Constant Vigilance: The Role of Pharmaceutical Companies in Medicine Safety

Abstract

Patient safety is the top priority for the pharmaceutical industry and requires constant vigilance. This article presents a thorough overview of the rigorous safety processes involved at each stage of a medicine's life cycle, as well as a review of current research, with the aim of changing the perception that safety is primarily a preapproval activity and not a major area of focus for the pharmaceutical industry. In reality, pharmaceutical companies and regulators work in partnership to make medicines as safe as possible, from long before they are marketed until well after approval for widespread use.

Current safety surveillance activities will be enhanced further in the future. For example, in the United States, a large market with well-established regulatory requirements, Congress recently passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). This law emphasizes the importance of postapproval medicine safety activities and provides FDA with increased funding and enforcement authority to build on the postapproval safety processes already in place. The combination of industry practice and increased FDA authority should further assure patients of the safety of medicines on which they rely to lead longer, healthier lives.