Compliance officers in the pharmaceutical industry, take note: New voluntary standards will soon take effect that offer best practice guidance related to company-sponsored speaker programs.
The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing U.S. pharmaceutical companies, announced revisions in August to its voluntary “Code on Interactions with Health Care Professionals.”
“The PhRMA Code reinforces PhRMA’s intention that pharmaceutical company interactions with health care professionals follow the highest ethical standards and applicable legal requirements,” PhRMA stated.
Signatory companies, including both PhRMA members and nonmembers, submit annual certifications to the trade group certifying they have policies and procedures in place to foster compliance with the PhRMA Code. The latest revisions mark the third time the code has been revised since being published in 2002 (2009, 2019).
The new revisions follow a rare Special Fraud Alert issued by the U.S. Department of Health and Human Services’ Office of Inspector General in November 2020 warning of inherent fraud and abuse risks “associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs.”
For compliance professionals in the pharmaceutical industry, it brings to bear critical questions about whether paid speaker programs are worth the risk, especially since numerous companies in the last few years have paid hundreds of millions of dollars to resolve enforcement actions related to speaker programs.
“The PhRMA Code has long recognized that company-sponsored speaker programs provide important substantive educational information about the benefits, risks, and appropriate uses of company medicines and related disease states,” PhRMA said.
“Building on this fundamental principle, the PhRMA Code now 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 (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. Invitations to speaker programs should be limited to those who have a bona fide educational need for the information presented at the program.”
The new code also describes the following additional amendments, summarized below:
Incidental meals and modest venues. The updated code “states that pharmaceutical companies should not pay for or provide alcohol in connection with speaker programs. The updated PhRMA Code also clarifies that high-end restaurants and other such venues are not appropriate locations for speaker programs.”
Attendance. “The PhRMA Code now states that 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,” the trade group stated. “Furthermore, the PhRMA Code clarifies that attendance by speakers as participants at programs after speaking on the same or substantially the same topic is generally not appropriate.”
PhRMA further reiterated guests of speakers or attendees should not attend company-sponsored informational presentations, “unless these individuals are health care professionals for whom the informational presentation is appropriate.”
The updated code will take effect Jan. 1, 2022.