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Ther Innov Regul Sci. 2023 Sep;57(5):1074-1080. doi: 10.1007/s43441-023-00547-9. Epub 2023 Jun 25.
This evaluation assesses the quantity, uniqueness, and innovative nature of the past 20 years of Rx-to-OTC (RTO) switches, where a current prescription (Rx) product is reclassified for over-the-counter (OTC) status. Broadening access to more OTC drugs with well-established safety and efficacy could help to reduce healthcare expenditure and address public health challenges.
The FDA-maintained RTO switch list website was accessed to generate the primary dataset. Each product listed was assessed for the current OTC availability in the United States of its active ingredient, pharmacological class, and indication to determine its innovative quality. Descriptive statistics were employed in this study.
From January 2002 through August 2022 there were 45 RTO switches. Among these, 51.1% involved a new to OTC active ingredient, 22.2% involved a new pharmacological class, 6.6% involved a new indication, and 82.2% were considered follow-on products that introduced a new to OTC active ingredient or new dosage form of an already marketed active ingredient to treat an existing OTC indication. A small minority (6.6%) were considered an exceptional innovation that would offer US consumers a genuinely novel OTC product, providing a new to OTC active pharmaceutical ingredient, pharmacological class, and indication. Overall, there was 1 exceptional innovation every 6.7 years.
Over 40 RTO switches have come to the OTC market in the past 20 years; however, exceptional innovations that expand access to new to OTC active ingredients for new indications are rare. Policies and strategies that result in more innovative switches that can benefit consumers and public health should be evaluated.
本评估考察了过去 20 年来 Rx-to-OTC（Rx 到 OTC）转换的数量、独特性和创新性，Rx 产品重新分类为 OTC 状态。扩大具有良好安全性和疗效的更多 OTC 药物的可及性有助于降低医疗支出并应对公共卫生挑战。
访问 FDA 维护的 Rx-to-OTC 转换清单网站以生成主要数据集。评估列出的每个产品，以确定其创新质量，包括其活性成分、药理类别和适应证在美国的当前 OTC 可用性。本研究采用描述性统计。
从 2002 年 1 月至 2022 年 8 月，有 45 个 Rx-to-OTC 转换。其中，51.1%涉及新的 OTC 活性成分，22.2%涉及新的药理类别，6.6%涉及新的适应证，82.2%被认为是后续产品，引入了新的 OTC 活性成分或已上市活性成分的新剂型来治疗现有的 OTC 适应证。极少数（6.6%）被认为是一项特殊创新，可为美国消费者提供一种真正新颖的 OTC 产品，提供一种新的 OTC 活性药物成分、药理类别和适应证。总体而言，每 6.7 年出现 1 次特殊创新。
在过去 20 年中，已有 40 多种 Rx-to-OTC 转换进入 OTC 市场；然而，扩大新适应证的新 OTC 活性成分的可及性的特殊创新很少。应评估导致更多创新转换的政策和策略，以造福消费者和公共卫生。
