Speaker Programs Still Under Scrutiny

In October 2024, Gardner Law attended the 25th Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, where OIG Keynote Speaker Mary Riordan, Senior Counsel in the Office Inspector General (OIG) for the U.S. Department of Health and Human Services, emphasized the OIG’s ongoing scrutiny of Anti-Kickback Statute (AKS) risks associated with speaker programs. She cautioned attendees to expect further enforcement actions, emphasizing that speaker programs remain a key area of concern—and now, we’ve seen just that. Pfizer Inc., on behalf of its wholly owned subsidiary, Biohaven Pharmaceutical Holding Company Ltd., recently agreed to pay nearly $60 million to settle the False Claims Act (FCA) and AKS allegations.

🔗 Read the OIG’s official press release on the settlement here.

This latest enforcement action follows a pattern of OIG scrutiny on speaker programs, including the November 2020 Special Fraud Alert, which identified “suspect characteristics” that increase compliance risk. Past settlements involving speaker program violations have resulted in substantial financial penalties and highlight the need for proactive compliance measures.

What Happened? Key Allegations in the Settlement

The case, initiated by a whistleblower complaint from a former sales representative, led to government intervention due to concerns that the company’s speaker programs violated AKS by functioning as a marketing tool rather than a legitimate educational initiative. The settlement outlined several problematic practices, including:

• Excessive Speaker Payments: Speakers received “tens of thousands” of dollars and, in some cases, over $100,000 in honoraria.
• Inappropriate Attendees: Program attendees included spouses and family members, friends, colleagues from the speaker’s own practice, and non-medical personnel with no legitimate educational need to attend the program.
• Lavish Meals & Entertainment: Attendees were treated to high-end meals, drinks, and venues, suggesting an intent to influence prescribing behavior rather than educate.
• Repeat Attendance by the Same HCPs: Some physicians attended multiple programs on the same topic with no added educational benefit.

The OIG contends that these practices resulted in the provision of unlawful remuneration, leading to false claims being submitted to federal healthcare programs.

Key Compliance Takeaways: How Companies Can Reduce Risk

This settlement serves as a warning for FDA-regulated companies: the OIG continues to closely monitor speaker programs and companies must ensure these programs are structured for genuine education—not as marketing or promotional tools.

• Evaluate Speaker Program Compliance – Ensure speaker honoraria are aligned with fair market value (FMV) and that speakers provide meaningful, documented education. We recommend limiting the number of speaker programs for each speaker and the total number of speaking programs. Companies should establish limits on the number of speaking engagements per HCP and regularly review the number of speakers, their fees, and overall program spending.
• Control Attendance – Restrict participation to HCPs with a legitimate educational need. Exclude spouses, family members, office staff, and other non-essential attendees.
• Enforce Reasonable Spending on Meals & Venues – Ensure that all food, beverage, and venue selections are modest, appropriate, and compliant with industry codes such as AdvaMed and PhRMA. Avoid luxury settings or high-end venues.
• Monitor Speaker & Attendee Trends – Implement tracking systems to identify repeat attendees and speakers participating in multiple events on the same topic. Regulators view excessive program participation as a potential red flag.
• Strengthen Internal Oversight – Conduct regular audits, risk assessments, and ongoing compliance monitoring to ensure adherence to AKS regulations. Maintain detailed documentation on program objectives, speaker selection, attendee lists, and expense reports to demonstrate compliance.

Taking these proactive steps can help companies mitigate risk, prevent enforcement actions, and ensure speaker programs remain educationally driven and compliant.

OIG’s Special Fraud Alert on Speaker Programs: Key Risk Factors

The OIG has consistently raised concerns about the compliance risks associated with speaker programs, emphasizing that these events can potentially serve as improper inducements rather than genuine educational opportunities.

In November 2020, the OIG issued a Special Fraud Alert: Speaker Programs, highlighting specific practices that heighten compliance risks. The alert stated that the OIG is skeptical about the true educational value of speaker programs and identified the following "suspect characteristics" that could indicate potential violations:

• The company sponsors speaker programs where little or no substantive information is actually presented;
• Alcohol is available or a meal exceeding modest value is provided to the attendees of the program (the concern is heightened when the alcohol is free);
• The program is held at a location that is not conducive to the exchange of educational information (e.g., restaurants or entertainment or sports venues);
• The company sponsors a large number of programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in relevant information;
• There has been a significant period of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product;
• HCPs attend programs on the same or substantially the same topics more than once (as either a repeat attendee or as an attendee after being a speaker on the same or substantially the same topic);
• Attendees include individuals who don't have a legitimate business reason to attend the program, including, for example, friends, significant others, or family members of the speaker or HCP attendee; employees or medical professionals who are members of the speaker's own medical practice; staff of facilities for which the speaker is a medical director; and other individuals with no use for the information;
• The company's sales or marketing business units influence the selection of speakers, or the company selects HCP speakers or attendees based on past or expected revenue that the speakers or attendees have or will generate by prescribing or ordering the company's product(s) (e.g., a return on investment analysis is considered in identifying participants); and
• The company pays HCP speakers more than fair market value for the speaking service or pays compensation that considers the volume or value of past business generated or potential future business generated by the HCPs.

For additional details on the OIG’s Special Fraud Alert, read our analysis here: OIG Issues Special Fraud Alert on Speaker Programs.

Contact Gardner Law

The recent settlement underscores the importance of proactive compliance strategies. Gardner Law can help companies evaluate the structure and execution of their speaker programs, develop and implement compliance policies that align with OIG guidance, and conduct internal audits to identify and mitigate AKS risks. Contact us.