Appendix F
Disclosure of Unavoidable Conflict of Interest
The conflict of interest policy of the National Academies of Sciences, Engineering, and Medicine (http://www.nationalacademies.org/coi) prohibits the appointment of an individual to a committee authoring a Consensus Study Report if the individual has a conflict of interest that is relevant to the task to be performed. An exception to this prohibition is permitted if the National Academies determines that the conflict is unavoidable and the conflict is publicly disclosed. A determination of a conflict of interest for an individual is not an assessment of that individual’s actual behavior or character or ability to act objectively despite the conflicting interest.
Robert M. Califf has a conflict of interest in relation to his service on the Committee on Security of America’s Medical Product Supply Chain because he is employed by Verily Life Sciences and has current relationships with Google Health and Cytokinetics.
The National Academies has concluded that for this committee to accomplish the tasks for which it was established, its membership must include at least one person who has substantial relevant experience in FDA regulatory policy, drug and device development, drug and device manufacturing, and drug shortages. As described in his biographical summary, Dr. Califf has extensive current experience as Head of Clinical Policy and Strategy for Verily Life Sciences and Google Health in FDA regulatory policy, drug and device development and manufacturing. As Commissioner of the U.S. Food and Drug Administration (FDA), and as Deputy Commissioner for Medical Products and Tobacco, Dr. Califf gained valuable expertise and perspective on the entirety of the health care ecosystem, including companies, hospitals, and health systems. Additionally, Dr. Califf has led clinical
research studies and clinical trials and previously served as vice chancellor of clinical and translational research and the director of the Duke Translational Medicine Institute.
The National Academies has determined that the experience and expertise of Dr. Califf is needed for the committee to accomplish the task for which it has been established. The National Academies could not find another available individual with the equivalent experience and expertise who does not have a conflict of interest. Therefore, the National Academies has concluded that the conflict is unavoidable.
The National Academies believes that Dr. Califf can serve effectively as a member of the committee, and the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the study.
