Members of Congress this summer ramped up bipartisan efforts with the introduction of at least eight bills that seek to help the United States prepare for and respond to pandemics and other public health emergencies.
Most recently, the Disease X Act, S. 2640, proposed on Aug. 5 by U.S. Sens. Tammy Baldwin (D-WI) and Angus King (I-ME), would establish a program for developing medical countermeasures for unknown viral threats. The bill is under consideration in the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee.
“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 Baldwin, who sponsored the bill. “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 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 U.S. 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 program, BARDA would coordinate and collaborate with agencies across the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), leveraging the expertise of officials across the government to inform a strategic approach to developing medical countermeasures.
Investment strategies across HHS and the U.S. Department of Defense would be coordinated through the PHEMCE, with HHS leading on products needed to protect the American public and DOD taking the lead on products targeted to protect military personnel. Funding would be reserved specifically for U.S. companies, with a 25 percent set aside for companies having less than 500 employees, according to the text of the bill.
The Senate HELP Committee also is considering the bipartisan Securing America’s Medicine Cabinet Act of 2021, S. 2589, introduced on Aug. 3 by U.S. Sens. Marsha Blackburn (R-TN) and Robert Menendez (D-NJ). If enacted, S. 2589 would permit the designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, according to the text of the bill.
Such centers would develop the chemical methods and train the necessary workforce to bring pharmaceutical manufacturing back to the U.S. to help secure a vital supply chain and reduce America’s dependence on China for pharmaceutical manufacturing, according to Blackburn.
“The ongoing COVID-19 pandemic has demonstrated the importance of investing and supporting biomedical research and innovation as a means for preparing and responding to any national health crisis,” added Menendez, who said the bill also would encourage drug manufacturers to foster partnerships with higher education to promote medical manufacturing innovation.
“As we develop new drugs and treatments, it is imperative we also ensure next-generation production of life-saving vaccines and drugs occurs here” in America, Menendez said. “We must ensure that more states like New Jersey, a leader in the life sciences industry and higher learning, have the tools they need to enhance existing synergies for medical research, innovation, and manufacturing.”
A related bipartisan bill introduced on July 16 by U.S. Reps. Carolyn Maloney (D-NY) and James Comer (R-KY), the bipartisan Made in America Pandemic Preparedness Act, H.R. 4470, would ensure the availability of personal protective equipment (PPE) during pandemics and other public health emergencies through stockpile requirements and domestic manufacturing incentives.
Specifically, H.R. 4470 would ensure that all PPE procured for the Strategic National Stockpile is produced in America and that a biannual report would be issued by the director of the Office of Management and Budget and the HHS Secretary to Congress that includes information on the state of PPE inventory in the Strategic National Stockpile; the state of PPE inventory in stockpiles of other federal agencies; and estimates of the quantities of PPE that would be required for an array of possible emergencies, including a pandemic or other federally declared emergency, according to the text of the bill.
H.R. 4470 is under consideration in both the House Ways and Means Committee and the House Oversight and Reform Committee.
On July 29, the bipartisan, bicameral Border Health Security Act of 2021, H.R. 4812 / S. 2570, was unveiled by U.S. Reps. Veronica Escobar (D-TX) and Tony Gonzalez (R-TX) in their chamber, and by U.S. Sens. Ben Ray Luján (D-NM) and Martin Heinrich (D-NM) in the U.S. Senate.
If enacted, the proposed measure would establish grant programs to improve the health of residents along the United States-Mexico and U.S.-Canada borders, and for all hazards preparedness in the border areas, including bioterrorism, infectious diseases, and other emerging biothreats.
“Diseases don’t recognize international borders,” Gonzalez said. “The COVID-19 pandemic has demonstrated that North American cooperation and coordination is vital to protect the people of the United States, Canada, and Mexico. This bill is critical to south Texas’ and the entire continent’s ability to prepare for, respond to and confront emerging health threats.”
H.R. 4812 has been referred to both the House Energy and Commerce and House Foreign Affairs Committees for consideration. S. 2570 is being reviewed by members of the U.S. Senate Foreign Relations Committee.
Also introduced in July and under consideration in the Senate HELP Committee is the bipartisan Public Health Emergency Response and Accountability Act, S. 2467, which was offered by U.S. Sens. Bill Cassidy (R-LA) and Brian Schatz (D-HI) to create a permanent fund that would allow a quick and effective response to future public health emergencies.
“We may not know when the next infectious disease outbreak will happen, but we can be better prepared,” Cassidy said. “This bill provides immediate funding and takes lessons learned from COVID-19 to quickly and effectively respond to future public health emergencies.”
If enacted, S. 2467 specifically would provide automatic funding for the existing Public Health Emergency Fund in section 319 of the Public Health Service Act based on a formula similar to the budget authority provided for FEMA, according to a bill summary provided by Cassidy’s staff.
The funds would be available for response after a public health emergency regarding an infectious disease, bioterrorist attack, or disaster that is declared by the HHS Secretary, thereby guaranteeing that the money would be used “to address truly imminent threats to public health,” said Cassidy.
Additionally, the bill includes safeguards to ensure funds are spent according to best practices learned from previous responses to public health emergencies, appropriated based on historic needs, and properly accounted for through robust accountability and oversight mechanisms for expended funds, the summary says.
The funds also would carry emergency authorities to the agencies that use them, including transfer authority, flexible hiring, exemption from certain administration restrictions, and flexible contracting authorities to enable a timely response to the threat.
Also this summer, the bipartisan COVID-19 and Pandemic Response Centers of Excellence Act of 2021, H.R. 4292 / S. 2307, was introduced on June 30 by U.S. Reps. John Katko (R-NY) and Nydia Velázquez (D-NY), and on July 12 by U.S. Sens. Cassidy and Kristen Gillibrand (D-NY). The House version is under consideration in the Energy and Commerce Committee, while the Senate HELP Committee is reviewing the Senate bill.
“More than a year has passed since the pandemic began, and we still have many unanswered questions,” Katko said. “This bipartisan and bicameral bill will support our local medical centers by funding additional research to provide us with a better understanding of COVID-19 variants, the impacts this virus has on our health, and how to better prepare for future public health emergencies.”
According to the text of the bill, not later than 90 days after the date of enactment, the HHS Secretary would award grants, contracts, or cooperative agreements to academic medical centers to establish or continue support of not less than 10 centers of excellence that would address issues associated with COVID–19, including future pandemic preparedness and response.
The COVID-19 and Pandemic Response Centers of Excellence Act would authorize federal funds specifically to academic medical centers that have demonstrated a high level of expertise in COVID-19 research.
“Medical centers like SUNY Upstate Medical University and the University of Rochester have been at the forefront of our pandemic response and recovery efforts,” Katko said. “The critical research being done by our academic medical centers has not only informed public health guidance to keep us safe but also advanced several life-saving medical breakthroughs.”
On June 24, the U.S. Senate Foreign Relations Committee received the bipartisan International Pandemic Preparedness and COVID-19 Response Act, S. 2297, for consideration.
Introduced by U.S. Sen. James Risch (R-ID) and Sen. Menendez, S. 2297 aims to improve global health and pandemic preparedness and enhance COVID-19 response efforts via a detailed strategy that includes having the U.S. join global efforts to develop vaccines for epidemic diseases and by authorizing funding for the Coalition for Epidemic Preparedness Innovations (CEPI), a public-private partnership focused on developing vaccines for highly infectious pathogens.
“As COVID-19 continues to surge across the globe, we are coming together in recognition that the novel coronavirus will continue to pose a real threat to American lives and livelihoods as long as it persists anywhere in the world,” said Menendez. “The United States must lead an international response.”
If enacted, S. 2297 would also call for global vaccine distribution to ensure access to countries most in need and for leveraging other global health programs to help bolster international COVID-19 response, according to a bill summary provided by the senators.
Additionally, S. 2297 would require the president to advance the strategy with clear goals, objectives, and lines of responsibility to better guide U.S. investments in global health security, eliminate duplication and waste, and enable partner countries to close capacity gaps. The president also would be encouraged to establish a Committee on Global Health Security and Pandemic and Biological Threats at the National Security Council to ensure policy coherence and continuity of effort across the agencies engaged in international and domestic prevention, preparedness, and response, the summary says.
At the same time, a special representative for global health security and diplomacy would be established at the U.S. State Department who would be supported by a deputy at the United States Agency for International Development (USAID) to lead diplomatic efforts and ensure the efficient and effective execution of U.S. foreign policy and assistance for global health security.
“Our legislation will help to identify and close gaps in global health security that make us vulnerable to outbreaks, improve the coordination of U.S. global health diplomacy and assistance efforts, establish effective and transparent international early warning systems, and create an accountable, international incentive fund to advance global health security and pandemic prevention and preparedness,” said Sen. Risch. “With all of these tools, we should be better prepared to prevent, detect, and respond to future infectious disease threats.”
Another bill related to CEPI in July received approval from the U.S. House of Representatives. The bipartisan Securing America from Epidemics (SAFE) Act, H.R. 2118, which was introduced in March by U.S. Reps. Ami Bera (D-CA) and Brian Fitzpatrick (R-PA), would authorize U.S. participation in CEPI.
“We have seen firsthand the widespread, devastating effects of a global pandemic on our health, economy, and national security this past year,” Fitzpatrick said. “Unfortunately, this will not be the last contagious and deadly virus our world will battle and confront, which is why it is of the utmost importance that our country continues to be a leader in global health.”
H.R. 2118 is now under consideration in the U.S. Senate.