Drug Manufacturers Take Note: Updated PhRMA Code Released

The PhRMA Code was first published in 2002 and is a voluntary ethics code to which numerous drug manufacturers pledge adherence. The Code addresses both improper and proper ways for manufacturers and representatives of drug manufacturers to interact with prescribers in the United States, which, given the provisions of the Federal Anti-Kickback Statute, Federal False Claims Act, and Beneficiary Inducement Statute, represent highly sensitive interactions.

The Code was last revised in 2019, and was most recently updated to take into account a 2020 Special Fraud Alert issued by the Department of Health and Human Services Office of Inspector General (OIG) regarding speaker programs. A copy of the Special Fraud Alert can be found here.    

Highlights of the revisions include:

·       Clarification 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 (no guests).

·       Companies should not pay for or provide alcohol in connection with speaker programs. High-end restaurants and other such venues are not appropriate locations for speaker programs.

·       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 revised Code (found here) takes effect on January 1, 2022.