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