What’s New/Significant

Pharmaceutical Research and Manufacturers of America (PhRMA) released on Aug. 6 revisions to the Code of Interactions with Health Care Professionals (PhRMA Code). The revisions, which take effect Jan. 1, 2022, are intended to reinforce the ethical nature of the interactions that pharmaceutical manufacturers have with health care professionals when marketing and selling their prescription drug products and to reinforce the professional nature of those exchanges, with a goal of benefiting patients and enhancing the practice of medicine.

Rationale

With these latest revisions, PhRMA seeks to reinforce, clarify and expand on previously articulated guidance and to formalize new guidance as well, taking into consideration recent enforcement actions and the Office of the Inspector General’s Special Fraud Alert. In light of this revised PhRMA Code, pharmaceutical manufacturers should assess their current interactions with health care providers against the revised code and adjust their activities and their policies and practices accordingly.

Scope/Impact

  • Incidental Meals – Incidental meals offered in connection with informational presentations made by field sales representative or their immediate managers continue to be limited to in-office or in-hospital settings, with a new limitation that they may “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."
  • Consultants – Compensation or reimbursement made in conjunction with a consulting arrangement should be reasonable, based on fair market value. The revised PhRMA Code further limits compensation so that it “should not take into account the volume or value of past business that may have been or potential future business that could be generated for the company by the health care professional consultant.”
  • Venue – The description of inappropriate venues for consultant meetings is expanded to include “luxury resorts, high-end restaurants, and entertainment, sporting, or other recreational venues or events.”
  • Meals – The value of meals that are appropriate to provide to consultants must now be “modest as judged by local standards.”
  • Speaker Programs – PhRMA significantly expanded Section 7, “Speaker Programs and Speaker Training Meetings,” to reinforce and clarify the following:
    • Speaker Selection. Companies should select speakers using defined criteria such as “general medical expertise and reputation, knowledge and experience regarding a particular therapeutic area and communication skills.”
    • Transparency. During a speaker program, speakers must clearly identify that “they are presenting on behalf of the company, and that the speaker is presenting information consistent with FDA guidelines.”
    • Purpose. The purpose of the speaker program must be to “present substantive educational information, designed to take into account recent substantive changes in relevant information.”
    • Venue. For speaker programs at third-party venues, the venue “should not be extravagant or the main attraction of the event or perceived as such. Luxury resorts, high-end restaurants, and entertainment, sporting, or other recreational venues or events are not appropriate.”
    • Meals and Beverages. Incidental meals furnished to attendees must be “modest as judged by local standards as well as subordinate in focus to the educational presentation,” and “companies may not pay for or provide alcohol in connection with the speaker program.”
    • Attendees. Only attendees with a “bona fide educational need for information should be invited to a speaker program,” and repeat attendance at a speaker program on the same or substantially the same topic is generally not appropriate unless an attendee has a bona fide educational need to receive the information presented. Friends, significant others, family members and other guests of a speaker or an invited attendee are not permitted to attend a speaker program unless they have an independent, bona fide educational need to receive the information presented.
    • Training. Companies may compensate speakers for training when (i) the speakers receive extensive training on the company’s products or other topics that are to be presented in compliance with FDA requirements for communications, (ii) the training will result in the participants providing a bona fide service to the company, and (iii) the speaker will enter into a bona fide consulting agreement with the company.
    • Compensation. Compensation for speaking services must be in accordance with fair market value and “should not take into account the volume or value of past business that may have been or potentially future business that could be generated for the company by the health care professional.” Companies must cap the total amount of annual compensation they will pay to an individual health care professional in connection with all speaking arrangements.
    • Utilization. Companies must assess the appropriate use of speakers, including utilization of speakers after training and the appropriate number of engagements for any particular speaker over time.