As you are likely aware, on July 1, 2009, Massachusetts General Law Chapter 111N – the Pharmaceutical and Medical Device Manufacturer Conduct Law – became effective. We have previously provided client updates on the development of this law, which among other things requires most drug and device manufacturers to track and report payments and other gifts provided to Massachusetts-licensed health care practitioners and certain other entities, to avoid certain payments altogether, to adopt a marketing code of conduct that reflects the state-specified requirements, and to make an annual filing with the state certifying that the company is in compliance with its marketing code of conduct. The first certification deadline for all companies was July 1, 2009.
With regard to the requirement for certifying compliance, some clients have asked what steps to take if they do not yet meet the Massachusetts requirements in full. According to guidance received from the state on July 6, 2009, companies are advised to send in their $2,000 fee and the compliance form required by the state as soon as possible. The state has advised that companies should indicate only the portions listed on the form that they can currently comply with, and attach a note stating when they plan to come into compliance with the other portions. Once the company does fully come into compliance, it should then resubmit the compliance form with all sections filled out, and include a note saying they previously sent in a partially completed form.