Today, BIO releases Points to Consider on Truthful and Non-Misleading Product Communication. This document advances the dialogue on this issue toward achieving the shared aim of getting the right medicine to the right patient at the right time.
The current “Information Age” holds significant promise to improve the ability of stakeholders to make well-informed healthcare decisions. Never before has information about healthcare interventions, including innovative medicines, been so readily available from so many different sources and through so many different platforms. In this era of data-driven medicine, health care professionals and payers of health care seek more, not less, information about the safety, effectiveness, and value of treatments. As scientific research and clinical practice make huge strides toward treating and curing the serious diseases we face, how can this promise be practically translated, while mitigating the risks from inaccurate, imprecise, or potentially confusing information along the way?
The Points to Consider demonstrate that resolving this issue is not just a legal or regulatory matter, but implicates bioethical imperatives. Last week, BIO and PhRMA released joint Principles on communications with health care professionals and payers that make a significant contribution to answering that question from a legal and regulatory perspective. The Principles are intended to guide the establishment of clear standards to govern responsible, truthful and non-misleading communications that inform healthcare professionals and payers about the safe and effective use of medicines. The Points to Consider we release today complement the Principles by exploring the bioethical foundation of the need for changes to the current legal and regulatory regime and further sketch out the parameters of an ideal information environment that can support our broader goals for improving the healthcare system. In other words, the Points to Consider address “why” change is needed, and the Principles explain “what” that change should be.
The Points to Consider are the conclusion to a year-long study of the bioethical underpinnings of truthful and non-misleading product communication. During the course of the document’s development, BIO’s Board Standing Committee on Bioethics—whose remit is to consider, through the lens of bioethics, issues impacting BIO members—engaged with a diversity of stakeholders, including hosting discussions with bioethicists and representatives of the provider and patient communities. Through this dialogue, we sought to obtain insights into different perspectives on relevant bioethical norms and implications with regard to product communication and, relatedly, understand the value of this information to different stakeholders.
BIO also relied on our existing Statement of Ethical Principles(the “Statement”), which identifies our commitments with respect to the socially responsible development and use of biotechnology to help save or improve lives.1 Enshrined in this Statement is the commitment to contribute to improving the information available to stakeholders at the point of healthcare decision-making and a recognition of the role of science-based regulation to facilitate the communication of product information.
Applying the Statement to the issue of product communication, and working through the lens of diverse input, BIO identified four primary Considerations that can foster an ethical ecosystem for truthful and non-misleading product communication:
- All parties communicating product information should ensure that timely, truthful and non-misleading information—including, but not limited to, clinical and other information contained in a product’s FDA labeling—is available to all relevant stakeholders;
- Timely, efficient mechanisms should be in place to ensure the quality of the truthful and non-misleading information that is communicated;
- Any regime governing truthful and non-misleading communication should take into account whether such information is meaningful in the context of patient care; and
- Conflicts of interest should be assessed through a common mechanism, not through stakeholder-specific means, and mechanisms to address COI should be built based on the existing work on this subject.
These Considerations will inform BIO’s perspective as we engage in broader conversations with regard to biopharmaceutical companies’ product communication.
BIO hopes that the Points to Consider can act as the foundation for further discussion on this critical topic. We believe that the framework outlined will further enable patient access to the most appropriate biotechnologies for them and contribute to increasing the efficiency and effectiveness of the healthcare system.
 BIO. 2013. BIO Statement of Ethical Principles. Available at: https://www.bio.org/articles/bio-statement-ethical-principles.
Allen Waxman is Executive Vice President at Eisai Inc., and serves as Chair of BIO’s Board Standing Committee on Bioethics.