Healthy Skepticism Library item: 12095

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Publication type: report

Subcommittee on Science and Technology, US FDA
FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology
: Subcommittee on Science and Technology, US FDA 2007 Nov
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf

Abstract:

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……………………………………………………..21 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…………………………………………………42 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 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……..B-1
C. Center for Food Safety and Applied Nutrition (CFSAN)…………..C-1
D. Center for Veterinary Medicine (CVM)…………………………………D-1
E. Center for Drug Evaluation and Research (CDER)………………….E-1
F. Center for Biologics Evaluation and Research (CBER)……………F-1
G. National Center for Toxicological Research (NCTR)……………….G-1
H. Center for Devices and Radiological Health (CDRH)………………H-1
I. Genomics…………………………………………………………………………I-1
J. Surveillance/Statistics………………………………………………………J-1
K. Information Technology (IT)……………………………………………..K-1
L. Task 1: Outline of Core FDA Regulatory Functions…………………L-1
M. Task 2: Identify Limitations of Today’s Regulatory Science, Mapped to Regulatory Functions………………………………………..M-1

Notes:

Free access to full report (.pdf)