Months before the Food and Drug Administration (FDA) decides to approve or reject a new drug, it often asks committees of drug experts for their recommendations. The experts receive nonpublic technical reports from drug firms and FDA staff. We find significant abnormal options trading before the final reports are created and the committees meet, particularly for small drug firms. These options trades appear to be informed because there are more calls (puts) purchased before approvals (rejections), and a majority have maturities covering the dates when the reports are publicly released. Our results imply that securities regulators should consider monitoring trades early, well before FDA drug approval decisions.

美国食品和药物管理局 (FDA) 决定批准或拒绝新药的几个月前，通常会征求药物专家委员会的建议。专家们收到来自制药公司和 FDA 工作人员的非公开技术报告。我们发现在最终报告创建和委员会开会之前存在重大异常期权交易，特别是对于小型制药公司。这些期权交易似乎是知情的，因为在批准（拒绝）之前购买了更多的看涨期权（看跌期权），并且大多数期权的到期日涵盖了报告公开发布的日期。我们的结果表明，证券监管机构应考虑尽早监控交易，早在 FDA 做出药品批准决定之前就进行监控。