仿制药商 Somerset 同意支付 400 万美元:品牌药转非处方后仍按处方药标签销售

美国司法部 10 月 16 日宣布,仿制药企业 Somerset Lifesciences 同意支付 400 万美元达成和解。
司法部表示,Somerset 生产的仿制滴眼液 Olopatadine,其对应品牌药于 2020 年由处方药转为非处方药后,Somerset 本应相应修改标签,却仍按处方药标签销售该产品,导致 Medicare Part D 为本不应覆盖的非处方药付了款。和解依据普通法上的错误付款与不当得利主张达成。
Olopatadine 是常见的抗过敏滴眼液成分。案件细节以司法部公布文本为准。
Generic Drug Maker Somerset to Pay $4 Million Over Misbranded Eye Drug Paid for by Medicare Part D
The U.S. Department of Justice announced on October 16 that generic drug maker Somerset Lifesciences has agreed to pay $4 million to settle federal claims.
According to the department, after the brand-name version of Somerset's generic eye drop olopatadine was switched from prescription to over-the-counter status in 2020, Somerset should have relabeled its product but continued selling it with prescription labeling. As a result, Medicare Part D paid for a non-covered over-the-counter drug. The settlement resolves common-law claims including payment by mistake and unjust enrichment.
Olopatadine is a widely used anti-allergy eye drop ingredient.
发布:GSM·美国(发布链接)
图片来源:Olopatadine 滴眼液产品。图:Wikimedia Commons「CVS Health Olopatadine HCI Eye Drops.jpg」,CC BY-SA 4.0 授权。 / Photo: an olopatadine eye-drop product. Source: Wikimedia Commons ("CVS Health Olopatadine HCI Eye Drops.jpg"), CC BY-SA 4.0.
GSM Global · 本篇英文版 English edition of this story

