This is a must-read analysis for anyone navigating the ongoing debate over drug regulation, where economists John Vernon and Henry Grabowski dig into decades of empirical evidence on the FDA's impact on pharmaceutical innovation, drug approval delays, and industry profitability, tracing the effects of the 1962 Kefauver-Harris amendments to build a data-driven case for regulatory reform that remains essential reading for policymakers, healthcare professionals, and anyone concerned with the true costs of drug regulation.