General Requirements

(1) By July 1, 2009, each pharmaceutical or medical device manufacturing company that employs or contracts with a pharmaceutical or medical device manufacturer agent shall: (a) adopt a marketing code of conduct in compliance with the requirements of 105 CMR 970.000; (b) adopt and submit to the Department a description of a training program to provide regular training to appropriate employees including, without limitation, all sales and marketing staff, on the marketing code of conduct. The training program must: 1. ensure that all representatives who are employed by or acting on behalf of the company and who visit health care practitioners have sufficient knowledge of: a. the marketing code of conduct, b. general science, and c. product-specific information to provide accurate, up-to-date information, consistent with state law and FDA requirements; and 2. provide for regular assessments of persons who are employed by or acting on behalf of the companies to ensure that they comply with the requirements of 105 CMR 970.000 and other relevant company policies. (c) certify to the Department to the best of the company's knowledge, information and belief that it is in compliance with 105 CMR 970.000; (d) adopt and submit to the Department policies and procedures for investigating non-compliance with 105 CMR 970.000, taking corrective action in response to noncompliance and reporting instances of non-compliance to the appropriate state authorities; and (e) submit to the Department the name, title, address, telephone number and electronic mail address of the compliance officer it has identified as responsible for certifying compliance with 105 CMR 970.000 and implementing, monitoring, and enforcing the company's marketing code of conduct. (2) Each pharmaceutical manufacturing company that uses non-patient identified prescriber data to facilitate communications with health care practitioners shall: (a) maintain the confidential nature of prescriber data; (b) develop policies regarding the use of the data; (c) educate employees and agents about these policies; (d) designate an internal contact person to handle inquiries regarding the use of the data; (e) identify appropriate disciplinary actions for misuse of the data; and (f) comply with the request of any health care practitioner not to make his or her prescriber data available to company sales representatives. (g) Before utilizing health care practitioner prescriber data for marketing purposes, manufacturers must give health care practitioners the opportunity to request that their prescriber data : 1. be withheld from company sales representatives, and 2. not be used for marketing purposes. (h) Nothing in 105 CMR 970.005(2) shall prohibit pharmaceutical manufacturing companies from using prescriber data to: 1. impart important safety and risk information to prescribers of a particular drug or device; 2. conduct research; 3. comply with FDA mandated risk management plans that require manufacturers to identify and interact with health care practitioners who prescribe certain drugs or devices; or 4. track adverse events of marketed dugs, biologics or devices. (3) In all speaker and commercial consultant contracts, pharmaceutical manufacturing companies shall require any health care practitioner who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the nature and existence of his or her relationship with the company. This disclosure requirement must extend for at least two years beyond the termination of any speaker or consultant arrangement. st (4) Beginning on July 1, 2010, and annually on or before July 1 of each year thereafter, each pharmaceutical and medical device manufacturing company must certify to the Department that it has conducted annual audits to monitor compliance with 105 CMR 970.000. (5) Each pharmaceutical and medical device manufacturing company must report all incidents of non-compliance with 105 CMR 970.000 to the Department and to the Office of the Attorney General in a format specified by the Department. (6) Each pharmaceutical and medical device manufacturing company must register with the Department annually and must pay the $2,000 annual registration fee established by the Department. The annual registration fee replaces the disclosure fee described in 105 CMR 970.009(2), which is no longer required after July 1, 2012.