The FDA and RFID: Our policy and roadmap

Mr Erik Henrikson, DMPQ, Office of Compliance
FDA - Center for Drug Evaluation and Research, United States
 

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FDA presentation - updated 5 July*
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Presentation Summary

  • Issues regarding a layered approach to thwart counterfeit drugs which includes RFID technology
  • Current Compliance Policy Guide issues from a representative of the Center for Drug Evaluation and Research representative to the FDA RFID Work Group

Company Profile

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, Biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
 
Varied approaches
FDA's regulatory approaches are as varied as the products it regulates. Some products -- such as new drugs and complex medical devices -- must be proven safe and effective before companies can put them on the market. Other products -- such as x-ray machines and microwave ovens -- must measure up to performance standards. And some products -- such as cosmetics and dietary supplements -- can be marketed with no prior approval. These differences are dictated by the laws we enforce and by the relative risks that the products pose to consumers.
 
Benefits vs. Risks
At the heart of all FDA's regulatory activities is a judgment about whether a new product's benefits to users will outweigh its risks. Science-based, efficient risk management allows the agency to provide the most health promotion and protection at the least cost to the public. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great -- especially for products used to treat serious, life-threatening conditions.
 
Areas we regulate are
  • the nations food supply
  • medial products and medicines
  • vaccines, blood products, Biotechnology and gene therapy
  • animal drugs
  • radiation from products
  • cosmetics

Speaker CV

Erik Henrikson is the Special Assistant to the Director, Division of Manufacturing and Product Quality, Office of Compliance in the Center for Drug Evaluation and Research. The Division reviews and follows up on all CGMP cases submitted by FDA field offices. It is responsible for the issuance of GCMP guidance to FDA field offices and to industry and for regulations that issue in the CGMP area. The Division also handles the Preapproval Inspection Program for foreign and domestic firms and is the home of the Foreign Inspection Team, which reviews all foreign pharmaceutical inspections.
 
Mr. Henrikson serves on the Commissioner's Special Task Force on Counterfeit Drugs, is a member of the Agency's RFID Working Group and is the Division's Project Manager for Counter-terrorism activities.
 
Mr. Henrikson holds a Bachelor of Arts (B.A.) degree in Botany and Master of Science (M.S.) in Microbiology. He began his FDA career in 1990 studying DNA repair mechanisms as a Laboratory Investigator. Prior to coming to CDER's Office of Compliance, he worked as a Laboratory Coordinator at the National Institute of Health in Bethesda, MD.