The US drug safety system: role of the pharmaceutical industry.

摘要

PURPOSE: Despite increasingly strident calls for improved drug safety in the United States, recent events underscore the continuing gap among manufacturers, regulators, patients, and physicians. In the period leading to the recent Institute of Medicine report on the future of drug safety, representatives from industry were given an opportunity to provide input into this report. In light of continuing concerns about drug safety and pending legislation, this original perspective provides an important context. METHODS: This work consolidates the views of representatives of individual pharmaceutical companies; the large industry trade associations, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) and the Biotechnology Industry Association (BIO); and those of the authors with regard to the industry role of drug safety in the United States. RESULTS: To ensure continued protection of the public's health, manufacturers must recognize themselves as critical to ensuring safe products; maintaincorporate safety functions separate from marketing functions; provide oversight by a senior medical executive; engage in structured epidemiological research, risk assessment, and risk communication; and mandate the formation and maintenance of an internal, interdisciplinary, senior level safety council. CONCLUSIONS: The importance of aggressive and accountable drug safety will only become more salient as the public and their elected representatives demand better accountability from industry. Individual corporations now have the opportunity to move first to counter perceptions of profit over safety and to ensure that their business practices adequately protect the public's health.