Earlier in May, Connecticut became the latest state to pass a bill requiring pharmaceutical and medical device manufacturers doing business in the state to adopt a compliance program that is at least as stringent as the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals and AdvaMed's Code of Ethics on Interactions with Health Care Professionals.
The bill requires pharma and medical device manufacturers to develop and implement an ethical code by January 1, 2011. It also demands that these companies form a compliance program that aligns with the Department of Health and Human Services Office of the Inspector General’s 2003 Compliance Program Guidance for Pharmaceutical Manufacturers. Compliance will be monitored by the Department of Consumer Protection, which can impose civil penalties of up to $5,000 if the company is found to have failed to adopt a code and compliance program, or if it has not conducted the required training or auditing to ensure compliance.
Among the requirements of the PhRMA and AdvaMed codes:
- Manufacturers can provide funding to support healthcare professionals' training, as long as they provide the subsidy directly to the meeting sponsor or educational institution.
- The meeting organizer must maintain control over content, and the meeting's purpose must be to promote “objective scientific and educational activities and discourse.”
- Meals and receptions are allowed, provided that they are “reasonable” and subordinate to the purpose of the meeting.
- Gifts to healthcare professionals must benefit either patients or the person's practice, and be valued at less than $100.
