Drugs

BIO Considerations for Truthful Speech

The Biotechnology Innovation Organization (BIO) has published a document with four “considerations” to provide the ethical foundation for any product communication. The group says that the considerations were drawn from application of relevant aspects of BIO’s Statement of Ethical Principles.

“In the past,” the document says, “BIO has primarily focused our advocacy with regard to the issue of truthful and non-misleading product communication around what aspects of FDA’s existing regulatory regime need to change, how those changes should be implemented, and to align the regime with First Amendment principles. Moving forward, as BIO participates in broader stakeholder discussions on this issue, BIO should ensure that our future advocacy around any changes to the legal and regulatory regime governing biopharmaceutical companies’ product communication is aligned with these four bioethical considerations emanating from the principles.”

The four considerations, BIO’s document says, are:

all parties communicating product information should ensure timely, truthful and non-misleading information—including, but not limited to, the 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 conflicts should be built from the existing work on this subject.

“In developing and executing an advocacy strategy to address the tension between the current ecosystem of biopharmaceutical companies’ communication and the need for truthful and non-misleading communications, BIO should take into account these considerations,” the group says.

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