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On the FDA website there is extensive information on risk management initiatives. Other FDA activities are covered elsewhere in this chapter and in other chapters of this manual.

In 1997, the federal government put forth a global framework for federal risk management of drug products. The fundamental concepts include the following:

Risk assessment is the estimation and evaluation of a risk in the pre- and post-marketing areas.

Risk confrontation determines the acceptable level of risk in the large context, including social and community values as well as the technical judgments of professionals. This includes the use of advisory committees, which get input from various concerned independent experts and stakeholders. In addition, the FDA has relationships with various groups of health professionals, consumer and patient advocacy groups, industry organizations, and other governmental agencies to gather information and advice.

Risk intervention is the evaluation of alternative risk control actions, selection among them, and their implementation. After the risks are identified and assessed, they must be managed or minimized. The FDA can refuse to allow the product to be marketed if the Agency concludes that the product’s risk outweighs its benefits. If the product is permitted on the market, the FDA minimizes risk by various mechanisms, including the review and approval of the original labeling and any subsequent changes. FDA also regulates the advertising and promotion of marketed products. Promotional materials must not be false (i.e., they must conform to the label and be substantiated), and they must not be misleading (i.e., they must be balanced and include the material facts). FDA also tracks medication errors and can act on issues there. FDA also can require other risk minimization or mitigation measures, including mandating education for product users, limiting product distribution (e.g., to specific hospitals or specialists), requiring prescriber qualifications, training, or informed consent, etc. The FDA may also require post-approval clinical or epidemiologic studies after marketing. In urgent situations, there are various mechanisms to remove products from the market.

Risk communication is aimed at conveying the needed information to the public. There are ongoing and rapidly changing mechanisms of risk communication using traditional as well as social media mechanisms to convey information to consumers and healthcare practitioners. The Internet and various new means of wireless communication challenge all parties to get the correct message out and make it visible in the large sea of available information. The product labeling (Package Insert) has been the classic mechanism of communication. The FDA has redone and revised how labels are made and how the information is communicated both to patients and practitioners. This is a controversial area as some feel the changes make labeling more complete but less useful and more ponderous. Medication guides for patients are also provided for some products in lay language to communicate how consumers should use products. Whether these changes lead to lowering risks for particular products remains to be seen.

Another controversial area is Direct-to-Consumer advertising, which is allowed in the United States but not in many other developed countries. Whether this promotes product use that is safer or more dangerous is a much-debated topic, with no clear answer.