In case you missed it, the Pharmaceutical Research and Manufacturers of America (PhRMA) recently issued a new set of Principles on Patient Organization Interactions. Notably absent from these principles is any mention of product promotion. Instead, these principles focus on how to structure and document patient organization and industry relationships in a manner that advances biomedical research, innovation, and access to care. Following are the key points of which companies should be aware:
- All interactions must be consistent with the organization’s mission and adhere to high ethical standards while respecting the organization’s independence
- Involvement of the company and the nature of company involvement should be clear at the outset
- Companies cannot require that they be the sole funder of any patient organization or program
- Companies should maintain documentation of financial or in-kind support of patient organizations or their activities, including the purpose of any activities or funding
- Industry financial support of organization meetings or activities is appropriate where the activities are educational or scientific or otherwise support the organization’s mission (e.g., fundraising events to support the organization’s mission)
- Companies may hold organization meetings in appropriate venues and locations conducive to information exchange, and any meals or refreshments must be modest by local standards
While the principles do not discuss the presence of promotional materials at patient organization events or activities, companies must ensure that any branded promotional materials made available at these events comply with the U.S. Food and Drug Administration’s regulations and that any interactions with health care professionals comply with the PhRMA Code. Companies also should be careful to ensure an on-label presentation of their products, only, at patient organization events that may focus on a larger disease area.
The new Principles on Patient Organization Interactions are available at http://phrma.org/sites/default/files/2392/phrma_principles_paper_20120919_final.pdf.