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Operation Warp Speed Releases Principles for Therapeutics

Operation Warp Speed (OWS), a joint effort by the departments of Defense and Health and Human Services, held a stakeholder call to discuss principles for allocation and distribution of therapeutics.

Officials updated stakeholders on the status of the U.S. government’s therapeutics development (specifically, monoclonal antibodies); summarized the process for future allocation and distribution of the product; and discussed anticipated drug administration requirements and challenges.

Federal allocation decisions will be informed by confirmed hospitalizations and confirmed cases, two data sources from HHS Protect, similar to the process used for remdesivir allocation. Principles for the U.S. government allocation and distribution of COVID-19 therapeutics include:

  • maximum use of existing infrastructure within the government, manufacturer, and distributor channels;
  • allocations that ensure both temporal and geographic equity;
  • state responsibility for allocation to final points of care; and
  • manufacturers tracking pharmacovigilance and following mandatory reporting guidance.

Further, OWS released a draft pre-emergency use authorization (EUA) playbook with details for health care facilities to start planning how to implement monoclonal antibody treatment in an outpatient setting for those with COVID-19.

The playbook includes a readiness checklist, as well as three activities for health care facilities to consider as they plan:

  • define facilities and patient visit logistics;
  • ensure sufficient supplies; and
  • develop a plan for staffing and personnel.

The playbook will evolve as other treatments and administration methods become available.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Abigail Painchaud is a policy associate at America's Essential Hospitals.

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