Provision of Meals

(1) Except as otherwise provided in 105 CMR 970.000, no pharmaceutical or medical device manufacturing company or its agent that employs or contracts with a pharmaceutical or medical device manufacturer agent may provide or pay for meals for health care practitioners that: (a) are part of an entertainment or recreational event; (b) are offered without an informational presentation made by a pharmaceutical or medical device marketing agent or without such an agent being present; or (c) are provided to a healthcare practitioner's spouse or other guest. (2) Pharmaceutical or medical device manufacturing companies and agents may provide or provide payment for modest meals to health care practitioners in the health care practitioner's office or hospital setting in connection with informational or educational meetings or presentations. (3) Pharmaceutical or medical device manufacturing companies and agents may provide or provide payment for modest meals and refreshments to health care practitioners outside of the health care practitioner's office or hospital setting for the purpose of educating and informing health care practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information, provided that such presentations occur in a venue and manner conducive to informational communication. For the purposes of 105 CMR 970.006(3), "appropriate uses" may not include the promotion of off-label uses of prescription drugs or medical devices. (4) No pharmaceutical or medical device manufacturing company may provide or provide payment for such meals and refreshments permitted under 105 CMR 970.006(3) unless such pharmaceutical or medical device manufacturing company files quarterly reports detailing all non-CME educational presentations at which such meals or refreshments are provided. Reports shall include: (a) the location of the non-CME presentation; (b) a description of any pharmaceutical products, medical devices or other products discussed at such presentation; (c) the total amount expended on such presentation; (d) an estimate of the amount expended per participant, factoring any meals, refreshments or other items of economic value provided at such presentation; and (e) such other information as determined necessary by the Commissioner.