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Security of America’s Medical Product Supply Chain

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In response to the CARES Act, the National Academies of Sciences, Engineering, and Medicine will establish an ad hoc committee to conduct a study to examine the security of the United States medical product supply chain. The committee will assess and evaluate the dependence of the United States on critical drugs and devices that are sourced or manufactured outside of the United States and provide recommendations to improve the resiliency of the medical supply chain.

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Description

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (National Academies) will conduct a study to examine the security of the United States medical product supply chain.
The committee will:
1) assess and evaluate the dependence of the United States, including the private commercial sector, States, and the Federal Government, on critical drugs and devices that are sourced or manufactured outside of the United States, which may include an analysis of:

  • the supply chain of critical drugs and devices of greatest priority to providing health care;
  • any potential public health security or national security risks associated with reliance on critical drugs and devices sourced or manufactured outside of the United States, which may include responses to previous or existing shortages or public health emergencies, such as infectious disease outbreaks, bioterror attacks, and other public health threats;
  • any existing supply chain information gaps, as applicable; and
  • potential economic impact and other considerations associated with increased domestic manufacturing; and

2) provide recommendations to improve the resiliency of the supply chain for critical drugs and devices and to address any supply vulnerabilities or potential disruptions of such products that would significantly affect or pose a threat to public health security or national security, as appropriate, which may include strategies to:

  • promote supply chain redundancy and contingency planning;
  • encourage domestic manufacturing, including consideration of economic impacts, if any;
  • improve supply chain information gaps;
  • improve planning considerations for medical product supply chain capacity during public health emergencies; and
  • promote the accessibility of such drugs and devices.

Contributors

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Conflict of Interest Disclosure

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 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 healthcare 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.

Committee Membership Roster Comments

Please note that there has been a change in the committee membership with the appointment of Dr. Lee Branstetter, effective 02/05/2021.

Please note that there has been a change in the committee membership with the resignation of Dr. Raquel C. Bono, effective 02/05/2021.

Please note that there has been a change in the committee membership with the resignation of Dr. Marta E. Wosinska, effective 04/23/2021.

Please note that there has been a change in the committee membership with the appointment of Dr. George Ball, effective 05/28/2021.

Please note that there has been a change in the committee membership with the resignation of Dr. Robert Califf, effective 11/15/2021.

Sponsors

Department of Health and Human Services

Staff

Lisa Brown

Lead

Carolyn Shore

Lead

Shalini Singaravelu

Margaret McCarthy

Kelsey Babik

Andrew March

Leah Cairns

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