Speaker Programs: Two Recent Enforcement Actions Serve as a Reminder of the Government's Longstanding Scrutiny

The pharmaceutical and medical device industries have long utilized speaker programs, which typically involve retaining health care professionals to speak or present on the companies’ products to educate their peers. Speaker programs continue to be relatively common in the industry and can play an important role in educating health care professionals on the appropriate uses of companies’ products and on emerging research or development programs. However, two recent enforcement actions by the U.S. Department of Justice (DOJ) highlight the government's ongoing scrutiny of these programs for potential violations of the federal Anti-Kickback Statute (AKS). 

Governmental scrutiny was notably emphasized in a 2020 Special Fraud Alert by the Department of Health and Human Services Office of Inspector General (OIG), in which OIG provided a list of suspect characteristics that may indicate a speaker program presents risk under the AKS. Suspect characteristics include the following:

• Speaker programs where little or no substantive information is presented.
• Alcohol and meals that exceed modest value provided at speaker programs.
• Speaker programs held at venues not conducive to education, like high-end restaurants, luxury resorts, or entertainment or sporting events.
• Health care professionals being allowed to attend multiple speaker programs on the same topic, either as a repeat attendee or as an attendee after previously being a speaker on the same topic.
• Sales or marketing personnel influencing the selection of speakers or attendees.
• Speakers paid in excess of fair market value for the speaking service. 

For more information on the Special Fraud Alert, please see our previous blog post. Further, in response to this OIG Special Fraud Alert, the Pharmaceutical Research and Manufacturers of America (PhRMA) updated its Code on Interactions with Health Care Professionals in 2021 to address these risks, which we also discussed in a blog post at the time. 

Below is a brief summary of the two recent enforcement actions involving speaker programs, both of which were brought by relators and entailed conduct that occurred years prior to the OIG’s Special Fraud Alert and accompanying changes to the PhRMA Code on Interactions with Health Care Professionals. 

Assertio Therapeutics Settlement

On May 9, 2025, Assertio Therapeutics Inc., formerly known as Depomed Inc. (Assertio), agreed to pay $3.6 million to resolve allegations centered on the company's use of speaker programs to induce physicians to prescribe its fentanyl product, Lazanda. The claims were initially brought by two former sales representatives of Assertio, and the relevant time period for the allegations is between 2013 and 2017. Central to the allegations is the claim that Assertio focused its marketing on pain specialists who did not specialize in cancer treatment even though Lazanda is solely approved for breakthrough cancer pain in patients who are tolerant to opioid therapy. Many of the allegations echo the concerns raised in the OIG’s Special Fraud Alert and numerous other enforcement actions focused on speaker programs. For example, Assertio allegedly offered speaking positions to high-volume prescribers rather than selecting prescribers based on their expertise; did not screen speakers based on their academic or clinical accomplishments; and paid speakers in excess of fair market value. 

Gilead Sciences Settlement

On April 29, 2025, Gilead Sciences, Inc. (Gilead) agreed to a $202 million settlement to resolve claims that it used speaker programs to induce physicians to prescribe its HIV drugs. The DOJ contended that, from January 2011 through November 2017, Gilead paid health care practitioners honoraria, meals, and travel expenses to speak at or attend its events. Of note, Gilead evidently had policies and procedures in place to ensure that speaker programs were held appropriately, including a process to monitor speaker programs live to ensure compliance with its policies. According to DOJ, however, Gilead allegedly failed to adequately follow these policies and procedures. For example, Gilead allegedly allowed repeat attendance at its speaker programs and failed to prevent sales representatives from being involved in selecting speakers. Though the use of live monitors for speaker programs is a best practice, the government contended that Gilead’s monitors attending certain programs failed to note and report when meal spend limits were exceeded and venues were inappropriate. This settlement with DOJ therefore underscores the importance of not only establishing compliance policies and procedures, but also actively implementing and enforcing them throughout the organization. 

Conclusion

The recent AKS settlements with Assertio and Gilead serve as a stark reminder of the government's history of enforcement actions against pharmaceutical and medical device companies related to inappropriate speaker programs. As always, pharmaceutical and medical device companies should ensure speaker programs are carefully structured in accordance with the OIG’s guidance and the PhRMA Code on Interactions with Health Care Professionals to mitigate risks in this area; should consider whether their policies and processes need revision; and should consider whether additional training or monitoring of employees may be advisable. 

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