In 2002 it was the PhRMA Code, in 2003 it was the OIG's Guidance for Industry, and in 2004 it was Justice Department enforcement.
Now, in 2005, it appears that regulation of the US pharma industry has a new focal point—state legislatures.
Rising costs and shifting public opinion appear to be driving states to take regulation into their own hands rather than wait
for movement at the Federal level. The charts on this page summarize a sampling of current state laws affecting pharma marketing
and sales and describes similar bills being considered in 18 states. States appear to be focused on two areas: codifying
existing guidance, such as the OIG Guidance for Industry and the PhRMA Code, and requiring the disclosure of pharmaceutical
These laws and pending bills are in a state of constant change; what appears to be on the books today might be completely
different tomorrow. So pharma companies should keep close and frequent watch over the developments and waste no time in preparing
for the onslaught of requirements to come.
Details on Marketing Disclosure Requirements
Noah Shannon is a manager and Judith Braun-Davis is a compliance officer at Polaris Management Partners in New York. They can be reached at (212) 502-1870.
Bills Pending in State Legislatures