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U.S. Department of Health and Human Services

Advisory Committees

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Minutes of the February 5, 2014 Meeting of the Science Board to the FDA

FDA White Oak Campus, Bldg 31, Room 1503
10903 New Hampshire Ave, Silver Spring MD, 20993

Wednesday, February 5, 2014
The Science Board to the FDA (Science Board) meeting was convened at approximately 8:30 a.m.

Members Present (Voting)
Russ B. Altman, M.D., Ph.D., Chair
Jeffrey Bender, DVM, MS, DACVM
Paul R. Billings, M.D., Ph.D., FACP, FACMG
Elazer R. Edelman, M.D., Ph.D.*
Maria C. Freire, Ph.D.
Michael C. Gibbons, M.D., MPH
Lynn R. Goldman, M.D., MPH*
William N. Hait, M.D., Ph.D.*
Isaac S. Kohane, M.D., Ph.D.*
Barbara B. Kowalcyk, Ph.D.
Frederick Kushner, M.D.
Mark R. McLellan, Ph.D.
Lisa K. Nolan, DVM, MS, Ph.D.
Steven M. Paul, M.D.*
Bruce M. Psaty, M.D., Ph.D., MPH
Dan M. Roden, M.D.
Alan J. Russell, Ph.D.*

Designated Federal Officer
Martha Monser, Office of Chief Scientist (OCS), Office of the Commissioner (OC)

FDA Participants
Margaret A. Hamburg, M.D., Commissioner, Food and Drugs
Jesse L. Goodman, M.D., M.P.H., Chief Scientist, OCS, OC
Stephen M. Ostroff, M.D., Chief Medical Officer, Center for Food Safety and Applied Nutrition (CFSAN) and incoming Acting Chief Scientist
David White, M.S., Ph.D., Chief Science Officer (Acting), Office of Foods and Veterinary Medicine*
Bernadette Dunham, DVM, Director, Center for Veterinary Medicine (CVM)*
John Graham, Ph.D., Director of Research, CVM*
Larisa Rudenko, Ph.D., Senior Advisor for Biotechnology, CVM
Donald Zink, Senior Science Advisor, CFSAN
Jeff Shuren, JD, MD, Director, Center for Devices and Radiological Health (CDRH)
Jan Johannessen, Ph.D., Deputy Director for Science, Office of Translational Sciences, Center for Drug Evaluation and Research, (CDER)
Carolyn Wilson, Ph.D., Associate Director for Science, Center for Biologics Evaluation and Research (CBER)
William Slicker, Ph.D., Director, National Center for Toxicological Research (NCTR)
Allison Hoffman, PhD, Chief, Additions Branch, Div. of Individual Health Sciences, Office of Science, Center for Tobacco Products (CTP)
Steve Solomon, DVM, MPH, Acting Deputy Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs*

*denotes participation by telephone

Presentations and Presenters

Commissioner’s Report and Science at the FDA Update
Margaret A. Hamburg, M.D.
Jesse L. Goodman, M.D., MPH

Scientific Achievement Award Recipients’ Presentation for Excellence in Laboratory Science
Gonçalo Gamboa da Costa, PhD, NCTR “For elucidating the toxicities associated with melamine and cyanuric acid and providing leadership in the Laboratories of Mass Spectrometry and NMR Spectroscopy at the NCTR.”

CDRH Response to Subcommittee Science Review
Jeff Shuren, JD, MD

Global Health Framework
Mary Lou Valdez, M.S.M. Associate Commissioner and Director, Office of International Programs

Global Health Subcommittee Final Draft Report
Jeff Bender, D.V.M, Subcommittee chair

CBER Post-marketing Safety Review Subcommittee: Update
Michael C. Gibbons, MD, PhD, Subcommittee Member

Office of Women’s Health Research Roadmap
Pamela Scott, PhD, Director, Research and Development, Office of Women’s Health
The following is a summary of the discussion.  Additional information and specific details may be obtained from the transcript of the meeting. The transcript may be viewed on the Science Board to the Food and Drug Administration web page approximately 6 – 8 weeks after the meeting.
 

Summary of Committee Discussions and Recommendations
Following member introductions, Ms. Monser provided the conflict of interest statement for the meeting.

Commissioner’s Report and Science at the FDA Update
Margaret A. Hamburg, M.D., Commissioner, Food and Drugs
Jesse L. Goodman, M.D., M.P.H., Chief Scientist

Dr. Hamburg welcomed the members and commented that in the past year the advances in science and technology are coming together with the regulatory responsibilities enabling the agency to do things in new and improved ways and work in partnership with all of FDA’s stakeholders to harness the opportunities in science today in order to really serve the public. She provided updates on the budget in that for the past several years there have been increases each year.  She mentioned 4 pieces of legislation passed while she has been at FDA: the Food Safety and Modernization Act, Tobacco Prevention and Control Act (highlighting prevention campaigns), the Food and Drug Administration Safety and Innovation Act (highlighting that it re-implemented User Fees and provided a new pathway for regulatory review called the breakthrough pathway) and the FDA Quality and Security Act (highlighting compounding and track and trace elements).  She pointed to the recent personalized medicine report as an example of regulatory science success.  She also thanked Dr. Goodman for his service to FDA as his departure is at hand and enumerated many of his accomplishments over the past years as Chief Scientist.  She introduced Dr. Stephen Ostroff who will serve in the capacity of Acting Chief Scientist.  She also introduced Dr. Lucia Borio who will serve as Acting Deputy Chief Scientist.  Dr. Goodman welcomed new members and provided an update on new and continuing regulatory science activities and reflected on challenges and opportunities as the Agency moves forward. (See slides

Relevant Discussion:

  • Discussion focused on the overall progress FDA has made in advancing regulatory science, the focus on engaging externally and transparency in the face of the rapid scientific developments and challenges of increasing globalization. Questions were raised regarding metrics that would demonstrate the effectiveness of the Board as advisors.  One member voiced support for ensuring that FDA scientists are provided the opportunity to attend professional meetings to keep pace with science and innovation.

Scientific Achievement Award Recipient’s Presentation:   The Board members expressed appreciation for the presentation and asked a few clarifying questions.

CDRH Response to the CDRH Subcommittee Science Review
Jeff Shuren, JD, MD, Director Center for Devices and Radiological Health (CDRH)

  • Dr. Shuren provided CDRH’s response to the subcommittee’s recommendations. (See slides)

Relevant Discussion:

  • The Board commended CDRH on the breadth of their responses to the recommendations and expressed a desire to continue to serve as advisors and reviewers to the Center. 
  • Members also asked several questions about unique device identifiers (UDI), including interfacing with electronic health records (EHRs), coordinating with the Centers for Medicare and Medicaid Services (CMS) for claims information, cybersecurity surrounding UDIs and using UDIs to understand the impact of drugs and devices on underserved populations.
  • One member also asked for clarification about what CDRH meant regarding rethinking clinical trials.  CDRH commented that they are focusing in three areas.
  • One member pointed out that perhaps the definition of a medical device may also be changing as even the definition of health care evolves.

Global Health Framework and Subcommittee Final Draft Report
Mary Lou Valdez, M.S.M. Associate Commissioner and Director, Office of International Programs
Jeff Bender, D.V.M, Subcommittee chair

  • Ms. Valdez provided an overview of the framework for the global health subcommittee, outlining the three elements from the Institute of Medicine’s report “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad” that the subcommittee was asked to focus on. 

Dr. Bender provided an overview of the charge and scope for this subcommittee and the recommendations from the subcommittee to the Agency. (See slides)

Relevant Discussion:

  • The committee recommended that the report be accepted as written.

CBER Post-marketing Safety Review Subcommittee: Update
Michael C. Gibbons, MD, PhD, Subcommittee Member

  • Dr. Gibbons provided an update on the progress of the committee including that they anticipate a final draft report to be available for the Board’s review at the next meeting. (See slides

Office of Women’s Health Research Roadmap
Pamela Scott, PhD, Director, Research and Development, Office of Women’s Health

Dr. Scott gave an overview of the development process for the OWH Research Roadmap and asked for the Board’s input. (See slides)

Relevant Discussion

  • The Board recommended in response to the first question that the vision and areas for consideration first need to be determined and that it was difficult to answer the remaining questions until the priority areas were proposed.

An open public hearing session was scheduled for 12:10 PM and began at approximately 12:20 PM; there were no requests from the public to make statements. 

Final Closing Remarks from the Chair and Board Comments:

Dr. Altman summarized the committee’s recommendations as follows:

  • Send the personalized medicine report to the members.
  • The Board and the Centers should consider together ongoing engagement after reports are issued as a check-up process and to maintain a connection with the Science Board between reviews so the Board does not have to start from scratch every time a new review begins.
  • Consider whether some of the recommendations in the subcommittee reports can be elevated in some way to apply and be general advice to other centers that were not necessarily the focus of the review.
  • The Board accepted the global health subcommittee report.
  • There is a strong sense that the Board needs to reaffirm the importance of travel for FDA scientists to scientific meetings.

One member asked for an update on the “Science Looking Forward” subcommittee.  FDA commented that the progress report is a bit behind schedule, but a very diverse subcommittee has been selected and this remains as an important priority for FDA.

The meeting adjourned at 1:12 p.m.

I certify that I attended the February 5, 2014, meeting of the Science Board and that these minutes accurately reflect what transpired.
 
________/s/_____________    ____________/s/______________
Martha E. Monser                     Russ Altman, M.D., Ph.D.
Designated Federal Officer       Chair