FDA BRIEF: Week of Dec 18, 2017
Looking 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- Removing Outdated Rules
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
New, 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
Image credits: FDA, CDC