Clinical Oncology Department, Suez Canal University, Ismailia, Egypt.
Ann Oncol. 2013 Sep;24 Suppl 5:v17-22. doi: 10.1093/annonc/mdt324.
While most of the attention and spending in the oncology community in the United States has been focused on the remarkable scientific inventions of the newer targeted drugs, the shortage of the older essential cancer drugs that are off patent, mostly generics and injectables, has a threatening impact on the health of cancer patients, the execution of clinical trials and the identification of newer drugs and thus impacts upon the burden of costs and pressures on the health system in the United States. It is a part of the problem of the scarcity of generics across all medical specialties, but its oncology is particularly vulnerable. The problem in The United States has been increasing since the beginning of the 21st century until the 2011; since then there has been some improvement in 2012 and the first two quarters of 2013. In the second quarter of 2012, there were 211 active shortages, down from 246 reports of active shortages in the same quarter of 2011. The Food and Drug Administration (FDA) officials ascribe the improvement to efforts that the agency made after President Obama issued an executive order in 2012 that impel the FDA to obtain early reports from companies about potential shortages. The drivers of the shortages are multi-factorial. But are largely economic and are due to the lack of incentives to produce generics. There are efforts from the US government, politicians and the medical, pharmacy and oncology communities. However, the problem is still serious. There is a general agreement that efforts so far have not been adequate, and that there is a need for addressing effectively the fundamentals and the underlying causes. There is a lot that could be done in the United States and across the world to improve the accessibility of economically sustainable better value cancer drugs regardless of whether they are brand or generics and aiming at a win-win outcome for all stakeholders.
虽然美国肿瘤学界的大部分注意力和资金都集中在更新的靶向药物的显著科学发明上，但已过专利期的较老的基本癌症药物（主要是仿制药和注射剂）短缺，对癌症患者的健康、临床试验的实施以及更新药物的发现构成了威胁，从而影响了美国医疗体系的成本负担和压力。这是所有医学专业普遍缺乏仿制药问题的一部分，但肿瘤学领域尤其脆弱。自 21 世纪初以来，美国的这一问题一直在加剧，直到 2011 年；自那时以来，2012 年和 2013 年前两个季度有所改善。2012 年第二季度，有 211 种药物处于活跃短缺状态，低于 2011 年同期 246 种药物的报告。美国食品和药物管理局（FDA）官员将这一改善归因于该机构在奥巴马总统于 2012 年发布行政命令后所做的努力，该命令促使 FDA 从公司获得有关潜在短缺的早期报告。短缺的驱动因素是多方面的。但主要是经济方面的，是由于缺乏生产仿制药的激励。美国政府、政治家以及医疗、药房和肿瘤学界都在努力解决这一问题。然而，这一问题仍然很严重。人们普遍认为，迄今为止所做的努力还不够，需要有效地解决根本问题和潜在原因。无论品牌药还是仿制药，无论在经济上是否可持续，都有很多工作可以在美国乃至全球范围内开展，以提高癌症药物的可及性，为所有利益相关者创造双赢的结果。
