Research Summary
Research Summary
Regulatory negotiations and risk communication
Description
In the pharmaceutical industry a drugs benefits and risks are constantly being weighed by companies, regulators, physicians and drug consumers. While companies and regulators must make decisions based on population statistics about drug outcomes, physicians and drug consumers make one at a time decisions based primarily on their own past experience. As a result, consumers can be expected to underweight rare but serious side effects. However, in its role as gatekeeper for new drug approvals, it is the FDAs mission to protect the consumer from the sale of unsafe medications. This goal is mitigated by both organizational and agency issues as is evident in their negotiations with companies over the information about risks that is communicated to physicians and consumers. This research explores the complexity of such negotiations and how they relate to issues of agency, cognitive biases, organizational issues, risk perception and decision making.