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Saturday, November 30th, 2024

Stakeholders commend approval by Congress of pandemic preparedness, response bill

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The Blue Ribbon Study Panel on Biodefense, the Alliance for Biosecurity, and the Trust for America’s Health on Wednesday applauded the overdue reauthorization of the nation’s all-hazards preparedness and response law addressing public health threats, whether naturally occurring or man-made.

The U.S. House of Representatives on Tuesday afternoon voted to approve the Pandemic and All-Hazards Preparedness and Advancing (PAHPA) Innovation Act of 2019, S. 1379, and now that both chambers of Congress have passed the bill, it heads to the president’s desk to be signed into law.

The current law expired on Sept. 30, 2018.

“Naturally occurring diseases and biological weapons continue to endanger our nation,” said former Pennsylvania Gov. Tom Ridge, co-chairman of the Blue Ribbon Study Panel on Biodefense. “The panel is pleased to see that Congress addressed 15 of our recommendations in this legislation, which will help the nation better prepare for, detect, respond to, and recover from large-scale biological events, bioterrorism or other biological events.”

S. 1379, sponsored by U.S. Sen. Richard Burr (R-NC) on May 8, aims to bolster the nation’s health security strategy, strengthen the country’s emergency response workforce, prioritize a threat-based approach, and increase research and development of medical countermeasures (MCMs), among numerous provisions contained in the comprehensive bill.

Many of the provisions contained in S. 1379, in fact, harken to the Blue Ribbon Study Panel’s 2015 report, A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts, which recommended changes to U.S. policy and law to improve national biodefense and maximize resource investments.

“The passage of this broad legislation builds on important progress Congress has been making in addressing concerns detailed in our initial blueprint,” said former U.S. Sen. Joseph Lieberman, the panel’s co-chairman with Ridge. “Along with the inclusion of three panel recommendations in last year’s Farm Bill, Congress is demonstrating just how seriously it takes the biological threat and the recommendations that could help the public if a large-scale outbreak occurs.”

For example, S. 1379 directs the U.S. Department of Health and Human Services to establish guidelines and a corresponding pilot project for regional systems of hospitals and health care facilities, which corresponds with the panel’s Recommendation 21 in its 2015 blueprint.

Other panel blueprint recommendations that made it into the approved S. 1379 include the development of a national strategy to address cyber threats to public health security (Recommendation 24); streamlining the use of flexible contracting authorities by the Biomedical Advanced Research and Development Authority, or BARDA, (Recommendation 29); and coordination between the U.S. Department of Defense and Department of Homeland Security to report on biological detection technology and information sharing (Recommendation 31), among others.

Passage of the legislation also was a top recommendation in the recent report, Ready or Not: Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism, published by the Trust for America’s Health (TFAH).

“The Pandemic and All-Hazards Preparedness and Advancing Innovation Act shows that we are learning the lessons from recent disasters and disease outbreaks and addressing ongoing challenges,” said John Auerbach, president and chief executive officer of TFAH.

For instance, it took about nine months during the Zika outbreak for the federal government to approve emergency supplemental funding, Auerbach said, adding that recent severe weather also showed that the United States still isn’t prepared for a “worst-case scenario event.”

“In this legislation, lawmakers try to address some of the gaps that these events exposed,” he said on Wednesday. “The bill makes it easier to get money out more efficiently to address a public health emergency.”

S. 1379 also codifies the roles of federal agencies in managing preparedness programs and seeks to ensure that grant awardees consistently improve their performance, said Auerbach.

Additionally, the legislation supports outbreak detection through workforce and strategy enhancements; reauthorizes programs for research, development and stockpiling of MCMs, and will help speed the capability to deploy such products, he added.

“The fact that Congress passed this bill is acknowledgement that health security is national security,” Auerbach said. “Now, we call on Congress to give this legislation the teeth it needs by providing adequate funding for these critical public health programs.”

Chris Frech and Brent MacGregor, co-chairmen of the Alliance for Biosecurity, also heralded federal lawmakers’ commitment to strengthening the nation’s preparedness and response capabilities.

“PAHPA enables long-term public-private partnerships, which are essential in safeguarding public health and building resilience against chemical and biological threats and emerging infectious diseases,” said Frech, who is also senior vice president of global government affairs for Emergent BioSolutions. “We, as an industry, look forward to continuing to support the government’s national security strategy.”

Emergent BioSolutions, a global biopharmaceutical company that develops, manufactures and delivers a portfolio of MCMs for biological and chemical threats, as well as emerging infectious diseases, has been in several long-term and ongoing contracts with the government.

The same is true for Seqirus, where MacGregor is senior vice president of commercial operations. The global influenza vaccine company has manufacturing and R&D hubs across three continents, an internationally integrated supply chain, and a commercial presence in more than 20 countries.
MacGregor said passage of S. 1379 “marks a critical milestone” for such public-private partnerships to protect Americans against a new influenza pandemic threat.

For instance, section 404 of the legislation addresses preparations for pandemic influenza, antimicrobial resistance, and other significant threats, according to the text of the bill, and through BARDA, a variety of strategic initiatives may be implemented, including for “threats that consistently exist or continually circulate and have a significant potential to become a pandemic,” like the flu.

Countering such threats may entail development of processes to support the advanced R&D of countermeasures that include vaccines, multi-use platform technologies for diagnostics, therapeutics, virus seeds, and clinical trials, among others, according to the bill.

“We are proud to stand on the front line with our partners to provide rapid access to life-saving influenza pandemic vaccines,” said MacGregor.