What the Food and Drug Administration and the Pharmaceutical Industry Could Better Understand about Each Other

Abstract

Although the Food and Drug Administration (FDA) and the pharmaceutical industry share a common goal in bringing safe and effective medicines to the public, each has misunderstandings about the other. Dispelling some of these misunderstandings about each other could speed the drug development process by virtue of better communication. FDA could have a better understanding of the pharmaceutical industry with regard to: the time and costs for clinical trials; assurance of consistency in package inserts for different products in the same clinical indication; understanding of why data in scientific papers might differ from those in package inserts; and recognition of industry expertise in specific clinical areas. The pharmaceutical industry could better understand the FDA with regard to: recognition of the professionalism of FDA reviewers and the valuable resource that FDA can provide; willingness to contribute by providing new data to the FDA that can shape policy; understanding the acceptability of seeking another opinion within the FDA; and willingness to provide a comprehensive interpretation of safety and efficacy data.