The Pharmaceutical Research and Manufacturers of America (PhRMA) recently updated its principles addressing speaker programs in its Code on Interactions with Health Care Professionals (PhRMA Code or Code). The PhRMA Code is a voluntary code of ethics addressing pharmaceutical company interactions with U.S. healthcare professionals. The revised Code reaffirms that interactions between pharmaceutical manufacturers and healthcare professionals in the context of company-sponsored speaker programs should focus on the provision of substantive product, scientific, and educational information. It also reiterates that meals provided as a business courtesy in connection with such programs should be modest as judged by local standards and incidental to bona fide educational programming.
Key affirming statements, clarifications, and updates to PhRMA Code principles addressing speaker programs involving meals include the following:
- The purpose of speaker programs should be to present substantive educational information designed to help address a bona fide educational need among attendees. In determining whether a bona fide educational need exists, companies may take into account recent substantive changes in relevant information (e.g., new medical or scientific information or a new Food and Drug Administration-approved indication for the product) or the importance of the availability of such educational programming.
- Only those with a bona fide educational need for the information presented at the program should be invited. Repeat attendance on the same or substantially the same topic is generally not appropriate unless the attendee has a bona fide educational need to receive the information presented. Attendance by speakers as participants at programs after speaking on the same or substantially the same topic is generally not appropriate.
- Incidental meals furnished to attendees must continue to be modest as judged by local standards as well as subordinate in focus to the educational presentation. Companies should not pay for or provide alcohol in connection with speaker programs.
- High-end restaurants are among the venues that are not appropriate for speaker programs.
The PhRMA Code is a leading set of industry principles that has shaped the scope of ethical interactions between pharmaceutical companies and healthcare professionals since its inception in 2002. Since 2003, the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) has recognized compliance with the PhRMA Code as “substantially reduc[ing] the risk of fraud and abuse [under the Anti-Kickback Statute]” and a demonstration of “good faith effort to comply with federal healthcare program requirements.” The updates to the PhRMA Code follow a November 2020 HHS-OIG Special Fraud Alert addressing speaker programs and sustained enforcement activity against pharmaceutical manufacturers targeting alleged conduct at speaker programs involving meals to attendees.
The updated Code is scheduled to take effect January 1, 2022. Both PhRMA members and nonmembers comprise a group of signatory companies that certify they have policies and procedures in place to foster compliance with the Code. In light of these updates and the broader enforcement environment, companies that are not signatories to the Code would likely benefit from considering their policies, practices, and controls governing speaker programs where meals are offered as well as their efforts to comply with state laws that reference PhRMA Code compliance.
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