In a report released on September 2, 2021 the Biden administration announced its plan to help prepare the nation for future pandemic threats. In the report, named American Pandemic Preparedness: Transforming Our Capabilities, the administration described what it sees as the vital need to change the nation’s capabilities to better respond to any future pandemics or biological threats.

The report organizes the proposed actions under five pillars: (1) Transforming Medical Defenses, (2) Ensuring Situational Awareness, (3) Strengthening Public Health Systems, (4) Building Core Capabilities, and (5) Managing the Mission

The report calls for action to “not just refill our stockpiles, but also to transform our capabilities.” The report compares the proposed plan to the Apollo space program because of the importance that the administration is placing on the efforts as well as the proposed coordination among agencies and departments.

Ultimately, the administration is planning to create a centralized “mission control” that would work to coordinate resources and expertise from multiple agencies within the Department of Health and Human Services like the National Institutes of Health, Centers for Disease Control and Prevention, Biomedical Advanced Research and Development Authority (a component of the office of the Assistant Secretary for Preparedness and Response), Food and Drug Administration and the Centers for Medicare and Medicare Services, along with other cabinet-level departments such as the Department of Defense, Department of Energy, and the Veterans Administration.

This “mission control” would manage the goals set forth throughout the plan. It would be given wide authority and responsibility to execute these plans and would also have the ability to update them if need be. The centralized control would also coordinate with international stakeholders and support the establishment of an international expert group to support global pandemic preparedness.

Medical Defenses and Situational Awareness

The focus and funding of the plan is heavily centered on improving medical defenses. Proposed efforts include increasing the national ability to rapidly make effective vaccines, therapeutics, and diagnostic tests for any virus family. For example, a proposed goal under this subarea is to have the national ability to produce enough vaccines for the entire United States population within 130 days of the recognition of an emerging pandemic threat.

The plan also aims to ensure better situational awareness through the implementation of effective early-warning and real-time monitoring systems. One proposed method of doing so is through environmental monitoring. For example, the plan calls for an expansion of wastewater sampling to better detect viral threats.

Public Health Capabilities

The administration’s plan also focuses on strengthening the national Public Health system. This goal will be met through the modernization of current public health infrastructures both domestically and globally. The other focus of this pillar is to establish an international infrastructure for pandemic preparedness that will remain funded through sustainable financing.

The plan also calls for improvements to “core capabilities”. This would include the development of effective and affordable PPE and an effort to restore and expand the stockpiles that have been depleted from the current pandemic. This pillar also calls for improved safety efforts in laboratories, and for efforts to prevent the development of biological weapons. Interestingly, this pillar also calls for regulatory improvement. Namely, it calls for an increase in the regulatory capacity of the FDA but also includes a general plan to improve regulatory systems.

Plan Costs

The total proposed cost of the plan is $65.3 billion over a 7-10 year period. A majority of the funds will go to the effort to transform medical defenses, more specifically to the development of vaccines ($24.2 billion), therapeutics ($11.8 billion), and diagnostics ($5.0 billion).

In light of the long lasting and devastating effects of the current Covid-19 pandemic, the administration has identified a clear need for preparation to fight future pandemics. If implemented, this plan could provide important funding for industry leaders to develop new vaccines and other health care resources. Furthermore, it could serve as a catalyst for regulatory changes that could have a great impact on the entire health care industry. Although it is still early, it will be important to track the implementation of these goals.

Reed Smith will continue to track the progress of this and any related regulations. Please reach out to the health care attorneys at Reed Smith if you have any questions about this or any other health care needs.