FDA Voice: IMEDS, CRISPR & Genome Edited Products, Advisory Committees, Oncology Center of Excellence, Opioid Misuse – Drug and Device Digest

FDA BRIEF: Week of January 16, 2017



By : Robert M. Califf, M.D., Former FDA Commissioner 

Introducing IMEDS, a Public-Private Resource for Evidence Generation


  • Nonprofit public-private partnership by the Reagan-Udall Foundation for FDA
  • FDA Sentinel System’s distributed data, scientific methods and tools available to entities outside of FDA for medical product research

Access to:

  • Database on privacy-protected information from millions of patients
  • Data quality checked and formatted according to FDA standards
  • Modular programs with FDA’s epidemiologic methods and software templates
  • Collective experience with drug safety analyses
  • Transparency with detailed descriptions of analytic decisions and results
  • [email protected] for additional information..

FDA’s Science-based Approach to Genome Edited Products


Genome editing technologies used to introduce, remove, or substitute one or more specific nucleotides at a specific site in genome

  • Most recent discovery – CRISPR/Cas9
  • Treat HIV, cancer or rare diseases by genetically altering specific types of cells
  • Control or alter organisms that carry infectious diseases
  • Improve health and welfare of food producing animals, alter food plants or fungi

Maintaining product-specific, risk-based regulation

  • Relevant to three main FDA-regulated product classes- Medical Products, Foods derived from Plants, Animals
  • Medical products reviewed under CBER program and policies, NIH Recombinant DNA Advisory Committee (RAC)

Other Initiatives

  • Collaborating with Federal agencies : White House Office of Science and Technology Policy (OSTP), FDA,  EPA and  U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS)
  • Scientific engagement and horizon-scanning: Co-sponsoring 2 studies on innovative technology
  • Working with international partners: e.g. International Pharmaceutical Regulators’ Forum (and its Gene Therapy working group)


FDA Advisory Committees: Independent, Informed, Essential, and Evolving


Need to improve FDA’s Advisory Committees (ACs) function

  • impartiality, transparency, affect FDA decision-making
  • system seen as overburdened with unnecessary paperwork by Academia
  • “imputed interest” of significant academic leaders and conflicts relating to grants

FDA taking steps

  • Process improvement evaluation using Lean concepts
  • Evaluate current policies and modernize evaluation of conflicts of interest
  • Develop criteria for disqualifying members
  • Discuss best ways for FDA to get advice


Oncology Center of Excellence


 Richard Pazdur, M.D., Director, Oncology Center of Excellence

  • Coordinated clinical review of drugs, biologics and devices across FDA’s three medical product centers
  • Overarching effort to better address the needs of cancer patients
  • Uniting experts to collaborate on clinical review of oncology products
  • Advance oncology-related regulatory science, streamline stakeholder engagement.


Working Together to Reduce the Devastating Effects of Opioid Misuse

Medicine Bottle with Hydrocodone Label and Tablets

Critical Issue of opioid misuse, addiction and overdose

FDA actions

  • Improved product labeling
  • Prescriber education
  • Abuse-deterrent formulations
  • New intranasal and auto-injector forms of naloxone — reversal agent
  • Partnerships with CDC to understand prescription use

FDA Priorities

  1. Encouraging appropriate prescribing by healthcare practitioners
  1. Considering the family as well as the patient
  1. Finding better ways to treat pain with new medications and holistic pain management
  1. Improving how companies, professional societies and academics communicate
  1. Finding new ways to curb diversion and misuse
  1. Increasing pragmatic research for appropriate pain therapy
  1. Treating addiction as a disease, not as criminal behavior



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