Speaker Bureau & Educational Programs Flashcards

Under AdvaMed's Code of Ethics, educational programs involving medical device speakers must primarily:

Answer: Serve a genuine educational function for healthcare professionals about relevant clinical topics

AdvaMed's Code requires that all educational programs serve a legitimate educational purpose for healthcare professionals and are not designed primarily as a reward or inducement.

When a company uses a third-party speaker bureau vendor, which compliance obligation remains with the manufacturer?

Answer: The manufacturer retains responsibility for ensuring vendor practices comply with applicable laws and company policies

Outsourcing to a third-party bureau does not transfer the manufacturer's legal and ethical compliance obligations; due diligence, oversight, and ultimate accountability remain with the company.

A pharmaceutical company's compliance officer discovers that a speaker program on the same drug was held six times in the same ZIP code within 90 days, with largely overlapping attendees. This pattern MOST likely indicates:

Answer: A potential Anti-Kickback Statute concern because programs may be functioning as sales calls with meals

Repeated programs in tight geographies with repeat attendees indicate the educational need has been met and additional programs may be a pretext for providing meals or remuneration, raising Anti-Kickback Statute concerns.

Under PhRMA guidelines, what is the meal limit standard for company-sponsored speaker programs?

Answer: Meals may be provided but must be modest and not the primary draw of the event

PhRMA guidelines permit modest meals that are incidental to the educational program, but prohibit extravagant meals or entertainment that could be viewed as the real incentive for attendance.

What action should a compliance officer require when a company speaker makes unsolicited off-label statements during a sponsored program?

Answer: Immediately stop the program, document the incident, and report it through the company's adverse event and compliance reporting channels

Off-label promotion at a sponsored program creates regulatory risk; the company must stop the off-label communication, document the incident, and escalate through compliance and potentially FDA reporting channels.

How should attendee lists from speaker programs be managed from a compliance perspective?

Answer: Lists should be retained securely and used only for legitimate compliance purposes such as Open Payments reporting and program audits

Attendee lists must be retained for Open Payments and audit purposes, but access should be restricted and use limited to compliance functions rather than serving as marketing leads for sales representatives.

Which of the following BEST describes a compliant speaker training program under PhRMA guidelines?

Answer: Training that equips speakers with accurate, balanced, and scientifically rigorous content about the disease state and product

Speaker training must provide accurate, balanced scientific information; training designed to maximize sales messaging or held in inappropriate venues violates PhRMA's intent for educational programs.