GSK To Pay $3 Billion To U.S. Government

GlaxoSmith Kline (GSK), the UK’s largest manufacturer of prescription and over-the-counter (OTC) drugs, has recently become the subject of significant criticism. Accordingly, the pharmaceutical powerhouse has announced that it has reached an agreement with the U.S. Government, multiple states and the District of Columbia so that it may conclude an investigation that has been ongoing since 2004. Under the terms of the settlement, GSK has plead guilty to misdemeanor violations of the Federal Food, Drug, and Cosmetic Act that witnessed them practice fraudulent and unsanctioned marketing techniques. In light of their transgressions, GSK has agreed to pay $3 billion to the U.S. Government.

As a worldwide leader in the pharmaceutical industry, GlaxoSmithKline has been responsible for the distribution of healthcare products since the beginning of the eighteenth century. Currently headquartered in the UK, the global organization has offices in over 100 countries. Furthermore, major research centers have been established in the UK, USA, Spain, Belgium and China; each of which are dedicated to improving the quality of human life through the development of innovative medications.

Several GSK products have become world renown for their contributions to the healthcare community. However, of significant concern to regulatory agencies around the world are the methods in which GSK promoted and advertised several prominent products. Subsequently, the questionable marketing practices used by GSK led to a significant investigation. In 2004, the U.S. Attorney’s office of Colorado initiated an investigation that was later headed by the U.S. Attorney’s office of Massachusetts. The investigation focused on the sales and marketing practices of nine GSK products.

As a result of the eight year investigation, GSK pleaded guilty to a three-count criminal indictment, which included two counts of introducing the misbranded antidepressants Paxil and Wellbutrin into interstate commerce. Under the terms of the settlement, GSK will plead guilty to misdemeanor violations of the Federal Food, Drug, and Cosmetic Act related to certain aspects of the marketing of Paxil for paediatric use and of Wellbutrin for certain uses that it was not approved for. The third count included GSK’s failure to report Avandia safety data to the U.S. Food and Drug Administration (FDA) upon request. In addition to pleading guilty to these three counts, GSK was ordered to pay $3 billion to the U.S Government.

Commenting on the agreement, GlaxoSmithKline CEO Sir Andrew Witty announced: “Today brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.”