Touro College of Pharmacy, New York, NY, USA.
Touro College of Pharmacy, New York, NY, USA; Nova Southeastern University, College of Pharmacy, Ft Lauderdale, FL, 33328, USA.
Res Social Adm Pharm. 2022 May;18(5):2811-2816. doi: 10.1016/j.sapharm.2021.06.009. Epub 2021 Jun 26.
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.
药品评估与研究中心（CDER）通过确保、评估和监测药品在美国上市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（品牌药和仿制药）的治疗益处带来的健康益处超过潜在风险。该法案于 1992 年首次由国会通过，《处方药使用者付费法案》（PDUFA）允许食品和药物管理局（FDA）向制药商收取费用，以资助新药批准。该法律允许 FDA 加快药物批准，但可能降低了安全性标准，并在 FDA 和制药行业内部带来了潜在的利益冲突。为了检查利益冲突，我们使用 Excerpta Medica 数据库、美国国家医学图书馆美国国立卫生研究院数据库（PubMed）、Scopus 和 Google 进行了审查。我们的搜索结果显示，Vioxx（罗非昔布）和 Exondus-51（eteplirsen）是 FDA 和制药行业过于紧密结盟时的后果的例子。我们进一步研究了制药行业如何通过向国会游说或直接雇用前 FDA 专员来间接影响 FDA。
