Introduction
Outcomes research, including pharmacoeconomic and health economic research, is conducted to provide stakeholders (patients, physicians, institutional providers, health benefit plan decision-makers, government authorities) with information about the value of pharmaceuticals, medical devices and medical procedures. Outcomes research is valuable to a stakeholder only if the data are relevant for that stakeholder and the information is received at a time and in a format that can assist the stakeholder in a decision about the use of the product or service. Outcomes research information is not useful if it has limited application (e.g., the cost data do not apply to the stakeholder’s setting) or it is received after a decision about the use of the product or service has been made.

Under our current system of health care delivery, outcomes research can be especially useful at the time a new product is introduced; a time when physicians, providers, patients and payers all have questions about the clinical and economic impact of a new treatment on the management of patients with the target disorder. At the time a new product is introduced, most of the data about it will have been gathered under the sponsorship of a corporate developer (pharmaceutical, biotechnology or medical device manufacturer). These corporate developers are regulated by the US Food and Drug Administration (FDA), and the dissemination of outcomes research information by these companies must comply with applicable FDA rules. When do those rules apply and what are the standards for dissemination of outcomes research information?