GlaxoSmithKline (GSK) pleaded guilty to a count of failing to report safety data surrounding its diabetes drug rosiglitazone (Avandia) as part of a fraud investigation that includes a $3 billion settlement.
According to the Department of Justice (DoJ), GSK pleaded guilty to three criminal counts involving the company’s three drugs: Paxil and Wellbutrin (for misbranding); and Avandia (for failure to report safety information to FDA).
GSK’s guilty plea has now been tapped as the largest healthcare fraud settlement in U.S. history and the largest payment ever by a drug company, the DoJ said in a statement.
The settlement will cease the previous investigation launched by Health and Human Services, FDA, FBI and others. According to the DoJ, GSK will be subject to certain requirements under the corporate integrity agreement, which will help enhance accountability and transparency.
GSK’s diabetes drug rosiglitazone has been under scrutiny since 2007 when FDA placed two black box warnings on the drug after data showed that the drug could increase the risk of congestive heart failure and MI. The criminal charges filed against GSK alleged that between 2001 and 2007, the company failed to make FDA aware of these potential risks, even though the data existed.
The concerns with rosiglitazone were discussed at length in a 2010 meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. However, the panel decided that the drug can stay on the market, but only with further restrictions and black box warnings. Twelve of the members argued that the drug should be pulled from the shelves and one member abstained. In November 2011, further restrictions and labels were slapped on the drug.
The U.S. alleged that GSK promoted programs that suggested cardiovascular benefit from Avandia; however, FDA-approved labeling on the drug said otherwise. GSK will pay $657 million relating to the false claims surrounding Avandia. The federal share of this settlement is $508 million and the state share is $149 million.
“This case demonstrates our continuing commitment to ensuring that the messages provided by drug manufacturers to physicians and patients are true and accurate and that decisions as to what drugs are prescribed to sick patients are based on best medical judgments, not false and misleading claims or improper financial inducements,” said Carmen Ortiz, U.S. Attorney for the District of Massachusetts, in a statement July 2 regarding the Avandia decision.
According to DoJ, the guilty plea will not be finalized until it is accepted by the U.S. District Court.
Court documents related to the GSK settlement can be viewed at www.justice.gov/opa/gsk-docs.html .