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 leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She…

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

  • the Department of Veterans Affairs (VA);
  • the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
  • the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
    the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.