司法部：Somerset Lifesciences付400万美元和解 被指标签违规致医保Part D为非处方药买单
美国司法部10月16日宣布，Somerset Lifesciences Inc.同意支付400万美元，就其行为导致联邦医疗保险（Medicare）付款的普通法索赔达成和解。
据司法部，涉案产品是仿制药盐酸奥洛他定（Olopatadine）。原研药于2020年由处方药转为非处方药（OTC）后，Somerset仍以「仅限处方」标签销售其仿制药，未按义务改换为非处方标签。由于Medicare Part D不承保无需处方即可在零售渠道买到的非处方药，该公司的标签做法导致Part D为这款本可自行购买的非处方药付了款。
和解金额为400万美元，解决的是相关普通法索赔。
信息来源：美国司法部民事司新闻稿（10月16日）
Somerset Lifesciences to Pay $4 Million; DOJ Says Rx-Only Labeling Caused Medicare Part D to Pay for an OTC Drug
The Justice Department announced on Oct. 16 that Somerset Lifesciences Inc. has agreed to pay $4 million to resolve common law claims that its conduct caused Medicare to pay claims.
According to the department, the product involved is generic olopatadine hydrochloride. After the brand-name drug switched from prescription-only to over-the-counter status in 2020, Somerset continued selling its generic with Rx-only labeling despite its obligation to switch to OTC labeling. Because Medicare Part D does not cover drugs available over the counter without a prescription, the labeling caused Part D to pay for a drug that was available OTC at retail.
The $4 million payment resolves the common law claims.
Source: U.S. Department of Justice, Civil Division, Oct. 16
发布：GSM·美国（发布链接）
图片来源：图片来源：美国司法部总部罗伯特·F·肯尼迪大楼（资料图），维基共享资源，CC BY-SA 4.0。Robert F. Kennedy Department of Justice Building (file photo), Wikimedia Commons, CC BY-SA 4.0.
GSM Global · 本篇英文版 English edition of this story
