Professional Development

32 - FDA, PhRMA and OIG
The FDA and its FDA Final Guidance also help maintain independence and limit the commercial supporter influence over the content of the activity.For their part, the pharmaceutical industry also has its own set of voluntary guidelines on interactions with healthcare professionals from the Pharmaceutical Research and Manufacturers of America (PhRMA). Similar to the AMA opinion, these stipulate the proper ways of interacting with physicians regarding the marketing of products. Supporting CME is one of these. Finally, the U.S. Office of the Inspector General or OIG came out with their own Compliance Program Guidance for Pharmaceutical Manufacturers in 2003. This document provides guidance to help pharmaceutical companies create programs to avoid risk of fraud and breaking anti-kickback laws. Although the section related to CME is small, it has had a big impact on the pharmaceutical industry's relationship with CME. As a result, the industry and CME providers have been implementing mechanisms that clearly separate promotional and educational activities to avoid influence or bias.