Massachusetts Proposes Regulations for Pharmaceutical and Medical Device Disclosure Law Compliance
January 9, 2009
On December 10, 2008, the Massachusetts Department of Public Health released the Pharmaceutical and Medical Device Manufacturer Code of Conduct Regulations (the Proposed Regulations) that set forth the requirements for pharmaceutical and medical device manufacturers to comply with the Commonwealth’s pharmaceutical and medical device disclosure law (the Massachusetts Disclosure Law). The Proposed Regulations augment the statutory Marketing Code of Conduct and economic disclosure requirements and attempt to account for industry-specific differences between pharmaceutical and medical device manufacturers by incorporating additional defined terms or interpretive requirements. While the Proposed Regulations provide some level of clarity, they create a new layer of concerns by incorporating additional substantive restrictions on activity not explicitly addressed in the Massachusetts Disclosure Law, such as restrictions on pharmaceutical manufacturer use of non-patient identified prescriber data. Equally important, the Proposed Regulations broadly define the scope of reportable sales and marketing activity, which, without further clarification, may result in extensive and ambiguous reporting requirements.
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