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
Published by GSM · USA (original Chinese edition)
Photo: 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.
