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Baldwin Introduces Disease X Act to Respond to Future Viral Outbreaks

The bill would provide $2 billion to BARDA over four years to help better prepare against unknown threats

Washington, D.C. – Today, U.S. Senator Tammy Baldwin introduced the Disease X Act, to allow the United States to prepare for the future, and work to rapidly develop the necessary medical countermeasures to combat future pandemics. The COVID-19 pandemic has laid bare the devastating domestic and international consequences that deadly infectious disease epidemics can cause. However, there is no sustained funding, program or strategy dedicated to accelerating the development of medical countermeasures for previously unidentified infectious disease threats.

“Infectious disease outbreaks now occur three times more often than they did 40 years ago. The next pandemic, driven by an unknown Disease X, will come,” said Senator Baldwin. “We should not be waiting for the next viral threat to emerge. We must invest in the development of novel antivirals, vaccines, and diagnostics for unknown threats now so that we are better prepared to control the spread than we were at the start of the COVID-19 pandemic.”

“The profound effects of this pandemic should galvanize members of Congress to do everything in their power to prevent a global pandemic like COVID-19, or worse, from happening again and to be better prepared if it does,” said Anita Cicero, Deputy Director of the Johns Hopkins Center for Health Security. “Senator Baldwin’s legislation to establish a dedicated ‘Disease X’ medical countermeasure program will enable the U.S. to rapidly develop drugs, diagnostics, and vaccines against unknown viral threats in order to save lives and safeguard the economy in future events.”

“The Disease X Act introduced by Senator Baldwin at the HELP committee hearing, coordinating the federal agencies to fund disease preparedness efforts is a significant and necessary step to enable the discovery and development of essential therapeutics, vaccines and diagnostics to address future emergent infectious agents with pandemic potential,” said Kara Carter, President of the International Society for Antiviral Research.

“The COVID19 pandemic has taught us that we must be ever vigilant against unexpected infectious diseases that threaten the health and lives of Americans and the world,” said Paul V Radspinner, President & CEO of FluGen Inc. “Senator Baldwin’s bold Disease X Act is exactly the kind of initiative that will promote the public-private partnerships that made this year’s vaccines available in record time. FluGen is especially encouraged that the Act focuses on American companies both large and small.”

“Infectious diseases physicians are on the frontlines of the COVID-19 response and have seen firsthand the critical importance of therapeutics, diagnostics and vaccines to save lives,” said Barbara D. Alexander, President of the Infectious Diseases Society of America and Professor of Medicine and Pathology at Duke University School of Medicine. “The Infectious Diseases Society of America (IDSA) supports Senator Baldwin’s legislation to strengthen our preparedness by promoting rapid development of these medical countermeasures for future viral threats, with a focus on simple distribution and administration to facilitate equitable access for patients.”

“The Disease X Act introduced by U.S. Senator Tammy Baldwin, will enable our country to have a jump start to prepare for future pandemics,” said Bill Jackson and Attilio DiFiore, Co-Founders of Attwill Medical Solutions. “We have been vulnerable for quite some time from the threats of viral and bacterial infections, but the innovative approach that Senator Baldwin is undertaking will simply spur advancement in countermeasures, secure the domestic supply chain, and most importantly, save lives both domestically and abroad. This bill also secures the ability for small and medium sized companies to develop life-saving therapeutics, which will create a level playing field in innovation for the benefit of the American public. Attwill Medical Solutions/Attwill Vascular Technologies is proud to endorse the Disease X Act and urge the Senator’s colleagues to both co-sponsor and vote for this essential piece of legislation.”

The Disease X Act would provide $500 million per year for four years, starting in Fiscal Year 2022, for the Biomedical Advanced Research and Development Authority (BARDA) at the Department of Health and Human Services (HHS) for a Disease X Medical Countermeasures Program aimed at developing responses to unknown viral threats.

  • To establish the Disease X medical countermeasures program, BARDA would coordinate and collaborate with relevant agencies across the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), leveraging the expertise of officials across the government to inform a strategic approach to MCM development.
  • HHS and DOD investment strategies would be coordinated through the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), with HHS leading on products needed to protect the diverse American public, including children and other at-risk populations, and DOD taking the lead on products targeted to protect military personnel.
  • Equity and accessibility, including ease of administration and distribution, would be top priorities in the development of MCMs under the Disease X program.
  • Funding would be specifically for American companies, with a 25 percent set aside for companies with less than 500 employees.

While it is not possible to identify exactly which virus may cause the next pandemic, certain viral families possess the attributes most likely to lead to large scale outbreaks. This knowledge can be used as a guide, and aligns with priorities already outlined by the Biden Administration—which recently announced a $3.2 billion plan to jump-start antiviral research to develop new drugs and test whether existing drugs show promise against the novel coronavirus.

Senator Baldwin has been focused on preparedness since the start of the COVID-19 pandemic. Early on, she championed additional funding for the CDC to track variants and was able to secure a $1.7 billion investment in the American Rescue Plan. As the Delta variant spreads rapidly across the country, she’s continued to work closely with a lab in Madison, Wisconsin that has been conducting genomic surveillance sequencing.

The Disease X Act is supported by the Johns Hopkins Center for Health Security; Infectious Diseases Society of America; FluGen; AttWill Medical Solutions; International Society for Antiviral Research.

The full text of the bill can be found here