Creating a recovery provision. The provision of the Company Integrity Agreement, known as the Executive Financial Recoupment Program, states that GSK implements a program that „reports the risk of cancellation and recovery of up to three years of annual compensation – annual bonuses and long-term incentives – for an executive involved in significant misconduct.“ However, the basic rule is GSK`s exceptionally strict 123-party agreement on the integrity of the business with the Department of Health – Human Services Office of Inspector General. This agreement will allow OIG to oversee GSK`s compliance program for the next five years. Kevin Colgan, a GSK spokesman, said the company voluntarily implemented this provision in July 2010, „which was later included as part of our business integrity agreement.“ The GSK agreement eclipses the previous record for the settlement of health fraud with the Department of Justice. In 2009, Pfizer agreed to pay $2.3 billion to resolve criminal and civil liability arising from the illegal promotion of four of its drugs. Like GSK, the company signed an integrity agreement that ordered it to continue its business compliance program for a period of five years. GSK has agreed to plead guilty in a three-year criminal record, including two counts of introducing the poorly stigmatized drug, Paxil and Wellbutrin, in interstate trafficking and a charge of failing to report safety data on the drug Avandia to the Food and Drug Administration (FDA). Under the appeal agreement, GSK will pay a total of $1 billion, including a fine of $956,814,400 and a deduction of $43,185,600. The criminal advocacy contract also includes certain non-monetary compliance obligations and certifications by the U.S. President and the GSK Board of Directors. GSK guilty plea and sentence is not final until the U.S. District Court agrees. The goal of a business integrity agreement is to „create enough security slides that, at least in the future, are very difficult to obtain,“ says Thomas Beimers, special advisor for health fraud at the law firm Faegre Baker Daniels.

This may be the first agreement to put in place enough road slides to achieve this goal, he says. Avandia: In its civil transaction agreement, the United States asserts that GSK promoted Avandia to physicians and other health care providers with false and misleading statements about Avandia`s safety profile, which led to the transmission of false allegations to federal health programs. In particular, the United States asserts that GSK stated that Avandia had a positive cholesterol profile, although it does not have well-controlled studies to support this message. The United States also asserts that the company offers sponsored programs that offer cardiovascular benefits from Avandia therapy despite FDA-approved label warnings regarding cardiovascular risks.