Summary

Food, drugs, and medical devices are important routes of transmission of disease, and contamination of these products either accidentally or intentionally is of constant concern. Although there are well-practiced methods of conducting trace-back investigations to trace contaminated food shipments and procedures for reporting adverse events in our supplies of pharmaceuticals, more rapid conduct of such investigations will require further exploiting electronic sources of data, which presents fiscal, legal, and political challenges. The lack of vertical integration in food supply data poses a particularly vexing problem, but not an insurmountable one. Each level of the industry is concerned only with its immediate suppliers and customers, and not with the entire supply chain. Therefore, a manual trace-back investigation is the only method available to public health authorities to determine the source of a problem at the present time. Challenges facing investigators include a complex web of relationships between producers and consumers, limitations to governmental authority, and the limitations of existing information systems, limitations we are unlikely to overcome quickly unless we address the question of funding.

The FDA oversees various processes by which it can learn of problems with medicines. The medical community, drug industry, and consumers are all sources of information. Counterfeiting of medications is becoming a major issue, and here the FDA and the pharmaceutical industry have paired to introduce new methods and new technology, such as RFID, to protect and record information about drug shipments. These data are likely to be highly accessible from a technical standpoint, but accessing it will require legal and political agreements.

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