The Center for Drug Evaluation and Research (CDER) performs an essential role in public health by ensuring, evaluating, and monitoring the safety and efficacy of drugs before they are sold in the US. Before approving new drug applications, CDER ensures that therapeutic benefits of both prescription and over-the-counter drugs (brand name and generic) provide more health benefits than the potential risks. First passed by Congress in 1992, the Prescription Drug User Fee Act (PDUFA) allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund new drug approvals. The law allowed the FDA to expedite drug approvals, but possibly lowered standards for safety and brought potential conflicts of interest within the FDA and pharmaceutical industry. To examine the conflicts of interest, we conducted a review using the Excerpta Medica database, US National Library of Medicine National Institutes of Health Database (PubMed), Scopus, and Google.

Our search yielded Vioxx (rofecoxib) and Exondus-51 (eteplirsen) as examples of consequence when the FDA and pharmaceutical industry are too closely aligned. We further examine how the pharmaceutical industry may indirectly influence the FDA by lobbying to Congress or directly by hiring ex-FDA commissioners.

药物评估和研究中心 (CDER) 通过确保、评估和监控药物在美国销售之前的安全性和有效性，在公共卫生方面发挥着重要作用。在批准新药申请之前，CDER 确保处方药和非处方药（品牌和仿制药）的治疗益处比潜在风险提供更多的健康益处。1992 年首次由国会通过，处方药使用者费用法案 (PDUFA) 允许美国食品药品监督管理局 (FDA) 向药品制造商收取费用以资助新药批准。该法律允许 FDA 加快药物审批，但可能会降低安全标准，并在 FDA 和制药行业内带来潜在的利益冲突。检查利益冲突，

我们的搜索发现万络（罗非昔布）和 Exondus-51（eteplirsen）作为 FDA 和制药行业过于紧密结合时的后果示例。我们进一步研究制药业如何通过游说国会或直接聘请前 FDA 专员来间接影响 FDA。