FDA Oversight & Regulation - FDA aims to remove industry members from advisory committees where possible to preserve the scientific process [1] - FDA needs to monitor drugs and devices immediately after approval to detect safety signals early [2] - The industry should not wait 19 years after a drug's approval to learn about potentially fatal downstream effects, such as the alleged million deaths linked to Oxycontton [2] - FDA is eliminating the ability of a small group of bureaucrats to block safety epidemiology studies [3] - The safety team should work freely without barriers to evaluate drug safety [3] Potential Conflicts of Interest - There is a potential conflict of interest if the team that approved a drug is also responsible for evaluating its safety [4]

Opioid Crisis & Regulatory Reform - FDA 承认在阿片类药物监管方面存在失败，并对由此造成的阿片类药物滥用危机表示担忧 [1] - FDA 计划审查 OxyContin 等药物的标签，确保其准确性并与科学依据相符 [2] - FDA 致力于移除咨询委员会中所有可能的行业成员，以维护科学流程的公正性 [3] - FDA 将加强对已批准药物的上市后监测，利用大数据识别潜在的安全信号 [3][4] - FDA 将取消阻止安全流行病学研究的权限，确保安全团队能够自由工作，避免利益冲突 [5] Drug Approval & Transparency - FDA 正在进行全国范围的意见征集，听取 CEO 们对改进 FDA 的想法 [13] - FDA 致力于提高透明度，公开决策信函，使药品开发商能够了解药品未被批准的原因 [14][17] - FDA 正在利用 AI 技术来组织和分析大量的申请文件，以实现现代化 [18] - FDA 推出了一项试点计划，对于符合美国国家优先事项的药物，提供优先审查凭证，将决策时间缩短至 1-2 个月 [20] - FDA 员工数量自 2007 年以来翻了一番，存在大量冗余，需要进行整合 [21] Investment & Deregulation - FDA 采取放松监管的态度，旨在加快审批流程，同时不降低安全标准 [23] - FDA 将与行业保持沟通，确定哪些产品符合国家优先事项，例如满足未满足的公共卫生需求、实现国内生产以及提高药品的可负担性 [24] - FDA 计划对承诺在 OECD 国家和美国之间实现药品价格均等化的公司发放国家优先审查凭证，以激励市场中的良好行为 [25]

Regulatory Failures & Conflicts of Interest - The FDA failed in its oversight of opioids, contributing to the opioid epidemic [1] - Regulatory capture at the FDA is suspected, though unproven, with reviewers moving to Purdue Pharma after approving OxyContin for chronic pain based on a 14-day study [2] - Industry members have been removed from FDA advisory committees where possible to address potential conflicts of interest [3] - A conflict of interest exists if the team that approved a drug is responsible for evaluating its safety post-approval [6] Post-Market Drug Monitoring & Safety - The industry emphasizes the need for continuous monitoring of drugs and devices after approval [4] - The industry should not wait 19 years after a drug's approval to discover potentially deadly downstream effects, such as the alleged million deaths linked to OxyContin [5] - The industry advocates for using big data and epidemiology to monitor drugs for emerging safety signals [5] - The FDA previously had a system where bureaucrats could block safety epidemiology studies, which is being eliminated [5][6] Labeling & Scientific Integrity - The industry aims to ensure the accuracy and consistency of OxyContin and similar medications' labels with scientific evidence [3] - The industry is committed to preserving the scientific process in drug evaluation [4]