On August 6, Pharmaceutical Research and Manufacturers of America (PhRMA) released an updated and enhanced version of its voluntary Code on Interactions with Health Care Professionals (HCPs). The updated Code will take effect on January 1, 2022. The update to the Code is at least partly in response to the Special Fraud Alert issued by the Department of Health and Human Services Office of Inspector General (OIG) in November 2020 related to company-sponsored speaker programs, and addresses several of the risk areas OIG identified in the fraud alert.
The updates to the PhRMA code, which is voluntarily followed by many, if not most, pharmaceutical and biotech companies, will have broad implications for how companies interact with health care professionals. While much of the updated guidance reflects industry best practices, the updated Code signals that companies should reassess, and in some cases reconsider, their policies with respect to speaker programs and certain other company interactions with HCPs.
There are several notable updates to PhRMA’s guidance[1] regarding company-sponsored speaker programs:
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Speaker Programs, generally. In what appears to be a response to OIG’s expressed skepticism about the educational value of speaker programs in the Special Fraud Alert,[2] PhRMA reaffirms the industry’s position that “company-sponsored speaker programs provide important substantive educational information about the benefits, risks and appropriate uses of company medicines and related disease states.” However, PhRMA notes that speaker programs should “present substantive educational information designed to help address a bona fide educational need among attendees, taking into account recent substantive changes in relevant information (e.g., new medical or scientific information or a new FDA-approved indication for the product) or the importance of the availability of such educational programming.” Further, the Code adds that “only those with a bona fide educational need for the information should be invited.”
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Alcohol. In what is likely to be the headline for this refresh of the Code, PhRMA adopts OIG’s position that companies should not pay for or provide alcohol in connection with speaker programs. Although many pharmaceutical and biotech companies recently have been curbing alcohol at company-sponsored events, often setting limits on the type and/or amount of alcohol available, the outright prohibition is likely to require further policy changes by companies who have adopted the PhRMA Code.
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Restaurants/Venues. Updating previous guidance stating that resorts were not appropriate venues, the revised Code elaborates that “[v]enues should not be renowned, extravagant, or the main attraction of the event or perceived as such.” Venues such as “luxury resorts, high-end restaurants, entertainment, sporting, or other recreational venue or event” are not appropriate for company programs. The Code, however, rejects OIG’s position that restaurants are inappropriate venues for speaker programs. In Q&A Question 13, PhRMA recognizes that a private room at a local restaurant is an appropriate venue conducive to an information discussion. This language remains unchanged from the prior version of the Code and is only updated to reflect the more fulsome standard for venue selection.
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Repeat attendance by program attendees. Repeat attendance at a speaker program on the same or substantially the same topic where a meal is provided to the attendee is generally not appropriate, unless the attendee has a bona fide educational need to receive the information presented.
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Repeat attendance by program speakers. Attendance by speakers as participants at programs after speaking on the same or substantially the same topic is generally not appropriate.
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Attendance by friends, family, significant others, and other guests. 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.[3]
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Meals. The Code clarifies that “incidental” meals must be modest “as judged by local standards” and be subordinate in focus to the presentation.
The Code also refreshes guidance with respect to other interactions with health care professionals.
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Consultant/Speaker selection and compensation. Though the Code long has provided that consultants/speakers should be selected based on their expertise and experience in a particular therapeutic area, the Code explicitly adds that consultants or speakers cannot be selected based on, and their compensation should not consider, past or future expected revenue generated “by prescribing or ordering a company’s products.”
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Meals accompanying company representative presentations. The updated Code elaborates that incidental meals provided by company representatives in connection with an informational presentation to a health care professional must be “modest as judged by local standards” and should be provided only “where there is a reasonable expectation, and reasonable steps are taken to confirm, that each attendee has a substantive interaction or discussion with the company representative.” The Code further emphasizes that “grab-and-go” meals are inappropriate.
Beyond these updates, the refresh of the Code is noteworthy for at least one topic that it failed to address in a meaningful way: virtual programs. Although the Code recognizes that third-party educational programs, including CME, may be virtual, the Code fails to provide any meaningful guidance on company-sponsored virtual programs. In June 2020, PhRMA issued guidance addressing virtual presentations by company representatives, which quickly proliferated during the early days of the public health emergency.[4] It is surprising that PhRMA failed to incorporate and further elaborate on this guidance in the refresh of the Code as virtual programs are likely to continue even once the public health emergency expires.
Companies have a few months before the Code becomes effective to consider what policy changes may be appropriate in light of both OIG’s Special Fraud Alert and PhRMA’s updated guidance.
If you have any questions about the updates to the PhRMA Code or speaker programs generally, please feel free to contact one of the authors of this alert or the Hogan Lovells Attorney with whom you work most closely.
Authored by Ron Wisor, Thomas Beimers, Eliza Andonova, Helen Trilling, Laura Hunter, and Jonathan Elsasser
