Since 1992, there has been a 50% reduction in the length of new-drug review by the US Food and Drug Administration (FDA). However, the withdrawal of ten drugs from the market for safety reasons since 1997 has raised public concerns about the safety of new medicines. A key question is whether faster new-drug reviews have led to reductions in new-drug safety. Little research has examined the effects of drug review times on pharmaceutical risks or safety over time because of the difficulty of measuring drug safety. Hence, there is little data available to speak to this important drug policy and patient safety issue. The proposed research will utilize adverse drug reaction (ADR) data from the FDA's Spontaneous Reporting System and its Adverse Event Reporting System for the new drugs approved between 1990 and 1998 to investigate this issue. The project has two primary aims: (1) to determine whether increases in the speed of new-drug review are associated with higher counts of serious adverse drug effects among new drug approvals; and (2) to explore the factors that influence serious adverse drug reaction levels associated with newly approved drugs. The proposed project will build upon existing research and will bring new evidence to bear on the debate regarding safety and access in new-drug review. Evidence from this study will enable policymakers to better assess the consequences of faster new-drug reviews on product safety. In addition, this study will provide a greater understanding of the factors that may influence ADR levels among new-drug approvals. [unreadable] [unreadable] [unreadable]
NIH ExPorter
NIH ExPorter