The Food and Drug Administration

The FDA represents the American regulatory authority. Its mission statement defines its goal simply as being to 'protect public health'. In fulfilling this role, it regulates many products/consumer 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 officially 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 activities 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

Figure 4.10 Partial organizational structure of the FDA, displaying the various centres primarily responsible for regulating drugs, devices and food

The major FDA responsibilities with regard to drugs include:

• assessing preclinical data to decide whether a potential drug is safe enough to allow commencement of clinical trials;

• protecting the interests and rights of patients participating in clinical trials;

• assessing preclinical and clinical trial data generated by a drug and deciding whether that drug should be made available for general medical use (i.e. if it should be granted a marketing licence);

• overseeing the manufacture of safe effective drugs (inspecting and approving drug manufacturing facilities on the basis of compliance to the principles of good manufacturing practice as applied to pharmaceuticals);

• ensuring the safety of the US blood supply.

In relation to the drug development process, the CDER has traditionally overseen and regulated the development and marketing approval of mainly chemical-based drugs. The CBER is more concerned with biologics. 'Biologic' has traditionally been defined in a narrow sense and has been taken to refer to vaccines and viruses, to blood and blood products, and to antiserum, toxins and antitoxins used for therapeutic purposes. Because of this, many established pharmaceutical products (e.g. microbial metabolites and hormones) have come under appraisal by the CDER, even though one might initially assume they would come under the biologics umbrella. The CDER has now also been assigned regulatory responsibility for the majority of products of pharmaceutical biotechnology (Table 4.8).

The criteria used by the CBER and CDER regulators in assessing product performance during the drug development process are similar, i.e. safety, quality and efficacy. However, the administrative details can vary in both name and content. Upon concluding preclinical trials, all

Table 4.8 Major biotechnology/biological-based drug types regulated by CDER and CBER

CDER regulated

CBER regulated

Monoclonal antibodies for in vivo use

Cytokines (e.g. interferons and interleukins)

Therapeutic enzymes

Thrombolytic agents


Growth factors

Additional miscellaneous proteins


Blood proteins (e.g. albumin and blood factors) Vaccines

Cell- and tissue-based products Gene therapy products Antitoxins, venoms and antivenins Allenergic extracts the data generated regarding any potential new drug are compiled in a dossier and submitted to the CDER or CBER in the form of an investigational new drug application (IND application). The FDA then assesses the application; if it does not object within a specific time-frame (usually 30 days), then clinical trials can begin. The FDA usually meet with the drug developers at various stages to be updated, and often to give informal guidance/advice. Once clinical trials have been completed, all the data generated during the entire development process are compiled in a multi-volume dossier.

The dossier submitted to the CDER is known as a new drug application (NDA), which, if approved, allows the drug to be marketed. If the drug is a CBER-regulated one, then a biologics licence application (BLA) is submitted.

Diabetes 2

Diabetes 2

Diabetes is a disease that affects the way your body uses food. Normally, your body converts sugars, starches and other foods into a form of sugar called glucose. Your body uses glucose for fuel. The cells receive the glucose through the bloodstream. They then use insulin a hormone made by the pancreas to absorb the glucose, convert it into energy, and either use it or store it for later use. Learn more...

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