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Minutes of the June 4, 2014 Meeting of the Science Board to the FDA

MINUTES OF THE
SCIENCE BOARD TO THE FDA
 
FDA White Oak Campus, Bldg 31, Room 1503
10903 New Hampshire Ave, Silver Spring MD, 20993
 
Wednesday, June 4, 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
Maria C. Freire, Ph.D., Co-Chair
Michael C. Gibbons, M.D., MPH
Lynn R. Goldman, M.D., MPH
William N. Hait, 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.
Bruce M. Psaty, M.D., Ph.D., MPH
Dan M. Roden, M.D.
Alan J. Russell, Ph.D.
Michael J. Yaszemski, MD, PhD

Invited Consultants
Linda Detwiler, DVM
Dean Goeldner, DVM
Christina Sigurdson, DVM, PhD (participated by telephone)
Robert Rohwer, PhD

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
Stephen M. Ostroff, M.D., Acting Chief Scientist, OCS, OC
Dan Acosta, PhD, Deputy Director for Research, National Center for Toxicological Research (NCTR)
Steven Anderson, Director, Office of Biostatistics and Epidemiology, Center for
Biologics Evaluation and Research (CBER)
David Asher, MD, Director, Laboratory of Bacterial and Transmissible Spongiform Agents, Office of Blood Research and Review, CBER
David Ashley, PhD, Director, Office of Science, Center for Tobacco Products (CTP)
Bernadette Dunham, DVM, Director, Center for Veterinary Medicine (CVM)
Ann Farrell, MD, Director, Division of Hematology Products, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research (CDER)
Jan Johannessen, Ph.D., Deputy Director for Science, Office of Translational Sciences, CDER
Michelle McMurry-Heath, MD, PhD, Associate Director for Science, Center for Devices and Radiological Health (CDRH)
Steve Solomon, DVM, MPH, Deputy Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs (ORA)
Daniel Tadesse, DVM, PhD, Division of Animal and Food Microbiology, Office of Research, CVM
Leslie Wheelock, RN, MS, Director, Office of Scientific Professional Development, OCS
David White, M.S., Ph.D., Chief Science Officer, Office of Foods and Veterinary Medicine (OFVM)
Carolyn Wilson, Ph.D., Associate Director for Science, CBER
Janet Woodcock, MD, Director, CDER
Lawrence Yu, PhD, Acting Director, Office of Pharmaceutical Science, CDER

Presentations and Presenters
Commissioner’s Report
Margaret A. Hamburg, MD

Science at the FDA Update
Stephen M. Ostroff, MD

Scientific Achievement Award Recipient’s Presentation for Outstanding Junior Investigator
Daniel Tadesse, DVM, PhD, CVM
“For coordinating the integration and implementation of microarray technology and whole genome sequencing into the Center for Veterinary Medicine’s antimicrobial resistance research projects.”

Commissioner’s Fellowship Program Evaluation: New Subcommittee and Charge
Leslie Wheelock, MS, MD

CBER Post-marketing Safety Review Subcommittee: Final Draft Report
Lynn R. Goldman, MD, MPH, Subcommittee Chair

Heparin Sourcing
Janet Woodcock, MD
Ann Farrell, MD
David Asher, MD
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
Margaret A. Hamburg, M.D., Commissioner, Food and Drugs

  • Dr. Hamburg welcomed the members and reflected on transitions with Dr. Ostroff joining as acting Chief Scientist, the change in HHS Secretary leadership and the expansion of the White Oak campus as both the Center for Biologics Evaluation and Research (CBER) and the Center for Tobacco Products (CTP) are in the process of moving onto the campus. She updated the committee on activities at CTP, including the Population Assessment of Tobacco and Health (PATH) study, the Tobacco Centers of Regulatory Science (TOCRS), the public education campaign and the proposed deeming rule. She commented on the progress of implementing the Food and Drug Safety and Innovation Act (FDASIA) requirements, highlighting interest in the new pathway for expedited drug approval-- breakthrough therapies, and the section 907 report regarding the inclusion of demographic subgroups in certain applications. She emphasized the importance of research in the area of antimicrobial resistance and development and evaluation of new antibacterial drugs. She mentioned the new legislation regarding voluntary facility registration enacted after the pharmacy compound crisis and FDA’s efforts to promote registration of pharmacies. She closed with remarks regarding the FY15 budget.

Relevant Discussion:

  • Members asked questions regarding personalized medicine and subpopulations, sought input into what areas advice is needed from the Science Board, and whether risk based reporting for health IT would be advantageous.

Science at the FDA Update
Stephen M. Ostroff, MD

  • Dr. Ostroff provided an update on new and continuing regulatory science activities (see slides).

Relevant Discussion:

  • Members asked questions regarding minority health and food safety; regulatory science, policy and medical decision making for health IT; status of engagement of extramural communities and whether there is global engagement regarding antimicrobial resistance.

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

Commissioner’s Fellowship Program Evaluation: New Subcommittee and Charge
Leslie Wheelock, MS, MD

  • Ms. Wheelock presented a history of the fellowship program, along with metrics to date and the proposed charge for the subcommittee (see slides)

Relevant discussion:

  • Members asked a few clarifying questions with regard to the presented metrics. The Board unanimously agreed with the need to form the subcommittee. Several members volunteered to participate on the subcommittee.

CBER Post-marketing Safety Review Subcommittee: Update
Lynn R. Goldman, MD, MPH

  • Dr. Goldman provided an overview of the subcommittee’s review process and summarized the subcommittee’s recommendations. (See slides)

Relevant Discussion:

  • Members asked whether there is a specific advisory board for OBE, whether PK/genetics data are routinely being requested across different populations and provided some recommended edits to the report. One member suggested an economic analysis for the genomics computational infrastructure to determine whether it would be better to partner with other stakeholders than to establish alone. The Board unanimously accepted the report with revisions for editorial updates.

Heparin Sourcing
Janet Woodcock, MD
Ann Farrell, MD
David Asher, MD

  • A presentation on the need for diversifying the heparin supply chain and a proposal to re-introduce bovine sourced heparin to the US market was given (see slides). Then the clinical history of bovine heparin and background on the potential safety concerns raised by the bovine spongiform encephalopathy (BSE) agent were presented along with possible steps to mitigate the risks associated with bovine sourced heparin (see slides).

Relevant Discussion:

  • There was significant discussion regarding the three questions posed to the Science Board. In summary, the Board agreed that diversifying the heparin supply chain is important to help ensure the un-interrupted supply of high quality heparin products in the US. The Board also recommended a multiple step approach for minimizing the risks of BSE agent contamination in bovine sourced heparin, including: assessment of the prevalence of disease within the source country, slaughterhouse practices and the capability of the heparin manufacturing processes to eliminate BSE agents (if present).

An open public hearing session was scheduled for 3 PM; there were two speakers.

Final Closing Remarks from the Chair and Board Comments:
Dr. Altman followed up on two issues that were raised during the February 5, 2014, meeting: support for travel to attend scientific meetings and inclusion of the Unique Device Identifier (UDI) code in medical claims reviewed by the Center for Medicare and Medicaid Services (CMS). The Board considers that both topics are very important and to that end will be sending letters to the Commissioner detailing the Board’s recommendations.

The meeting adjourned at approximately 3:30 p.m.

I certify that I attended the June 4, 2014, meeting of the Science Board and that these minutes accurately reflect what transpired.

_______/s/___________________
Russ B. Altman, M.D., Ph.D.
Chair
________/s/_____________
Martha E. Monser
Designated Federal Officer
_______/s/___________________
Maria C. Freire, MD
Co-Chair