Science at Work in CDRH:

The Role of Science in the Regulatory Process

 

Presented to the

FDA Science Board

 

By the CDRH External Review Subcommittee

November 2001

External Science Review Committee

A Note of Thanks

Objective of

CDRH Review

To assess the quality of science across the organization and its relevance to the organization’s regulatory mission.

Outline of Report

Internal Review Process

External Review Process

July 24 - 26 Review

 

Scientific Expertise

Findings address:

Decision-making Process

Expertise in the CDRH

Regulatory Role

Internal Expertise for ODE

Scientific Expertise

Findings:

Scientific Expertise

Findings (continued):

Human Resource Issues

Findings address:

Human Resource Issues

Findings:

Organizational and

Process Issues

Findings address:

Organizational and

Process Issues

Findings:

"semi-porous silos"

beyond those who sit on existing

FDA Advisory Panels

Recommendations

  1. CDRH needs to communicate, both internally and externally, a clear vision of the fundamental role of science in the regulatory process.
  2. CDRH needs to rethink how it carries out its mission, prioritizing its activities, outsourcing those functions it can while still maintaining oversight, and reallocating its resources so as to expand its investment in science; as part of this CDRH should examine its existing organizational structure as well as other regulatory models.
  3. As part of its restructuring of activities to enhance the fundamental role of science, CDRH should assess and reconsider the structure of OST to focus on emerging science and technology; this assessment likely will require a separate review of OST.
  4. Recommendations (Continued)

  5. CDRH should develop a plan for enhancing cross-office and inter-agency (e.g., FTC, FCC) communication and collaboration.
  6. CDRH should establish an electronic database for liaison functions and an internal and external expertise inventory.
  7. CDRH should develop and implement a formal process for capturing institutional knowledge so that when a decision is reached it does not only remain in the "mind" of the reviewer.
  8. With the large staff turnover anticipated in the next 5 years and in order to fill gaps in scientific expertise, CDRH should expeditiously perform an assessment of the current level and breadth of expertise so as to develop a long-term strategic staffing and recruitment plan.
  9. Recommendations (Continued)

  10. CDRH needs to develop procedures and staff development opportunities to ensure that reviewer mandates for such issues as sample size or randomized trials are shaped by realistic clinical perspectives and relevant ethical considerations.
  11. CDRH needs to streamline processes that encourage scientific growth within the staff and provide for a more inviting career path and reward structure for scientific personnel.
  12. CDRH should encourage and facilitate the use by ODE of internal, but non-ODE expertise and also external expertise, including the development of policies that promote a more liberal use of external experts.
  13. CDRH should expand its outreach to and scientific interactions with industry and universities.
  14. Recommendations (Continued)

  15. CDRH should develop a plan in collaboration with other Centers for the evaluation of combination products; this plan may require changes in organizational structure and operational procedures
  16. CDRH should implement a quality evaluation and improvement program, and as part of this develop metrics for the assessment of quality as well as the timeliness of results.
  17. CDRH should implement a quality system with a focus on CDRH as an organization and on the development of activities that contribute to high quality decisions and the most productive use of resources.

Evaluation of the Review Process

Components of the Process

Components of the Process (continued)

Concluding Comments

Concluding Comments (continued)

 

 

Concluding Comments (continued)