FDA BRIEF: Week of June 27, 2016

Voice

Acting director of the FDA Oncology Center of Excellence

By : Robert Califf, MD, FDA Commissioner

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FDA honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative (“Cancer Moonshot”)

Creating Oncology Center of Excellence (OCE) – to  expedite development of novel combination products and support an integrated approach to tackle disease

FDA’s own Dr. Richard Pazdur,  chosen as director to serve as central point of engagement for oncology stakeholders, including patient-focused advocacy groups, professional associations, industry, academia and sister agencies such as NIH.

Will leverage thought leaders inside and outside Agency including center directors from CDER, CBER, CDRH

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Leveraging the Power of Collaboration – FDA’s New Oncology Center of Excellence

By: Richard Pazdur, M.D., Acting Director, Oncology Center of Excellence

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Honored to be selected by Commissioner Califf today as the acting director of OCE

OCE will combine skills of regulatory scientists and clinical oncology reviewers

 

Personal experiences at FDA:

  • Joined FDA from MD Anderson Cancer Center in  1999
  • Oncology products reviewed in different divisions within CDER
  • Director of Office of Hematology and Oncology Products (OHOP) created in 2005 to consolidate
  • Additional reorganization into disease-specific teams in 2011
  • Between 2010 – present, OHOP approved 61 NMEs with most approvals before deadline.
  • Wife Mary, an oncology nurse, died of ovarian cancer last November.

OCE will

  • Be collaborative
  • Incorporate patient view in regulatory decision-making
  • Support innovation and address multiple treatment and diagnostic options in the best interest of patients.

 

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FDA Advisory Committee Members and ‘Appearance Issues’

By: Michael Ortwerth, Ph.D., Director of the Advisory Committee Oversight and Management Staff

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  • FDA relies on advisory committees for independent scientific and technical expertise and advice on challenging public health issues
  • Members  appointed as “special government employees” (SGEs)
  • Subject to Federal conflict of interest laws and regulations
  • “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees.” (2008) described requirements
  • “Appearance Issues.” not addressed
    • Interests and relationships creating appearance that they lack impartiality
    • Examples: Household member working with sponsor,  past financial interests, consulting
  • New Guidance for evaluating appearance issues
    • Ethical principles
    • FDA determination of potential issue
    • FDA makes final decision

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