The Massachusetts Department of Public Health (DPH) recently adopted some of the nation’s most stringent regulations (the “Final Regulations”) restricting the marketing activities of pharmaceutical and medical device manufacturers (“Manufacturers”).1 Mintz Levin summarized the Final Regulations in a Health Law Client Alert entitled “Massachusetts DPH Releases Final Rules for Pharmaceutical and Medical Device Manufacturers’ Conduct.” In response to the tremendous interest in the Final Regulations, this Advisory expands upon our Client Alert and offers information responsive to questions frequently asked by clients.
*highlights important submissions that Manufacturers must make to DPH by July 1, 2009;
*highlights changes to the Final Regulations in response to public comments on the proposed regulations, dated December 10, 2008 (“Proposed Regulations”); and
*compares, for purposes of example, several key provisions of the Final Regulations to the PhRMA Code on Interactions with Healthcare Professionals (“PhRMA Code”)2 and the AdvaMed Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”).3
Please see full advisory for more information.
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