The Pharmaceutical Research and Manufacturers of America (PhRMA) is a trade group representing companies in the pharmaceutical industry in the United States. Last week PhRMA issued an updated and enhanced "Code on Interactions With Health Care Professionals." The updated Code takes effect on January 1, 2022. The Code is similar to the previous version, which was revised in September 2019, with some key differences regarding Speaker events and meals provided to HCPs, and also appears to align with the recent OIG Speaker Program Fraud Alert ("OIG Alert").
The most extensive changes to the Code are in Section 7/Speaker Programs and Speaker Training Meetings. Several guidelines were added to this section, including what the purpose of speaker programs should be, and that invitees should have a bona fide need for attending, companies should not pay for or provide alcohol, company representatives should be physically present at speaker programs, and venues should not be luxury resorts or high-end restaurants. The updated Code also notes that repeat attendance on the same/substantially same topic is generally not appropriate unless there is a bona fide educational need, and attendance by speakers as participants at programs after speaking on the same topic is generally not appropriate.
Section 2/Informational Presentations by Pharmaceutical Company Representatives and Accompanying Meals remained mainly unchanged except for a statement that notes "Incidental meals can 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. Offering “grab-and-go” meals are not appropriate."
The Code refers to meals provided to HCPs in multiple sections, and when referenced, often includes the term "incidental" in the description, although "incidental" is not defined within the Code.
Additional language was added to some sections taking into consideration events that may be “virtual” and in person, such as CME events, third-party scientific and educational conferences, or professional meetings.
When discussing the use of HCPs as consultants or speakers, the Code consistently notes that companies "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."
The Question & Answer section was also updated based upon the above-referenced additions. For example, Q7 discusses company representatives or immediate managers conducting presentations/discussions with an occasional meal in the office or hospital setting, whereby the answer included that "an incidental meal can be provided only where there is a reasonable expectation, and reasonable steps are taken to confirm, that each attendee receiving a meal has a substantive interaction or discussion with the company representative. Offering “grab-and-go” meals are not appropriate."
According to PhRMA, the Code "is to reinforce our intention that our interactions with health care professionals are professional exchanges designed to benefit patients and to enhance the practice of medicine."
A copy of the revised PhRMA Code is available here.