In response to recent legislation requiring FDA to consider patients' views in its regulatory decision making, the Pharmaceutical Research and Manufacturers of America (PhRMA) has adopted “principles” to guide interactions between companies and patient organizations.
The FDA Safety and Innovation Act requires the agency to “develop and implement strategies to solicit the views of patients,” as well as identifying “patient representatives who do not have any, or have minimal, financial interests in the medical products industry.”
PhRMA's principles in response to this have been posted on its Web site and are being distributed to all PhRMA member companies. They state that:
• All interactions with patient organizations must be consistent with the organization's mission and hold to ethical standards.
• Companies that provide financial support or in-kind contributions to patient organizations should have written documentation setting out the nature of support.
• Companies may provide financial support for patient organization meetings or other activities provided that the primary purpose of the activity is professional, educational, or scientific in nature, or otherwise supports the mission of the patient organization.