Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns

对于患者和医生来说，有经济和临床上的激励， 在可用时使用仿制药，因为改用仿制处方药可能会 减少处方药的总支出，因为它们的成本大大降低。的 国会预算办公室估计，医疗保险D部分下的仿制药替代减少了 2007年，Medicare受益人的处方药总成本为330亿美元，比2008年低55%。 没有发生通用名替换。简化新药申请（ANDA） 包括体内血浆生物等效性研究，以证明试验药物的治疗等效性 产品与参考产品。这种方法经过时间的考验，通过回顾 研究和临床实践中，作为确保安全性和疗效相当的有效方法 的测试产品。然而，在某些情况下，体内血浆生物等效性研究 可能不是获得通用批准的适当途径。需要提供新的、安全的 因此，对患者有效的仿制药的创新评价受到争议 方法. FDA对批准后药物的安全性、有效性、 这些仿制药的使用和替代模式。我们提出以下具体建议： 目的：1）通过进行系统的 临床试验和观察性研究的评价; 2）估计仿制药和品牌药物 利用率和切换率以及与一般交换相关的医疗服务利用率 使用医疗保险索赔数据库来评估品牌产品及其 仿制药;以及3）确定围绕仿制药批准的争议是否影响了人们的看法 通过对患者和医生的经验进行全国调查， 关于模型品牌和仿制药产品的使用。研究结果将具有重要的临床意义， 政策对美国当前和未来仿制药使用的影响，因为这项研究将 向原子能机构通报评估安全性和有效性的方法的制定情况 市场上的仿制药，特别是当仿制药批准存在争议时 过程拟议的研究是创新的，其积极主动，混合方法的方法， 使用Facebook和在线医生论坛等社交媒体进行调查。的 这项研究的预期成果是新的决策科学和战略办公室 仿制药的安全性和有效性的评估方法 市场，特别是当新的生物等效性方法已用于仿制药时 审批过程。

There are economic and clinical incentives for both patients and physicians to preferentially utilize generic medications when available, since switching to generic prescription drugs can reduce total prescription medication expenditures due to their substantially lower costs. The Congressional Budget Office estimates that generic substitution under Medicare Part D reduced total prescription drug costs for Medicare beneficiaries in 2007 by $33 billion, 55% lower than if no generic substitution had occurred. The Abbreviated New Drug Application (ANDA) usually includes in vivo plasma bioequivalence studies to demonstrate therapeutic equivalence of test product to the reference product. This method has been time-tested, through retrospective studies and in clinical practice, as an effective method to ensure comparable safety and efficacy of the test product. However, there are situations where in vivo plasma bioequivalence studies may not be the appropriate route to generic approval. The need to provide access to new, safe and effective generic drugs for patients is therefore met with controversial innovative evaluation methods. It is important for the FDA to monitor the post-approval drug safety, effectiveness, usage, and substitution patterns of these generic drugs. We propose the following specific aims: 1) Assess clinical outcomes with brand and generic drugs by conducting a systematic evaluation of clinical trials and observational studies; 2) Estimate generic and brand medication utilization and switchback rates and medical service utilization associated with generic switching using Medicare claim databases to assess individual level use of a brand product and its generics; and 3) Determine if controversy around a generic drug approval impacted perceptions of the generic drug quality by conducting a national survey of patient and physician experiences about the model brand and generic drug product use. Findings will have significant clinical and policy impacts on current and future generic drug use in the United States, as the study will inform the agency on the development of methods to assess the safety and effectiveness of generic drugs in the marketplace, especially when a controversy exists in the generic approval process. The proposed study is innovative with its proactive, mixed-methods approaches, and use of social media such as Facebook and online physician forums to conduct surveys. The expected outcomes of this study are new decision science and strategies for the Office of Generic Drugs on methods to assess the safety and effectiveness of generic drugs in the marketplace, especially when novel bioequivalence methodology has been used in the generic approval process.