I recently started reading a fascinating book Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA by Daniel Carpenter. As I read through it, I will be highlighting interesting points throughout.
One key point is that while the Food and Drug Administration (FDA) regulates pharmaceuticals in the US, how it does so influences pharmaceutical regulation around the world as well. The table below provides a nice summary of some key features of the FDA’s regulatory power and how their regulatory framework was later adopted in many other countries.
Standardized NDA application and NDA review process
Evolved 1938-1955, NDA form federally published 1955
Later adopted in:
- W. Germany (1961)
- Japan (1962)
- European Economic Community (EEC) (1965)
- France (1967, 1978)
- Britain (1971)
- China (1985)
- Australia (1989/1990)
Regulated R&D Process (Phased studies) and protocol requirements
Investigational New Drug (IND) regulations, 1963
Later adopted worldwide, in:
- Britain (1963)
- EEC (1975)
- Netherlands (1975)
- Norway (1975)
- Sweden (1975)
- W. Germany (1978)
- Australia (1989/1990)
- China (1999)
Bioequivalence and bioavailability regulation
First regulations 1979; final regulations 1978
Later adopted worldwide, including:
- EEC and Europe (1983)
- World Health Organization (WHO) directive (1975)
- Australia (1990)
Guidelines for clinical evaluation
First distributed 1971
Later adopted worldwide, including
- Britain (1974, 1977)
- EEC (1975)
- Japan (1992)
- China (1999)
The FDA also had significant influence regulating pharmaceutical manufacturing practices. The FDA regulations around good manufacturing practices were instituted in 1956 and adopted worldwide largely through the 1970s.
Source:
- Carpenter, Daniel. Reputation and power: organizational image and pharmaceutical regulation at the FDA. Vol. 137. Princeton University Press, 2014.