FDA BRIEF: Week of Dec 18, 2017

Dr. Scott GottliebLooking ahead: Some of FDA’s major policy goals for 2018

By: Scott Gottlieb, M.D., Commissioner

Modernize approach to work and improve efficiency, while fulfilling mandate to protect and promote public health and uphold gold standard for regulatory decision-making

  • Serve public health by advancing innovations that improve patient care, enhance choice and provide competition
  • Take action against serious threats to public health
  • Empower patients, consumers, healthcare providers with accurate and up-to-date information
  • Recognize need for new, more flexible regulatory approaches

Key priorities

  • Addressing the Nicotine Addiction Crisis
  • Advancing Drug Safety
  • Promoting Food Safety
  • Empowering Consumers
    • Providing Better Information on Drugs
    • Broadening Access to Nonprescription Drugs
  • Modernizing Standards
    • Harmonizing Global Standards
    • Modernizing Mammography Standards
    • Embracing Electronic Submissions
    • Removing Outdated Rules

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Gene Therapy

What Is Gene Therapy? How Does It Work?

Gene therapy can used to modify cells inside or outside the body

  • Inside: Inject vector carrying the gene directly into the part of the body that has defective cells
  • Outside: Modify cells outside of body; blood, bone marrow, or another tissue taken from patient, and specific types of cells separated out. Vector containing desired gene is re-introduced into cells, multiplied and injected back into the patient
  • FDA is committed to helping speed up development by prompt review of groundbreaking treatments that have the potential to save lives

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CaptureNew, Risk-based Enforcement Priorities to Protect Consumers from Potentially Harmful, Unproven Homeopathic Drugs

Homeopathy, an alternative medical practice first systematized in the late 1700s with two principles:

  • Substance that causes symptoms can be used in diluted form to treat symptoms and illnesses (“like-cures-like”)
  • The more diluted the substance, the more potent it is (“law of infinitesimals”)

Risk-based approach for drug products labeled as homeopathic and marketed without required FDA approval; enforcement and regulatory actions for products

  • With reported safety concerns
  • With ingredients associated with potentially significant safety concerns
  • For routes of administration other than oral and topical
  • Intended to be used for the prevention or treatment of serious and/or life
    threatening diseases and conditions
  • For vulnerable populations
  • Deemed adulterated under section 501 of the FD&C Act

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Image credits: FDA, CDC

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