Do Faster Food and Drug Administration Drug Reviews Adversely Affect Patient Safety? An Analysis of the 1992 Prescription Drug User Fee Act
研究了FDA审评时间、药物新颖性及国内外上市时滞对1992-2002年间美国新药严重不良事件数量的影响，发现审评时间与不良事件无关，但新颖药物和上市时滞短的药物风险更高。
Food and Drug Administration (FDA) review times have significantly declined under the user‐fee regime. This situation has provoked concerns that drug safety has been adversely affected. Combining information from several comprehensive databases, we analyze how the FDA's review time, a drug's novelty, and a lag between the foreign and U.S. launches of a drug affect the number of serious adverse events associated with new‐drug introductions in the United States in 1992–2002. We find that more novel drugs, those with shorter U.S. launch lags, and those with black‐box warnings have a larger number of serious adverse events. After controlling for these and other factors, we find no association between the FDA's review time and adverse events. Because many serious adverse events involve rare occurrences that are not observable in premarket clinical trials, policy makers should direct increased agency attention and resources to postmarketing surveillance.