Off-label marketing regulation in the U.S and Taiwan

• Main Authors: Lin,Limin, 林勵民
• Other Authors: Yang,Chih-Chieh
• Format: Others
• Language: zh-TW
• Published: 2018
• Online Access: http://ndltd.ncl.edu.tw/handle/gae7w8

碩士 === 國立雲林科技大學 === 科技法律研究所 === 106 === Since the 1990s United States government began to investigate and penalize the selling model and promotional behaviors of certain pharmaceutical companies, as the US government advocates these drug companies are doing off label marketing and misbranding, which caused the US government and insurance institutions to cause excessive insurance payments due to these "falsely misleading" marketing. Government officials even pointed out that such marketing behavior may affect the patient safety, and the US government sued these pharmaceutical companies with the False Claims Act (FCA). Then these pharmaceutical companies negotiate settlement, pay fines, and sign the Corporate Integrity Agreement (CIA) for such "falsely misleading" marketing activities. Also because of signing the Corporate Integrity Agreement (CIA), pharmaceutical companies began to actively make self-control for the promotion of their marketing, the most important of which is to establish a compliance department, with its own internal control, and hope to achieve reasonable standards, the standards of pharmaceutical business marketing. In Taiwan, following pharmaceutical affairs act Article 66 “ For publishing or broadcasting medicament advertisement, pharmaceutical firms shall, before publishing or broadcasting, submit all texts, drawings or pictures constituting an advertisement to the central or municipal competent health authority for approval, and shall forward the approval to mass media enterprises for verification. No mass media enterprise shall publish or broadcast any medicament advertisement which has not been approved.” Based on these regulations, pharmaceutical companies need to apply to authority before advertising. Based on Chief Justice of the Court, Interpretation No. 414:” The law and its rules shall be in accordance with the regulations approved by the competent authority for the publication of drug advertisements, which are consistent with the Constitution.” Therefore, drug advertisements in Taiwan are subject to be pre-approved by health authority. However, in fact, most of the marketing activities of pharmaceutical companies are the result of speeches and information exchange between business representatives and physicians. Can such behavior be deemed as the freedom of speech of the business representative? After the Caronia case in the United States, the US court allowed the pharmaceutical company to do a "true and misleading” off label promotion. Following the Chief Justice’s Interpretation No. 634, “As the content is not false or not misleading, can be an economically reasonable choice to consumers, should be protected by the freedom of constitutional speech.” The Justice agrees that "real and misleading" marketing is protected by freedom of speech, however in real practice; does the government have a way to control the speech behavior of each businessperson? This article, with the status of the global pharmaceutical factory being punished in the United States, with the American scholar Kathryn Bi's discussion of the GlaxoSmithKline case, as well as the legal judgment of Taiwan’s cases, hopes to provide the Taiwan government with deeper insights to understand pharmaceutical marketing and its required standards. At the same time, I hope that this research will enable pharmaceutical company representatives and compliance department to understand that patient-oriented drugs selling with real drug information provided can enable company and representative become the partner to physicians to treat patients and improve medical technology together.