Postmarketing Surveillance of Generic Drug Usage and Substitution Patterns

患者和医生都有经济和临床上的激励措施优先考虑 在可用时使用仿制药，因为改用仿制药可能 减少处方药总支出，因为它们的成本大大降低。这个 国会预算办公室估计，联邦医疗保险D部分下的仿制药替代减少 2007年医疗保险受益人的处方药总费用减少了330亿美元，比 没有发生任何非专利替代。简写新药申请(ANDA)通常 包括体内血浆生物等效性研究，以证明试验的治疗等效性 产品与参考产品的关系。这种方法经过了时间的检验，经过了回溯 在研究和临床实践中，作为确保可比安全性和有效性的有效方法 测试产品的一部分。然而，在某些情况下，体内血浆生物等效性研究 可能不是获得仿制药批准的适当途径。需要提供新的、安全的 因此，有效的患者仿制药面临着有争议的创新评估 方法：研究方法。对于FDA来说，监测批准后的药物安全性、有效性、 这些仿制药的用法和替代模式。我们提出了以下具体建议 目的：1)通过开展系统性的临床试验评估品牌和仿制药的临床结果 评估临床试验和观察性研究；2)评估仿制药和品牌药 与通用交换相关的利用率和切回率以及医疗服务利用率 使用Medicare索赔数据库评估品牌产品及其 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 通过对患者和医生经验进行全国性调查，了解仿制药的质量 关于型号品牌和仿制药产品的使用情况。这些发现将具有重要的临床和 政策对美国当前和未来仿制药使用的影响，这项研究将 向该机构通报评估以下项目安全性和有效性的方法的发展 市场上的仿制药，特别是在仿制药批准存在争议的情况下 进程。拟议的研究具有创新性，采用了积极主动的混合方法，以及 使用Facebook和在线医生论坛等社交媒体进行调查。这个 这项研究的预期结果是办公室的新决策科学和战略 仿制药的安全性和有效性评价方法的研究 市场，特别是在仿制药中使用了新的生物等效性方法时 审批流程。

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.