On September 19, 2012, the Massachusetts Department of Public Health (Department) posted emergency regulations to immediately implement recent changes to Massachusetts’ Pharmaceutical and Medical Device Manufacturer Conduct Law [Mass. Gen. Laws Ch. 111N] (Law). The Law requires the Department to “adopt a standard marketing code of conduct for all pharmaceutical or medical device manufacturing companies that employ a person to sell or market prescription drugs or medical devices in the commonwealth.” Recent changes to the law permits pharmaceutical and medical device manufacturers to provide “modest meals and refreshments in connection with non-CME educational presentations 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.” The presentation must occur “in a venue and manner conducive to informational communication.” Additionally, pharmaceutical and medical device manufacturing companies who provide these meals must file quarterly reports detailing all non-CME educational presentations in which they provide such meals or refreshments. The emergency regulations are set to expire on December 19, 2012.
On November 21, 2012, the Massachusetts Bureau of Health Care Safety and Quality submitted a request to the Public Health Council to approve final regulations to implement recent changes to the Law. The final regulations permit pharmaceutical or medical device manufacturing companies to provide or pay for modest meals in the health care practitioner’s office or hospital setting in connection with informational or educational meetings or presentations. Companies may also provide or pay for modest meals outside of the health care practitioner’s office or hospital setting, provided that the meal is “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.” Please note that the regulations state that “appropriate uses” may not include the promotion of off-label uses of prescription drugs or medical devices.
The final regulations define “modest meals and refreshments” as “food and/or drinks provided by or paid for by a pharmaceutical or medical device manufacturing company or agent to a health care practitioner that, as judged by local standards, are similar to what a health care practitioner might purchase when dining at his or her own expense.”
In addition, echoing the amended law, the final regulations also require that the quarterly reports include:
- The location of the non-CME presentation;
- A description of any pharmaceutical products, medical devices, or other products discussed;
- The total amount spent on the presentation;
- The estimated cost per participant, including meals, refreshments, and other items of economic value provided; and
- Any other information as determined necessary by the Commissioner.
Further, the final regulations clarify that companies will need to register annually and submit a $2,000 annual registration fee .
Although the final regulations require companies to continue submitting annual disclosure reports to the Department, companies are not required to disclose information that has been disclosed to a federal agency pursuant to federal law.