The governor of Connecticut has signed into law Senate Bill 428 that requires pharmaceutical and medical device manufacturers to implement, at a minimum, the Pharmaceutical Research and Manufacturers of America’s “Code on Interactions with Healthcare Professionals” (the PhRMA Code) or the Advanced Medical Technology Association’s “Code of Ethics on Interactions with Health Care Professionals” (the AdvaMed Code) on or before January 1, 2011.1 Connecticut joins a number of states that have enacted similar laws regulating pharmaceutical and medical device companies’ interactions with healthcare professionals.
The new law requires pharmaceutical and medical device companies to adopt and implement a code that is consistent with and contains, at a minimum, all of the requirements set forth in the PhRMA Code or AdvaMed Code, as such codes were in effect on January 1, 2010. Further, under the new law, pharmaceutical and medical device manufacturers are required to adopt a comprehensive compliance program in accordance with the guidelines provided in the “Compliance Program Guidance for Pharmaceutical Manufacturers,” issued by the Department of Health and Human Services, Office of Inspector General on April 28, 2003. Manufacturers must conduct training and regular audits of compliance with such codes.
Under the law, the Connecticut Commissioner of Consumer Protection is authorized to investigate and impose civil penalties of up to $5,000 for failure to implement a compliant code, or failure to conduct training or regular compliance audits related to the code.
Currently, California, Massachusetts and Nevada have similar “Code of Conduct” laws in place, and other states are considering similar measures. Pharmaceutical and device companies marketing their products in Connecticut should make sure they are in compliance with the new law by January 1, 2011.