United States v. GlaxoSmithKline

United States v. GlaxoSmithKline was a landmark legal case in the United States, involving the pharmaceutical company GlaxoSmithKline (GSK). The case was a significant event in the history of pharmaceutical industry regulation and corporate accountability.

Background

GlaxoSmithKline is a British multinational pharmaceutical company. The company has a significant presence in the United States and is subject to the country's laws and regulations, including those enforced by the Food and Drug Administration (FDA).

The case of United States v. GlaxoSmithKline arose from allegations that GSK had engaged in illegal marketing practices for several of its drugs, including Paxil, Wellbutrin, and Avandia. The company was accused of promoting these drugs for off-label uses, not approved by the FDA, and of failing to report safety data about Avandia to the FDA.

The Case

The case was initiated by the United States Department of Justice (DOJ) in 2012. The DOJ accused GSK of a range of illegal activities, including the distribution of misbranded drugs, failure to report safety data, and payment of kickbacks to physicians.

In response to the charges, GSK agreed to plead guilty and to pay a fine of $3 billion, the largest healthcare fraud settlement in U.S. history at the time. The settlement also included a five-year corporate integrity agreement between GSK and the Department of Health and Human Services.

Impact

The case had a significant impact on the pharmaceutical industry, leading to increased scrutiny of marketing practices and greater emphasis on corporate accountability. It also highlighted the importance of regulatory compliance in the pharmaceutical industry and the potential consequences of non-compliance.

The case has been cited in discussions about the need for reform in the pharmaceutical industry, and has been used as a case study in business ethics and corporate law courses.

See Also

• Pharmaceutical industry in the United States
• Off-label use
• Corporate crime

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