The Drug development process - Pharmaceutical Biotechnology: Concepts and Aapplications - page 92

Table 4.6 The main product categories (and annual sales value) that the FDA regulate
US$500 billion worth of food
US$350 billion worth of medical devices
US$100 billion worth of drugs
US$50 billion worth of cosmetics and toiletries
4.14.1 The Food and Drug Administration
The FDA represents the American regulatory authority. Its mission statement defi nes its goal
simply as being to 'protect public health'. In fulfi lling this role, it regulates many products/con-
sumer items (Table 4.6), the total annual value of which is estimated to be US$1 trillion. A more
detailed list of the types of product regulated by the FDA is presented in Table 4.7. Its work entails
inspecting/regulating almost 100 000 establishments in the USA (or those abroad who export
regulated products for American consumption). The agency employs over 9000 people, of whom
in the region of 4000 are concerned with enforcing drug law. The FDA's total annual budget is in
the region of US$1 billion.
The FDA was founded in 1930. An act of Congress offi cially established it as a governmental
agency in 1988, and it now forms a part of the US Department of Health and Human Services.
The FDA Commissioner is appointed directly by the President (with the consent of the US
Senate).
The FDA derives most of its statutory powers from the Federal Food, Drug and Cosmetic (FD
& C) Act. This legislation was originally signed into law in 1930, but has been amended several
times since. The agency interprets and enforces these laws. In order to achieve this, it draws up
regulations based upon the legislation. Most of the regulations themselves are worded in general
terms, and are supported by various FDA publications that explain/interpret these regulations in
far greater detail. The publications include: 'Written Guidelines', 'Letters to Industry' and the
'Points to Consider' series of documents. As technological and other advances are made, the FDA
further supplements their support publication list.
A partial organizational structure of the FDA is presented in Figure 4.10. The core activ-
ities of biopharmaceutical drug approval/regulation is undertaken mainly by the Center for
Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research
(CBER).
Table 4.7 A more detailed outline of the substances regulated by the FDA
Foods, nutritional supplements
Drugs: chemical-based, biologics, and biopharmaceuticals
Blood supply and blood products
Cosmetics/toiletries
Medical devices
All radioactivity-emitting substances
Microwave ovens
Advertising and promotional claims relating to the above product types