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The pharmaceutical industry, in a number of states, is currently required to track, and in some cases report on, promotional activities, such as gifts, meals, consulting fees, and grants provided to healthcare professionals. These disclosures consist of the value, nature and purpose of gifts, payments, or other economic benefits provided to healthcare professionals in the advancement of a drug product or service. It is vital that all companies understand and comply with current marketing and advertising disclosure laws. With the state’s first disclosure report due in less than one month, it is critical that companies understand the Massachusetts reporting requirements for physician payments.
Below is summary of the legislation and frequently asked questions.
| Effective Date | July 1, 2010 |
| Disclosure Limit | $50 |
| Reportable Items | Any fee, payment, subsidy or other economic benefit with a value of at least $50 to any covered recipient in connection with the company’s sales and marketing activities |
| Report Due | July 1, 2010 (for activities occurring during the period July 1, 2009 – December 31, 2009) |
| Reporting Responsibility | Company's Compliance Officer |
| Responsible Party | Any pharmaceutical or medical device manufacturing company which includes any pharmaceutical or medical device manufacturing company or distributor |
| Report To | Massachusetts Department of Public Health; Email:pharmameddata@massmail.state.ma.us; Disclosure Report Example (CSV) The subject line of emails should contain only the manufacturer’s Department-assigned user ID and company name. If you do not have any data to disclose for this period, send an e-mail to this address stating that fact. The Department will deem such emails as meeting the requirement for filing an annual disclosure report. |
| Fee | $2,000 |
| Fine | Not more than 5,000 per transaction or occurrence |
What does this regulation do?
The regulation:
- Establishes a code of conduct that must be adopted by pharmaceutical and medical device companies.
- Requires companies to designate a compliance officer and to establish a compliance program pursuant to the regulatory requirements.
- Requires disclosure of certain financial interactions between the industry and covered recipients.
Who are "covered recipients" for the purposes of disclosure? (Click the link to read more)
