Do Important Drugs Reach the Market Sooner?
研究美国食品药品监督管理局(FDA)1962年修正案后,药物从首次全球专利申请到获批的平均时间从3.5年增至13.5年,并检验了药物重要性是否影响审批速度,发现重要药物确实更快上市,暗示审批延迟的成本可能被高估。
Since the Food and Drug Administration (FDA) Amendments of 1962, the average from a drug's first worldwide patent application to its by the FDA has risen from 3.5 to 13.5 years. FDA policies and manufacturers' incentives suggest that more important drugs may have reached the market sooner. To test this, we develop measures of time to approval and importance, and determine how the latter affects the former. Our results indicate that more important drugs are developed and approved more rapidly than less important drugs. These results imply that the costs of lags have probably been overstated and challenge estimates of the returns to research and development in the pharmaceutical industry.