Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance programs. Patient assistance programs also have been the subject of recent Congressional inquiries related generally to the increasing price of certain prescription drugs.
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On July 24, 2013, GlaxoSmithKline (GSK) announced a settlement in principle with the Attorneys General of eight states related to the development and marketing of Avandia and a separate settlement with the Attorney General of Louisiana totaling $229 million. GSK previously paid $3 billion to settle civil and criminal allegations related to the marketing of Avandia and other company products.
The U.S. Department of Justice (DOJ) announced on July 18, 2013 that pharmaceutical manufacturer Mallinckrodt LLC agreed to pay $3.5 million to settle a civil False Claims Act suit. The complaint alleged that Mallinckrodt paid illegal kickbacks to health care professionals in the form of speaker honoraria, clinical trials funding, and honoraria for consulting activities, and that these illegal kickbacks caused the submission of false and tainted claims to federal health care programs. The investigation arose from a whistleblower suit filed by a former Mallinckrodt employee in April 2008. The investigation was conducted by the U.S. Attorney’s Office for the Northern District of California, the U.S. Department of Health and Human Services Office of Inspector General (OIG), U.S. Food and Drug Administration (FDA) Office of Criminal Investigations (OCI), the Federal Bureau of Investigation (FBI), and the National Association of Medicaid Fraud Control Units (NAMFCU).