The world has been almost singularly focused on the 2019 coronavirus for more than 18 months now, but the fact remains that we still face an array of other known pathogens with pandemic potential and any number of unknown pathogens that could pose a similar risk.  These threats have periodically been an area of congressional focus since the 2009 H1N1 influenza pandemic, and most recently a bill for the Disease X Act would renew this focus and direct it at new, currently unknown viral threats.  The bill is poised to be a key piece of legislation in ongoing and future biodefense initiatives and pandemic preparedness.

In particular, the bill would provide significant funding for countermeasure development by American companies of all sizes.  As introduced, the bill would authorize appropriations of up to $2 billion for a program run through the Biomedical Advanced Research and Development Authority (“BARDA”) between fiscal years 2022 and 2025, to be awarded to American companies with research and development and manufacturing operations based in the United States.  At least a quarter of the funding would be set aside for companies with 500 or fewer employees.  The bill would authorize development funding to be awarded through grants, contracts, cooperative agreements, and/or other transactions with eligible entities, with priority given to equity and accessibility in the administration and distribution of potential countermeasures.

The proposed funding for this program is a significant addition to prior funding levels for pandemic preparedness efforts, which historically have been split among general chemical, biological, radiological, and nuclear threats (or specific threats like influenza and Ebola), and procurement of countermeasures for the Strategic National Stockpile.  As proposed, the Disease X Act would be focused solely on countermeasure  development, as opposed to procurement of existing countermeasures, and is specifically targeted toward currently unknown viral threats that could suddenly arise in the future as quickly as the 2019 coronavirus pandemic.[1]

The bill requires the Secretary of Health and Human Services and BARDA to coordinate with other agencies working in the biodefense space and the Public Health Emergency Medical Countermeasures Enterprise concerning investment strategies, diverse populations of the United States, including children and at-risk populations, and the protection of military personnel.

The Disease X Act would present a significant opportunity for industry participants engaged in biodefense research and development of countermeasures like vaccines, therapeutics, and diagnostics that respond to potential risks beyond the current coronavirus pandemic.  Platform and other “plug and play” technologies in particular may be of interest under the Act due to their ability to rapidly adapt to different circumstances.  Although the Act would represent an important step forward, Congress will also hopefully soon turn its attention to other non-viral pathogens with pandemic potential, including, for example, bacterial, parasitic, and fungal threats.

[1] The World Health Organization and U.S. Government pandemic reports have historically used terms like “Disease X” to recognize that a pathogen currently unknown to cause human disease could nevertheless cause a serious epidemic or pandemic in the future and, therefore, need to be considered in preparedness efforts.

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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch is co-chair of the firm’s Government Contracts practice group. Her practice includes a wide range of contracting issues for large and small businesses in both defense and civilian contracting. Her practice involves advising clients on contract proposal, performance, and compliance questions…

Jennifer Plitsch is co-chair of the firm’s Government Contracts practice group. Her practice includes a wide range of contracting issues for large and small businesses in both defense and civilian contracting. Her practice involves advising clients on contract proposal, performance, and compliance questions as well as transactional and legislative issues. Her practice also includes bid protest and contract claims and appeals litigation before GAO, agency boards and the federal courts. Ms. Plitsch has particular expertise in advising clients in the pharmaceutical and biologics industry. She advises a range of pharmaceutical and biologics manufacturers on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as research and development contracts and grants with various federal agencies. She also has significant experience advising on the requirements of various programs under which vaccine products and biodefense medical countermeasures are procured by the Government.

Photo of Tyler Evans Tyler Evans

Tyler Evans is a partner in the firm’s Washington, D.C. office and a member of the government contracts group.  His practice covers multiple subject-matter areas, including research and development, non-traditional contracting, intellectual property, contract negotiations, flow-down requirements, small business issues, sourcing restrictions, costs…

Tyler Evans is a partner in the firm’s Washington, D.C. office and a member of the government contracts group.  His practice covers multiple subject-matter areas, including research and development, non-traditional contracting, intellectual property, contract negotiations, flow-down requirements, small business issues, sourcing restrictions, costs, and compliance.