Revised PhRMA Code Took Effect on January 1, 2022, and Certain State Obligations Follow
January 5, 2022Happy New Year!
On January 1, 2022, the recently revised version of the PhRMA Code on Interactions with Health Care Professionals went into effect. We summarized the major revisions to the Code in a blog post when it was released in August 2021. Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance.
Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code. The updated Code incorporates the latest guidance from the Office of Inspector General at the U.S. Department of Health and Human Services (OIG). This includes a November 2020 Special Fraud Alert wherein OIG explained its enforcement focus regarding speaker programs. (We blogged about the Alert here).
Another reason drug manufacturers may want to update their marketing policies are the numerous state requirements tied to the Code. Several states, including Connecticut, California, District of Columbia, Massachusetts, and Nevada, have adopted or incorporated the Code in their statutes or regulations. In some cases, a revised PhRMA Code adds obligations for manufacturers to update their practices. For example, California’s drug marketing law requires pharmaceutical companies to adopt an internal marketing compliance policy that aligns with the PhRMA Code. See Cali. Health & Safety Code § 119402(b). If the Code is revised, the California law gives companies six months to update internal policies to conform to the new version. Other jurisdictions like D.C. require sales representatives to comply with the Code “as it may be amended or republished from time to time.” See D.C. Municipal Regulation § 8305.11.
Given these state requirements, following the PhRMA Code is not only an approach to mitigate litigation risk – it is an explicit requirement for manufacturers that interact with health care practitioners in a state that has adopted or incorporated the Code.