Risk Management for a Marketed Schedule II Product

Pinney Associates was approached by a pharmaceutical company in need of risk management activities in support of a marketed schedule II product. PA worked closely with company corporate leadership to define and prioritize issues, assess the scientific and political context, and prepare and implement a plan. Among other issues management activities, we helped the company identify and develop relationships with experts and opinion leaders, which included the coordination of and participation in expert advisory meetings.

Our experts conducted original analyses of federal surveys, and developed papers later accepted to scientific peer-review publications. The results of our analyses were used to correct misperceptions, including those made by the media and among policy makers, about trends in and characterizations of drug misuse and abuse. This included the development of a database using public records of individual events, and development of a novel system for case categorization based on analysis of the data. This last publication has been widely cited by other scientific publications, and may lead to changes in how these events are reported.