Congresswoman Rosa L. DeLauro (CT-3), Ranking Member on the Labor, Health, and Human Services Appropriations Subcommittee, issued the following statement in response to the Department of Justice's announcement that GlaxoSmithKline agreed to plead guilty and to pay $3 billion to resolve allegations of fraud and withholding of safety data about the controversial diabetes drug Avandia from the Food and Drug Administration (FDA). This is the largest health care fraud settlement in U.S. history.
"It is critical that American patients have access to safe and effective drugs, and also that they and their healthcare providers have accurate information about how risky those drugs are. It is simply unconscionable that lives were placed at risk because a private company withheld drug safety data from the FDA and healthcare professionals. Today's settlement is a step forward, and we must do more to prevent this from happening again."
Congresswoman DeLauro repeatedly called for an independent review of Avandia because of concerns about data integrity and drug safety. Independent studies have linked the drug to an increased risk of cardiovascular complications.