Massachusetts Department of Public Health Issues Proposed Marketing Code Regulations

December 10, 2008

By Jeffrey N. Wasserstein, Alan M. Kirschenbaum & Bryon F. Powell

On December 10, 2008, the Massachusetts Department of Public Health (Department) issued proposed regulations pursuant to Mass. Gen. L. § 111N, which requires the Department to promulgate regulations that adopt a standard marketing code of conduct (the Code) for all prescription pharmaceutical and medical device manufacturers.  The law also requires the Department to establish a public database of payments by such companies to health care practitioners, to collect fees associated with marketing cost disclosure, and to enforce the law’s marketing requirements.  We previously reported on the enactment of this statute (here and here).

The Department issued a unified Code that covers both pharmaceutical and medical device manufacturers.  However, recognizing the differences between the PhRMA Code and the AdvaMed Code, the Code includes some provisions that are applicable only to pharmaceutical manufacturers, and other provisions applicable only to device manufacturers (such as reimbursement for certain training costs, discussed below).  The Code mirrors the PhRMA Code to some extent, while also including specific prohibitions and permissions required by the statute. 

The Code’s discussion of specific marketing practices includes tight restrictions regarding the provision of meals, support for CME, and other payments to health care practitioners.  While the restrictions are similar to those in the revised PhRMA Code, which we previously reported on, there are some differences.  Notably, the PhRMA Code limits the in-office/in-hospital restriction on meals to health care professionals to sales representatives and their immediate supervisors.  Other business people may provide meals out of the office or hospital on occasion, and meals may be provided outside the office or hospital in connection with a health care speaker provided by the company.  The Code does not mirror the PhRMA Code in this respect and limits all meals to in-office or in-hospital.  Another difference is that the Massachusetts Code apparently prohibits funding of unaccredited CME programs, whereas the PhRMA and AdvaMed Codes permit such funding.  Yet another difference between the Code and industry standards is that the Code permits reimbursement for certain medical device training costs, provided the costs of the training are specified in the purchase agreement for the device.  The AdvaMed Code permits device companies to train health care professionals on medical devices even whether or not such training is provided for in a purchase agreement.  

Manufacturer/practitioner interactions permitted by the Code include, among other things, payments for genuine research projects or clinical trials; product samples or evaluation units; normal price concessions, such as rebates and discounts; provision of reimbursement-related information; and medication for patient assistance programs.  The proposed regulations also address the use of prescriber-identifiable data, in a manner similar to the PhRMA Code. 

The Code also requires companies to: adopt and comply with the Code by July 1, 2009; adopt a training program to ensure compliance with the Code; conduct annual audits to ensure compliance with the Code; adopt policies and procedures for investigating noncompliance; appoint a compliance officer responsible for compliance with the Code; submit a description of the training program, the company’s investigation policies, and the contact information for the compliance officer; certify annually that the company has conducted an annual audit and is in compliance with the Code; and submit an annual disclosure report, described more fully below.

Under the Code’s disclosure requirements, manufacturers must annually report all payments of at least $50 made “in connection with the company’s sales and marketing activities.”  The Department proposed a $2,000 fee to be paid by reporting manufacturers to fund the disclosure program.  The first disclosure report is due July 1, 2010, covering the period of July 1, 2009 through December 31, 2009. 

The Massachusetts Public Health Council  discussed the proposed regulations at its December 10th public hearing.  Public hearings regarding the proposed regulations will also be held in Boston on January 9, 2009 and in Worcester on January 12, 2009.  Comments are due by February 10, 2009. 

Categories: Drug Development