Science in Regulation

1
Science in Regulation

• A Visionary Overview
• Arthur Kibbe, Ph.D.

2
The Regulation of Science??

• To look forward we must look back first
• Where have we been?
• USP 1817 Dr. Spalding of NYC Quality of Drugs
• APhA National Formulary 1888 Quality of
  Compounded Prescriptions
• Industrial Self Regulation E.R Squibb

3
Government Regulation

• 1848 Quinine
• Food Drug Act of 1906 - It is what is claims
  to be
• 1912 Misbranding
• 1938 Must be safe
• 1951 Dirham Humphrey Rx OTC
• 1962 Safe Effective

4
Cost of Drugs

• 1950s Tetracycline 50 cents a capsule
• Average cost of Rx 1.75
• Waxman Hatch Act 1984
• Re-importation??

5
What is Next

• New drugs not only safe effective BUT better
• International regulation of Quality
• Control of Cost to Consumer
• Continuous Quality improvement
• PAT
• Federally funded efficacy testing

6
Challenge to FDA

• Ensure Quality of Drug Products
• Improve Productivity of the Industry
• Maintain public confidence
• Avoid unnecessary political involvement
• Maintain International cooperation
• Decriminalize Grandma