“In recent years, the United States has seen a significant increase in federal and state government-initiated enforcement actions against life sciences companies, many of which have resulted in multi-million, or even multi-billion, dollar settlements and penalties. Furthermore, while the FDA retains the authority to take action to protect the public from dangerous and illegal products and to punish drug companies that violate the law, the recent trend in state enforcement actions against life sciences companies suggests the Department of Justice and state attorneys general become increasingly involved in enforcing violations of the FDCA, as well as state consumer protection and false claims laws.
This trend shows no sign of slowing. As recently as 18 September 2013, Vermont’s Attorney General’s Office settled 25 independent suits with pharmaceutical companies for violations of Vermont’s Prescribed Products Disclosure Law, including failure to file annual reports with the attorney general’s office of expenditures and gifts provided to Vermont health-care providers by manufacturers. Off-label marketing accounted for the largest amount of…”
Please click here to read the full chapter.