Since the Office of the Inspector General (OIG) issued its Special Fraud Alert in November 2020, speaker programs have remained under intense regulatory scrutiny. Recently, the Department of Justice (DOJ) reached a settlement with a global pharmaceutical company, resolving allegations that one of its subsidiaries paid kickbacks to healthcare providers (HCPs) to drive prescriptions of their drug. The company agreed to pay nearly $60 million in fines and penalties.

According to the settlement, the subsidiary allegedly paid improper remuneration in the form of excessive speaker honoraria and high-end meals to influence prescribing behavior, violating the Anti-Kickback Statute. Some HCPs were paid tens of thousands of dollars, with a few receiving over $100,000. These individuals were selected for the speakers’ bureau with the expectation that their honoraria and lavish meals would encourage them to prescribe the company’s drug.

Beyond concerns about speaker selection and compensation, the settlement also highlighted issues with program attendees and the lack of legitimate educational content at these events. The DOJ found that some HCPs in attendance, including speakers’ spouses, family members, friends and colleagues, had no legitimate need to attend the programs. Additionally, HCPs were allowed to repeatedly attend programs on the same product without receiving new educational benefits, and many events were held at luxury venues with extravagant meals.

Ensuring Compliant Speaker Programs

This settlement serves as a stark reminder for life sciences companies that the government is continuously monitoring these programs, and that they must ensure these programs are structured for genuine education, not as a vehicle for sales and marketing. To mitigate risk, life sciences companies should evaluate and enhance their event management practices in these key areas:

  • Speakers
    • Select speakers based on their qualifications, expertise and ability to deliver meaningful, well-documented education, and not based on past or potential prescribing behavior.
    • Ensure speaker compensation aligns with Fair Market Value (FMV).
    • Limit the number of speaker programs per speaker and monitor the overall program volume.
    • Conduct regular reviews of the number of speakers, their fees and the total program spending.
  • Attendees
    • Restrict attendance to HCPs with a legitimate educational need.
    • Prevent spouses, family members, office staff and other non-essential attendees from registering or participating.
    • Implement tracking and analytics systems to monitor and identify excessive and repeat participation in programs on the same topic.
  • Spending
    • Select venues that are modest and appropriate for an educational setting, adhering to company policy and industry codes of ethics such as AdvaMed and PhRMA.
    • Ensure food and beverage costs are reasonable and compliant with company policy and industry guidelines.
    • Avoid luxury venues and high-end restaurants.
  • Auditing & Monitoring
    • Conduct regular audits and risk assessments to ensure compliance.
    • Maintain detailed documentation of program objectives, speaker selection, attendee lists and expense reports to demonstrate compliance.
    • Continuously review the number of speakers, their fees and the total speaker program spend.
    • Identify repeat attendees attending multiple events on the same topic.

How to Strengthen Your Speaker Program Compliance

The DOJ’s latest enforcement action underscores the need for life sciences companies to proactively assess and enhance their speaker program policies.

MediSpend’s events management solution helps companies structure compliant, data-driven speaker programs by offering visibility into HCP engagements, tracking program spend and ensuring adherence to industry regulations.

Interested in learning more? Contact us today to see how our platform can help your organization stay ahead of compliance risks.


March 28, 2025

Jay Ward
Director, Life Science Solutions