The Food and Drug Administration

The FDA monitors and regulates the process of manufacturing the APIs, which are the key ingredients of any drug the FDA approves for marketing. The FDA holds the drug's maker responsible for producing a product that works as intended, is of consistent quality, and is free of contamination. These are necessary conditions to win the public's confidence. As noted above, the FDA regulates the manufacture of drugs: it licenses the API, approves the manufacturing process, and requires manufacturers to maintain records related to the manufacture of drugs. Any failure to comply, or deviation by the manufacturer, from the approved drug manufacturing process, can lead to the FDA ordering a shutdown of the manufacturing plant producing the API, a recall, or even withdrawal of the drug from the market. The FDA mandates the generation of data, which FDA inspects during its audits; the manufacturer, however, holds the data and it is from the manufacturer that a biosurveillance system would obtain data. Manufacturers closely guard these data as proprietary and confidential, and so governmental public health would have to obtain administrative, legal, and political agreements in order to gain access to them.

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