FDA Brief: Week of Mar 28, 2016
PRIORITIES- TEAMWORK TO ACHIEVE COMMON GOALS
By: Robert M. Califf, M.D. Commissioner , FDA
FDA FACTS
- Regulates 20% nation’s economy
- Mission to protect and promote public health
- Makes decisions vital to the well-being of all Americans
- High-quality and impartial judgments—although many may disappoint
CLEAR, REALISTIC, FOCUSED PRIORITIES
- Workforce Initiative to build professional environment
- Evidence Generation Systems to meet technological advances
- Specific Critical Issues:
Pain: Opioid action plan
Tobacco product deeming: Oversight over all tobacco products
Food Safety Modernization Act: Implementation
Antimicrobial resistance: Appropriate use and novel antimicrobials
Interagency effectiveness: With NIH, CDC, CMS
Precision Medicine: Future for biomedicine and agriculture
Cross-Cutting Issues: Combination products, improving product labeling
BIOSIMILAR PRODUCT LABELING
Leah Christl, PhD, Associate Director, Therapeutic Biologics, FDA CDER
PRESCRIPTION DRUG LABELING
- Communicates the product’s safety and effectiveness information
- Summarizes key scientific information on risk-benefit profile and appropriate use
- Physician Labeling Rule (PLR) provides format and content
BIOSIMILAR PRODUCT
- Similar to reference therapeutic biologic e.g. monoclonal antibodies, cell signaling proteins
- Comparative data on structural/functional characterization, animal, clinical studies
BIOSIMILAR LABELING
- Issued GUIDANCE
- Addition of “Biosimilarity Statement”
- Incorporate relevant reference information; may differ from reference
- Do not recommend comparative data