Food

1
Food Drug Administration

• Sharon T. Risso, Acting Director
• Office of Therapeutics Research Review
• Center for Biologics Evaluation Research
• Center for Drugs Evaluation Research

2
How Do Biotech Products Differ from Chemical
Drugs?

• Produced from living cells
• Large, complex molecules
• Extremely sensitive to their environment
• Production
• Storage
• Manufacturing changes

3
Why is Biotechnology Special?

• Tool with special advantages
• Products impossible to produce 10 years ago
• Improved production efficiency
• Requires special scientific skills
• Still on the cutting edge of science
• Require special production facilities

4
What Does FDA Do?

• Approve products
• Safety
• Effectiveness
• Risk/Benefit determination
• Monitor drug performance
• Monitor investigational studies
• Inspect manufacturers
• Inform physicians and consumers

5
Who Does the Work at FDA?

• Physicians
• Pharmacologists
• Immunologists
• Biochemists

• Nurses
• Pharmacists
• Statisticians
• Data managers

6
What are the Rewards?

• Money? ?
• Fame? ?
• Loved by Congress and the Wall Street Journal?
  ? ?

7
Because.

• We have the most important job in the world
  Protecting the health of this nation and many
  countries around the world!
• Sense of accomplishment
• Devotion to public health
• Continuous scientific challenge
• Cutting edge science
• Broad collection of information