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Massachusetts Amends Its Drug and Device Marketing Law

On July 8, Governor Deval Patrick signed a bill amending the Massachusetts law regulating marketing activities by pharmaceutical and device manufacturers, one of the strictest state laws in the country.

The law previously barred pharmaceutical and device manufacturers from providing meals to health care practitioners outside the practitioner’s office or hospital setting.  See 111N  Mass. Gen. Laws § 2.  The amendment will now permit pharmaceutical and device manufacturers to provide modest meals and refreshments outside of the practitioner’s office or hospital setting, if the meal or refreshment is furnished with a non-CME educational presentation for the purpose of providing bona fide medical information, and the meal is furnished in a venue and manner conducive to communicating information.  The amendment directs the Massachusetts Department of Public Health to promulgate regulations to define “modest meals and refreshments.”  Pharmaceutical and device companies, however, will be required to submit quarterly reports describing all meals provided in connection with non-CME educational presentations.

The law also previously permitted device companies to provide technical training for a device only if the training was included as part of a contract to purchase the device.  The amendment relaxes that restriction, permitting device companies to pay for reasonable expenses necessary to train on the use of a device, even if not part of a purchase contract.

The Department of Health will now need to update the information collection forms that manufacturers are required to submit regarding their marketing expenses.  In addition, as noted, the Department will need to develop quarterly report forms to enable companies to report meals furnished during educational presentations and will need to promulgate a regulation defining “modest meals and refreshments.”

A copy of the Massachusetts law, with revisions made by the amendment, can be found here.

© 2023 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume II, Number 198
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About this Author

Jesse Witten, Drinker Biddle Law Firm, Washington DC, Healthcare and Litigation Attorney
Partner

Jesse A. Witten defends health care providers, pharmaceutical manufactures and other clients in the health industry against fraud and abuse matters in government investigations and litigation, particularly False Claims Act matters. Jesse also assists clients in internal corporate investigations and self-disclosures to the government of regulatory violations and Medicare/Medicaid overpayment. He counsels clients on compliance with Anti-Kickback Statute and Stark Law and laws governing the sale and marketing of medical devices and pharmaceutical products...

(202) 230-5146
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