 The FDA cannot fulfill its mission because its scientific

workforce does not have sufficient capacity and

capability.............4

1.2.3 The FDA cannot fulfill its mission because its information

technology (IT) infrastructure is

inadequate................................5

1.3 Summary Statement and

Recommendations.............................6

1.4 The Structure of This

Report.....................................................8

2.0 Context: The Changing FDA

Environment..................................9

2.1 Growing Disparity between Responsibilities and Resources.....9

2.2 The Criticality of

Science.........................................................12

2.3 The Changing Nature of

Science.............................................16

3.0 Discussion of Key Findings and

Recommendations..................20

3.1 Science: Capability, Capacity and

Organization.......................20

3.1.1 Finding: FDA does not have the capacity to ensure the safety

of food for the

nation..............................................................2

1

3.1.2 Finding: The development of medical products based on " new

science " cannot be adequately regulated by the

FDA...................24

3.1.3 Finding: There is insufficient capacity in modeling, risk

assessment and

analysis.........................................................30

3.1.4 Finding: The FDA science agenda lacks a coherent structure and

vision, as well as effective coordination and prioritization.......33

3.2 Workforce: Securing Critical Scientific Capability and Capacity38

3.2.1 Finding: The FDA has substantial recruitment and retention

challenges...........................................................

...................40

3.2.2 Finding: The FDA has an inadequate and ineffective program for

scientist

performance.........................................................4

2

3.2.3 Finding: The FDA has inadequate funding for professional

development..........................................................

.................42

3.2.4 Finding: The FDA has not taken sufficient advantage of

external and internal

collaborations...........................................43

3.3 Information

Infrastructure.....................................................45

3.3.1 Finding: The Subcommittee believes that there is evidence of

important, but slow, progress to improve information sciences and

technology at the FDA over the past few years, yet significant gaps

remain......................................................46

3.3.2 Finding: The FDA lacks the information science capability and

information infrastructure to fulfill its regulatory

mandate............47

3.3.3 Finding: The FDA cannot provide the information infrastructure

support to regulate products based on new

science..............................................................

....................49 Confidential i

FDA Science and Mission at Risk Report of the Subcommittee on

Science and Technology

3.3.4 Finding: The FDA IT infrastructure is obsolete, unstable, and

lacks sufficient controls to ensure continuity of operations or to

provide effective disaster recovery

services............................50

3.3.5 Finding: The IT workforce is insufficient and suboptimally

organized............................................................

...................51

4.0 Overarching Findings of this FDA

Review................................53

4.1.1 Finding: The FDA has experienced decreasing resources in the

face of increasing

responsibilities.........................................53

4.1.2 Finding: Recommendations of excellent FDA reviews are seldom

followed.............................................................

.........56

List of Appendices

A. Subcommittee to the FDA Science

Board...................................A-1

B. The State of Science at the Food and Drug Administration