Clinical approaches to post-marketing drug safety assessment

Monitoring and understanding the safety of drug and therapeutic biological products is a process that proceeds throughout the product’s life cycle, spanning the period prior to first administration to humans through the entire marketing life of the product. Pre-approval drug safety assessment includes animal toxicology and pharmacology studies, clinical pharmacology studies (also known as phase 1 studies), proof-of-principle studies for the disease or condition under study (also known as phase 2 studies), and confirmatory studies of safety and efficacy (also known as phase 3 studies). In each of these stages of drug development, important drug safety information is obtained. These topics have been covered elsewhere in detail [1]. At the time a drug product is approved, there is a substantial amount of data regarding its safety profile. In the pre-approval review process, FDA reviews these data, along with data on the product’s efficacy, to determine if the potential benefits of the drug exceed the potential risks for its intended use. As part of the approval process, FDA reviews the product’s professional labeling (also referred to as the package insert), to insure that, amongst other things, the product’s uses and its risks are explained. Risks of the products are presented in the following sections of the label: Highlights, Boxed Warnings, Contraindications, Warnings and Precautions, and Adverse Reactions [2,3].