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

13 August 2021 Health Care Law Today Blog
Author(s): Kyle Y. Faget

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.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services