Policymakers across branches of government are proposing improvements to US pandemic preparedness and response capabilities. These proposals include a White House framework released in late 2021 and recently-introduced bipartisan legislation entitled “The Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act),” which was marked up by the Senate Health, Education, Labor, and Pensions Committee on March 15. Both proposals emphasize strengthening public health infrastructure, including disease surveillance, response capabilities, and the Strategic National Stockpile; improving development and manufacturing of medical countermeasures, including drugs, vaccines, and devices; and improving health outcomes in vulnerable communities by addressing social determinants of health (SDOH). The proposals demonstrate policymakers’ recognition of opportunities to enhance US public health infrastructure for pandemic preparedness and threat response and to streamline regulatory processes that improve the development and deployment of medical countermeasures.

The PREVENT Pandemics Act is the latest in a series of legislative proposals designed to address gaps in US preparedness and response capabilities exposed by the COVID-19 pandemic. Other proposals are included in:

• Cures 2.0: Legislation that aims to improve research and development for new preventives and treatments, including for pandemic preparedness, and improve how they are delivered to patients.
• Pandemic and All Hazards Preparedness Act (PAHPA): Legislation that is reauthorized every 5 years and includes broad pandemic preparedness priorities. Past PAHPA iterations established Biomedical Advanced Research and Development Authority and the National Health Security Strategy.
• User Fee Amendments (UFAs): Amendments that are reauthorized every 5 years intended to expedite and modernize the landscape of drug approvals and oversight regulations. Upcoming UFA reauthorization could further reform product development to better accommodate pandemic preparedness.

Once authorized, program implementation requires funding. Since this funding is most likely to come through annual appropriations, these programs will require ongoing support from policymakers over the middle to long term.

The above legislative vehicles include at least 1 aspect of pandemic preparedness that could have direct implications for drug and vaccine manufacturers, as well as healthcare stakeholders more broadly, summarized in Table 1. For example, proposals aimed at reinforcing domestic supply-chain resilience and regulatory innovations could raise considerations for manufacturers regarding product development, regulatory review and approval, and product distribution. Additionally, new agencies and programs could create opportunities for manufacturers to engage and collaborate with other industry and advocacy partners and deliver programs that restore vaccine confidence and rebuild public health capabilities.

Continued monitoring, proactive engagement to shape policy specifics, and assessing potential implications for life sciences companies will be critical as these proposals advance through the legislative process, particularly at this juncture where pandemic preparedness is top of mind and policymakers may have increased appetite for funding these proposals. Avalere can support life sciences companies by tracking and analyzing proposals, anticipating new developments, and advising on engagement strategy.

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