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Summary of the Jan. 6, 2012 Meeting of the Science Board to the FDA

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

Friday, January 6, 2012

The Science Board to the FDA (Science Board) meeting was convened at approximately 9:00 a.m.

Members Present (Voting)

Martin Philbert, Ph.D., Chair
Jeffrey D. Bender, D.V.M, M.S., DACVM
Paul R. Billings, M.D., Ph.D., FACP, FACMG
James R. Broach, Ph.D.
Elazer R. Edelman, M.D., Ph.D
John D. Floros, Ph.D.
Lynn R. Goldman, M.D., MPH
Sangtae Kim, Ph.D.
Frederick Kushner, M.D.
Suzanne P. Murphy, Ph.D., R.D.
Joseph Pagano, M.D.
P. Hunter Peckham, Ph.D
Bruce M. Psaty, M.D., Ph.D., MPH
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 and Deputy Commissioner for Science and Public Health, OCS, OC
Vicki Seyfert-Margolis, Ph.D., Senior Advisor, OC
Jeffrey Shuren, J.D., M.D., Director, Center for Devices and Radiological Health (CDRH)
David White, M.S., Ph.D., Director, Office of Research, Center for Veterinary Medicine (CVM)
Douglas Throckmorton, M.D., Deputy Director, Center for Drug Evaluation and Research, (CDER)
Margaret Miller, Ph.D., Associate Director for Regulatory Activities, National Center for Toxicological Research (NCTR)
Carolyn Wilson, Ph.D., Associate Director for Research, Center for Biologics Evaluation and Research (CBER)
David Ashley, Ph.D., Director, Office of Science, Center for Tobacco Products (CTP)
Steven M. Solomon, DVM, MPH, Deputy Associate Commissioner for Compliance Policy, Office of Regulatory Affairs (ORA)
Donald Zink, Ph.D., Senior Science Advisor, Center for Food Safety and Applied Nutrition (CFSAN)
Chad Nelson, Ph.D., M.S.P.H., Office of Foods
Suzanne Fitzpatrick, Ph.D., Senior Science Advisor, OCS, OC, FDA
Henry Francis, M.D., Acting Deputy Director, Office of Surveillance and Epidemiology, CDER

Invited Guest Speakers

William Bentley, Ph.D., University of Maryland
James Polli, Ph.D., University of Maryland

Presentations

  • Commissioner’s Report - Margaret A. Hamburg, MD
  • Science at the FDA - Jesse L. Goodman, M.D., MPH
  • CDRH Research Review Subcommittee: Update - Alan J. Russell, Ph.D.
  • Centers of Excellence in Regulatory Science and Innovation (CERSI): Overview -  Vicki Seyfert-Margolis, Ph.D.
  • Regional CERSI – University of Maryland: Overview - William Bentley, Ph.D, and James Polli, Ph.D., University of Maryland
  • Scientific Database and Scientific Computing Initiatives: Update - Vicki Seyfert-Margolis, Ph.D.
  • Modernizing Toxicology Working Group: Overview and Planned Activities – Suzanne Fitzpatrick, Ph.D.
  • CDER Response to the Subcommittee’s Review of the Pharmacovigilance Program – Henry Francis, M.D.

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.

Summary of Committee Discussions and Recommendations

Commissioner’s Report

Margaret A. Hamburg, M.D., Commissioner of Food and Drugs

  • Dr. Hamburg provided the Board with highlights of major FDA accomplishments from 2011.  She commented that 2012 is expected to be as challenging, given likely budget challenges and the broader economic environment.  The 2012 budget for FDA was approved with an increase in funding, recognizing FDA’s important public health role and needs.  In addition, user fee legislation is due in Congress for re-authorization later this year.  Negotiations with industry have been proceeding well thus far.

Discussion:

  • Several members were interested in more information regarding the drug shortages that occurred this year.  FDA agreed to provide currently available reports on this topic to the members.  FDA is taking many steps with manufacturers to address issues, including seeking earlier notification of impending shortages, identifying alternatives, identifying other ways to increase production, looking overseas to see if gaps can be filled and working with patient and professional societies for physician and patient education.
  • One Science Board member was interested in more information regarding FDA’s role in and ongoing efforts to address obesity.  FDA has several ongoing efforts including menu labeling requirements, nutrition fact panels, increased efforts in education and communication of information.

Science at the FDA

Jesse L. Goodman, M.D., M.P.H., Chief Scientist and Deputy Commissioner for Science and Public Health

Dr. Goodman provided updates (see slides) on recent ongoing regulatory science activities including the regulatory science RFAs, current collaborations with DARPA, NIH, and NIST.  Dr. Goodman also highlighted activities of other programs and offices of OCS, which now include NCTR, the Office of Women’s Health and the Office of Minority Health.  He provided updates of accomplishments from 2011 and the goals for 2012 for the Medical Countermeasures Initiative (MCMi).  He also highlighted FDA’s new Scientific Integrity Policy, which should be finalized in the next few weeks and mentioned the continuing training and educational efforts of the Office of Scientific Professional Development.  Dr. Goodman also pointed out that for the first time in 2012, FDA had authority to support the Reagan-Udall Foundation (RUF) which should enhance opportunities for new programs and partnerships.

Discussion:

  • With regard to the MCMi, one Science Board member asked whether FDA is tracking the prevention side.  FDA stated that it is very important to understand the threat and FDA engages with other federal Agencies under the PHEMCE program to understand and reduce threats.  In addition, one hallmark of the program is that HHS and DOD plans to support new advanced development and manufacturing facilities that will be designed to be flexible, rapidly scalable and “dual-use”,  increasing the ability to respond to both natural occurrences and deliberate threats.  FDA will work closely with HHS and DOD, and the product developers, as these facilities, and other priority projects, are developed, to enhance the odds of success.  Because of the often unpredictable nature of threats, whether natural or man-made, it is not always possible to prepare through stockpiling so the system needs to be designed for agility with that can respond accordingly.  It is also anticipated that the underlying principles can be applied to other medical products.
  • One Science Board member suggested given the growth in the genomics arena that the FDA provide the Science Board with an overview of ongoing activities surrounding genomic work at the FDA.  
  • One Science Board member inquired about FDA efforts in communicating uncertainties.  FDA stated many activities are ongoing surrounding risk/benefit and strategies to transparently communicate.  Another member suggested engaging with social scientists to increase understanding of the best way to communicate uncertainties. 

CDRH Research Review Subcommittee: Update

Alan J. Russell, PhD, Science Board Member

  • Dr. Russell provided an update on the charge, identified the subcommittee members, and mentioned the recent two day site visit to CDRH. (See slides)

Discussion:

  • The chairperson inquired when the report may be available.  Dr. Russell replied that a draft report may be available within 6 months.

Centers of Excellence in Regulatory Science and Innovation (CERSI): Overview - Vicki Seyfert-Margolis, Ph.D., and Regional CERSI – University of Maryland: Overview - William Bentley, Ph.D., and James Polli, Ph.D., University of Maryland

  • Dr. Seyfert-Margolis provided an overview of the initiative.  Cooperative agreement RFAs were awarded to Georgetown University and University of Maryland.  The CERSIs consist of three main components: regulatory science collaborative research, training and scientific exchanges and core dedicated infrastructure to support these two components.  Dr. Seyfert-Margolis also discussed the expected outcomes and current work and next steps. (See slides)  Drs. Bentley and Polli provided specific information regarding the University of Maryland’s engagement which includes projects in three areas tied to FDA’s Strategic Plan for Advancing Regulatory Science: improving pre-clinical assessments of safety and efficacy, ensuring readiness to evaluate innovative and emerging technologies and harnessing diverse data through information sciences to improve health. (See slides)   

Discussion:
 

  • Several board members asked questions with regard to FDA’s participation in product or evaluation tool development (i.e., inventions), and patenting of such inventions as well as how this affects the ability to review subsequent product applications.  FDA stated that there are new Agency strategies around Strategic Partnership and Intellectual Property (SPIP) and legal counsel is actively being engaged as well as ongoing discussions with HHS and NIH.   The Agency is also working on ways to manage potential issues concerning conflict of interest
  • One member asked whether UMD’s Project 3 (Risk Evaluation and Mitigation Strategies) has links to the Sentinel Initiative.  At present, the goal of the project is primarily short term, i.e., 1 year.  FDA also mentioned that the RUF will administer the OMOP initiative

Scientific Database and Scientific Computing Initiatives: Update - Vicki Seyfert-Margolis, Ph.D.

  • Dr. Seyfert-Margolis opened by stating that FDA has recruited a new CIO who has experience in both information management and IT systems, but also drug discovery and development.  She provided an overview, accomplishments and current progress of the scientific database initiative being developed jointly with NIH/NCI as a clinical trial data repository to improve FDA’s management of structured scientific data.  Dr. Seyfert-Margolis also reviewed accomplishments from 2011 and priorities for 2012 of the Scientific Computing Board, including the Scientific Enclaves project (an environment to develop applications) and cloud computing. The SCB serves to identify and plan both the tactical and strategic capabilities required for enabling and optimizing FDA’s scientific mission.  She provided an update on communication efforts, mentioning HHS’s opendata.gov initiative. (See slides).

Discussion:

  • One Science Board member asked if there is an ongoing effort to share clinical data that are negative in outcome, e.g., from products and/or trials that do not meet their intended endpoints or results.  FDA mentioned that there are indicators within industry, e.g., Pzifer’s open innovation initiative, that this could be a potential future effort with more collaborations in a consortia model.  HHS has also been discussing many of these issues with patient groups and beginning to work with industry to obtain information from companies.
  • One Science Board member asked about cloud computing compatibility and security.  FDA responded that the CIO is assessing.

Modernizing Toxicology Working Group: Overview and Planned Activities – Suzanne Fitzpatrick, Ph.D.

  • Dr. Fitzpatrick provided an overview of the working group and an update regarding ongoing activities in training, partnerships and methods qualifications efforts. (See slides).

Discussion:

  • Science Board members commented on the importance of and difficulties in the method qualifications including the need for standardization and defining reliability parameters as well as correlating outputs to human responses.  FDA agreed, but also commented that it is not inherently different than what is currently being required for qualification of test methods, e.g., defining the operating characteristics of the method with requirements being based on test use, e.g., screening versus complementary.  Proof of principle is needed and parallel testing alongside traditional testing tools is anticipated.

CDER Response to the Subcommittee’s Review of the Pharmacovigilance Program – Henry Francis, M.D.

  • Dr. Francis provided CDER’s response to each of the recommendations from the Subcommittee. (See slides)

Discussion: 

  • The Science Board chair commented on the amount of information communicated and requested that the Board be given some time to review.
  • FDA also commented that additional ways to obtain data are also being explored such as data mining published literature and social media outlets.
  • Several Board members commented that a standing subcommittee might be advantageous to CDER.  CDER commented that it would prefer to obtain targeted input when needed. 

Comments from the Science Board Chair

Martin Philbert, Ph.D., Chair

  • Dr. Philbert reviewed action items from this meeting which included disseminating the papers on drug shortages to the Board, and updates at subsequent meetings on Scientific Computing initiatives, SPIP and genomics activities.  

The meeting adjourned at approximately 2:20 p.m.

I certify that I attended the January 6, 2012, meeting of the Science Board and that these minutes accurately reflect what transpired.

Martha E. Monser
Designated Federal Officer

Martin Philbert, Ph.D.
Chair