Final Pharmaceutical and Medical Device Manufacturer Conduct Regulations
March 19, 2009
On March 11, 2009, the Massachusetts Public Health Council promulgated final regulations (105 CMR 970.000) for the administration of Chapter 111N of the Massachusetts General Laws, which governs the marketing activities of pharmaceutical and medical device manufacturing companies. When the Legislature passed Chapter 111N in August 2008 (as Section 14 of Chapter 305 of the Acts of 2008) (the “Law”), Massachusetts joined the District of Columbia and six other states in regulating the relationships between the pharmaceutical and medical device industries and physicians.
Understanding these final regulations is of significant importance to anyone involved in the Massachusetts biotechnology, health care, and drug and device sectors. The regulations apply broadly to pharmaceutical or medical device manufacturing companies (“PMDMCs”), including companies that are “directly” engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs, biologics or medical devices. In accordance with the requirements of the Law, the regulations establish a fine of $5,000 for each knowing and willful violation.