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PhRMA Code Update Clarifies and Tightens Key Provisions Associated with Speaker Programs

Undoubtedly in response to OIG’s November 2020 Special Fraud Alert: Speaker Programs issued, on August 6, 2021, PhRMA issued a statement addressing an update to the PhRMA Code on Interactions with Health Care Professionals, which will become effective on January 1, 2022.  PhRMA updated its principles applicable to company-sponsored speaker programs and clarified other provisions of the PhRMA Code in the following ways:

  1. Education: The updated PhRMA Code reiterates that the purpose of a speaker program should be to present substantive educational information designed to help address a bona fide educational need among attendees, taking into account recent substantive changes in relevant information or the importance of the availability of such educational programming. Invitations to speaker programs should be limited to those who have a bona fide educational need for the information being presented.

  2. Meals: In addition to reiterating that meals should be an incidental business courtesy to attendees of company-sponsored speaker programs and modest as judged by local standards, the updated PhRMA Code states that pharmaceutical companies should not pay for or provide alcohol in connection with speaker programs. The update also clarifies that high-end restaurants and other such venues are not appropriate locations for speaker programs. 

  3. Attendance: The PhRMA Code states that repeat attendance at speaker programs that are substantially the same is generally not appropriate (unless an bona fide educational needs exists), attendance by speakers as participants at programs after speaking on the same or substantially the same topic is generally not appropriate, spouses or other guests should not attend company-sponsored informational presentations unless these individuals are health care professionals for whom the informational presentation is appropriate, and that attendance by friends, significant others, family members and other guests of a speaker or invited attendee is not appropriate (unless these individuals have an independent, bona fide educational need to receive the information presented).

The updated PhRMA Code on Interactions with Health Care Professionals, which becomes effective until Jan. 1, 2022, may be found here.

The current PhRMA Code on Interactions with Health Care Professionals, which is effective until Jan. 1, 2022, may be found here

Compliance with the PhRMA Code on Interactions with Health Care Professionals is generally recognized as a base line for pharmaceutical compliance programs, and historically recognized by OIG as a means to substantially reduce the risk of fraud and abuse for pharmaceutical manufacturers and help demonstrate a good faith effort to comply with federal health care program requirements.

© 2021 Foley & Lardner LLPNational Law Review, Volume XI, Number 225
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About this Author

Kyle Faget, Foley Lardner, Government policy lawyer
Partner

Kyle Faget is a Partner and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to joining...

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