9/6/96

DEPARTMENT OF HEALTH & HUMAN SERVICES

                                     Public Health Service

                                     Food and Drug Administration
                                     Rockville, Maryland 20857

March 1, 1996

David Korn, M.D.
Distinguished Scholar in Residence
Association of American Medical Colleges
2450 N Street, N.W.
Washington, D.C. 20037

Dear Dr. Korn:

I am very grateful for your willingness to serve on a special subcommittee of the FDA Science Board. The subcommittee's principal charge will be to recommend appropriate criteria for determining the quality and mission relevance of FDA-sponsored laboratory investigation. The subcommittee's recommendations will be forwarded for review and discussion by the entire Science Board. The subcommittee will not be asked to actually conduct peer review or site visit activities.

While there is no statutory language which precisely defines the size or scope of laboratory science within the FDA, there is currently a substantial and multifaceted research enterprise within the Agency. Drafting criteria that will be uniformly applied throughout the Agency will be a challenging task, given the breadth of the Agency's responsibilities and interests, the public's expectations, and the growth of biologic and material science.

In my capacity as Deputy Commissioner, I recognize the many advantages of a strong intramural research capability that supports our public health mission. Clearly, there are times when relevant scientific data, which are both reliable and readily accessible, are not luxuries but necessities. Moreover, in my brief tenure at FDA I have been favorably impressed by the skill, professionalism and dedication of many of its scientists. This, in spite of heterogeneous institutional expectations (imprecisely articulated), incomplete strategic planning across Centers, and inconsistent tactical resource allocations (varying levels of support).

Looking ahead, however, I am increasingly concerned about future resource and personnel limitations facing the FDA. We must have the capacity to rapidly and accurately answer the most important public health challenges facing the Agency. To properly do so, we must develop processes which assure that research of superior quality and mission relevance is conducted in an effective and efficient manner. Additionally, to maintain our commitment to being a science-based agency, we must improve our ability to collect and utilize information from all sources (internal and external) and to recruit, reward and retain a cohort of superb scientists.

To assist you in your deliberations, I ask you to consider four basic questions. Each entails a number of related topics, some of which I have enumerated below.

1. What categories or topic areas of basic and applied research are most appropriate for FDA intramural investigation?

• What criteria should be employed to identify research topics that best promote or support FDA's mandated regulatory responsibilities to promote and protect the public health.
• To what extent should "uniqueness" bear on prioritizing FDA support for research projects? Should consideration be given to whether projects could be or are being pursued anywhere else?
• How important is the research component of the FDA in providing a source of experts needed for review and policy functions? How important is a research component within the Agency to help maintain a state-of-the-art knowledge among Agency scientists?

2. What is the most appropriate model (and what the best mechanics) for a peer review system to be applied to FDA intramural research?

• How should peer review committees be constituted? How should members be identified, instructed, etc.?
• Should reviews be conducted on a Center-by-Center basis or should laboratories utilizing similar models, techniques and disciplines be reviewed together?
• Are there any special review criteria that are more relevant for FDA research?
• Should reviews be principally prospective (future plans), retrospective (past accomplishments) or a mixture?
• How should site visits be conducted? What sort of site visit reports would be generated by the review team? What follow-up response from the investigator would be expected?

• Should special review criteria exist for a scientist who devotes only part time to laboratory research (the rest for administration, product review, etc.)?
  

3. Since the Agency will never be able to obtain from intramural staff all the requisite scientific knowledge, expert opinion or insights necessary for all regulatory decisions, what other mechanisms should be utilized to obtain this information?

• How can more effective collaborations be forged with other federal agencies, academia and/or industry?

4. Are there novel approaches to the organization or structure of laboratory research at FDA that will enhance the long-term welfare of FDA's review and research components.

• Is the organization best configured to conduct intramural research or should restructuring be considered?
• What special incentives should be utilized to recognize excellence in FDA laboratory science?
• Are there new approaches to recruitment and retention of laboratory scientists at FDA?

These considerations present complex and difficult problems which deserve our utmost attention, especially if we want to achieve all that we can.

I look forward to working with you; I appreciate your willingness to serve.

                           Sincerely yours,
 
 
                           Michael A. Friedman, M.D.
                           Deputy Commissioner for Operations

Hypertext created on 03/14/97 by Jonathan Boswell, OSB, Center for Devices and Radiological Health.