[Senate Hearing 117-198]
[From the U.S. Government Publishing Office]


                                                       S. Hrg. 117-198

                           THE PATH FORWARD:
                      BUILDING ON LESSONS LEARNED
                       FROM THE COVID	19 PANDEMIC

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             FIRST SESSION

                                   ON

   EXAMINING BUILDING ON LESSONS LEARNED FROM THE COVID-19 PANDEMIC, 
                      FOCUSING ON THE PATH FORWARD

                               __________

                             JULY 27, 2021

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
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                               __________

                                
                    U.S. GOVERNMENT PUBLISHING OFFICE                    
46-778 PDF                  WASHINGTON : 2023                    
          
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                    PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont          RICHARD BURR, North Carolina, 
ROBERT P. CASEY, JR., Pennsylvania       Ranking Member
TAMMY BALDWIN, Wisconsin             RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut   SUSAN M. COLLINS, Maine
TIM KAINE, Virginia                  BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire         LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota                MIKE BRAUN, Indiana
JACKY ROSEN, Nevada                  ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico            TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado          MITT ROMNEY, Utah
                                     TOMMY TUBERVILLE, Alabama
                                     JERRY MORAN, Kansas

                     Evan T. Schatz, Staff Director
               David P. Cleary, Republican Staff Director
                  John Righter, Deputy Staff Director
                           
                           
                           C O N T E N T S

                              ----------                              

                               STATEMENTS

                         TUESDAY, JULY 27, 2021

                                                                   Page

                           Committee Members

Murray, Hon. Patty, Chair, Committee on Health, Education, Labor, 
  and Pensions, Opening statement................................     1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State 
  of North Carolina, Opening statement...........................     3

                               Witnesses

Becker, Les, Deputy Secretary of Innovation, Washington State 
  Department of Health, Olympia, WA..............................     7
    Prepared statement...........................................     8
    Summary statement............................................    16
Arthur, Phyllis, Vice President, Infectious Diseases and 
  Diagnostics Policy, Biotechnology Innovation Organization, 
  Washington, DC.................................................    17
    Prepared statement...........................................    18
Janz, David, M.D., Director, Medical Critical Care Services, 
  University Medical Center New Orleans, New Orleans, LA.........    27
    Prepared statement...........................................    29
    Summary statement............................................    34
Cicero, Anita, Deputy Director, Center for Health Security, Johns 
  Hopkins Bloomberg School of Public Health, Baltimore, MD.......    35
    Prepared statement...........................................    37
    Summary statement............................................    40

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
    S. 1543 STANDUP Act..........................................    67
    STANDUP ACT section-by-section...............................    75
    The Suicide Prevention Lifeline Improvement Act redline to 
      current law................................................    77
    S.2425.......................................................    79

                         QUESTIONS AND ANSWERS

Response by Les Becker to questions of:
    Senator Braun................................................    89
Response by Phyllis Arthur to questions of:
    Senator Braun................................................    92
Response by Anita Cicero to questions of:
    Senator Rosen................................................    92
Response by David Janz, M.D., to questions of:
    Senator Rosen................................................    93
    Senator Braun................................................    94

 
                           THE PATH FORWARD:
                      BUILDING ON LESSONS LEARNED
                       FROM THE COVID-19 PANDEMIC

                              ----------                              


                         Tuesday, July 27, 2021

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10 a.m., in room 
430, Dirksen Senate Office Building, Hon. Patty Murray, Chair 
of the Committee, presiding.
    Present: Senators Murray, Casey, Baldwin, Murphy, Kaine, 
Smith, Rosen, Lujan, Hickenlooper, Burr, Cassidy, Braun, 
Marshall, Scott, Romney, and Tuberville.

                  OPENING STATEMENT OF SENATOR MURRAY

    The Chair. Good morning. The Senate Health, Education, 
Labor, and Pensions Committee will please come to order. Today, 
we are holding a hearing on lessons learned from the COVID-19 
pandemic and how we make sure we are never in this situation 
again. Ranking Member Burr and I will each have an opening 
statement, then we will introduce our witnesses. And after they 
give their testimony, Senators will each have 5 minutes for a 
round of questions. While we are unable to have the hearing 
fully open to the public or media for in-person attendance, 
live video is available on our Committee website at 
help.senate.gov. And if anyone is in need of accommodations, 
including closed captioning, please reach out to the Committee 
or the Office of Congressional Accessibility Services.
    Before I begin my opening remarks, I do just want to 
personally comment on our loss in the Senate of former Senator 
Mike Enzi. He sat in this seat. I had the opportunity to work 
with him many times, especially on workforce issues. He chaired 
the Budget Committee. He was always--believed in his 
philosophy, which is everyone is right, but he was 
accommodating, he was a listener, and I know I speak on behalf 
of all my Democratic colleagues, and I am sure my Republican 
colleagues as well, that our thoughts and prayers are with his 
family today.
    Earlier this year, Patti Hayes, who is the Director of 
Public Health for Seattle and King County, reflected on the 
pandemic and noted one of the big things that the entire 
country realized, that if you allow your public health 
infrastructure to be dismantled, then when you have an 
emergency of this sort, it is not ready to handle it. And she 
is right. I have been pushing for greater investments in public 
health for years because even before this pandemic, the 
diminished state of our public health infrastructure was 
incredibly alarming. Since 2010, spending for state public 
health departments has dropped by 16 percent and spending for 
local health departments by 18 percent. In 2019, less than half 
of our state spent even $40 per person on public health, with 
only a few states spending over $100 per person.
    Even though our health care spending was over $11,000 per 
person nationwide, local and state health departments have lost 
nearly a quarter of their workforce since 2008. In other words, 
before the pandemic struck, public health departments across 
the country were woefully understaffed and underfunded, and our 
Nation was unprepared. How are we supposed to test for diseases 
like COVID-19 and sequence four new variants without modernized 
data systems and adequate lab capacity? How are health 
departments supposed to do contract tracing when a single case 
can have over 70 contacts? But a city like Detroit, with 
670,000 people, has only 200 workers in its public health 
department. How are we supposed to track disparities when we 
don't have a consistent, standardized way of reporting the data 
we get?
    When Federal data doesn't often accurately identify some 
communities like Pacific Islanders, beyond inequities, how are 
we supposed to track cases at all when data is coming into 
health departments by fax, thousands of printed pages at a 
time? Last July, in my home State of Washington, we brought in 
members of the National Guard just to help manually enter data 
from tests that weren't reported electronically. And then 
beyond the challenge of getting all that crucial data, how are 
we supposed to make good use of that data to fight public 
health threats when only 28 percent of local health departments 
have an epidemiologist or statistician?
    How are our communities supposed to get clear, science 
based guidance on public health issues, coordinate vaccination 
efforts to reach our most distant and vulnerable communities, 
or fight a deluge of misinformation about safe, effective 
vaccines when only half of all people in this country are 
served by a comprehensive public health system? We have to end 
the cycle of crisis and complacency in public health that led 
us here.
    As a public health leader in Kansas put it, we don't say to 
the fire department, oh, I am sorry, there were no fires last 
year, so we are going to take 30 percent of your budget away. 
And we shouldn't be doing that to public health either. We need 
to dramatically rebuild our public health infrastructure and we 
need to build it to last. We need to invest in modern 
technology in our health departments and hospitals. We need to 
invest in addressing inequities and making sure our data 
includes everyone, our vaccines reach everyone, and our health 
departments are building trust in communities of color, which 
we know are often hit the hardest when disaster strikes. And to 
do all this, we also desperately need more people like Patti 
Hayes. However, as Hayes retired from the health department 
this May, she is not alone.
    A survey taken before the pandemic showed nearly half of 
public health workers were considering retiring in the next 5 
years. That is why it is so critical we take steps to build our 
public health workforce, including steps to help address the 
reality that outside of big cities, more than a fifth of local 
public health workers earn less than $35,000 a year. In her 
comments earlier this year, Ms. Hayes went on to say, and I 
quote, ``I am hoping that the wisdom will prevail to really 
invest in the core public health infrastructure so that we are 
faster, better coordinated, and ready for the next thing.'' I 
am hoping for that, too, and I am pushing as hard as I can to 
make it happen, which is why I introduced the Public Health 
Infrastructure Saves Lives Act so we can finally end the cycle 
of crisis and complacency in public health funding. It is why I 
have been pushing so hard for Congress to invest in public 
health in our COVID response bills. And that is why I have been 
pushing for bipartisan work to reflect lessons learned from 
this pandemic.
    Of course, while the value of strong public health 
infrastructure may be the most important lesson we have to 
learn from this pandemic, there are many others we should be 
addressing as well, like the need to address supply chain 
disruptions, improve our stockpile of critical medical 
supplies, improve health equity, fight misinformation, prevent 
hospitals from being overwhelmed, and support and expand our 
health care and public health workforce. Additionally, Congress 
should enact an independent, comprehensive assessment of our 
Nation's COVID-19 response to make sure we have a full 
accounting of this chapter in our history and never repeat it.
    I know that is a goal that we all share, and I look forward 
to hearing from our all of our witnesses today. Thank you all 
so much for being here today. We look forward to your 
testimony. We look forward to learning what we can learn from 
this pandemic. And we will work with colleagues on both sides 
of the aisle to act on those lessons. With that, I will turn it 
over to Ranking Member Burr.

                   OPENING STATEMENT OF SENATOR BURR

    Senator Burr. Thank you, Madam Chair. Welcome to our 
witnesses today. I would also like to take a minute at the 
beginning to talk about our former colleague, Mike Enzi. 
Michael is a good friend. He is a great Senator. Mike was 
Chairman of this Committee and Ted Kennedy was the Ranking 
Member at the time, and I think Ted Kennedy taught Mike a 
really important thing, it is called the 80-20 rule, that this 
Committee can find 80 percent that we can agree on, and we can 
agree that 20 percent of it we will never find a solution to.
    Mike and I work together on many bills, especially with our 
good friend Tom Coburn, when Tom was alive. We worked on Ryan 
White program that helped provide affordable treatment to 
America's HIV and AIDS patients. He was a leader on protecting 
Americans from discrimination based upon their genetics in the 
GINA Act. He was a leader and a partner in pandemic 
preparedness.
    He was a thought leader with biology--with biologics 
legislation that created biosimilars--a biosimilar pathway at 
the FDA, which has allowed more drugs to be available that cure 
cancer, breast cancer, lymphoma, Crohn's disease, and many 
other things on the horizon. Most importantly, Mike was a good 
friend. He was a loving husband, and he was a devoted 
grandfather. Not only will we miss him, but his family misses 
him today. I urge my colleagues to keep he and Diane in your 
prayers.
    Madam Chair, I thank you for holding this hearing today. 
Even before the first case was identified in America, this 
Committee had been extremely dedicated in a bipartisan manner 
to understanding the impact of the COVID pandemic. Just last 
week, we heard from our Federal response team about the ongoing 
outbreak and what our next round of challenges may be. I am 
particularly looking forward to today's hearing because we are 
focused on this question, where do we go from here? I have 
worked on preparedness issues for as long a time and can see 
pretty clearly where some of our Country's vulnerabilities lie.
    My first priority is no secret. The CDC is desperately in 
need of reform. Primary reform CDC needs is to its culture. It 
is critical that CDC engage with the private sector, with 
academia, and integrate new technologies to keep the American 
people safe from 21st century public health threats. The 
culture change is always the most difficult, but it is 
possible. I know it because I have accomplished it. I went 
through it in 1997 with the FDA. The culture reform over 20 
years ago and other laws along the way gave the agencies the 
tools it needed to quickly respond and fight COVID.
    The FDA was a shining success, vaccines, treatments, and 
tests approved in record time while maintaining the gold 
standard of safety and efficacy over the last year. The 
Committee's learned that the CDC, one, did not have the 
surveillance tools in place to track the spread of the virus in 
near real time. Two, and had not hired the experts to meet its 
bio-surveillance mission despite congressional authority to do 
so. Three, experienced massive and systematic failures in 
deploying tests to public health labs, which delayed our 
testing in critical early days of the response and cost lives. 
Four, poorly communicated with Americans and was too often two 
steps behind the science.
    Last, its leadership is reluctant to meet with innovators 
raising their hands to say I want to help. While I am critical 
of the CDC, it is because I believe that we have a 
responsibility to protect the public health, and I want to help 
the CDC do it better. As a result of COVID-19, the agency has 
new resources and new tools to be the world's premier public 
health agency once again.
    We need to make sure they know what their mission is and 
focus the CDC on the right priorities. Business as usual has to 
be over. I am looking forward to hearing from our witnesses 
today on this extremely important task. We all witnessed the 
breaks in our medical supply chain during COVID-19. Our just in 
time inventory system that supported our health care providers 
were overwhelmed in the early days of the response. I have no 
doubt that every Member of this Committee received the same 
heartbreaking calls I did from their hospitals, brave, tired 
frontline workers asking for help that we could provide to get 
mask, gowns, and other medical supplies.
    I have mentioned in previous hearings the need to closely 
examine the effects of the pandemic that we did not anticipate, 
and our supply chain is the best example. Who would have 
expected companies like Heinz in my state to make masks or for 
Merck to offer their durum manufacturing facility to another 
drug company to make their vaccine? The efforts of the private 
sector to meet the demands was truly unprecedented.
    As the Federal Government, our ability to affect the supply 
chain for medical supplies, however, is limited. The Federal 
Government is just 4 percent of the purchases of PPE. The other 
96 percent belongs to the private sector, who have far greater 
capabilities to increase our preparedness if leveraged 
appropriately. Our reforms need to focus on sustainable 
policies that endure after the attention of this response 
fades. When we designed the stockpile, it was a bioterror event 
in mind.
    The stockpile should serve as a bridge for acute time, 
limited events, not as the primary source for surge level 
medical needs. It houses our countermeasures for Ebola, 
anthrax, and smallpox. But we never maintain the level of PPE 
and ancillary medical supplies that we have purchased for COVID 
in the long term. And that was never the goal of the stockpile. 
As the author of BARDA and a big fan of Project Bioshield, I 
remember how we had to fight for every bit of funding for these 
programs during peacetime. Remember that Bob? We cannot put our 
simple supply chain needs in the same position.
    We need to keep the private sector nimble and creative at 
meeting demands and to retain the market incentives, not 
Government commands. With COVID-19, we had no choice but to 
innovate. There were no shelf-ready tests, treatments, or 
vaccines. There was no humming manufacturing line capable of 
making vaccines to combat this novel virus. Even with our 
investments over the years in BARDA, the ASPR, and the 
stockpile, we need lead-time.
    A clear gap in our readiness capability is the work on the 
front end for countermeasures. Early stage discovery like what 
occurred through NIH and BARDA's RADx initiative, and NIH's 
newly announced AVID Program, will help build our library of 
medical platforms and technologies that we can pull off the 
shelf when the next novel pathogen arrives on our doorstep. But 
these programs need partners. And the engagement of academia 
alongside the private sector can produce the innovative 
products we need to be ahead of the curve. Once we develop the 
countermeasures, we also need to manufacture them at scale, 
which will depend on private sector partners to once again rise 
to the challenge.
    The FDA is a key partner in this enterprise and was 
prepared with the tools needed to truly rise to the challenge 
facing COVID. FDA has reviewed and authorized almost 400 tests, 
11 therapeutics, and 3 vaccines for emergency use that have 
changed the trajectory of COVID-19 pandemic. Two of the 
vaccines depend on a brand new platform. In fact, many of the 
countermeasures used to tackle COVID-19 use platform based 
technologies. Most of these countermeasures were developed for 
COVID-19 in less than 1 year, a process that usually takes more 
than three times that amount of time. The agency's actions 
helped speed deployment of needed medicines, send signals to 
innovators that FDA can be more nimble, more approachable and 
more efficient in its ability to bring new hope to all 
America's patients, not just in response to COVID. But it 
doesn't stop once these products are authorized.
    We need to get them in the hands of doctors and nurses to 
help patients just as urgently today to address the delta 
variant as we did previously in this response. Senator Murray 
and I know our priorities are big undertakings. The lessons we 
have learned from this pandemic and the solutions at hand will 
likely be different for each state, locality, and community. 
The HELP Committee has a long bipartisan history of putting in 
the work to bring together the right answers to solve problems 
facing Americans.
    Our goal is to provide a targeted legislative response this 
fall to the biggest gaps in our preparedness architecture. To 
our witnesses today, your part--you are a very important part 
of that process. Your testimony can help us understand where 
you all witnessed the biggest gaps in our preparedness and 
response framework, and how best to address these gaps so that 
we can leave our framework better prepared than in fact we 
found it. With that, I thank the Chair and I yield back.
    The Chair. Thank you, Senator Burr. Again, welcome to all 
of our witnesses. We will now introduce them. Our first witness 
is Mr. Les Becker. He is the Deputy Secretary of Innovation at 
Washington State Department of Health. His work leading the 
Department's first ever Office of Innovation and Technology 
includes overseeing data, informatics, and health technology.
    Before joining us in Washington State, Mr. Becker worked on 
public health in Harris County, Texas, leading the county's 
nationally acclaimed Public Health Innovation Lab. Mr. Becker, 
thank you for being here with us today. Next, I would like to 
introduce Ms. Phyllis Arthur, Vice President of Infectious 
Diseases and Diagnostics Policy at the Biotechnology Innovation 
Organization, or BIO for short. Ms. Arthur first joined BIO 
back in July 2009 as Director of Health Care Regulatory 
Affairs.
    In her role at the organization, she works with member 
companies in the areas of vaccines, molecular diagnostics, and 
biodefense. Prior to joining BIO, she worked for Merck in their 
vaccine division. Ms. Arthur, thank you for joining us. I look 
forward to your testimony. Dr. Janz is our next witness. He 
will be introduced by Senator Cassidy.
    Senator Cassidy. I think this is the fourth person I have 
had the privilege to introduce to whom I lectured on diarrhea 
and hepatitis. So it is--I was famous for that lecture--
lectures. But anyway, I had the privilege of representing Dr. 
David Janz, who is the Director of Medical Critical Care 
Services at University Medical Center in New Orleans. And Dr. 
Janz has seen firsthand what works and does not work in the 
COVID-19 pandemic response.
    On the front line, he helped direct the response--remember, 
New Orleans was terribly one of the first places that was hit 
right after Mardi Gras, where presumably it was introduced. And 
so as New York was higher in profile, we were also having our 
troubles. And Dr. Janz on the front line helped direct the 
response at the medical center and across Louisiana, hosting 
regular conference calls, updating colleagues on best 
practices. He continues to help coordinate Louisiana's 
statewide critical care response as a member of the Louisiana 
Department of Health Critical Care Task Force.
    With Dr. Janz, the Critical Care Task Force has developed 
easy to use patient care tools and operational solutions for 
hospitals across Louisiana. These have later been rolled out 
nationally, helping hospitals across the country fight the 
pandemic. Before the pandemic, Dr. Janz started with a medical 
degree from LSU School of Medicine and Internal Medicine 
Residency Critical Care Fellowship and Master of Science and 
Clinical Investigations at Vanderbilt.
    As we, elected officials, weigh the economic, social, and 
physical health impacts of proposed policies, it is valuable to 
hear from medical experts. I look forward to Dr. Janz's 
testimony. And with that, I yield.
    The Chair. Thank you, Dr. Janz. Welcome to you. Our final 
witness today is Anita Cicero. She is the Deputy Director of 
the Center for Health Security at the Johns Hopkins Bloomberg 
School of Public Health. As Deputy Director, Ms. Cicero has 
expanded the Center's efforts in epidemic preparedness, global 
biological risk issues, and international biosecurity.
    She also currently chairs multiple World Health 
Organization working groups on research and has 30 years of 
experience as a health lawyer. Ms. Cicero, thank you for 
joining us today. I am pleased to have you as well. With that, 
we will begin our witness testimony. And Mr. Becker, we will 
begin with you.

   STATEMENT OF LES BECKER, DEPUTY SECRETARY OF INNOVATION, 
       WASHINGTON STATE DEPARTMENT OF HEALTH, OLYMPIA, WA

    Mr. Becker. Good morning, Chair Murray, Ranking Member 
Burr, and Members of the Committee. Thank you for your 
leadership and inviting me to testify today to share lessons 
learned from COVID-19. Let me start by acknowledging that this 
pandemic is far from over. When my boss, Dr. Shah, Washington 
State Secretary of Health testified to this Committee in March, 
he noted 500,000 Americans have lost their lives. I would be 
remiss not to acknowledge the tragic loss of another 100,000 
since then.
    I want to thank Dr. Janz and all the other health care and 
public health professionals on the front lines across our 
Nation that are helping to keep our communities safe as we 
respond to this pandemic. While we still have a long way to go, 
I believe there are lessons that we have learned that can shape 
a public health system built for the 21st century to protect 
the safety of all Americans. My name is Less Becker, and I was 
recently hired from the private sector as the new Deputy 
Secretary of Innovation and Technology for Washington State 
Department of Health.
    Previously, I worked at Harris County Public Health for 11 
years with Dr. Shah, and we innovated, and we increased data 
systems and we use technology to make our work better, building 
one of the best local health departments in the country. I come 
at public health and innovation and technology from a slightly 
different perspective of some of my colleagues. My background 
is grounded in technology, business management, project 
management, and finance. I don't believe that people recognize 
how decrepit and desperate our current public health data 
systems are, and that it will take a lot of work, time and 
resources to modernize them.
    I believe to build and maintain strong public health 
infrastructure, we need to apply innovative practices that 
ensure efficient use of resources, achieve desired outcomes, 
and foster a continuous improvement environment that bridges 
the Federal Government, State Government, and local public 
health divide. Today, I want to touch on three main points, the 
criticality interoperable data systems, the value of public 
private-partnerships, and the need to invest in well-
coordinated local, state and Federal data systems through 
regional innovation hubs.
    First, we need policies that incentivize interoperability 
to connect public health data systems with a broad range of 
partner systems, including health care. For example, in 
Washington, WA Health was developed quickly as a public-private 
partnership with public health, our health care system, and 
Microsoft to provide actionable data for preparedness and 
response during the pandemic. WA Health provided decision-
makers with real time input from Washington's hospital system 
for staffing, emergency department availability, PPE, and other 
items needed during the response.
    When the need arose, WA Health was expanded to collect data 
from approximately 1,800 providers to feed the state's vaccine 
data locator system, and that included data on wheelchair 
accessibility and language translation options onsite. Second, 
we need to incentivize private partners to stay the course post 
pandemic. Through this pandemic, we have seen the amazing 
accomplishments industry and public health can achieve when we 
all come together.
    In Washington, one example of this is the Vaccine Action 
Command and Coordination Center, or VACS, which brought 
together health care organizations including Kaiser Permanente 
and countless private business partners such as Amazon, Costco, 
Microsoft, and Starbucks to figure out how to distribute 
vaccines equitably and efficiently across Washington State. 
Finally, we did an investment and well-coordinated local, 
state, and Federal data systems through regional innovation 
hubs. Right now we are funding siloed programmatic data systems 
that are not suited to handle the needs of today or tomorrow.
    Moving forward, we need a strong and empowered team of 
Federal, state, and local public health agencies to come 
together at one table, shaping the 21st century data systems of 
tomorrow. Let me close by saying, if nothing changes, we will 
get more of the same, systems without the robust capabilities 
and capacity to respond to the next emergency. And we are at a 
crossroads. Either we can act now and invest in public health, 
or we can react later. I hope COVID-19 will move us to action.
    Federal legislation like Chair Murray's Public Health 
Infrastructure Saves Lives Act could help make that hope a 
reality. On behalf of the State of Washington, Asato, and my 
colleagues across the Nation, I appreciate the opportunity to 
testify today. Thank you.
    [The prepared statement of Mr. Becker follows:]
                    prepared statement of les becker
    Let me start by expressing my sincere gratitude to Committee Chair 
Patty Murray, Ranking Member Richard Burr, and distinguished Members of 
the Committee, for the opportunity to appear before the Senate 
Committee on Health, Education, Labor, and Pensions to discuss lessons 
learned from the COVID-19 pandemic to innovate public health.
    The COVID-19 pandemic is the most significant public health 
emergency in the last century. More than 600,000 Americans have lost 
their lives to COVID-19, \1\ which is approximately the same population 
as Baltimore. \2\ To quote Chair Murray, ``[w]e have to make sure we 
learn from this history and take action so we never repeat it. This 
crisis has cost too much, has taken too many lives, for us to do 
anything less.'' \3\ And to quote Ranking Member Burr, ``[t]he window 
to update our public health and medical preparedness policies is now.'' 
In America, we can do anything if we do it together.
---------------------------------------------------------------------------
    \1\  Source: https://covid.cdc.gov/covid-data-tracker/#datatracker-
home (Accessed July 21, 2021).
    \2\  Source: https://www.census.gov/data/tables/time-series/demo/
popest/2010's-total-cities-and-towns.html (Accessed July 21, 2021).
    \3\  https://www.help.senate.gov/hearings/the-path-forward-a-
Federal-perspective-on-the-covid-19-response (Accessed July 21, 2021).

    Speaking on behalf of my colleagues in public health at the state 
and local level, thank you for the time and energy being devoted by 
this Committee to craft bipartisan policies to strengthen our public 
health infrastructure and invest in preparedness now to prevent and 
better prepare for future public health threats. As you know, to date, 
the state of Washington has had one of the Nation's most successful 
responses to COVID-19 under the leadership of Governor Jay Inslee, and 
---------------------------------------------------------------------------
I am proud to be a part of this response.

    As the new Deputy Secretary of Innovation & Technology for the 
Washington state Department of Health (DOH), I was recently hired from 
the private sector by Dr. Umair A. Shah, Washington's Secretary of 
Health, to join DOH in this immensely important time in our state's 
history and in this new and exciting role for our agency and the people 
of the Washington. This is a newly created role for a newly created 
office that sits at the highest level of DOH executive leadership, 
recognizing the importance of innovation and use of technology in our 
public health mission. In this role, I am responsible for building and 
supporting innovation work across the agency (and beyond) including 
overseeing our existing data/informatics and health technology services 
areas while building the Innovation First culture of tomorrow.

    Prior to my private sector role, I previously worked at Harris 
County Public Health (HCPH) in public service leadership serving the 
Nation's third largest county in Texas. At HCPH, I worked with Dr. Shah 
in his previous role as executive director of HCPH to advance an array 
of innovation, data systems, and technology work building one of the 
best local public health departments in the Nation. Our work included 
creating the nationally acclaimed Public Health Innovation (PHI) Lab, 
which focused on developing novel public health interventions into 
sustainable projects that improved the health of the community. We 
implemented an award-winning data warehouse used to deliver timely data 
for key public health decision across many domains. In my role there, I 
also led key areas of advancement including the Medicaid 1115 
transformation waiver implementation, public health accreditation and 
the agency's strategic plan development. I am excited to bring my 
experience to DOH and work with Secretary Shah in championing his 
vision of applying the cornerstone values of equity, innovation, and 
engagement to Washington and its public health systems.

    We all know that everyone, everywhere, in all communities, should 
be able to rely on a strong public health system that is able to 
support them when emergencies strike, and even beyond those 
emergencies--in their everyday lives. Indeed, Federal legislation like 
Chair Murray's Public Health Infrastructure Saves Lives Act \4\ could 
help make this a reality. Public health activities and services must be 
delivered efficiently and effectively, making the best use of 
innovation, technology, science, expertise, and reliance on a qualified 
and dedicated public health workforce that is truly valued and 
supported. While there have been so many uncertainties with the COVID-
19 pandemic, one thing is certain: this pandemic would have played out 
very differently if the capacity of the public health system across 
this Nation was better able to support the needs of communities 
everywhere, and if this capacity was adequately built and in place in 
advance of this crisis.
---------------------------------------------------------------------------
    \4\  https://www.help.senate.gov/ranking/newsroom/press/murray-
introduces-legislation-to-build-and-maintain-core-public-health-
infrastructure-needed-to-save-lives-fight-threats-like-covid-19.

    I come at the notion of public health innovation and technology 
from a different perspective than some of my colleagues because my 
background is grounded in project management, technology, and finance. 
While my experience may be different than others in the field of public 
health, I believe this expertise is critical to build the structures to 
transform our Nation's aging public health ecosystem. I have worked to 
develop plans to guide and prioritize work to align with strategically 
set goals and include strong performance measures to innovate our 
---------------------------------------------------------------------------
public health systems.

    The chronic underfunding of public health infrastructure is well 
documented, as well as examples of outdated technology that have 
hamstrung local, state, and Federal public health responses to the 
COVID-19 pandemic. \5\ And yet, we have heard many stories about how 
Americans came together, rose to the challenge, and persevered. In my 
own journey, I transitioned from the field of public health during the 
pandemic last year, but stayed connected to what was happening in the 
field and then rejoined to apply my expertise in the process of 
rebuilding what is necessary to advance our work. I want to highlight 
some of the progress we have made to improve public health systems in 
Washington state that exemplify structures and principles we can learn 
from and share some additional concepts I recommend the Committee 
consider as it looks ahead.
---------------------------------------------------------------------------
    \5\  https://www.help.senate.gov/hearings/examining-our-covid-19-
response-an-update-from-the-frontlines (Accessed July 21, 2021).

             Examples of Success--the Washington Experience
  WA HEALTH (Washington's Healthcare and Emergency Logistics Tracking 
                                  Hub)
    WA HEALTH was developed as a public-private partnership with our 
health care system and Microsoft to provide actionable data for public 
health and medical preparedness. \6\ WA HEALTH data categories were 
aligned with U.S. Department of Health and Human Services (HHS) 
hospital reporting requirements. \7\ WA HEALTH is a testament to what 
we can accomplish through public-private partnerships and innovation. 
DOH had to overcome several hurdles to operationalize WA HEALTH.
---------------------------------------------------------------------------
    \6\  https://www.doh.wa.gov/ForPublicHealthandHealthcareProviders/
WAHealth.
    \7\  https://www.hhs.gov/sites/default/files/covid-19-faqs-
hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf.

    The first hurdle was the lack of digital bridges between public 
health and health system electronic health records (EHRs). EHRs are 
generally not built to send data to public health systems 
automatically. Likewise, few public health departments participate in 
the U.S. Centers for Disease Control and Prevention (CDC) program to 
develop digital bridges due to lack of funding and capacity within 
health \8\ departments. \9\ In 2009, the Federal Government invested 
$27 billion to encourage the health system to adopt EHRs, but a similar 
investment was not made in public health and public health department 
needs were not considered when these systems were developed. \10\
---------------------------------------------------------------------------
    \8\  Centers for Disease Control and Prevention. 2020. Bridging 
Public Health and Health Care. Available at: https://www.cdc.gov/
surveillance/projects/bridging-public-health-and-health-care-better-
exchange-better-data.html (Accessed July 22, 2021).
    \9\  Miri, A., and D. P. O'Neill. 2020. Accelerating Data 
Infrastructure for COVID-19 Surveillance and Management. Health Affairs 
Blog. https://dponeill.com/2020/04/14/Accelerating-Data-Infrastructure-
For-COVID-19-Surveillance-And-Management.html.
    \10\  Gold, M., & McLaughlin, C. (2016). Assessing HITECH 
Implementation and Lessons: 5 Years Later. The Milbank quarterly, 
94(3), 654-687. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5020152/.

    To maintain WA HEALTH, hospital staff must run reports and send 
this data to the state public health data system. This is a labor-
intensive solution and once the emergency goes away, it is feared that 
the hospital participation and associated data will likely go away as 
well. WA HEALTH has demonstrated the benefit of digital bridges between 
public health and health systems that we must build upon in a 
---------------------------------------------------------------------------
sustainable and automated way.

    Going forward, it is critical that we operationalize rapidly 
configurable systems with the capacity to capture data quickly and 
share case data across states in a standardized way. To address the 
lack of digital bridges between public health and health system EHRs, 
Federal funding for electronic case reporting (eCR) could (1) initiate 
broad-scale, secure reporting from EHRs in clinical care organizations 
to public health agencies across all jurisdictions; (2) support 
interoperable and intelligent real-time reporting from multiple 
sources; and, (3) eliminate paper-based reporting.

    The second hurdle was the fact that data systems amongst entities 
such as hospitals, laboratories, and public health data systems, are 
not always interoperable. These data systems do not consistently rely 
on the same data standards (e.g. FHIR or HL7), so they cannot connect. 
During the COVID-19 response, DOH worked closely with hospitals to 
develop necessary mechanisms for exchange. Going forward, public health 
must ensure vendors are held responsible for standardization for 
transport protocols. Transfer protocols need to be built in to 
contracts, which need to be standardized through granting agency 
requirements. In today's world, interoperability is a bare necessity of 
a minimum viable product.

    To address interoperability of data systems amongst hospitals, 
laboratories, and public health data systems, Federal funding for areas 
such as syndromic surveillance and beyond should be ready to do the 
following: (1) expand the number of hospitals participating; (2) 
enhance reporting to other health system entry points such as urgent 
care centers; and, (3) add predictive analytics and artificial 
intelligence to uncover changes in the occurrence of illness and 
injuries.

    The third hurdle was having outdated public health case management 
data systems. These public health data systems were not set up to 
rapidly add new diseases or data variables. Many of the data systems 
used by public health labs or in epidemiology were created decades 
ago--some as old as forty years ago. Often these technologies have not 
matured and are certainly not as mature as hospitals or private labs. 
For example, the data surveillance system used by Washington and other 
public health jurisdictions faced challenges in capacity to upgrade 
this critical system rapidly. In addition, when data systems are 
hardware bound, they are not scalable to an emergency on the scale of 
the COVID-19 pandemic. With the additional data variables required for 
Federal reporting of COVID-19, there was a lot of work that had to go 
on behind the scenes because the data systems did not align with the 
mission and myriad needs.

    Going forward, we need sustained investment for entities to work 
across siloes, especially in bringing the private sector to the table 
to help maturate these critical public health data systems. Public 
health data systems must be ``cloud-based'' to allow for rapid 
scalability to respond to a host of issues including the most ominous 
one before us, namely a global pandemic in real-time. Funding must be 
systematic and sustained, while also being smart and strategic. We 
truly must have public health data systems that are scrappy and 
scalable; that are built for the 21st century.

    In our state, WA HEALTH informatics and visibility were used to 
allocate critical medical supplies and support health care capacity. It 
provided decision-makers with real-time input from Washington's 
hospitals for staffing, emergency department availability, room 
availability, personal protective equipment (PPE), and other needed 
items for preparedness and response. When the need arose, WA HEALTH was 
expanded to collect data from 1,800 vaccine providers to help with our 
vaccine efforts. The example of WA HEALTH shows that public health has 
the capability to develop modernized data systems and actionable 
dashboards when the structures for success are aligned.
2. VACCS Center (Vaccine Action Command and Coordination System Center)
    The VACCS Center is a unique public-private partnership launched in 
early 2021 to support efficient and equitable access to COVID-19 
vaccinations across Washington. \11\ VACCS is scheduled to demobilize 
on July 30, 2021. This effort built on a history of strong public-
private partnership in the state of Washington through efforts like 
Challenge Seattle, a coalition of regional employers that worked 
closely with Governor Inslee to address regional challenges throughout 
the COVID-19 pandemic.
---------------------------------------------------------------------------
    \11\  Building Public-Private Partnerships to Support Efficient and 
Equitable COVID-19 Vaccine Distribution, Access, and Uptake. Margolis 
Center for Health Policy. April 2021. https://healthpolicy.duke.edu/
publications/building-public-private-partnerships-support-efficient-
and-equitable-covid-19-vaccine (Accessed July 21, 2021).

    The VACCS Center was created by Secretary Shah as part of DOH's 
pandemic response, during the critical time of vaccine dissemination. 
Led by VACCS Center Director Dan Laster, who arrived to DOH with an 
array of private sector experience, the VACCS Center brought together 
key stakeholders within state government all the way up to the 
Governor's Office and extended beyond to critical partners such as 
health care organizations, including Kaiser Permanente and countless 
Washington large-scale private business partners, including Amazon, 
Costco, Microsoft, and Starbucks, as well as those representing 
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community pharmacies, clinics, and others.

    The VACCS Center had five complementary workstreams co-led by 
representatives from the public and private sectors: technology and 
data, communications, business processes, supply and logistics 
deployment, and situational awareness. Since launch, the partnership 
was incredibly successful, creating multiple integrated solutions to 
address early challenges, including an enhanced vaccine locator tool, 
an expanded 211 Call Center, and a Vaccine Playbook for Public-Private 
Partnerships. An example of synergy included having partners from 
Starbucks visit the state-led mass vaccinationsites set up in early 
2021, to review and enhance process flow and the consumer experience 
with respect to vaccine delivery at these sites.

    The VACCS Center acted as an intermediary between the public and 
private sectors ensuring private sector solutions are relevant to the 
needs of the public sector. The VACCS Center's structure worked to 
surface problem statements and needs, and then worked across 
participating organizations to identify opportunities to leverage 
resources and expertise. The VACCS Center served as a ``translator'' 
between sectors and matched the public sector's needs with the private 
sector's capabilities. This coordination structure was critical for the 
facilitation of meaningful and pragmatic partnerships. Not only was the 
VACCS Center's work recognized nationally, but it held true to its 
mission of ensuring that private sector solutions could be applied to 
public sector challenges in the area of vaccine delivery.

    The VACCS Center is an excellent example of the need for engagement 
through public-private partnerships. The public sector is often not 
nimble enough to assess effectively private sector resources and match 
relevant offerings with state needs; however, during a public health 
emergency many barriers are removed in order to get to the work at 
hand. I hope the Committee considers ways to support states and regions 
to establish and sustain coordination structures to help convene public 
and private sector interested parties, develop solutions, and direct 
resources where they can have the most impact. We must have Federal 
policies that permit flexibility in structure and incentives in place 
to allow state public health systems to sustain public-private 
partnerships once the emergency that brings the entities together 
passes.
         3. Washington's Notifiable Disease Surveillance System
    There are two ways to stop the spread of a pathogen like a flu 
virus, HIV, or COVID-19. \12\ Hard science examines the chemistry, the 
biology, and the response to the immune system of the pathogen. 
Epidemiology looks at the circumstances surrounding a disease or 
outbreak. The state of Washington, like other states across the 
country, has worked to increase visibility and improve data system 
collection of demographic data for COVID-19 and other notifiable 
conditions, so we can better understand the circumstances surrounding a 
disease and respond accordingly.
---------------------------------------------------------------------------
    \12\  Richtel, M. (2020). An elegant defense: the extraordinary new 
science of the immune system: a tale in four lives. William Morrow.

    When there is insufficient data, the problem remains invisible, and 
the initial lack of demographic data around morbidity and mortality 
from COVID-19 allowed some people to turn a blind eye to inequities. 
Standing up data systems that could handle demographic data for COVID-
19 was critical to reveal the disparate toll COVID-19 was particularly 
taking on Washington's African-American, Native Hawaiian, Asian-
American, Pacific Islander, and Hispanic communities, amongst 
other1A\13\ groups. \14\ HHS COVID-19 demographic data guidance 
provided minimum standards to states.
---------------------------------------------------------------------------
    \13\  Arias, E., Tejada-Vera, B., Ahmad, F., & Kochanek, K. D. 
(2021). Provisional Life Expectancy Estimates for 2020.
    \14\  https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/
data-tables/COVID-19MorbidityMortalityRaceEthnicityLanguageWAState.pdf.

    In Washington, we complied with both HHS guidance and Washington 
State Board of Health (WSBOH) notifiable condition regulations for 
health care providers, hospitals, and laboratories, including 
demographic data reporting requirements for patient race and ethnicity. 
\15\ During the COVID-19 pandemic, we had hoped to adopt more expansive 
categories for race and ethnicity to understand better the populations 
impacted by COVID-19, but ran into technical challenges with data 
collection and interoperability. Gaps in data collection, analysis, and 
dissemination, including in key areas such as data aggregation, can 
mask ``at-risk'' populations that may be disproportionately affected by 
a public health threat.
---------------------------------------------------------------------------
    \15\  https://sboh.wa.gov/News/Articles/ID/2856/Board-Adopts-
Fourth-Emergency-Rule-to-Extend-COVID-19-Reporting-Requirements.

    In the midst of the pandemic, DOH had to enhance data systems to 
accept the demographic data established by HHS guidance and often had 
to manually go back in to add demographic data because providers did 
not submit the information initially or data systems were not 
interoperable. Since then, DOH has found ways to address these 
technical challenges. Additionally, DOH and WSBOH came together to 
engage community partners and WSBOH adopted new notifiable condition 
regulations which include 71 reporting categories for race and 
ethnicity that were community-informed and incorporated standards 
established by the U.S. Office of Management and Budget and HHS Office 
of Minority Health. \16\
---------------------------------------------------------------------------
    \16\  https://sboh.wa.gov/Rulemaking/CurrentRulesandActivity/
NotifiableConditions.

    Through ongoing community engagement processes, additional 
demographic variables were identified that must be prioritized in 
future policy making, including but not limited to Tribal affiliation, 
disability status, and housing status. Getting these data categories 
correct requires meaningful engagement with a variety of communities, 
which takes time, resources, and trust. We must continue to develop 
frameworks for more equitable engagement and collaboration in order to 
---------------------------------------------------------------------------
promote health and achieve health equity for all of our communities.

    We know when dealing with health, a person's environment, physical, 
social, and emotional needs, all contribute to their immediate and 
future resiliency. Understanding these social determinant variables are 
crucial to decision-making. Data reporting for variables that reflect 
the social determinants of health is less mature and certainly not 
inter-connected as it should be. Moving forward, we absolutely need to 
be specific with the standards for housing, food insecurity, and other 
social determinant variables to get meaningful and usable data. Data 
governance will be critical. In addition, data related to social 
determinants is often being collected downstream in other disparate 
data systems. Data is being siloed, and we need to create public health 
data systems that reduce duplication of efforts or match the data to 
improve outcomes.

    In 2021, the Washington State legislature passed House Bill 1272 
that includes requirements for hospitals to submit patient discharge 
information to DOH that identify the patient's race, ethnicity, gender 
identity, sexual orientation, preferred language, any disability, and 
zip code of primary residence. \17\ Both the public and decision-makers 
demand informatics and information about community health and well-
being. I believe we must develop data systems that provide the same 
level of protection from a variety of threats whether infectious 
disease in nature such as a pandemic, or chronic disease related, or 
environmental in nature, regardless of where you live, who you are, or 
what your income is, because of our experience expanding reporting 
requirements and our ability to implement structures for public-private 
partnership and community engagement.
---------------------------------------------------------------------------
    \17\  https://app.leg.wa.gov/
billsummary?BillNumber=1272&Year=2021&Initiative=false.

    The issue of standardizing demographic data reporting practices is 
a challenge across the U.S. \18\ Currently, demographic categories and 
definitions differ between states. To understand the population's 
health, we need data systems that reflect the public we serve. To 
identify these demographic categories, state and local public health 
must be at the table because ultimately, we know our communities best.
---------------------------------------------------------------------------
    \18\  Blauer, B. (2021) Data disarray damages COVID-19 response, 
expert says. The Hub. https://hub.jhu.edu/2021/06/17/beth-blauer-data-
disarray-in-covid-reporting/.

    Federal funding to support a national notifiable disease 
surveillance system would improve: (1) data security across the 
infrastructure; (2) automated electronic receipt of data (existing and 
new data sources); (3) integrated, real-time analytics of data from 
multiple sources (clinical, lab, epidemiologic); and, (4) seamless, 
efficient communication and sharing of robust data to and from health 
---------------------------------------------------------------------------
care providers to public health agencies and onto CDC.

    To date, Washington's DOH has received approximately $120 million 
in Federal COVID-19 funds for data systems to support critical efforts 
such as disease surveillance and reporting, testing, case investigation 
and contact tracing, and vaccine distribution. Through 14 response 
missions and 38 data system projects, we have invested in a public 
health ``cloud'' environment, engaged countless vendor partners in 
development and modernization of essential infrastructure and systems, 
brought in new tools and resources, and ultimately identified over a 
hundred staff members to be trained to support these new capabilities. 
Essential costs include new equipment, cloud hosting, software 
licensing and maintenance. Without systematic and sustained funding, we 
will not be able to keep the forward progress made to innovate public 
health.
                     Looking Ahead--A Long Journey
    The stories above reflect some of the successes we have had in 
Washington while simultaneously protecting the public from the COVID-19 
pandemic in one of the Nation's most successful responses. They reflect 
DOH's cornerstone values of equity, innovation, engagement in practice. 
While these efforts are noteworthy, we know even after we are through 
this crisis, our work is far from over. We require investments, 
strategies and structures in place at every level of government to 
strengthen our public health systems to use sequencing technology 
efficiently and effectively, modernize data systems to track the spread 
of diseases and monitor the success of key initiatives such as 
vaccination efforts, standing up of testing and contact tracing to stop 
disease outbreaks, build partnerships in hard to reach communities, and 
build trust as communicators to fight misinformation.

    Looking ahead, we must think about ways to innovate data 
management, systems changes, and operational strategies to create a 
modern 21st century governmental public health system that we can all 
be proud of and rely on during times of emergency and beyond.
                           1. Data Management
    Significant work is needed to innovate public health data 
management, including governance and consensus-based standards. Prior 
to COVID-19, most people saw the systems that collected data and 
governance of that data as singular, but as we moved in to COVID-19 and 
cloud-based analytics, data and systems are increasingly being 
separated. When data is housed outside of the original data system, we 
need optimal governance to protect people's privacy and the security of 
this data while leveraging these insights to protect our communities. 
With these shifts, all levels of public health will require an equally 
strong and supported workforce that can help navigate and lead on these 
critical issues.

    Meanwhile, numerous organizations are developing public health data 
standards and technical roadmaps, including the Office of the National 
Coordinator for Health Information (ONC) and the Healthcare Information 
and Management Systems Society (HIMSS). They are working on the 
technical side of data systems. I believe we will need an equal focus 
on how to operationalize these standards. There are significantly 
different maturity levels for data systems across our federated public 
health ecosystem. As I follow the work of these technical groups on 
data standards, I believe we will need a substantial investment in 
resources to operationalize these standards and move forward from a 
long-term sustainability standpoint. I believe that most state, 
territory, local and Tribal public health entities may struggle with 
the organizational systems change needed to implement these vital 
frameworks and standards. We must consider new mechanisms for funding, 
incubating, and maturing all levels of the system.
                           2. Systems Change
    Federal funding in public health data systems and infrastructure 
needs to move away from programmatic siloed funding to enterprise-wide 
systems and shareable systems. We need to set aside pre-conceived 
expectations for how funds flow into these programs to build a 21st 
century governmental public health system that is connected, resilient, 
adaptable, and sustainable--a `pandemic-ready' system that can help us 
solve problems before they happen and reduce the harm caused by the 
problems that do happen.

    Currently most Federal funding channels provide for specific 
programs (e.g. immunization or STD prevention). The Public Health 
Emergency Preparedness cooperative agreement funding is used to create 
infrastructure to respond to emergencies, including capacity and 
supply. When we go into a public health emergency response, there is 
not always alignment between this programmatic funding and the 
emergency response needs. During an emergency, one must work with each 
program to realign personnel and IT systems, so it is hard to pivot. 
Programmatically siloed funding for data infrastructure and data 
systems creates barriers for innovation and barriers for emergency 
response.

    In addition to a shift toward investment in enterprise-wide systems 
and shareable systems, I believe we should consider funding and support 
that brings multiple states together to form regional innovation hubs. 
There is regional variance in both capacity and capabilities across 
America, as well as gaps in systems and workforce. The most efficient 
path to address this complexity is through regional innovation hubs.

    Placing the responsibility and decision-making at the regional 
level can best shepherd this modernization for the immediate and future 
needs of the impacted communities. These regional centers could bring 
together Federal, state, local, and Tribal governmental agencies in 
partnership with community stakeholders, academia, and private sector 
partners to innovate the way public health is delivered to their 
communities. These regional hubs should have the ability to direct and 
redirect resources while being held accountable for maturing the 
systems and demonstrating outcomes.

    One of the primary tenants of this type of approach would be having 
a Federal presence in the regional innovation hub that can communicate, 
bridge, and coordinate the myriad Federal agencies and programs that 
fund and support public health. The decentralization of the decision-
making will align public health at all levels to be nimble, cost 
effective, and outcome oriented.

    The reality is that there are regional differences in all aspects 
of community, health, resources, challenges, opportunities, and types 
of emergencies we face. Our Federal system provides ample opportunity 
for taking risks in our work with respect to innovation. Regional 
innovation hubs could provide a ``laboratory'' structure to implement 
public health data infrastructure strategically for the 21st century. 
Thanks to robust visualization tools, we have all been able to see the 
geographic uniqueness of this pandemic. After witnessing the pain and 
suffering COVID-19 has caused, we have an opportunity to acknowledge 
that uniqueness with a Federal approach that recognizes, embraces, and 
supports those unique regional public health needs.
                         Operational Strategies
    Data modernization is not just about the technologies, it requires 
operational strategies to implement successfully. More funding alone 
will not bring public health data systems in to the 21st century. 
State, territorial, local, and Tribal public health agencies will need 
increased organizational operational capacity, modernized enterprise IT 
architecture, and a culture of innovation to build the Innovation First 
culture of tomorrow. I hope the examples and concepts shared throughout 
my testimony capture these operational strategies.

    We will only be able to build a 21st century governmental public 
health system if we have the workforce to do it. During the COVID-19 
pandemic, as many public health entities across the Nation, DOH had to 
expand its own workforce rapidly. This translated into the hiring of 
over 500 staff members and the contracting of over 500 additional 
personnel, including for work in laboratory settings, case 
investigation and contact tracing, surveillance and informatics, 
outbreak response, public affairs/communications, diagnostic testing, 
and incident management command and control for dealing with the 
logistics of testing, contact tracing, PPE distribution and 
vaccinations. This ``just in time'' building of capacity in the midst 
of a crisis is no rational way of preparing our Nation for future 
emergencies.

    Technology's potential can only be realized if public health 
agencies are equipped to harness it. We must have systematic and 
sustained funding to increase salary caps to recruit and retain optimal 
staff and create new jobs in the public and private sector across 
jurisdictions, new curricula, professional development, post-graduate 
fellowships, and on-the-job training. Funding would help the public 
health system achieve full capacity to understand and securely 
integrate health data to: (1) provide more complete, accurate, and 
timely population-level monitoring; (2) ensure optimal health security 
through robust public health surveillance to prevent death and disease; 
(3) move data to action by driving policy and practice to accelerate 
health improvement; (4) reduce provider reporting burden; and, (5) 
bolster and maintain cybersecurity. The growth and retention of the 
public health workforce should contain a specific focus on diversity--
racial, ethnic and beyond--to address issues of trust, confidence, and 
representation of the diversity of the residents served by the public 
health agency in both rural and urban areas. The very health, well-
being, and resiliency of that workforce must also be maintained and 
supported.

    Congress should explore alternative funding models to ensure 
predictable and sustained funding over the next decade. These funding 
models could potentially be outside of discretionary appropriations and 
provided through a ``public health infrastructure fund'' approach, 
which is a critical component of Chair Murray's Public Health 
Infrastructure Saves Lives Act. Rather than constraining states by 
defining what types of occupations and how many individuals should be 
employed, workforce dollars should be flexibly administered to states 
either via block grants or an alternative mechanism for use in hiring 
the public health professionals and experts needed to meet both the 
current and future workforce needs of the jurisdiction. Ensuring key 
flexibility is critical to enabling public health agencies to recruit 
and retain staff.
                  Conclusion: The Future Is Achievable
    Moving forward, I am excited by what innovation and technology can 
bring to the issues at hand within public health and beyond. I 
recommend the following for further policy consideration by the U.S. 
Senate Committee on Health, Education, Labor, and Pensions, to improve 
our Nation's public health system:

        1. Coordinate policies, consensus-based standards, decision-
        making, and invest in enterprise-level IT and data 
        infrastructure that supports cloud-based platforms, shared 
        cross disease systems and real-time data automation. This 
        includes closer integration of state and Federal partners 
        including the CDC to develop interoperable systems that allow 
        for efficient data exchange and the development of more timely, 
        efficient and effective automated reporting systems to report 
        results to state (and local) health agencies.

        2. Create a system-wide environment of structured innovation 
        that modernizes public health systems and enables new public-
        private partnerships with healthcare providers, private sector, 
        and other entities to create new tools that serve communities, 
        patients, and consumers.

        3. Create regional innovation hubs for systems modernization 
        that allow for states to achieve economies of scale, small 
        enough to develop data standards to collect data that is 
        meaningful to communities, engage and leverage private sector 
        expertise located in the region and enable a unified Federal 
        voice that can be nimble within a localized structure that 
        actually operationalize state and local public health systems/
        data modernization efforts that are accountable.

    In closing, COVID-19 is the challenge of our lifetime, but it is 
also a watershed event to improve the health and well-being of all 
individuals through more robust, smart, and sustained investment in our 
public health system. There are critical investments that need to be 
made and innovative policies that should be considered to meaningfully 
modernize our public health system. On behalf of our state and my 
colleagues at ASTHO and across the public health system in this Nation 
(and beyond), we stand ready to work with you to begin the process of 
innovatively investing in public health. It is what our Nation needs 
and what our Nation requires to move forward successfully.

    Thank you for holding this hearing to discuss lessons learned from 
the COVID-19 pandemic as this Committee develops legislation to define 
the vision and capabilities for a 21st century governmental public 
health system that promotes health, prevents disease, and protects all 
communities across the country.
                                 ______
                                 
                   [summary statement of les becker]
    The U.S. public health system has worked around the clock to 
respond to the COVID-19 pandemic since the first identified U.S. case 
was confirmed in our State of Washington in January 2020. As you know, 
to date, the State of Washington has had one of the Nation's most 
successful responses to COVID-19 under the leadership of Governor Jay 
Inslee, and I am proud to be a part of this response. I want to 
highlight some of the progress we made to improve public health systems 
in the State of Washington and discuss ways to innovate data 
management, systems changes, and operational strategies to create a 
21st century governmental public health system to better prepare the 
U.S. for future public health emergencies.

    Public health has the capability to develop modern data systems and 
actionable dashboards when the structures for success are aligned. One 
example is WA HEALTH which was developed as a public-private 
partnership with our health care system and Microsoft to provide 
actionable data for public health and medical preparedness. It provides 
decision-makers with real time input from Washington's hospital system 
for staffing, ER availability, room availability, PPE, and other needed 
items for preparedness and response. More recently, WA HEALTH was 
expanded to collect data from 1,800 vaccine providers to feed into the 
state's Vaccine Locator tool and included data on wheelchair 
accessibility and language interpreters onsite. Another example is 
standing up data systems that could handle demographic data for COVID-
19 which was critical to reveal the disparate toll COVID-19 was 
particularly taking on Black, native Hawaiian and Pacific Islander, 
Asian-American, and Hispanic communities, amongst other groups. 
Washington recently adopted new notifiable condition regulations which 
include 71 reporting categories for race and ethnicity that were 
community-informed. We need data systems that reflect the public we 
serve.

    Public health emergencies strike and funding spikes; however, the 
funding is temporary and targeted and does not address the sustained, 
longitudinal needs of our public health system, including a 21st 
century public health workforce and modernizing public health data 
systems. Everyone, everywhere, in all communities, should be able to 
rely on a strong public health system that is able to support them when 
emergencies strike. Indeed, Federal legislation like Chair Murray's 
Public Health Infrastructure Saves Lives Act \1\ could help make this 
hope a reality.
---------------------------------------------------------------------------
    \1\  https://www.help.senate.gov/ranking/newsroom/press/murray-
introduces-legislation-to-build-and-maintain-core-public-health-
infrastructure-needed-to-save-lives-fight-threats-like-covid-19-.

                                 ______
                                 
    The Chair. Thank you very much.
    Ms. Arthur.

    STATEMENT OF PHYLLIS ARTHUR, VICE PRESIDENT, INFECTIOUS 
   DISEASES AND DIAGNOSTICS POLICY, BIOTECHNOLOGY INNOVATION 
                  ORGANIZATION, WASHINGTON, DC

    Ms. Arthur. Good morning, Chair Murray, Ranking Member 
Burr, and Members of the Committee. My name is Phyllis Arthur. 
I am the Vice President of Infectious Diseases and Emerging 
Science Policy at the Biotechnology Innovation Organization, or 
BIO. Thank you for the opportunity to share our thoughts 
regarding lessons learned from the COVID-19 pandemic.
    Since January 2020, our industry has initiated over 950 
unique therapeutics and vaccines against COVID-19, 
demonstrating our commitment to the critical research, 
development, and manufacturing of medicines that help save 
lives in a public health emergency. COVID-19 will not be our 
last public health emergency. We face numerous bio threats from 
natural and bioterror threats. Strong support for medical 
countermeasures R&D is critical to protecting our National 
Security.
    Today, I will share BIO's thoughts on how to strengthen our 
national preparedness through coordinated leadership, expanded 
partnership with industry, and better public health 
infrastructure. We applaud the success of the Government 
partnerships in developing and distributing vaccines and 
therapeutics. BIO believes a stronger PHEMCE led by the ASPR 
could accomplish similar success in the future given the health 
emergency expertise within ASPR. An interagency PHEMCE should 
prioritize products, move products swiftly through agencies for 
development, and procure MCMs through the SNS. Appropriate 
funding levels must be provided for early stage development 
through large clinical trials, manufacturing scale up, and 
procurement.
    Second, maintaining a permanent framework for MCM clinical 
trials such as ACTIV to rapidly evaluate products for emergency 
situations is the best way to rapidly respond. Third, our 
Government must work with industry on communicating clear 
product priorities and requirements, as well as strategies for 
maintaining excess capacity for emergencies through multiple 
partnerships. Any payment for this capacity should be viewed as 
a cost effective insurance policy for national preparedness.
    BIO agrees with the strategic focus of the American Jobs 
Act that proposes investment in the U.S. supply chain and 
domestic production. Congress should also consider several 
bills offered by the Ways and Means Committee that seek to 
incentivize investment in domestic manufacturing. Fourth, the 
Government must expand partnerships across a host of threats. 
PAHPAIA included authorities allowing strategic investments for 
novel platforms and manufacturing advancements. Congress should 
authorize BARDA funding for platforms to provide the most shots 
on goal for potential threats.
    Establishing partnerships with platform companies to work 
on a predetermined set of infectious diseases will shorten the 
development timelines for the next pandemic. Congress should 
also work with the FDA to clarify the regulatory mechanisms by 
which platforms can be authorized or approved when deployed 
against subsequent pathogens. There must also be continued 
investments in novel antiviral mechanisms. BIO is encouraged by 
the launch of the antivirals program for pandemics and UNC's 
READDI Program, which could stimulate early stage development. 
These programs then must be supported by BARDA funding for 
later stage development and manufacturing support.
    These initiatives must be in addition to the ongoing 
programs to develop, produce, and stockpile MCMs for specific 
CBRN and biological threats, preparing for all possible 
scenarios. This includes support of therapeutics that treat 
severe consequences like acute respiratory distress syndrome 
and antibiotic resistant infections. COVID-19 infections 
reinforce the urgent need for antimicrobial products as both 
major public health and a National Security threat.
    We therefore encourage the inclusion of PASTEUR and DISARM 
as part of the legislative effort. Last, we must invest in 
public health infrastructure by expanding CDC surveillance 
capabilities for viral testing and genomic sequencing, and also 
the HHS systems that capture utilization and demographic data 
for MCMs during an emergency, while sustaining the 
infrastructure improvements made this past year for delivery of 
therapeutics and adult vaccines.
    This will ensure that communities can get vaccines and 
treatments not only during a pandemic but also on a routine 
basis. BIO and our members are committed to working with 
Congress on these issues. And we thank you again for the 
opportunity to testify today.
    [The prepared statement of Ms. Arthur follows:]
                  prepared statement of phyllis arthur
    Good morning Chair Murray, Ranking Member Burr and Members of the 
Committee. My name is Phyllis Arthur and I am the Vice President of 
Infectious Diseases and Emerging Science Policy at the Biotechnology 
Innovation Organization, or BIO. Thank you for the opportunity to share 
our thoughts on the topic of the lessons learned from the COVID-19 
pandemic.

    BIO is the world's largest trade association representing 
biotechnology companies, academic institutions, state biotechnology 
centers and related organizations in the United States and over 30 
nations. Our mission is to advance biotechnology innovation by 
promoting sound public policy and fostering collaboration, both locally 
and globally. Our members range from entrepreneurial companies 
developing their first product to Fortune 500 multinational companies.

    BIO and our members appreciate that the Committee is proactively 
working to collect lessons learned from the COVID-19 pandemic and put 
forward legislation to prepare for future pandemics. As companies 
investing in novel therapeutics, vaccines, diagnostics, and platform 
technologies to help save lives from all types of biological threats, 
our members are committed to continuing to strengthen the public-
private partnerships enabling this critical research, development, and 
production, and we welcome the opportunity to provide comments on how 
to bolster our pandemic preparedness. To this effect, the global 
biopharmaceutical industry has initiated over 900 unique therapeutics 
and vaccines against COVID-19 since January 2020.

    Our national biodefense enterprise supports medical countermeasure 
(MCM) development for a host of known and unknown threats: chemical, 
biological, radiological, and nuclear (CBRN), pandemic influenza, 
emerging infectious diseases, and antimicrobial resistance (AMR). 
Pandemic preparedness relies on the Nation's ability to develop, 
procure, and deliver the necessary medicines and diagnostics to combat 
biological threats. The U.S. needs to maintain a robust stockpile of 
MCMs for each of these risks. We know that periodic threats, such as a 
100-year pandemic like COVID-19, will occur but each individual threat 
has such a rare occurrence rate that commercial markets for such 
countermeasures do not exist. That is why the U.S. Government, through 
the Biomedical Advanced Research and Development Authority (BARDA), the 
Project BioShield Special Reserve Fund (SRF), and the Strategic 
National Stockpile (SNS), must invest in and procure the necessary MCMs 
to be ready for the next pandemic and other biological threats.

    The Department of Health and Human Services (HHS) and the 
Department of Defense (DOD) work in partnership with the private sector 
on the development of vaccines, therapeutics, diagnostics, and 
platforms to protect the American people against these threats. As 
BARDA's portfolio has grown to include 61 approved products, funding 
levels for HHS Assistant Secretary for Preparedness and Response (ASPR) 
and BARDA initiatives have remained largely stagnant over the past 
decade. Recent iterations of the Public Health Emergency Medical 
Countermeasures Enterprise (PHEMCE) Multi-Year Budget have shown 
increased projections of necessary funding for BARDA advanced research 
and development (ARD), pandemic influenza, Project BioShield, and the 
SNS, and BIO would expect further increases projected in the next 
iteration of the Multi-Year Budget.
                               Leadership
                    Role of the ASPR and the PHEMCE
    Current statute clearly places authority for pandemic preparedness 
and response with the ASPR. The ASPR has the most appropriate expertise 
and statutory responsibilities for coordinating a public health 
emergency response, given their relationship across the healthcare 
supply chain, the pharmaceutical industry and public health 
preparedness leaders. This was the intent of the original Pandemic and 
All-Hazards Preparedness Act (PAHPA), which was further codified in 
PAHPA's subsequent bipartisan reauthorizations passed during the Obama 
& Trump Administrations. The ASPR should be empowered to lead the 
coordination of government preparedness initiatives, public health 
emergency and pandemic responses. Since the ASPR is intended to be the 
leader of the PHEMCE, in partnership with the DOD, other relevant 
agencies should work in collaboration and coordination with the ASPR.

    The ASPR currently lacks the authority to clearly direct the 
actions of the PHEMCE. While we certainly applaud the success of both 
Operation Warp Speed and the current White House COVID-19 Taskforce in 
developing and distributing COVID-19 vaccines and therapeutics, BIO 
believes a stronger PHEMCE could have accomplished similar goals 
without the delays of building new organizational structures. The roles 
within the PHEMCE should be clearly defined, with a clear, centralized 
power structure, in advance of a public health emergency. Legislation 
ought to clarify the responsibilities and authorities of the many 
actors for pandemic preparedness and response and determine the chain 
of command so that directives come from a single top-down source or 
inter-agency group. Confusion regarding leadership undermined the 
government's ability to clearly communicate with industry during its 
COVID-19 response, and a proper pre-planned organizational structure 
and procedures could help prevent these issues from occurring in the 
future.
     Leadership and Management of the Strategic National Stockpile
    Another specific area of concern is leadership of the SNS. As we 
learned during the COVID-19 pandemic, the SNS is vital for many 
healthcare products from personal protective equipment (PPE) to generic 
essential medicines to complex biologicals and vaccines. BIO strongly 
believes that the SNS must remain under the ASPR's jurisdiction with 
funding levels that account for the breadth of products in the 
Stockpile and the complexity of managing the myriad roles the SNS must 
play. For many MCMs, such as smallpox vaccines, anthrax antitoxins, and 
pandemic influenza products, the Federal government is the primary 
customer through procurements by the SNS and the SRF. The ASPR is best 
equipped to manage all of the products included in the Stockpile, 
especially MCMs, given the role of the office in setting requirements, 
coordinating responses to many types of health emergencies, leading 
BARDA investments in product development, and planning lifecycle 
management and stockpile operations. For MCMs, future stockpiling 
strategies must be applicable to each specific product being procured, 
based upon characteristics such as the market size, use, timelines for 
manufacturing, and the speed of pathogen spread for the different 
medical countermeasures.

    With respect to state and hospital-based stockpiles, BIO believes 
that they may be suitable for some products such as PPE, antibiotics, 
or threats endemic to the region, but they are not replacements for the 
national stockpile for specific MCMs for national security threats, 
like anthrax. Investment in state and hospital stockpiles does provide 
value to the preparedness of the Nation, though money spent on any 
potentially new state stockpiles should not come at the expense of the 
investment in, or replenishment and maintenance of, classic or non-
commercial MCMs within the Federal SNS.
                    Communications With Stakeholders
    The ASPR and PHEMCE leadership need to strengthen communications 
systems surrounding pandemic preparedness. Clarity on the distribution 
plan of an MCM is important for Federal, state, and local response to 
public health emergencies, and industry often has a role to play in 
communicating around and facilitating product distribution. Federal, 
state, and local government public health responses are intimately 
interconnected. There must be the infrastructure and resources to allow 
seamless communication and coordination between all parties for the 
fastest possible response. The ASPR and the Centers for Disease Control 
and Prevention (CDC) must be unencumbered in their ability to ensure 
coordination and communication between Federal, state, local, and 
industry partners when time matters most.
                    Threat Assessment and Awareness
    Congress must take steps to ensure its awareness of the threat 
assessments that drive PHEMCE's MCM requirements and decisions. 
Currently, this information is not regularly shared with Members of 
Congress, even though statute requires an annual submission of a 
threat-based review to Congress. To our knowledge, the threat-based 
review report required by the most recent PAHPA reauthorization has 
never been submitted to the appropriate congressional committees. BIO 
believes that a better understanding of these threat assessments would 
help Congress better understand the role played by the PHEMCE and the 
changes in the threat matrix on a year-to-year basis. Regular 
visibility into the threat assessment process would assist Congress in 
evaluating appropriate levels of funding to ensure the PHEMCE fulfills 
its statutory requirements. Congress would also be better able to 
perform its oversight role with an improved understanding of all 
biological threats, whether naturally occurring, deliberate, or 
accidental.
               Commitment to Public Private Partnerships
    Private sector partners must be treated as true partners rather 
than vendors. This means understanding the business needs of partners 
so that the private sector can be sustained and therefore all products 
can be available over time. These relationships should not be only 
transactional.
              Clear Communication on Product Requirements
    Industry partners need clarity around product requirements, plans 
for product replenishment, and when the U.S. Government thinks that a 
requirement or threat is fulfilled or completed. When there are changes 
in prioritization, those changes must be communicated with industry 
partners in a timely manner. The ASPR should use the Multi-Year Budget 
process to communicate the short-and long-term strategy and priorities 
of the U.S. Government for the development and procurement of MCMs.
                     Staffing for BARDA Contracting
    Another key aspect of the public-private partnership is the length 
and complexity of contracting timelines. Legislation should facilitate 
ASPR/BARDA to quickly bring in contracting staff from other Federal 
agencies or other implement other solutions for expedited contract 
reviews. This was recommended by the Bipartisan Commission on 
Biodefense and implemented by the last Administration. Contracting 
authority should principally remain with BARDA.

    The billions of dollars recently appropriated to ASPR and BARDA for 
COVID-19 response necessitates an increase in BARDA support staff. 
Limited contracting staff is a bottleneck to rapidly issuing contracts 
and other agreements to accelerate development of drugs, vaccines, and 
diagnostics that can save lives during a public health emergency. 
Additional contracting staff can enable not only a standard review 
process but an expedited process that is badly needed.

    Under usual circumstances, contract timelines at BARDA have been 
lengthy. At best, new contracts have taken about 60 days for very small 
awards (under $750,000) for BARDA's Division of Research Innovation and 
Ventures (DRIVe) program. For larger awards under routine BARDA 
programs, contract decisions can take 6-9 months.

    This is a bureaucratic issue but also fundamentally a staffing 
issue. Over the last several years (before COVID-19), companies 
interfacing with BARDA have experienced a severe shortage of 
experienced contracting staff within the agency. Several companies have 
reported up to four contracting manager changes in under a year.
          Increasing Domestic Biopharmaceutical Manufacturing
    The public-private partnerships for MCM research & development, 
manufacturing, and stockpiling are critical to the health security of 
the U.S. Neither the U.S. Government nor industry would be successful 
in this effort alone, and the investments made by the U.S. Government 
are important to sustaining and bolstering our national preparedness. 
The health security provided by a robust domestic market for medical 
products, along with the economic impact of high paying jobs, is of the 
utmost value to the United States. Fair and competitive markets are 
important for maintaining the rigor and vitality of the industry, and 
Executive Order 14005 (Ensuring the Future Is Made in All of America by 
All of America's Workers) includes many provisions to improve upon the 
economic ecosystem.

    There is a need to incentivize future investment in U.S. 
manufacturing capabilities, to ensure that the United States is the 
best place in the world to locate global biomanufacturing facilities. 
BIO recommends that Congress consider providing targeted incentives to 
grow and maintain the U.S. domestic biopharma manufacturing sector. 
Legislation should require clarity from the U.S. Government related to 
the requirements for MCMs, so Congress has needed visibility and 
private sector partners can accurately assess the government's needs.

    One model to consider strengthening is the Centers for Innovation 
in Advanced Development and Manufacturing (CIADM) program, which was 
created in 2012. This program, which had seen inadequate government 
investment over many years, has unfortunately resulted in the sale and 
exit from the program of one of the three facilities due to the 
unsustainability of the model as actually funded and supported.

    The American Jobs Act proposes investment in both the U.S. supply 
chain and domestic production, and currently the House Ways and Means 
Committee has several bills, including the ``Start-Ups for Cures Act,'' 
the ``More Cures Act,'' the ``Infectious Disease Therapies Research & 
Innovation Act,'' and the ``IP Repatriation Act'' that seek to 
incentivize onshoring and continued investment in domestic medical 
manufacturing. Passage of these bills would help ensure that the U.S. 
has a robust medical supply chain and the necessary domestic 
manufacturing capacity needed to combat the next pandemic.

    Investments also should be made in workforce development and 
training. Onshoring and growing the domestic manufacturing industry is 
more than just a health security priority, it is also a jobs and 
economic priority. One of the United States' major national strengths 
has been the high-quality workforce that manufactures our medicines and 
supply chain inputs through a diverse network of job training and 
occupational expertise respected around the world.

    We believe the United States should create a national industry/
academic preparation clearinghouse focused on new curricula and 
programs that incentivize an adequate supply of management, sales, 
marketing, and regulatory personnel experienced in manufacturing for 
the biotechnology industry.

    The US must also invest more significantly in science and Science, 
Technology, Engineering, and Math (STEM) education at all levels but 
especially at the college and graduate level. The rapid evolution of 
life science knowledge is a driving force in the biopharmaceutical 
industry and should be viewed as a core national security and domestic 
policy priority. These efforts should be complemented with a sound 
foundation of immigration policies that attract and retain the best 
technologists, scientists, and innovators from around the world.

    BIO supports increasing U.S.-based manufacturing of critically 
needed medicines, but not a broad mandate requiring MCMs, essential 
medicines, and related active pharmaceutical ingredients (API) to be 
made in the United States. There are numerous challenges to relying 
solely on U.S. manufacturing, including lack of access to certain raw 
materials, gaps in specialized workforce needs, and governmental 
regulations that would make it extremely challenging to produce in the 
United States without significant regulatory changes and cost 
considerations. This is especially important for those MCMs targeted to 
specific biological threats with limited demand. These medicines are 
generally made in one facility and shifting them to a U.S. production 
site may cause undue cost, delays, and manufacturing inefficiencies. 
Also, any changes would take significant time for companies to 
implement, as supply chains, including the facilities for manufacturing 
API, often are established years in advance of a product's launch, from 
the base of global regulatory filings/approvals, and are designed with 
global access and resiliency in mind.

    Any policies to incentivize U.S. medical supply manufacturing must 
be targeted and recognize the complex nature and inherent global 
aspects of the biopharmaceutical supply chain. The medical supply chain 
is incredibly delicate and complex. The many products in supply chain 
are unique and have their own market intricacies, and so BIO would 
caution against any one-size-fits-all or product-blind policy for 
managing the supply chain. At the same time, there is, of course, a 
need for redundancy built into the supply chain. When determining where 
redundancy is required, it is important to keep in mind production 
capability and the complexity of certain products.

    Investment across the whole supply chain, along with an incentive 
structure that rewards market entry as well as rewards those who choose 
to stay in the MCM market, is needed to create a domestic supply chain 
that is sustainable and secure.

    Private companies have solutions related to supply chain and 
manufacturing challenges, but the U.S. Government must be a 
transparent, communicative, and cooperative partner. The U.S. 
Government must work with industry to find strategies for maintaining 
some level of excess capacity for emergencies, a sustainable 
infrastructure that can surge during a public health crisis. To reserve 
manufacturer capacity to use when needed, the government would need to 
pay for that reserved capacity and ensure it is not double-booked for 
other clients. To ensure adequate capacity is achieved, the U.S. 
Government should pursue multiple partnerships, build excess 
manufacturing capacity into the system, and pay for capacity on top of 
existing demand--not supplant existing demand. These manufacturing 
partnerships should be viewed as a cost-effective insurance policy for 
national preparedness. Additionally, public-private partnerships to 
stockpile ancillary materiel such as glass vials and syringes that will 
be needed for fill-finish capabilities for a variety of products should 
also be utilized.
                Strategies That Support MCM Development
          Platform Technologies for Vaccines and Therapeutics
    COVID-19 will not be the last emerging infectious disease that the 
U.S. will need to respond to. Support for capacity and capability 
building for MCMs and our public health system is critical to 
protecting our national health security from emerging infectious 
disease threats. Investments must be made now in new technologies to 
ensure our national health security through preparedness and quick 
resolution of an outbreak when any emerging pathogen arises. The 2019 
Pandemic and All-Hazards Preparedness and Advancing Innovation Act 
(PAHPAIA) included clear authorities for ASPR and BARDA related to 
strategic innovation in countermeasures for emerging infectious 
diseases, especially through support of novel platform technologies and 
manufacturing advancements. The PHEMCE Multi-Year Budget has long 
highlighted the need for dedicated emerging infectious disease funding, 
but neither Congress nor multiple Administrations have called for 
annual investments to better address this critical need. Funding during 
a crisis is often too late, as development of drugs, vaccines, 
diagnostics, and platform technologies takes time. Even with 
accelerated timelines during the COVID-19 pandemic, biotechnology 
innovations took the better part of a year to bring to FDA 
authorization. As COVID-19 demonstrated, that delay risks lives and 
causes trillions of dollars in losses to our economy--considerably more 
than any upfront investments in these MCMs and rapid response 
capabilities.

    Establishing flexible partnerships with industry, particularly 
those with established vaccine, therapeutic, and diagnostic platforms, 
to then work on developing MCMs for a pre-determined set of emerging 
infectious diseases and families of viruses that have pandemic or even 
regional outbreak potential, will shorten the development timelines for 
the next outbreak or pandemic. When an outbreak of a novel pathogen 
occurs, companies can then pivot to applying that platform to the novel 
pathogen.

    Congress should specifically authorize funding within BARDA to 
allow for investments in numerous platforms (such as mRNA, protein 
subunit vaccines, monoclonal antibodies) so that the U.S. has the most 
``shots on goal'' to be able to respond quickly and effectively to any 
potential threat. BARDA should, in collaboration with the National 
Institutes of Health (NIH) and the DOD, create a prioritized list of 
emerging infectious diseases and viral families with outbreak 
potential, including vector-borne diseases. This list should be 
incorporated into the MCM advanced research and development and 
procurement programs at HHS and DOD, including the SNS, to ensure the 
U.S. can meet a surge in demand when outbreaks occur.

    Additionally, Congress should work with FDA to clarify the 
regulatory mechanisms by which platforms can be authorized or approved 
in a timely manner for the next pathogen. Platforms that are tested and 
proven for a certain pathogen hold the promise of potentially 
shortening timelines for other pathogens, but FDA's thinking about how 
they are viewing regulatory considerations for the base platform in 
addition to review and approval for specific products could help spur 
further innovation in novel technologies.
            Investment in Novel Antivirals and Therapeutics
    Investments in novel mechanisms for developing antivirals as well 
as treatments for the secondary consequences of infections can make 
future public health emergency responses more efficient and potentially 
faster. Almost 20 percent of the therapeutics tested against SARS-CoV-2 
were repurposed from other fields and served as a model for not only 
quickly understanding the virus but also for directing the development 
of novel clinical products designed specifically to counter the unique 
nature of the virus.

    BIO is encouraged by important programs like the Antivirals Program 
for Pandemics and the University of North Carolina Rapidly Emerging 
Antiviral Drug Development Initiative (READDI). These programs will 
help invest in new antiviral technologies through partnerships between 
government, academic, and industry scientific leaders. These programs 
must be accompanied by funding at BARDA for later stage development and 
manufacturing support for the most promising technologies, especially 
those that could be applied to both commercial and pandemic pathogens.

    While there is a need for more R&D in versatile products that can 
address an array of threats, such as antivirals, the government must 
continue to stockpile and invest in MCMs for specific CBRN and biologic 
threats so that the Nation is prepared for all possible predictable 
scenarios. Novel therapeutics for the treatment of the severe 
consequences of a serious infection should be supported and developed 
as well. Many of these products developed during the COVID-19 pandemic 
may be effective for treating the same or similar consequences of other 
respiratory illnesses, like a bad influenza season. BARDA and the SNS 
must balance their investment between specific countermeasures and 
versatile ones to fully prepare for any future threat.

    Additionally, investments in novel and more accessible delivery 
systems for MCMs can improve the emergency response of the Nation and 
provide better outcomes for patients. Less invasive MCMs and easier 
delivery mechanisms improve access for Americans, especially in 
underserved or rural communities where, for example, access to infusion 
centers may be difficult to reach.
                      Pandemic Influenza Strategy
    Pandemic influenza remains as likely a threat as it has ever been, 
and investments through BARDA, NIH, and the CDC are critical to 
preparing the Nation and the world for a pandemic influenza event. The 
development and manufacturing of influenza vaccines, therapeutics, and 
diagnostics by industry is dependent on Federal funding to support the 
scale and scope of U.S. Government requirements. There is no commercial 
market for pandemic influenza vaccines. Continued investment is 
necessary to maintain a robust R&D pipeline and sustain the 
capabilities the U.S. has developed.

    The September 2019 ``Executive Order on Modernizing Influenza 
Vaccines in the United States to Promote National Security and Public 
Health'' acknowledges that the current domestic enterprise for 
manufacturing influenza vaccines has critical shortcomings. Further 
funding for BARDA's pandemic influenza activities will support work on 
the development of more effective, longer lasting vaccines, as well as 
novel antivirals and therapeutics and rapid diagnostics. These 
additional funds are critical to meeting the needs and objectives 
expressed in the Executive Order with respect to preventing the spread 
of influenza viruses and protecting the United States from future 
pandemics.
      Antimicrobial Resistance (AMR) as a National Security Threat
    Antimicrobial resistance (AMR) represents a major public health and 
national security threat. The CDC estimates almost 3 million Americans 
suffer from AMR-relevant infections annually, with over 48,000 deaths 
resulting from those infections. As the COVID-19 pandemic continues, a 
sizable minority of patients are suffering from secondary infections, 
with the CDC identifying resistant secondary infection outbreaks in 
COVID-19 units. This reinforces the urgent need for access to effective 
antimicrobial products as a part of our pandemic preparedness and 
response.

    A key component of addressing AMR is to address the market 
challenges that have caused a deterioration of the antimicrobial 
medicines pipeline. The Government Accountability Office (GAO)'s 2019 
``Antibiotic Resistance Report'' concluded that pull incentives as well 
as reimbursement reform are needed to ensure the Nation has the AMR 
medicines it needs. While BARDA's CARB-X program makes investments to 
help support R&D, HHS has indicated it does not have the authority to 
implement the policies to reform these market challenges. However, 
Congress has put forward two pieces of legislation, the Developing an 
Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) 
Act of 2021, which address reimbursement barriers to patient access, as 
well as The Pioneering Antimicrobial Subscriptions to End Upsurging 
Resistance (PASTEUR) Act, which creates a sustainable return on 
successful R&D investments into AMR. BIO believes both policies are key 
steps to address the market challenges of AMR and should be included in 
any pandemic preparedness package.
                  MCM Marketplace and SNS Investments
    For many MCMs, the SNS is the only market. Industry partners have 
invested in these technologies in part due to the guarantee that there 
is a sustained government market. In order for the SNS to be properly 
prepared for the next pandemic, it must be fully funded. For the last 
10 years, funding of the SNS has been flat while new FDA approved MCMs 
have been added to the Stockpile. Though the President's fiscal year 22 
budget and the draft budget in the House do propose an increase in 
funding, it still lags behind the amount recommended by the 
professional judgment in the PHEMCE Multi-Year Budget. Because of this 
deficit in funding, many products have not been replenished as they 
should have been. This is particularly true for MCMs against biological 
threats like smallpox and anthrax. Adequate, sustainable funding for 
the SNS keeps the MCM manufacturers in the countermeasure space, allows 
for companies to properly plan for long-term development, and propels 
competition and innovation.

    Additionally, ASPR and BARDA play a critical role in managing the 
lifecycle of an MCM as the entities responsible for late-stage 
countermeasure development and procurement. When funded effectively, 
they facilitate the transition of every medical countermeasures from 
BioShield to sustainable procurement by the SNS, which is vital for the 
continued health of the MCM marketplace.
                   MCM Priority Review Voucher (PRV)
    BIO is supportive of the Medical Countermeasure PRV program created 
by the 21st Century Cures Act and sees the program as an important 
incentive for the research and development of medical countermeasures. 
However, the current five-year sunset of the program will likely offset 
any incentive that the program offers. The program should be extended 
through the removal of the sunset.
                 Clinical Trials for Pandemic Response
    During the COVID-19 pandemic, the NIH established the Accelerating 
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, which 
is managed by the Foundation for the National Institutes of Health 
(FNIH) and includes BARDA, the CDC, FDA, DOD, the Department of 
Veterans Affairs (VA), ``The Operation'' (formerly known as Operation 
Warp Speed), the European Medicines Agency (EMA), and representatives 
from academia, philanthropic organizations, and numerous 
biopharmaceutical companies.

    This public-private partnership seeks to develop a coordinated 
research strategy for prioritizing and speeding development of the most 
promising treatments and vaccines. The problem that it sought to 
address was that there were numerous products in development, all 
competing for patients to participate in clinical studies. ACTIV worked 
to coordinate and streamline processes to make the best use of 
biomedical research resources and testing of preclinical and clinical 
compounds. It also worked to prioritize the most promising candidates 
and move them into clinical trials in a way that was safe and 
efficient.

    This coordination across agencies and with industry led to many of 
the successful products, especially the therapeutics, being used today 
to combat the pandemic. The fast-tracking framework gave needed 
guidance to industry, led to the development and use of master 
protocols, and also expedited the trials process while maintain the 
highest standards of safety and oversight.

    Setting up and maintaining a permanent structure for a clinical 
trial framework to rapidly evaluate products for emergency situations 
is the best way to rapidly respond to emerging health threats. NIH, FDA 
and BARDA should lead, and coordinate with international partners 
(e.g., the Coalition for Epidemic Preparedness Innovations (CEPI), the 
Foundation for Innovative New Diagnostics (FIND), European Health 
Emergency Preparedness and Response Authority (HERA)), in the 
identification of priority pathogens and the creation of a global 
research agenda to accelerate the development of therapeutics, 
vaccines, and diagnostics against emerging infectious diseases. There 
is no reason to disassemble or abandon this successful program, only to 
have to rebuild it again sometime in the future. An ACTIV-like program 
as a long-term part of the pandemic preparedness infrastructure will 
ensure the fastest, safest, and best-planned pathways to vaccines, 
treatments and diagnostics in the future.

    Also, diversity in clinical trials was an important aspect of the 
COVID-19 response and must be prioritized going forward. Prioritizing 
diversity in trials not only leads to better data generation and more 
effective outcomes, but it also strengthens the public confidence in 
the products across the many groups represented in the trials.
  Strengthen and Clarify the Emergency Use Authorization (EUA) Process
    The EUA process functioned largely as designed during the COVID-19 
pandemic. Since going through the process in a pandemic setting, it may 
be of value to set up an emergency response framework to more rapidly 
get decisions made by FDA, NIH, CDC, and/or the Advisory Committee on 
Immunization Practices (ACIP). Expedient communication with industry 
and stakeholders is paramount to an effective EUA process. Making the 
process standardized and providing as much transparency to the public 
as possible will ensure a successful response in the future and help to 
combat vaccine hesitancy by helping to ensure the American people 
understand the safety, effectiveness, and quality of any vaccines and 
therapeutics that receive EUA. This should be coordinated with 
promotional outreach efforts for EUA products that could help with the 
uptake or use of vaccines and therapeutics to directly combat 
misinformation.

    However, the EUA process proved to be more complex and challenging 
in terms of providing requirements and authorization to a number of 
manufacturing facilities--even with a significant, frequent, and 
sometimes embedded presence from the FDA as well as Operation Warp 
Speed representatives from HHS and DOD.
           Health Defense Operations (HDO) Budget Designation
    Congress should authorize an HDO budget designation for a narrow 
set of programs, projects, and activities critical to our Nation's 
health security. The HDO designation would exempt certain programs from 
statutory (and deemed) budget caps to ensure Congress is able to 
appropriate sufficient sums to protect our national health security. In 
order to understand the true need of agencies, Congress should require 
agencies to provide a bypass professional judgment budget that is not 
constrained by spending caps.
                      Public Health Infrastructure
                       U.S. Surveillance Systems
    As our Nation's public health agency, CDC is the lead for viral 
surveillance. CDC's efforts help to provide early warnings of emerging 
infectious diseases and emergent variant strains of infectious 
diseases. More funding is needed to support and expand CDC's viral 
testing, genomic sequencing, and surveillance capabilities so that we 
continue to have an accurate picture of disease epidemiology and 
circulating viral strains to properly direct public health response. 
This is pivotal to track the evolution of SARS-CoV-2 but also emerging 
infections, both viral and bacterial.

    We must remain vigilant against other infectious diseases during 
the COVID-19 pandemic by increasing surveillance of seasonal and 
pandemic influenza and other novel viruses and bacteria.

    To improve our understanding of emerging infectious diseases in the 
U.S., Congress should improve CDC surveillance by expanding the 
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) 
Division of Vector-Borne Diseases' ArboNet system to enhance active 
data collection and analysis of vector-borne diseases, within our 
borders or from returning travelers into the U.S. and enhance 
collection of information on geographic and behavioral risk factors. In 
addition, Congress should ensure adequate funds are authorized for the 
CDC for the collection, sequencing, and analysis of viruses with 
outbreak or pandemic potential and improve overall data collection by 
directing the CDC to request that States and territories include 
serious vector-borne diseases, as ``reportable'' diseases.
                            Data Generation
    Over the course of the COVID-19 pandemic, ASPR worked closely with 
hospitals, public health departments, and other organizations to 
distribute therapeutics. However, the data systems used to track the 
distribution, availability, and use of COVID-19 medicines were not 
robust enough to help industry truly understand where, how, and in 
which populations federally purchased doses of vaccines and 
therapeutics were being utilized.
    HHS should invest in more robust systems that capture complex and 
important data on the location, utilization, and patient demographics 
for all MCMs.
                    Immunization Information Systems
    Our national public health infrastructure is not only vital in 
``normal'' times, it is the backbone of our pandemic response and 
recovery system. Investing in this infrastructure by increasing support 
for state, local, and territorial health departments and state data 
systems, like immunization registries, can help track immunization 
uptake, ensure individuals receive all of their necessary doses, and 
help restore our routine immunization rates. Taking action here will 
also enhance our ability to respond better to outbreaks of vaccine-
preventable diseases as well responses to future pandemics.
    One way that Congress can support public health is by strengthening 
the functionality and interoperability of state immunization 
information systems (IIS) by including H.R. 550, the ``Immunization 
Infrastructure Modernization Act.'' Immunization information systems 
are computerized, multi-faceted systems that operate in 62 
jurisdictions, and have the ability to maintain immunization records 
across the lifespan. They can be used by providers to order vaccines 
and maintain an accounting of inventory, project what a patient needs 
based on what they have received previously (preventing both over-and 
under-vaccination), remind patients when they are due to receive a 
recommended vaccine, and, at a population level, track coverage and 
identify areas where there are low immunization rates so public health 
programs can develop targeted immunization efforts in response. IIS are 
managed at the state level, creating a patchwork of these systems' 
functionality across the country. Having immunization data systems that 
are able to efficiently and effectively manage vaccine ordering, 
inventory, and patient records, and securely exchange information 
across providers, health systems, and public health agencies in real-
time is essential to COVID-19 vaccine efforts, as well as routine 
vaccination efforts.
               Strengthen the Adult Immunization Program
    The COVID pandemic and mass vaccination efforts has driven 
substantial immunization infrastructure investments at the state and 
local level that includes systems, provider recruitment and developing 
relationships and partnerships with community-based organizations that 
supports the diverse needs of adult populations. Adult immunization 
infrastructure improvements and investments in the CDC Immunization 
Program made during the pandemic must be sustained for routine 
vaccination beyond COVID-19. It is vital for public health and pandemic 
preparedness that adult immunization infrastructure remains a priority 
over the long-term if we are going to have a life course approach to 
immunization. This infrastructure is also critical to replicating the 
success of high childhood immunization rates for the adult population. 
It is important that communities can get vaccines to where people are, 
whether it's through a community provider, pharmacy, health care 
center, senior center, or through a mobile van that can go to remote 
areas or provide vaccine services to disabled and homebound 
individuals. This capability is essential not only during a pandemic, 
but also for routine immunizations, such as annual flu vaccine 
campaigns. Having a reliable immunization network for adults will also 
ensure that this form of preventive health is available those who 
otherwise would not be able to afford it.
                               Conclusion
    Thank you for considering BIO's recommendations on pandemic 
preparedness. BIO, along with the rest of the country, learned a lot 
from the experience of COVID-19, and we hope that our insights shared 
here can help prepare us better for the next pandemic. BIO and our 
member companies are committed to working with the HELP Committee as it 
drafts legislation on these issues and would be happy to serve a 
resource. Thank you again for the opportunity to provide testimony for 
today's hearing.
                                 ______
                                 
    The Chair. Thank you.
    Dr. Janz.

STATEMENT OF DAVID JANZ, M.D., DIRECTOR, MEDICAL CRITICAL CARE 
 SERVICES, UNIVERSITY MEDICAL CENTER NEW ORLEANS, NEW ORLEANS, 
                               LA

    Dr. Janz. Chair Murray, Ranking Member Burr, and the 
distinguished Senators of the Committee, I am grateful to have 
the opportunity to testify today and discuss important lessons 
that have been learned during the COVID-19 pandemic, and how 
might these lessons inform future pandemics and other crises in 
health care. These lessons learned from my experience at 
University Medical Center in New Orleans as the Director of 
Medical Care Services, as a health care worker who has treated 
hundreds of critically ill adults with COVID-19.
    University Medical Center in New Orleans cares for a 
diverse and underserved patient population, including uninsured 
patients in low income communities. The first lesson I would 
like to discuss is that learning in real time from forward 
positions in a pandemic prepares locations which will soon 
experience a similar strain in their health care system. In 
March 2020, New Orleans had a rate of rise of COVID positive 
patients similar to the Lombardy region of Italy, which was 
already experiencing marked strain in their ability to deliver 
health care.
    An early description from this region, not just of what 
illness coronavirus causes, but how large numbers of patients 
with this disease impact the health care system was critical to 
our preparation. These operational reports early in the 
pandemic made it clear that early in the fight against this 
disease, success would be driven by public health measures and 
a hospital's ability to manage what is called hospital strain. 
Hospital strain is defined as an excess of demand on the 
resources or abilities of a hospital and is a problem that has 
existed in health care for decades. For example, what systems 
are in place to respond when emergency department is full of 
patients and there is a large number of patients in the waiting 
room? How does a hospital manage mass casualty incidents, or 
how do we care for critically ill adults when intensive care 
units are full? Hospital strain occurs much earlier than the 
nightmare scenarios of running out of ventilators.
    Even more worrisome, hospital strain is associated with 
worse patient outcomes. At University Medical Center in New 
Orleans, we responded to the soon to come strain by scaling 
critical care services for COVID-19, adding personnel such as 
nurses and physicians, giving them evidence based patient care 
tools that allowed them to provide high value critical care to 
a large number of patients. Strain will continue to affect 
hospitals in various ways in the future, and successful 
responses to strain may avoid poor patient outcomes. The 
ability for us and others to share these operational successes 
with other hospitals via seminars conducted by the Louisiana 
Department of Health and the Department of Health and Human 
Services was vital to smaller, more resource limited hospitals 
to aid them during times of current and future strain.
    The past year and a half has also been characterized by an 
unprecedented repair and discovery of effective vaccines and 
treatments for COVID-19 due to an integration of clinical 
research into health care systems. Another key response to 
future pandemics will be high quality clinical research 
conducted efficiently alongside clinical care to develop new 
preventive and treatment strategies for future pandemics.
    The final lesson learned I like to discuss today is the 
lesson that worries me most today in my home city of New 
Orleans and home State of Louisiana. That is specifically 
caring for the caregiver is a vital component to crisis 
response. We have asked a lot of health care providers caring 
for COVID-19 patients over the past year and a half, a first, 
second, and now third, and now fourth wave. We have strained 
the human beings providing this care to a critical point. 43 
percent of nurses around the Nation are considering leaving the 
health care profession this year. The past and current COVID-19 
surges and future health care crises will likely be 
characterized by running out of health care workers rather than 
running out of ventilators.
    Beyond COVID-19, how do we improve care for underserved 
patient populations, increase access to care, make inroads in 
decrease cardiovascular disease and diabetes when--and improve 
many other aspects of health care when health care is asked 
repeatedly instead to focus on COVID-19 surges? Over one-third 
of health care workers are experiencing anxiety or depression. 
As many as one in four are experiencing symptoms of post-
traumatic stress disorder. And symptoms of burnout experience 
over half of critical care physicians. This is the state of the 
workforce asked to return to the COVID-19 front lines for a 
second, third, and now fourth wave.
    We will continue to confront this current wave that we are 
experiencing, which is our duty, knowing that our physical and 
mental health is the cost that we will continually pay. But we 
are still focused on saving the patients in front of us who 
unfortunately may pay a higher price. However, in this time, 
when almost all of this suffering may be prevented by a 
vaccine, we ask, why is this suffering unnecessary and when 
will it end?
    In conclusion, learning from the front lines, health care 
systems responding effectively to strain, rapid dissemination 
of medical evidence, understanding that good clinical research 
results in better clinical care, and taking better care of the 
caregivers are just a few of many approaches to future crises 
in health care.
    Let's continue to develop the national resolve to end this 
current crisis by embracing the gift medical science has 
repeatedly provided to humanity for hundreds of years, that 
gift being vaccinations.
    [The prepared statement of Dr. Janz follows:]
                    prepared statement of david janz
    Chair Murray, Ranking Member Burr, and distinguished Senators of 
the Committee. I am grateful to have the opportunity to testify before 
this Committee and discuss my opinion as to what important lessons have 
been learned during the COVID-19 pandemic and how might these lessons 
inform our response to future pandemics and other crises in healthcare. 
I offer my testimony as only one member of the healthcare community, a 
community which certainly has a wealth of lessons from this pandemic we 
can all learn from, and we should continue to elicit these lessons from 
all of my colleagues beyond my testimony today. These lessons learned I 
present to the Committee are from my experience at University Medical 
Center New Orleans as an Intensive Care Unit physician, the Director of 
Medical Critical Care Services, and as a healthcare worker who has 
treated hundreds of critically ill adults with COVID-19. University 
Medical Center New Orleans is a public-private partnership with the 
State of Louisiana carrying on the legacy of Charity Hospital in the 
city of New Orleans and aims to provide the best possible care for a 
diverse and underserved patient population, including the uninsured and 
low-income populations.

    Learning in real-time from ``forward positions'' during a pandemic 
prepares locations which will soon experience similar strain in their 
healthcare system.

    Pandemic preparation in early 2020 had been well underway prior to 
the first positive test in the New Orleans area on March 9, 2020. 
Existing guidelines \1\ for care and hospital organization were being 
incorporated into pandemic planning; however, at the time there was 
relatively little known about how the COVID-19 pandemic could strain 
the healthcare system. When large numbers of patients seek healthcare 
for an illness that has the potential to cause severe disease, where 
would we see the healthcare system strain under that new weight?
---------------------------------------------------------------------------
    \1\  Hick JL, Einav S, Hanfling D, et al. Surge Capacity Principles 
Care of the Critically Ill and Injured During Pandemics and Disasters: 
CHEST Consensus Statement. Chest. 2014;146(4):e1S-e16S. doi:10.1378/
chest.14-0733.

    In March 2020, New Orleans had a rate of rise of positive SARS-CoV-
2 tests \2\ similar to New York City and the Lombardy Region of Italy. 
\3\ The Lombardy Region was already experiencing marked strain in their 
ability to deliver healthcare due to this rapid influx of patients with 
COVID-19. This was, perhaps, not just a forward position in the fight 
against COVID-19 with early experience with this disease, but also one 
of the first regions to report how the pandemic was straining their 
healthcare infrastructure. Importantly, this experience was relayed to 
the world in not just the news media but also rapidly in the scientific 
literature. While New Orleans was experiencing our first positive cases 
and seeing an exponential rise, on March 13, 2020, physicians from the 
Lombardy Region reported their experience in the Journal of the 
American Medical Association about how patient surges were affecting 
hospital operations. It was an early description not just of what 
illness SARS-CoV-2 causes, but how large numbers of patients with this 
disease impact a healthcare system. Among groups of healthcare 
personnel in New Orleans planning a response to a potential surge of 
patients, their report on forecasting ICU demand was both shocking and 
critical to our own preparatory work.
---------------------------------------------------------------------------
    \2\  Zeller M, Gangavarapu K, Anderson C, et al. Emergence of an 
early SARS-CoV2 epidemic in the United States. Medrxiv. Published 
online 2021:2021.02.05.21251235. doi:10.1101/2021.02.05.21251235.
    \3\  Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization 
for the COVID-19 Outbreak in Lombardy, Italy. Jama. 2020;323(16):1545-
1546. doi:10.1001/jama.2020.4031.

    Nothing captured our attention more than the forecast modeling 
included in the publication suggesting that if an exponential growth 
model predicting possible ICU demand was accurate, as many as 14,542 
ICU admissions would occur in the Lombardy Region in the next 7 days. 
From our perspective as healthcare personnel in New Orleans planning 
how to respond to a surge in COVID-19 patients, we were alarmed that a 
similar exponential rise in positive cases had begun in New Orleans and 
there is not a healthcare system in the world that can manage the 
influx of thousands of critically ill adults over such a short period 
---------------------------------------------------------------------------
of time.

    The Lombardy region went on to experience marked strain in their 
healthcare system during March 2020; however thankfully not to the 
degree that their exponential forecast modeling predicted. \4\ Of 
critical importance to our preparations at University Medical Center 
New Orleans and other hospitals in the region was being able to learn, 
in almost real-time, not just information from the lay press media but 
also actionable information on operations in healthcare systems 
currently experiencing strain and their response to that strain. 
Furthermore, if operational impact occurred, potential mitigation 
strategies, countermeasures, and predictive modeling could be used to 
estimate the potential scope of the problem.
---------------------------------------------------------------------------
    \4\  Grasselli G, Greco M, Zanella A, et al. Risk Factors 
Associated With Mortality Among Patients With COVID-19 in Intensive 
Care Units in Lombardy, Italy. Jama Intern Med. 2020;180(10). 
doi:10.1001/jamainternmed.2020.3539.

    Planning for future COVID-19 surges and for any new crisis that 
will impact the healthcare system worldwide should involve organized, 
intentional information gathering from locations currently experiencing 
the crisis. Information collected should be beyond what is reported in 
the lay media and include specific operational information of local 
healthcare systems, the degree of strain in each operational unit, 
identification of common problems, and elucidation of solutions. This 
information should be available to other hospital systems in real-time 
and disseminated not only in medical journals but also in an open-
access, nationally centralized method, so that healthcare systems 
planning their response to an emerging problem can get information from 
a single location on the experiences of systems currently responding to 
the crisis. Our ability to learn from the experiences in Italy and New 
York City was vital in planning how our system of hospitals in New 
Orleans would respond to this crisis. It was clear that in the early 
fight against the pandemic, successful public health measures would be 
key in preventing complete collapse of the healthcare system and 
success on the level ofindividual hospital systems would be determined 
by their ability to manage a commonproblem in healthcare: hospital 
---------------------------------------------------------------------------
strain.

    Managing hospital strain is vital in a healthcare system's response 
to COVID-19 and any future healthcare crisis.

    Hospital capacity strain, defined as ``excessive demand on the 
strength, resources, or abilities of a hospital and any resource the 
hospital uses to provide care (e.g. beds, nurses, physicians, 
equipment)'', is a problem that has existed in healthcare for decades. 
\5\ Prior to the COVID-19 pandemic, hospitals would experience strain 
on a smaller scale. For example, what systems are in place to respond 
when an emergency department is full with a large number of patients in 
a waiting room, how does a hospital manages mass casualty incidents, or 
how do we care for critically ill adults when the ICU is full and these 
patients have to remain in the emergency department? Hospital strain 
occurs much earlier than the nightmare scenarios of running out of 
ventilators or other vital resources and having to invoke crisis 
standards of care. However, prior to and during the COVID-19 pandemic, 
\6\ hospital strain has been repeatedly associated with increased risk 
of poor patient outcomes. A recent study in the Annals of Internal 
Medicine estimates that influxes of COVID-19 patients causing excessive 
demand on hospital resources may have contributed to as many as 1 in 4 
deaths related to COVID-19 in the United States. \7\
---------------------------------------------------------------------------
    \5\  Eriksson CO, Stoner RC, Eden KB, Newgard CD, Guise J-M. The 
Association Between Hospital Capacity Strain and Inpatient Outcomes in 
Highly Developed Countries: A Systematic Review. J Gen Intern Med. 
2017;32(6):686-696. doi:10.1007/s11606-016-3936-3.
    \6\  Bravata DM, Perkins AJ, Myers LJ, et al. Association of 
Intensive Care Unit Patient Load and Demand With Mortality Rates in US 
Department of Veterans Affairs Hospitals During the COVID-19 Pandemic. 
Jama Netw Open. 2021;4(1):e2034266. doi:10.1001/
jamanetworkopen.2020.34266.
    \7\  Kadri SS, Sun J, Lawandi A, et al. Association Between 
Caseload Surge and COVID-19 Survival in 558 U.S. Hospitals, March to 
August 2020. Ann Intern Med. Published online 2021. doi:10.7326/m21-
1213.

    As previously stated, it was clear early in the COVID-19 pandemic 
that hospital strain would be a vital problem for healthcare systems to 
manage in order to save as many lives as possible. Our response in 
March 2020 to decrease the impact of this strain on our hospital system 
and specifically our intensive care units was to ``scale'' critical 
care services. Scaling critical care services via the development of 
what is referred to as surge capacity has been performed for decades 
around the world in times of acute, brief periods of need. Guidelines 
on how to respond to ICU strain by creating ICU surge capacity have 
been published prior to the COVID-19 pandemic. These guidelines were 
used by many hospital systems during the COVID-19 pandemic, including 
ours, and provided a framework on how to create additional care teams, 
how to re-organize staff to accommodate more patients, recommendations 
on communications and triage, and other operational guidance. These 
guidelines are purposefully broad in recommendations so that they are 
applicable to any disaster or pandemic and, therefore, additional 
response was needed on the hospital level to address the strain unique 
to COVID-19: an illness that causes a large influx of critically ill 
adults with a high severity of illness and continues to strain the 
---------------------------------------------------------------------------
system over the course of months and now, over a year.

    At University Medical Center New Orleans, we scaled critical care 
for COVID-19 in the following ways. First, we focused on increasing the 
uniformity of critical care provided by improving the application of 
evidence-based critical care practices to all ICU patients. Too many 
different ways of caring for a large number of critically ill adults 
would quickly extinguish the bandwidth of an ICU. Given the concern 
early in the pandemic of hospitals running out of ventilators or ICU 
beds, we used the medical evidence that has existed for decades in 
critical care medicine that tells us what practices to use to prevent a 
patient needing a ventilator, if a ventilator is needed using evidence-
based practices to help the patient improve and be liberated from the 
ventilator as soon as possible, and uniformly applying practices known 
to help patients survive and no longer need an ICU bed.

    Second, we scaled critical care capacity by adding more nurses, 
therapists, and physicians to ICUs, as recommended in guidelines, by a 
partnership between the LCMC Network of hospitals and the Louisiana 
State University and Tulane Schools of Medicine who provided additional 
physician support. Experienced nurses and other staff were brought in 
from other areas of the hospital. I cannot emphasize enough the 
importance of our existing and newly added ICU healthcare workers in 
responding to this crisis and their bravery for running toward the 
problem and not away. They work incredibly hard with a sense of purpose 
and duty, selflessly asking only how they can help their colleagues and 
our patients. Patients are alive today because of these heroes and 
institutional partnerships. These additional personnel needed quick, 
simple instruction on four decades of previous medical evidence of best 
critical care practices and how to apply this evidence to a large 
number of COVID-19 ICU patients. We created a number of local protocols 
and guidelines that were simple enough to hand to a new ICU provider 
and they could then easily apply best practices to their patients.

    Finally, we added processes to make this uniform, evidence-based 
care reliable with observers ensuring a checklist of good ICU practices 
was occurring with each and every patient and notifying providers when 
items needed to be performed. With this approach, intensive care units 
at University Medical Center New Orleans have achieved COVID-19 
survival rates as good or better than survival rates reported in the 
medical literature, despite high rates of medical comorbidities that 
portend a worsened prognosis with COVID-19. \8\, \9\
---------------------------------------------------------------------------
    \8\  Janz DR, Mackey S, Patel N, et al. Critically Ill Adults With 
Coronavirus Disease 2019 in New Orleans and Care With an Evidence-Based 
Protocol. Chest. 2021;159(1):196-204. doi:10.1016/j.chest.2020.08.2114.
    \9\  Rosenthal N, Cao Z, Gundrum J, Sianis J, Safo S. Risk Factors 
Associated With In-Hospital Mortality in a US National Sample of 
Patients With COVID-19. Jama Netw Open. 2020;3(12):e2029058. 
doi:10.1001/jamanetworkopen.2020.29058.

    Responding to hospital strain by scaling critical care services and 
creating surge capacity is applicable to future COVID-19 waves and any 
new emerging threat that has the potential to strain the healthcare 
system. The implementation of simple, easy to use patient care tools 
that increase uniformity and reliability are key when healthcare 
systems are stressed and may avoid the associated increase in poor 
---------------------------------------------------------------------------
patient outcomes historically associated with hospital strain.

    Dissemination of early experiences and knowledge improves patient 
care outside of individual hospitals.

    After several hospital systems in Southeast Louisiana began to 
experience an influx of COVID-19 patients in March 2020 and had 
developed their operational responses to the subsequent strain, Dr. 
Alex Billioux at the time was the Assistant Secretary for the Louisiana 
Department of Health's Office of Public Health. Dr. Billioux recognized 
the extensive organizational work occurring in hospital systems in New 
Orleans and Baton Rouge and decided to create a task force of intensive 
care unit physicians and nurses that would collect the COVID-19 patient 
care resources developed so far in these hospitals and disseminate 
those current best practices to hospitals around the state. This 
Louisiana Department of Health COVID-19 Critical Care Task Force 
conducted numerous online seminars in the Spring of 2020 where we 
educated hospitals around Louisiana on the most current, evidence-based 
practices in caring for COVID-19 patients in the ICU, shared our own 
operational challenges and solutions, and helped other hospitals solve 
other challenges they were experiencing. The feedback from hospitals 
around the state was positive: these hospitals were commonly too busy, 
too overwhelmed, too understaffed to have time to develop these easy to 
use patient care tools or come up with operational solutions and these 
seminars immediately solved many of those problems. The Office of the 
Assistant Secretary of Health and Human Services (Preparedness and 
Response), learned of our early experience with COVID-19 in Louisiana 
and our dissemination of this experience with the Louisiana Department 
of Health. The Office of HHS ASPR then added our materials developed in 
Louisiana to the nationwide HHS ASPR COVID-19 Clinical Rounds and had 
representatives from our Louisiana Task Force conduct live seminars via 
these clinical rounds.

    I personally witnessed two significant impacts during these state-
and nation-wide educational seminars. First, many hospitals 
experiencing strain from a pandemic do not have the time or expertise 
to develop patient care and operational tools that are evidence-based, 
easy to use, and reliable. Published pandemic response guidelines from 
national organizations are available to all hospitals during these 
crises, but often hospitals need more specific help and problem solving 
that is not covered in general guideline statements. Hospitals 
responded with gratitude when we were able to share what we created 
with them and allowed them to spend more time in patient care at the 
bedside. Second, non-evidence-based practices were being disseminated 
frequently at the time via the internet, social media platforms, and 
other non-peer reviewed sources. \10\ This created a great deal of 
confusion amongst healthcare providers early in the pandemic as to how 
to treat a patient with COVID-19. These state- and nation-wide 
educational seminars helped clarify questions from healthcare providers 
on which practices were supported by medical evidence and recommended 
by national guidelines.
---------------------------------------------------------------------------
    \10\  Rice TW, Janz DR. In Defense of Evidence-Based Medicine for 
the Treatment of COVID-19 ARDS. Ann Am Thorac Soc. 2020;0(ja). 
doi:10.1513/annalsats.202004-325ip.

    Future responses to healthcare crises and pandemics need to 
incorporate on a national level not only the generation of guidelines 
by medical societies and health organizations, but also frequent, open-
access educational offerings and interactive seminars where providers 
on the front line can share knowledge and help others solve their own 
operational challenges. Strained hospitals, especially critical access 
hospitals and hospitals in resource-limited settings, do not have the 
time or resources to develop their own approach to every aspect of a 
pandemic. Larger hospital systems can share their experiences via a 
national educational platform to lighten the workload of the more 
resource-limited hospitals and collectively decrease strain on the 
---------------------------------------------------------------------------
entire healthcare system.

    A Learning Healthcare System is vital in the response to the 
current and future pandemics.

    Early information gathering and creation of surge capacity were 
only the first steps in the response to the COVID-19 pandemic. The 
approaches described above are only a way to save lives while new 
preventative and treatment tools are created through scientific 
discovery. Even during a pandemic, ``The randomized, double-blind, 
placebo-controlled trial with systematic and comprehensive collection 
of safety, biomarkers, short-and long-term survival outcomes, remains 
the most effective and ethical science to save lives.'' \11\ Within 
weeks of COVID-19 spreading around the world, not only were healthcare 
systems focused on treating patients but of equal importance these 
systems were focusing on learning from these patients in order to save 
lives in the future. Randomized, controlled trials were designed and 
instituted in parallel with the provision of patient care, giving the 
world high-quality answers to questions about almost any proposed 
treatment for COVID-19. This allowed the medical community to focus on 
what was discovered to be high-value care for COVID-19 and avoid 
interventions that were found to be of no benefit.
---------------------------------------------------------------------------
    \11\  Singer M, Kalil A. Do not just sit there, do something but do 
no harm: the worrying aspects of COVID-19 experimental interventions. 
Intens Care Med. Published online 2021:1-3. doi:10.1007/s00134-021-
06460-9.

    The first treatment to show robust evidence of benefit in 
critically ill patients with COVID-19, a steroid medication named 
dexamethasone, was published online in the New England Journal of 
Medicine on July 17, 2020 in a randomized trial of over 2,000 patients. 
\12\ In the span of only approximately 7 months, a novel viral pathogen 
had been discovered, a pandemic had ensued causing high rates of 
critical illness, and a randomized trial of over 2,000 patients was 
able to be conducted and shared with the world a treatment that saves 
lives. Five months later on December 10, 2020, approximately 1 year 
since the first reports of patients infected with the novel SARS-CoV-2 
pathogen, the results of a randomized trial of the BNT162b2 vaccine in 
over 43,000 patients was published. \13\ The rapidity of these 
discoveries is unprecedented in the history of Medicine, is a result of 
the integration of clinical research into patient care via a learning 
healthcare system approach and is clearly lifesaving.
---------------------------------------------------------------------------
    \12\  The RECOVERY Collaborative Group. Dexamethasone in 
Hospitalized Patients with Covid-19--Preliminary Report. New Engl J 
Med. Published online 2020. doi:10.1056/nejmoa2021436.
    \13\  Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy 
of the BNT162b2 mRNA Covid-19 Vaccine. New Engl J Med. 
2020;383(27):2603-2615. doi:10.1056/nejmoa2034577.

    A learning healthcare system aims to provide high-quality 
healthcare to patients while also integrating in parallel clinical 
research infrastructure to learn from patients during their care as to 
how to improve medical care in the future. \14\ This integration of 
patient care and discovery allows the medical community to ``learn from 
what we do and do what we learn.'' Lives will be saved in future 
pandemics as hospital systems continue to integrate clinical research 
infrastructure into the care of patients.
---------------------------------------------------------------------------
    \14\  Lindsell CJ, Gatto CL, Dear ML, et al. Learning From What We 
Do, and Doing What We Learn: A Learning Health Care System in Action. 
Acad Med. 2021;Publish Ahead of Print. doi:10.1097/
acm.0000000000004021.

---------------------------------------------------------------------------
    Caring for the caregiver is a vital component in crisis response.

    We have asked a lot of healthcare providers caring for COVID-19 
patients over the past year and a half. At the beginning of the 
pandemic, ICU nurses, physicians, advance practice providers, 
respiratory therapists, pharmacists, environmental services staff, and 
many others ran toward the problem, not away from it. This was in the 
setting of many unknowns at the time about caring for COVID-19 
patients, including how much of a risk this type of work would be to 
the health of the caregiver, how long this pandemic would last, when 
was more help coming, when would we see family again or have a day off, 
and how do we care for both critically ill patients and our loved ones 
at home. Healthcare workers responded to this overwhelming amount of 
work with a sense of purpose, meaning, and duty. People needed help, it 
is the nature of the healthcare worker to help them. There is not an 
option to run away from this problem, that is not who we are.

    Since the beginning of this pandemic, it is easy to see what we 
have asked of the healthcare system and the people who perform the work 
of caring for COVID-19 patients. In Louisiana, that has been asking 
healthcare providers to help rescue all of us from an initial COVID-19 
surge in March 2020, followed by again by a second surge in July 2020, 
a third in December 2020, and now the beginning of our fourth COVID-19 
surge in Louisiana in July 2021. The human beings performing these jobs 
are being strained with every additional COVID-19 patient admitted and 
every additional COVID-19 surge that occurs.

    There is developing evidence that we have strained the human beings 
providing care to patients with COVID-19 to a critical point. Even a 
brief review of healthcare news over the past year immediately reveals 
countless stories of nurses, healthcare's most precious resource and 
who have shouldered the heaviest load in the COVID-19 response, are 
leaving the profession at high rates. A recent report by Vivian Health 
revealed 43 percent of nurses are considering leaving the healthcare 
profession in 2021 and 72 percent report hospital morale has worsened 
over the past year. In my specialty of Critical Care Medicine, 48 
percent of ICU nurses are considering leaving healthcare. The past and 
current COVID-19 surges and future healthcare crises will likely be 
characterized by running out of healthcare workers rather than running 
out of ventilators and stretching existing healthcare workers to an 
even greater degree. Expending healthcare resources on recurring COVID-
19 surges and losing valuable healthcare workers from the profession 
will almost certainly impact all the other important goals we hope to 
accomplish in improving the health of the nation. How do we improve 
care for underserved patient populations, increase access to care, make 
in-roads on decreasing cardiovascular disease and diabetes, improve 
outcomes for patients with cancer, and improve many other aspects of 
healthcare delivery when healthcare is asked repeatedly to instead 
focus on COVID-19 surges? How do we accomplish all these goals when so 
many healthcare workers leave the profession?

    Studies of healthcare workers caring for COVID-19 patients have 
shown that the risk for the development of mental health problems may 
be as high as other disasters such as the September 11th attacks or 
Hurricane Katrina. \15\ Recent research focusing on the psychological 
impact of COVID-19 on healthcare workers suggests that over one third 
of healthcare workers are experiencing anxiety or depression, \16\ as 
many as one in four have symptoms of post-traumatic stress disorder, 
\17\ and symptoms of burnout are experienced by over half of critical 
care physicians. \18\ This is the state of the workforce asked to 
return to the COVID-19 front lines for a second, third, and now fourth 
wave. We will continue to confront current and future waves, which is 
our duty, knowing that our physical and mental health is the cost we 
will continually pay. Our eyes are forward, focused on saving the 
patients in front of us who unfortunately may pay a higher price. 
However, in this time when almost all this suffering may be prevented 
by a vaccine, we ask why is this suffering necessary and when will it 
end?
---------------------------------------------------------------------------
    \15\  Wright HM, Griffin BJ, Shoji K, et al. Pandemic-related 
mental health risk among front line personnel. J Psychiatr Res. 
2021;137:673-680. doi:10.1016/j.jpsychires.2020.10.045.
    \16\  Sun P, Wang M, Song T, et al. The Psychological Impact of 
COVID-19 Pandemic on Health Care Workers: A Systematic Review and Meta-
Analysis. Front Psychol. 2021;12:626547. doi:10.3389/fpsyg.2021.626547.
    \17\  d'Ettorre G, Ceccarelli G, Santinelli L, et al. Post-
Traumatic Stress Symptoms in Healthcare Workers Dealing with the COVID-
19 Pandemic: A Systematic Review. Int J Environ Res Pu. 2021;18(2):601. 
doi:10.3390/ijerph18020601.
    \18\  Azoulay E, Waele JD, et al. Symptoms of burnout in intensive 
care unit specialists facing the COVID-19 outbreak. Ann Intensive Care. 
2020;10(1):110. doi:10.1186/s13613-020-00722-3.

                               Conclusion
    I present these lessons learned as one member of the healthcare 
community, eager to also learn lessons from my colleagues around the 
world. Experiences during this pandemic have been diverse and we need 
to learn from everyone's successes and failures by ongoing discussions 
as we are having today. Learning from the frontlines, healthcare 
systems responding effectively to strain, rapid dissemination of 
medical evidence and operational strategies, understanding that good 
clinical research results in better clinical care especially when these 
are integrated, and taking better care of the caregivers are just a few 
of many approaches to future crises in healthcare. Let us continue to 
develop the national resolve to end the current crisis by embracing the 
gift Medical Science has repeatedly provided to humanity for hundreds 
of years: vaccinations.
                                 ______
                                 
                   [summary statement of david janz]
  Lessons Learned During the COVID-19 Pandemic and How These Lessons 
                  Apply to Future Crises in Healthcare
    1. Learning in real-time from ``forward positions'' during a 
pandemic prepares locations which will soon experience similar strain 
in their healthcare system.

        Summary: Healthcare systems first to experience a crisis can 
        inform those about to experience a crisis.

        How this applied to COVID-19: Many healthcare institutions 
        benefited from not just the early descriptions of the disease 
        caused by SARS-CoV-2, but also from learning what operational 
        challenges locations experienced early in the pandemic.

        How this applies to future crises: organized dissemination of 
        operational information from forward positions in a pandemic 
        can prepare the locations at highest risk of spread.

    2. Managing hospital strain is vital in a healthcare system's 
response to COVID-19 and future healthcare crises.

        Summary: Excessive demand on hospital resources, referred to as 
        strain, has occurred for decades in healthcare, occurs much 
        earlier than running out of a resource, and is associated with 
        worse patient outcomes.

        How this applied to COVID-19: Healthcare systems response to 
        COVID-19 has largely been a story of how successful a system is 
        in dealing with strain on a large scale.

        How this applies to future crises: Adding healthcare personnel 
        and effective, evidence-based patient care tools will mitigate 
        strain in COVID-19 surges and beyond.

    3. Dissemination of early experiences and knowledge improves 
patient care outside of individual hospitals.

        Summary: Operational experiences of hospitals have historically 
        existed in silos.

        How this applied to COVID-19: The ability to disseminate 
        solutions from our hospital system to hospitals around the 
        country improved care of COVID-19 patients.

        How this applies to future crises: Future crises should be 
        responded to by breaking down silos around healthcare 
        institutions so others can learn from their experiences.

    4. A Learning Healthcare System is vital in crisis response.

        Summary: A Learning Healthcare System emphasizes and integrates 
        both patient care and discovery of new treatments.

        How this applied to COVID-19: The rapidity of discoveries of 
        treatments and vaccines to prevent COVID-19 is lifesaving, 
        unprecedented, and a result of clinical research.

        How this applies to future crises: Lives will be saved in 
        future pandemics if we continue to integrate clinical research 
        into healthcare systems.

    5. Caring for the caregiver is a vital component in crisis 
response.

        Summary: The ability for a system to respond to a healthcare 
        crisis is largely dependent on the physical and mental health 
        of the healthcare worker.

        How this applied to COVID-19: The COVID-19 pandemic has 
        resulted in healthcare workers experiencing increasing rates of 
        physical and mental health problems.

        How this applies to future crises: Our ability to respond to 
        future crises or improve the health of the Nation will be 
        limited by healthcare workers leaving the profession due to the 
        ongoing COVID-19 pandemic.
                                 ______
                                 
    The Chair. Thank you.
    Ms. Cicero.

 STATEMENT OF ANITA CICERO, DEPUTY DIRECTOR, CENTER FOR HEALTH 
  SECURITY, JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH, 
                         BALTIMORE, MD

    Ms. Cicero. Chair Murray, Ranking Member Burr, and Members 
of the Committee, thank you so much for the opportunity to 
speak with you today. I am the Deputy Director of the Johns 
Hopkins Center for Health Security. The opinions expressed are 
my own and don't necessarily reflect the views of Johns Hopkins 
University. For over 20 years, the mission of our Hopkins 
Center for Health Security has been to protect people's health 
from epidemics and disasters, and to ensure that communities 
are resilient to major challenges.
    Last year, our center launched the Capitol Hill Steering 
Committee on Pandemic Preparedness and Health Security, and I 
would like to acknowledge the excellent leadership from 
Senators Baldwin, Burr, and Casey, three of the six Senate co-
chairs of the steering committee. For as long as I can 
remember, this HELP Committee has crafted and supported 
comprehensive bipartisan policies. Thank you for continuing 
that tradition today. The profound effects of the COVID-19 
pandemic should galvanize this Committee and Congress broadly 
to do everything in your power to prevent this or worse from 
happening again, and to better--be better prepared if it does. 
Our goal should be a pandemic free future. When we take a step 
back and look at the big picture, and identify the lessons 
learned from the COVID-19 pandemic, what jumps out is the need 
to fundamentally shift from a largely reactive posture to a 
more proactive posture across the board.
    In my remarks this morning, I will focus on three points 
where we need to shift to a more proactive stance. First, we 
support the $30 billion investment over the next 4 years to 
improve pandemic preparedness as called for in the American 
Jobs Plan. This would bolster our public health capabilities 
and biomedical preparedness to better protect Americans. Second 
is the need for a dedicated Disease X medical countermeasure 
program at BARDA. BARDA has a proven track record of partnering 
with private industry and developing vaccines, therapeutics, 
and diagnostics against a defined list of biological threat 
agents. However, there is no sustained funding or program, or 
strategy dedicated to accelerating the development of medical 
countermeasures for previously unidentified infectious disease 
threats.
    While it is not possible to identify which specific virus 
will cause the next pandemic, we do know that certain viral 
families possess the kinds of attributes such as high 
lethality, high transmissibility, and asymptomatic spread that 
are likely to lead to large scale outbreaks. Because we know 
that viral families with these attributes can produce our next 
pandemic pathogen, BARDA could was sufficient and sustained 
resources work in partnership with companies to advance the 
development of innovative technologies and specific vaccine 
platforms that are best suited against these viral families. 
That way, when the next viral pathogen emerges, we would have 
the ability to adapt the technologies and platforms quickly, 
and quickly develop effective vaccines and drugs before the 
outbreak has a chance to spread.
    A dedicated Disease X medical countermeasure initiative 
should be created in BARDA in coordination with NIH, DOD, and 
other Federal stakeholders. My final example is the need for 
innovation in next generation masks and respirators for medical 
workers, essential workers, and the public. Advances in this 
area are long overdue. Despite the importance and daily utility 
of masks, health care workers have been using basically the 
same surgical masks, procedure masks, and respirators that--for 
decades.
    By incentivizing innovation, we can develop medical masks 
and respirators that are reusable, better fitting, and more 
comfortable for long stretches. The public should also have 
better quality masks. While it is great that you can buy a mask 
almost anywhere these days made of cloth, there is very little 
quality control. The Government could establish standards 
around breathability, wearability, and effectiveness of masks 
to ensure more reliable protection. Currently, also, most masks 
and respirators are either made overseas or their materials are 
sourced from overseas. BARDA could provide financial support to 
domestic companies to scale up production, and the SNS could 
purchase enough to meet future needs based on a range of severe 
scenarios.
    In conclusion, there are many more common sense, attainable 
things that we can do today with your vision and leadership and 
support to save American lives and our Nation's jobs and 
economy tomorrow. Thank you for inviting me to contribute and I 
look forward to answering any questions you may have.
    [The prepared statement of Ms. Cicero follows:]
                   prepared statement of anita cicero
    Chair Murray, Ranking Member Burr and distinguished Members of the 
Committee, thank you for the opportunity to speak with you today about 
the COVID-19 pandemic.

    I am the Deputy Director of the Johns Hopkins Center for Health 
Security and a Senior Scientist in the Department of Environmental 
Health and Engineering at the Johns Hopkins Bloomberg School of Public 
Health. The opinions expressed herein are my own and do not necessarily 
reflect the views of the Johns Hopkins University.

    For over 20 years, the mission of our Center for Health Security 
has been to protect people's health from epidemics and disasters and 
ensure that communities are resilient to major challenges. We have 30 
faculty at the Center with expertise in fields including infectious 
disease, epidemiology, medicine, law, the social sciences, and 
immunology.

    During the past year and a half, I have co-led our Center's policy 
work in response to the pandemic and our efforts to understand what the 
Nation should do to be better prepared for even more catastrophic 
pandemics in the future. Last year our Center launched the Capitol Hill 
Steering Committee on Pandemic Preparedness and Health Security, a 
bipartisan, bicameral educational initiative to provide congressional 
staffers and other stakeholders with information and analysis on 
current and future national health security priorities. I would like to 
acknowledge the excellent leadership of HELP Committee Members, 
Senators Baldwin, Burr and Casey--three of the four Senate co-chairs of 
the steering committee--along with Senator Cindy Hyde-Smith of 
Mississippi and Senators Ben Cardin and Chris Van Hollen of Maryland.

    I also would like to express my appreciation for this Committee's 
long-standing leadership and bipartisan work to improve our Nation's 
pandemic preparedness and biodefense. For as long as I can remember, 
the HELP Committee has crafted and supported comprehensive, bipartisan 
policies. Thank you for continuing that tradition.

    Covid-19 has done great damage to our country in terms of sickness, 
loss-of-life, terrible economic consequence, and job loss. And we are 
not in the clear yet.

    The profound effects of this pandemic should galvanize Members of 
Congress to do everything in their power to prevent this, or worse, 
from happening again and to be better prepared if it does. We should 
aim for creating a pandemic-free future. Investing $30 billion over the 
next 4 years to improve pandemic preparedness, as called for in the 
American Jobs Plan, would get us on a more solid footing by bolstering 
our public health capabilities, innovation, and biomedical preparedness 
to better protect Americans.

    When we take a step back and look at the big picture to identify 
important lessons learned from the COVID-19 pandemic, what jumps out is 
the need to fundamentally shift from being largely reactive to being 
more proactive across the board.

    Before the next large scale outbreak occurs, we need to be more 
proactive in improving our situational awareness through better data 
collection, diagnostics, surveillance and genomic sequencing; more 
proactive in bringing our antiquated public health infrastructure into 
the 21st century; more proactive in using cutting-edge technologies to 
quickly develop medical countermeasures; more proactive in having a 
reliable supply chain and stockpile in place; more proactive in our 
ability to provide excellent care for patients in our health system, 
even during large surges; and more proactive in earning the trust of 
diverse communities before a pandemic so that there is greater support 
for outbreak response measures. We have learned the hard way that 
trying to play catch up and accomplish these things in the midst of a 
pandemic is like swimming against a strong rip tide.

    Our Johns Hopkins Center for Health Security has submitted 
recommendations to Senator Murray and Senator Burr for improving the 
Nation's public health and medical preparedness response programs.

    In my remarks today I will focus on two of the important areas 
where we need to shift to a more proactive stance if we want to be 
better prepared for a future pandemic--one that could be more 
catastrophic than COVID-19. The first area is advancing biomedical 
preparedness and the second is improving our public health 
infrastructure.

    I want to stress that the examples I will give of innovations in 
each of these areas are not futuristic, out-of-reach goals. They are 
achievable and realistic improvements that, with the support of 
Congress, can enormously advance our Nation's preparedness for future 
pandemics.
         1. Advancing Innovation in our Biomedical Preparedness
    Three ambitious but achievable goals for advancing innovation in 
our biomedical preparedness are: (1) establish a dedicated ``Disease 
X'' medical countermeasure program; (2) incentivize innovation in masks 
and respirators for health care workers and the public; and (3) 
prioritize development and review of at-home diagnostic technologies.

    We have seen firsthand during this pandemic how powerful and 
lifesaving it is to have rapid and safe vaccines and therapeutics, as 
well as reliable diagnostics against novel infectious disease threats. 
The Biomedical Advanced Research and Development Authority (BARDA) 
within the Office of the Assistant Secretary for Preparedness and 
Response (ASPR) at the Department of Health & Human Services (HHS) has 
a proven track record of partnering with private industry and 
developing medical countermeasures against a defined list of biological 
threat agents.

    However, there is no sustained funding, program, or strategy 
dedicated to accelerating the development of medical countermeasures 
for previously unidentified infectious disease threats. The U.S. should 
set an ambitious goal of rapidly developing medical countermeasures for 
novel or unknown viral threats in just a few months. Innovative 
technologies, outside-the-box thinking, sustainable partnerships, and 
game-changing science can be harnessed to meet this goal.
                               Disease X
    The next deadly virus, or ``Disease X,'' could be right around the 
corner. The U.S. will need to move even faster to develop and deploy 
medical countermeasures to save lives and safeguard the economy. 
Accordingly, a new dedicated Disease X Medical Countermeasures 
Initiative should be created to accelerate this process at BARDA, in 
coordination with DOD and other Federal stakeholders. BARDA needs 
sufficient and sustained Federal funding dedicated to developing 
medical countermeasures against future viral threats that are unknown 
and therefore not on the ``material threat determination'' list.

    It is not possible to identify which specific virus will cause the 
next pandemic, but we do know that certain viral families possess the 
kinds of attributes--such as high lethality, high transmissibility, and 
asymptomatic spread--that are likely to lead to large scale outbreaks. 
Because we know that viral families with these attributes can produce 
our next pandemic pathogen, BARDA could, with sufficient, sustained 
resources, advance the development of the technologies and vaccine 
platforms that are best suited to use against these viral families, and 
support innovations that enable rapid, large-scale response. That way, 
when the next viral pandemic pathogen emerges, we would have the 
ability to quickly adapt those technologies and platforms to develop 
effective vaccines and other medical countermeasures before the 
outbreak picks up speed.
                 Next Generation Masks and Respirators
    Just as we need to commit to developing medical countermeasures in 
weeks, not months or years, we should likewise increase our 
expectations for effective masks for medical workers, essential 
workers, and the public. Innovations in this area are long overdue. 
Medical masks and respirators for health care workers are essential 
pieces of personal protection equipment (PPE), especially during 
outbreaks of contagious respiratory pathogens. However, despite their 
importance and daily utility, health care workers have been using 
basically the same surgical masks, procedure masks, and respirators for 
decades. Through incentivizing innovation, we can develop masks and 
respirators that are reusable, better fitting, and more comfortable for 
long stretches.

    The public should also have better-quality masks that are certified 
to meet breathability, wearability, and effectiveness standards 
established by government. It's great that anyone can buy a cloth mask 
almost anywhere these days, but there is little quality control for 
public use masks. BARDA launched a Mask Innovation Challenge, and they 
should continue to foster technical advances in this area. Using new 
information gleaned from this challenge, BARDA could create target 
product profiles for new and better-quality medical respirators and 
public use masks.

    As with other types of PPE and medical supplies, we must ensure the 
stability of a reliable supply chain for a range of respiratory 
devices. Currently, most masks and respirators are either made 
overseas, or their materials are sourced from overseas. Once devices 
meet new target product profiles established, BARDA should provide 
financial support if needed to domestic companies to scale up 
production, and the SNS should purchase enough to meet anticipated 
future needs based on modeling of various severe scenarios.

    Although it is uncomfortable to imagine, a future viral pathogen 
could be even deadlier and spread more easily than SARS-CoV-2. On the 
most basic level, health care workers, other essential workers, and the 
public must have an abundant supply of masks that can protect them from 
infection while countermeasures are being prepared.
                          At-Home Diagnostics
    Another area ripe for innovation are at-home diagnostics for viral 
threats. Limitations around access to reliable diagnostic testing have 
dominated much of the response to COVID-19. As outbreaks emerged in 
countries around the world, the US was unable to quickly deploy 
reliable testing tools. Looking ahead, a world in which individuals and 
families have access to reliable home testing for infectious disease 
threats is in reach if we set that as our goal. We can change the 
paradigm if there is enough will and commitment to do so. People 
already can take home HIV tests, and BARDA is currently funding 
advanced development of at-home diagnostics for influenza. Imagine if 
you could conveniently and cheaply test yourself and your family for 
things like strep throat, flu or a new dangerous virus. Currently, we 
mostly fly in the dark without knowing what kinds of viruses are 
infecting us or circulating in our communities.

    Congressional funding, and the development and review of at-home 
diagnostic technologies by BARDA, FDA, and CMS should be prioritized. 
BARDA could increase the development of direct-to-consumer home tests 
for infectious diseases. FDA could help to streamline regulatory 
pathways for such devices. And CMS and private insurers should provide 
payment and reimbursement schedules for these devices to facilitate 
uptake. There are now some at-home COVID tests on the market, but it 
took us more than a year into the crisis to get there, and their 
pricing puts them out of reach for many people.

    At-home diagnostics for infectious diseases, coupled to information 
technology, could have a transformative benefit for current and future 
pandemic response. Not only could it decrease the unnecessary use of 
antibiotics, but it could also greatly improve our early warning 
surveillance for infectious disease threats.

    For these and other achievable advances in our Nation's biomedical 
preparedness, it is critical to have strong Federal leadership that is 
motivated and empowered to maintain the momentum and contribute to the 
success of our pandemic response efforts. In this regard, it is 
important to have a strong, operational, well-functioning office of the 
Assistant Secretary for Preparedness and Response which has the hiring 
and budgeting authorities it needs to respond quickly and proactively 
during serious health emergencies that the Nation could face.
      2. Advancing Innovation in our Public Health Infrastructure
    In addition to innovation in biomedical preparedness, we must 
support innovation in our public health capabilities at the state and 
local levels; they are our first line of defense against dangerous 
outbreaks. We also need to fully support the creation and annual 
funding of a National Center for Epidemic Forecasting and Outbreak 
Analytics.
                 State and Local Public Health Capacity
    Because we have never sufficiently prioritized public health in the 
past, its infrastructure is woefully inadequate now. Some of our state 
and local public health agencies are still reliant on 1950's 
technologies--using pencil, paper, and fax machines to manage data--
while the hospitals down the street from them are fully in the 21st 
century. There is a technological disconnect between public health and 
health systems that greatly hinders our ability to collect, share, and 
appropriately respond to actionable data during a public health crisis.

    A strong public health infrastructure is not something that can be 
ramped up after a large-scale outbreak has already gained steam. We 
have certainly seen this across the board during the COVID-19 pandemic 
from spotty and irregular collection and reporting of COVID-19 case 
data to the too little/too late attempt to hire contact tracers to 
trace infections once there was already rampant community spread of the 
virus.

    Although Congress has appropriated $1 billion for data 
modernization across the CARES Act and the American Rescue Plan, it 
will take years for our country's public health data infrastructure to 
be brought up to speed. In the meantime, we are now in a position where 
we are facing a new wave of Covid-19 without the data we need to make 
crucial decisions. We do not conduct surveillance in a way that gives 
us real time data about who is getting sick from which variant. Many 
states are moving to weekday-only or even weekly reporting of cases. 
Data on mild breakthrough cases of fully vaccinated people is not being 
collected. There is no central tracking of outbreaks in schools. These 
kinds of gaps make it difficult to understand how the virus is 
circulating in our communities.

    What does a more proactive strategy for public health 
infrastructure look like? Given sufficient resources, people, and 
modern IT systems, public health agencies at the local and state levels 
could be seamlessly connected to health care providers and labs and 
collect more accurate, standardized, real-time data. We need to leave 
the disjointed, local reporting systems behind and develop uniform 
systems for reporting on testing, positive cases, hospitalizations, and 
deaths.
    National Center for Epidemic Forecasting and Outbreak Analytics
    There is $500 million in the American Rescue Plan for the National 
Center for Epidemic Forecasting and Outbreak Analytics, as well as data 
modernization. To establish this as a permanent capability, the 
epidemic forecasting center should be included in annual appropriations 
to support its ongoing mission.

    I thank Congress for the investments it has already made in our 
data infrastructure and encourage a continued commitment to supporting 
our Nation's public health institutions with the authorities and 
funding they need to ensure we have a proper infrastructure in place 
for the next pandemic.

    Again, I hope that my testimony has shown that there are 
commonsense, attainable things we can do today, with your vision, 
leadership, and support, to save American lives and our Nation's jobs 
and economy tomorrow.

    Thank you for inviting me to contribute to the hearing and for your 
important work on pandemic preparedness. I look forward to answering 
any questions you may have.
                                 ______
                                 
                  [summary statement of anita cicero]
    Chair Murray, Ranking Member Burr and distinguished Members of the 
Committee, thank you for the opportunity to speak with you. I am the 
Deputy Director of the Johns Hopkins Center for Health Security and a 
Senior Scientist in the Department of Environmental Health and 
Engineering at the Johns Hopkins Bloomberg School of Public Health. The 
opinions expressed are my own and do not necessarily reflect the views 
of the Johns Hopkins University.

    The profound effects of the COVID-19 pandemic should galvanize 
Congress to do everything in its power to prevent this from happening 
again and to be better prepared if it does. Investing $30 billion over 
the next 4 years to improve pandemic preparedness, as called for in the 
American Jobs Plan, would bolster our public health capabilities, 
innovation, and biomedical preparedness to better protect Americans.

    When we take a step back and look at the big picture of lessons 
learned from the COVID-19 pandemic, what jumps out is the need to 
fundamentally shift from being largely reactive to being more proactive 
across the board. I will focus on two of the important areas where we 
need to shift to a more proactive stance if we want to be better 
prepared for a future pandemic that could be even more catastrophic 
than COVID-19. The first area is advancing biomedical preparedness and 
the second is improving our public health infrastructure.
         1. Advancing Innovation in our Biomedical Preparedness
    Three ambitious but achievable goals for advancing our biomedical 
preparedness are: (i) Establish a dedicated ``Disease X'' medical 
countermeasure program in BARDA to leverage platform technologies and 
rapidly develop medical countermeasures against those viral families 
that have the attributes likely to lead to future pandemics. (ii) 
Innovate and set quality standards for next generation masks and 
respirators for health care workers and the public; ensure the 
stability of a reliable supply chain for a range of respiratory 
devices; and stockpile sufficient quantities. (iii) Prioritize 
development, facilitate regulatory review, and find workable 
reimbursement and payment mechanisms for at-home infectious disease 
diagnostics to increase surveillance and accessibility. For these and 
other achievable advances in our Nation's biomedical preparedness, it 
is critical to have strong and operational ASPR.
      2. Advancing Innovation in our Public Health Infrastructure
    In addition to innovation in biomedical preparedness, we must 
support innovation in our public health capabilities at the state and 
local levels. We must bridge the technological disconnect between 
public health and health systems that greatly hinders our ability to 
collect, share, and appropriately respond to actionable data during a 
public health crisis. What does a more proactive strategy for public 
health infrastructure look like? Given sufficient resources, people, 
and modern IT systems, public health agencies could be seamlessly 
connected to health care providers and labs and collect more accurate, 
standardized, real-time data on testing, positive cases, 
hospitalizations, and deaths. We also need to fully support the 
creation and annual funding of the National Center for Epidemic 
Forecasting and Outbreak Analytics.

    These recommendations are attainable with your vision, leadership, 
and support, to save American lives and our Nation's jobs and economy 
tomorrow. Thank you.
                                 ______
                                 
    The Chair. Thank you. And again, thank you to all of our 
witnesses for being here today and for your testimony. We will 
now begin around a 5-minute questions for our witnesses. I 
again ask our colleagues, keep track of the clock and please 
stay within those 5 minutes. Mr. Becker, let me start with you. 
You do have significant experience building innovative data and 
laboratory infrastructure for state and local health 
departments.
    As we have all seen over this past year and a half, 
complete and accurate data on cases, hospitalizations, and 
deaths allows us to reduce community spread and it saves lives. 
I want to ask you, what was the biggest initial barrier to 
effectively sharing COVID-19 data between public health 
systems, medical systems, and Federal agencies?
    Mr. Becker. Thank you for the question, Senator. I would 
say interoperability is the biggest challenge, but it is only 
the biggest by an nth degree. So interoperability with our 
hospital systems create a lot of workload and stress on the 
public health system, which is already underfunded and 
understaffed. And one of the issues that we have from a public 
health standpoint is that our systems don't talk the same 
language. So we are talking at each other, but not to each 
other and that creates confusion and especially in the 
pandemic.
    That is the top one. But I would say just underneath that 
is just the scalability of the systems that exist today. These 
systems were built 20, 30, even some of them 40 years ago, and 
they are slow and they don't adapt to today's world. One of the 
issues that we had, for instance, in Washington State was the 
electronic lab reporting system, which was designed many, many 
years ago, could only handle about 350,000 cases per year in 
the State of Washington. And that is about what we asked of it.
    In the pandemic, we were asking it to do that in less than 
a month, and it created slow systems that couldn't respond, a 
frustrated workforce, and that just leads to error and the 
ability--the lack of ability to respond to the immediate needs 
of the system. So I think those were two. I took liberties with 
your question but thank you.
    The Chair. That was great. Thank you so much. You know, the 
flood response to this pandemic caused new health inequities 
and exacerbated existing ones. And without improved data on 
race and ethnicity, it is difficult to know the extent of the 
impact and to adjust our response accordingly. How can we 
improve data collection and sharing so we can have a better 
understanding of the impact of the pandemic on communities of 
color?
    Mr. Becker. Thank you for the great question. And that is a 
true issue that we are going to have to deal with at all levels 
of state, local, and Federal Government. And we need standards 
for one on the collection of that data, so it is normalized 
across all those systems. And it sounds very simple when you 
talk about just collecting additional race, ethnicity, and 
demographic data, but it is actually quite complicated. It is 
complicated by the systems that don't allow for those quick 
changes.
    But it is complicated by the way the questions need to be 
asked and the workforce that needs to be trained to ask them 
and the regional variations that happen across this country 
with racial and ethnic diversity. For instance, in Washington 
State, we have tribal Governments and there is 29 of those. And 
we need to get those affiliations right so we can report back 
to those tribal partners. And that is a lot of work for them 
right now to classify themselves once that data is in our 
system.
    The Chair. Okay, thank you. Ms. Cicero, we have to address 
all the facets of our public health infrastructure while 
working to improve our response workforce, data, medical 
countermeasures to state and local capacity. We can't solve 
just one of these challenges, ignore all the others, and expect 
our system to work better the next time around. What is your 
top recommendation for Federal action that will allow us to 
comprehensively and systematically address the failures we have 
seen over the course of this pandemic?
    Ms. Cicero. Thank you for that question, Senator. Once 
again, I believe it is very important to invest sufficiently in 
our future for long standing, sustained support for our public 
health infrastructure, for biomedical preparedness, for our 
hospitals, frontline workers. And we can do that through the 
$30 billion investment, or at least that is a good start, 
through the American Jobs Plan. And that money would be well 
spent so that we don't just react to this crisis and move on in 
that crisis complacency cycle but invest in the future in a 
sustained way.
    The Chair. Thank you. I will retain the balance of my time. 
We have a number of Senators and a vote at 11:30 a.m. So, 
Senator Burr, I will turn it over to you.
    Senator Burr. Thank you, Madam Chair. Mr. Becker, what if I 
told you that technology was available today that through 
video, an algorithm could determine the pulse rate, the 
oxygenation level, the respiration rate of individuals in the 
video and could predict a potential outbreak of COVID in any 
given geographical area 3 days before somebody presented 
themselves to the emergency room for a test. Would that be a 
plus for the surveillance network?
    Mr. Becker. Thank you, Senator. It would be an absolute 
plus. I mean that--real time data analytics and the ability to 
predict things and catch them before they spread in the 
community are a fantastic thing, but the challenge is 
operationalizing that within the current system.
    Senator Burr. The challenge is incorporating that in a 
layered surveillance system and a culture that looks and says, 
no, we just need a bigger computer that processes 10 day old 
data faster. That is the challenge that we are in right now, is 
that we are not taking advantage of technology in all aspects. 
And we have seen it in development. We have seen it in 
manufacturing, but we haven't seen it in the early stages. Ms. 
Cicero.
    Ms. Cicero. Yes. Thank you, Senator Burr. I wanted to add 
to that I agree with your point. And we have the ability now, 
if we invest and commit to it, to develop at home diagnostics 
for infectious diseases. People can already get HIV testing 
from home. I know that HHS is working on supporting companies 
that are developing at home influenza testing, and that should 
be the future. That wouldn't it be great if we could test our 
families for strep or for flu or for the new unknown virus and 
better diagnose those viruses so that we can have early warning 
and reduce use of antibiotics and also better protect 
Americans.
    Senator Burr. Great point. Ms. Arthur, you said solutions 
like READDI at the University of North Carolina, Chapel Hill 
have established--have been established to fill the gaps in the 
early stage discovery development so that we can better be 
prepared when the next pandemic comes. How can early stage 
discovery of treatments targeting virus families better prepare 
us for future pandemics, and what tools do we need to succeed 
in that type of work?
    Ms. Arthur. Thank you, Senator. I think this is an example 
of how we invest in early stage development in peacetime. It is 
very similar to what Anita was saying, that we should be 
working on leveraging novel technologies, both platform 
technologies for viral families as well as new antiviral 
mechanisms for viral families. We can do a lot of different 
work across these families, the coronaviruses, the 
flaviviruses, and have a base of knowledge and understanding of 
how those different technologies actually could respond if we 
see a novel virus in that family.
    I think we learned that with SARS and MERS, with the SARS-
CoV-2 outbreak, and doing a deeper analysis and a deeper set of 
testing of these kinds of new mechanisms could actually allow 
us to spring forward even faster with new products if we see a 
disease x that we don't know. It has to have that funding on 
the back that pulls those products through from early stage 
development through the more expensive later stage clinical 
trials and the manufacturing scale up. But that partnership 
between the agencies could do that.
    Senator Burr. Let me just remind you, the shelf life of 
Congress funding programs is about 18 to 36 months. And then we 
sort of forget about it unless there is a crisis that 
materializes. So it is a challenge. Ms. Cicero, let me ask you 
a question, but before I do, let me just--you talk about the 
expanded jurisdiction authority of BARDA. BARDA does have the 
authority today to invest and develop massively in technology 
platforms. So even though it is not there in an increased 
threat list, we did add antibiotics to their portfolio.
    From the standpoint of the technology platforms, it has 
expanded their capabilities significantly. Now, Hopkins gave 
the CDC a good run for their money with COVID tracking. Not 
only did it become a useful tool for the American people to be 
able to track the virus in their communities, Federal officials 
were also using it as a resource, and it was quoted frequently.
    How can the Federal Government better partner with the 
private sector and academia to advance virus surveillance 
capabilities?
    Ms. Cicero. Thank you for that question, Senator, and I 
agree with your stated goal early on that for CDC it should be 
the premier CDC in the world. It has been for years, and that 
needs to be our goal going forward into the future. We need to 
provide CDC with a sufficient resources and purpose to be able 
to expand, to be able to work more seamlessly with the private 
sector, with academia, and to invest in the kinds of systems 
that they need for better surveillance, to work more seamlessly 
with state and local public health agencies, and to be able to 
really have that real time data that is more actionable so that 
it informs the response.
    Senator Burr. Madam Chair, just one last question. Dr. 
Janz, how was Dr. Cassidy as lecturer?
    [Laughter.]
    Dr. Janz. Best diarrhea there is.
    Senator Burr. Very good answer. Thank you.
    [Laughter.]
    The Chair. Thanks.
    Senator Casey.
    Senator Casey. Chair Murray, thank you for calling this 
hearing. I want to thank you and Ranking Member Burr, and I 
want to get to our witnesses, we are honored you are here, and 
get to my questions. I did want to join so many of our 
colleagues in paying tribute to Mike Enzi, former Senator from 
Wyoming. Probably the best way to describe Mike Enzi is he was 
a paragon of decency in a town where that is often in short 
supply. Just such a good person.
    It is always interesting what you remember when you hear 
about the passing of someone that you knew or someone that you 
had some familiarity with. And I got to know Mike on this 
Committee. But before I was on this Committee, I think it was 
my first year. I remember standing on the Senate floor, just 
one of those interactions you remember at a moment like this 
where our former Senate Majority Leader, Harry Reid, was 
standing next to me toward the back of the chamber and he made 
reference, and he pointed across the room and said, he said, 
Bob, that is Mike Enzi. He is a good man. That is all he said. 
And then as Harry Reid often does, he didn't say much more. But 
I didn't know Mike at that point in time and then got to know 
him a few years later on this Committee. And we are going to 
miss him in so many ways. And we are just so saddened that soon 
after leaving this chamber that he, in this legislative body, 
that he was taken from us.
    We are thinking of him, remembering him with respect and 
fondness, but also, of course, thinking of his family and 
praying for them. So we are all going to be paying tribute to 
him in the next number of days. I wanted to thank the witnesses 
for sharing their remarkable expertise with the Committee on 
Pandemic Preparedness legislation, all kinds of legislation.
    I appreciate the opportunity to have worked with Chair 
Murray in the past on these issues. And Ranking Member Burr, he 
was working on these issues before, just a number of years 
before I got to the Senate, also with Ted Kennedy, I guess, 
Richard, at that time, as he made reference to, Senator Enzi, 
Senator Kennedy working together. But I appreciate both the 
Chair and the Ranking Member and the work they have done, 
especially on previous authorizations of the so-called Pandemic 
All Hazards Preparedness Act. We are still grappling, of 
course, with the COVID-19 pandemic. And we also need to look 
ahead to the next public health emergency and get prepared for 
that. So I will start with me Ms. Arthur. I want to thank you 
for your testimony today and the expertise you bring. The 
many--and also the many times you have shared that expertise 
with members of our staff. I wanted to ask you to expand on 
what you had in your written testimony on page 13.
    Just for reference, you made reference to state 
immunization information systems, and you describe them this 
way on page 13, ``computerized multifaceted systems that 
operate in 62 jurisdictions and have the ability to maintain 
immunization records across the lifespan that can be used--can 
also be used for providing for providers, I should say, to 
order vaccines and maintain an accounting of inventory and it 
goes on from there. But I guess the basic question with regard 
to these information systems is what are some of the challenges 
they currently face?
    Ms. Arthur. Thank you, Senator, for that question. These 
systems are very, very important to the core public health 
infrastructure of each state, and they face many different 
challenges. Data capture, the way that they are built. Some of 
them are older. Each state has their own. Some of them do not 
yet include or had to quickly add space for adult immunization 
because of the pandemic. I think what is most important, very 
much like Mr. Becker said, is the interoperability of systems.
    Interoperability with the electronic health record, 
interoperability between states. Many people might live in one 
state and work in another. It is really important that we think 
of these immunizations information systems as one of the core 
foundations of our vaccination infrastructure.
    Senator Casey. How about, are there resources available 
from the Federal Government to support both as you make 
reference to functionality and interoperability?
    Ms. Arthur. Absolutely there are. The CDC actually has 
immunization cooperative agreements with the 50 states, 
territories, HHS, etc. But the funding here has been stagnant 
for many years. And each state then apportion some, or maybe a 
very small amount of their state budget to these systems. They 
really do need an overhaul and a clear modernization. And 
certainly there are several legislative bills moving that 
actually seek to help the states modernize their immunization 
information systems. We strongly support those among the 
vaccine companies at BIO. And thank you for your support of 
that as well.
    Senator Casey. Thank you.
    The Chair. Thank you.
    Senator Cassidy.
    Senator Cassidy. Thank you. Let me just follow-up right 
there, Ms. Arthur. You allude to it in your testimony and going 
back to what Chair--Ranking Member Burr said earlier. Congress 
gave $1 billion to CDC to upgrade information systems. And I 
was specifically asking last year for more money for 
immunization information systems and was told that billion was 
going out to states in order to upgrade. That is where it was 
targeted because I was frustrated with CDC's inability to give 
real time data.
    Now, Mr.--so it seems as if we are advocating for dollars 
of which a billion has already been appropriated and we are 
told that is where it went. But Mr. Becker, in your testimony, 
you indicate that in Washington State there has been inadequate 
money to upgrade the immunization information system. I say 
that because it seems like there is a disconnect here. We gave 
$1 billion.
    I was specifically told it is going to go to upgrade state 
information systems. And I am hearing from a very innovative 
state that you have inadequate resources to upgrade. So let me 
ask, did you receive money from that $1 billion that we gave 
CDC last year?
    Mr. Becker. Thank you, Senator. I will have to go back and 
find out how much Washington State actually received from the 
CDC. But I can tell you that whatever we received was not 
adequate to meet the needs of what we have faced today.
    Senator Cassidy. Now, it could be that the state used it 
for something else. Let's just be fair to CDC. Unless they came 
down with a specific instruction to spend it on immunization 
information systems. But it does seem, let me just ask, in your 
testimony, you do mention that you had a hard time keeping 
track, but this is exactly what information--immunization 
information systems are supposed to do. Why was Washington 
State's not adequate to do so?
    Mr. Becker. Thank you, Senator. Is this the scalability, 
interoperability that I mentioned in the very first part?
    Senator Cassidy. But in the interoperability, you mentioned 
by EHRs, but the way if a child is given a measles, mumps, 
rubella vaccine, the provider actually enters that. So, and we 
have had other states come in here and testify that their IIS 
was able to, is currently accepting adult immunizations on 
COVID. Now, I guess I am just exploring, I am not trying to 
accuse. I am just trying to understand why this is not the 
case. Why isn't it the case in Washington?
    Mr. Becker. I think it is this disparate system. So you 
have very big hospital systems that can invest the 
infrastructure to send those things seamlessly. You have 
private providers----
    Senator Cassidy. What I am not sure about though, if a 
pediatrician has any measles, mumps, rubella in that big 
hospital system, clearly the mechanism occurs. I won't belabor, 
but it does seem--I am just not, I am just not getting a clear 
picture into what the problem is. We get $1 billion the CDC. 
Somehow it is not happening. And yet the system works for 
childhood immunization, but it is not working for adult. I 
won't belabor. Dr. Janz, I think one thing is clear. You 
mentioned in your testimony the need to have uniform standards 
of care. Fecal material is hitting the fan. And we don't have 
enough ICU beds--I probably used that line in my diarrhea 
lecture.
    We don't have enough ICU beds, but then we learned that we 
are putting too many people on ventilators and putting on 
ventilators at too early a stage actually was associated with 
negative outcomes. How do we--I have to think that there is 
probably uneven uptake of that information in ICUs across the 
Nation. I don't know that I am just assuming. How do we 
establish that uniform communication of care when--how we 
manage a ventilator patient, to ventilate or not, really is 
critical in terms of both ICU utilization, but also the 
patient's survival?
    Dr. Janz. Yes. Thank you, Senator. It was vital for us to 
be able to spread evidence based medicine, how to prevent 
patients----
    Senator Cassidy. How did you do it?
    Dr. Janz. Via the Louisiana Department of Health and the 
Department of Health and Human Services. When we have conducted 
seminars with hospitals around the state in the Nation where 
they asked us, how do you solve these specific operational 
problems? We gave them answers.
    Senator Cassidy. Were you also able to give them like a 
checklist, similar----
    Dr. Janz. Yes, we shared with them all of the materials we 
developed on our own hospital. We stepped outside of the silo 
of an individual hospital system and shared all that.
    Senator Cassidy. Sorry to interrupt but I am almost out of 
time. And you want went nationally. Who sponsored your national 
outreach?
    Dr. Janz. ASPR with the Department of Health and Human 
Services.
    Senator Cassidy. Well hats off to ASPR for pulling that 
together.
    Dr. Janz. Absolutely.
    Senator Cassidy. Did you--were you able to demonstrably see 
that how patients were being managed kind of stayed in lockstep 
with best practices across the nation?
    Dr. Janz. Yes, it did catch up over time into what----
    Senator Cassidy. Over time, how long over time? A month, a 
week?
    Dr. Janz. Oh, in the scale of weeks. It was very quick. 
Hospital, the feedback I got from hospitals----
    Senator Cassidy. One more thing. We were short--I got a 
call from an anesthesiologist in San Francisco when things were 
really bad in New Orleans. He goes, we shut down elective, but 
COVID hadn't hit us yet. We should be shipping all our machines 
to you and then you ship them back when it hits us because we 
understood there is going to be an uneven kind of 
implementation. It never happened. Instead, we are scrounging 
to build new ventilators when they were sitting idle in many 
parts of our Nation. I just say that because I do think part of 
what we are doing here would be to source existing resources 
where they are needed from one part of the Nation to another, 
as opposed to attempting to build from scratch a lot of 
machines that are very sophisticated, but then we don't need 
them when it is all done. So anyway, with that, I thank you all 
for your service and your testimony.
    The Chair. Thank you.
    Senator Smith.
    Senator Smith. Thank you, Ranking Member Murray--I mean, 
Chair Murray and Ranking Member Burr. I really appreciate this 
bipartisan hearing. I am struck--here we are today. We are at a 
pivotal point in the COVID-19 pandemic. There has been a 400 
percent increase in new COVID cases over the past month. So 
what we do right now is going to determine what happens next 
with COVID-19. So today we are talking about lessons learned, 
but I feel driven to remind us that we need to learn these 
lessons like today and then apply them today so that we can 
avoid and mitigate what looks to me like being another very 
concerning surge. So that is in my mind as I think about where 
we are.
    Mr. Becker, I was really struck by how you described our 
public data systems as decrepit. I think you are right. So many 
of us during this pandemic have talked about the need of 
following the science and the data, yet our data systems are so 
inadequate to the task that we have. But I want to pull in on 
the issue that Senator Murray raised about the issues of how 
the COVID-19 pandemic has really laid bare the deep inequities 
and disparities in our health care system as we see that 
communities of color are so much more likely to get sick and 
even to die.
    I think that this disparity is caused in large part by the 
social determinants of health, right. By our access to housing, 
food security, employment, education, transportation. Some 
people say that these upstream, so-called upstream impacts are 
responsible for up to 80 percent of a patient's outcome, likely 
outcome.
    I want to ask you about this, could you tell us what steps 
you think we should be taking as we think about data to help 
improve--how can the Federal Government work better with state 
and local entities on data collection related to these social 
determinants of health?
    Mr. Becker. Thank you, Senator. If I described our public 
health system as decrepit and old, I would describe that as 
social determinants of health system as infantile. It hasn't 
developed. It is in its infancy. And there are no standards 
across the country about how the last mile of those systems 
around housing and food insecurities collect data and then 
report it back up to the health care system or the public 
health system.
    There needs to be an adequate investment in that technology 
now to create the technology of the future. And I certainly 
believe in honor of our Seattle Kraken, our new NHL team, that 
we don't need to skate to where the puck is as we work today, 
we need to skate to where the puck is going. And social 
determinants of health is where it is going from an infancy 
standpoint. We have a huge opportunity in front of us for that.
    Senator Smith. A huge opportunity. And I can only imagine 
the challenges around interoperability between data systems 
that tackle social determinants of health issues like housing 
and employment and integrating that with the public health 
system. But the opportunity to actually have an impact on 
population health here is really, really huge.
    Dr. Janz, I am very interested in the work that you have 
been doing, and I am wondering if you could tell us a little 
bit about how health equity issues factored into the work that 
you did, that you are doing around scaling up critical care 
capacity in the hospital.
    Dr. Janz. Thank you, Senator, for that question. As I 
mentioned earlier, University Medical Center in New Orleans 
cares for a vulnerable patient population in a low income 
community where over 80 percent of the patients that we serve 
are patients of color. We aim to improve their care. And it is 
difficult to do when we have to deal with COVID surge after 
surge after surge.
    When I leave here today, I will go back to New Orleans. 
Instead of working on improving care for these patients, 
improving cardiovascular care, decreasing rates of diabetes, 
improving access to care, things like that, instead, we will 
deal with how do we manage this next COVID surge. And that is 
predominately the majority of what we will spend their time 
dealing with. That means this unlevel playing field will remain 
unlevelled. Every time we have to spend time and resources 
dealing with the next COVID surge is time we have lost.
    Senator Smith. Right. Well let me--in fact, it strikes me 
that as we grapple with this next surge of COVID, we are going 
to be exacerbating health disparities as sort of people, 
communities of color, black and brown people fall further and 
further behind because of lack of access to basic care for 
chronic diseases that are caused by the social determinants of 
health that Dr. Becker and I were talking about.
    I am out of time, but I just want to pause and acknowledge 
the powerful statements that you made about the impact of 
stress and your concerns about the mental health of health care 
providers. I think that this is a deeply concerning issue and 
something that we can't look away from. We need to see, and we 
need to address. So I am grateful for you bringing that up 
also.
    The Chair. Thank you.
    Senator Marshall.
    Senator Marshall. Thank you, Madam Chair, and welcome to 
our witnesses as well. I want to talk about innovation for a 
second. And Ms. Arthur, that means I am looking at you. 
Certainly the lessons to be learned. I have always believed 
that innovation could do more to drive the cost of health care 
down than any legislation we can write. That innovation could 
impact this current pandemic and future pandemics more than any 
legislation we can write here if we would just get out of your 
way and let your people do their job.
    I think a good analogy here is FMD, foot mouth disease. And 
we are starting to build vaccine banks. Much like the COVID 
virus, there are different variants of FMD, and that is one of 
the challenges. Is there any talk in your world of any type of 
vaccine banks being built?
    Ms. Arthur. Not exactly. But I think that the companies 
want to work with the Government to again exploit these 
opportunities to work on viral families. Many companies 
actually do that. They are constantly looking at the genetic 
sequence data for both existing pathogens of pandemic potential 
as well as novel pathogens when they show up in these various 
global databanks.
    Companies are constantly exploring whether or not the 
products they have, be they vaccine technology or diagnostic 
technology or treatment technology, could work in some way 
against that pathogen. So I think that companies rely on the 
big public data banks, but they are constantly pressure testing 
their products in that case.
    Senator Marshall. Would you agree with me, if you were 
going to try to set up these vaccine banks, knowing the origin 
of COVID would be very helpful. So, for instance, if it was 
from a bat cave and you had a collection of the eight most 
similar viruses, that those might be clues to help you develop 
future vaccines.
    Ms. Arthur. I think it is very important to always 
understand the zoonotic nature of every virus, whether you know 
what animal it comes from, how it, animal to human 
transmission. All very important in understanding the 
epidemiology of a disease.
    Senator Marshall. Is there much talk in your world about 
viral gain of function and how that would impact vaccine 
development?
    Ms. Arthur. We don't talk about that very much within the 
industry.
    Senator Marshall. Okay, I am going to turn to Dr. Janz just 
for a second. Dr. Janz, the doctors, nurses, respiratory 
therapist were the heroes of this pandemic. Extra shifts, 
working days at a time, major burnout going on. We put our 
lives on the line. And I say we, I spent time in an ICU 
treating COVID patients in an ER and certainly understand the 
stress that is going on there. You know, as we stand here 
today, and I talked to my docs back home, the biggest concern 
treating COVID patients isn't therapeutics and what type of 
respiratory therapy to give, it is a nursing shortage. Would 
you agree that is certainly a huge limiting factor for your 
docs, and just not in big hospitals, but small hospitals and 
across the Nation?
    Dr. Janz. Oh, I couldn't agree more, Senator. If we ever 
ran out of ventilators in our hospital, we would have run out 
of nurses 30 ventilators ago. The nursing shortage--nurses are 
perhaps the most vital responders to this pandemic. They have 
shouldered the greatest workload in responding to taking care 
of patients with COVID-19. And among their most precious, 
precious resource, we have too few of them. And we are not 
supporting them enough.
    Senator Marshall. I just want to bring to the attention of 
the Committee that I spoke to a hospital yesterday who is 
trying to bring in some nurses from the Philippines, and they 
have worked with this agency for quite some time, but they are 
running into passport issues and State Department issues and 
they de-prioritize nurses down to forgive me the nomenclature, 
may be a level four. We need the State Department to go back to 
work to the office to get through these.
    I hope that you all would join me in letters urging our 
State Department to help get some of these nurses from other 
countries in here as well. Last thing I want to talk about when 
it comes to doctors is I am getting lots of phone calls from 
doctors and they are referring--they would tell me, well we 
appreciate the word of thanks from Congress, but why are you 
trying to cut our pay? Thanks to the budget neutrality clause 
in the Medicare physician fee schedule, we are going to say 
thanks to all these doctors by cutting their pay up to 10 
percent.
    I just think that is the wrong message to send to be 
sending to the health care heroes who have saved our lives. I 
am not sure if your association, your medical associations is 
looking into that issue or not, but certainly a lot of concern 
from docs back home about their pay getting cut.
    Dr. Janz. I think all health care professionals right now 
need help, especially our nursing colleagues who again, are 
shouldering the heaviest load in responding to this pandemic. 
And we need to think of ways to help bolster them, not things 
that we can take away from them or else otherwise we are not 
going to get out of this any time soon.
    Senator Marshall. Thank you, Dr. Janz. Thank you, Madam 
Chair. I yield back.
    The Chair. Senator Lujan.
    Senator Lujan. Thank you, Chair Murray and Ranking Member 
for this important hearing. Before us today, we have a 
distinguished panel of experts whose thoughtful approaches 
about how to better prepare for the next pandemic. However, as 
Dr. Janz notes in his testimony, non-evidence based practices 
were being disseminated frequently at the time via the 
Internet, social media platforms, and other non-peer reviewed 
sources. Going down the panel, yes or no, does COVID 
misinformation spread online undermine public health efforts? 
Dr. Becker--Mr. Becker?
    Mr. Becker. I would say any information that is 
misinformation hurts public health.
    Ms. Arthur. Absolutely.
    Senator Lujan. Dr. Janz.
    Ms. Cicero. Yes. Yes, it does.
    Senator Lujan. Mr. Becker, you also state that we must 
operationalize systems that capture uniform data quickly and 
shared across state lines rapidly. In your testimony, you state 
that eliminating paper based reporting is the best way to 
achieve that goal. How can we better equip and prepare rural 
providers who at times do not have access to the broadband 
needed to move away from paper based reporting?
    Mr. Becker. Yes, I think, Senator, you are hitting on a 
fundamental problem that I am really hitting at with the 
regional concept. Each region faces different infrastructural 
problems, community problems, and we need solutions that 
address that from the beginning of the process to the end of 
the process at CDC. And that is going to be different in each 
community, whether it is a broadband connection, whether it is 
the lack of resources from a workforce. And we need everyone at 
the table from the local, state and Federal level to help solve 
those problems and direct funding that can directly impact 
those problems.
    Senator Lujan. It is just a reminder of why the 
infrastructure package must have the goal of 100 percent 
connectivity across the country, and it would allow us to have 
better health outcomes as well based on your advice there, Mr. 
Becker. I appreciate that. Mr. Becker, Ms. Cicero in sustained 
investment--is sustained investment in public health 
infrastructure the best way to ensure that we are receiving the 
best on the ground data?
    Mr. Becker. Certainly sustained support has to be there for 
the long term. We can do a lot with the money that has been 
given, but it will only triage the problem. The sustained 
funding will get us to that next mile.
    Senator Lujan. Ms. Cicero.
    Ms. Cicero. Yes, thank you, Senator. We do need that 
bolstering of capability around data. Right now, we don't 
know--we don't have a central way of tracking outbreaks in 
schools. We don't have real time data to let us know if when 
someone is infected, which variant they are infected with. We 
are beginning to do this. It takes a while with the funds that 
are appropriated to be usefully used. It takes a while to scale 
up those systems, but that will be very important to do going 
forward.
    Senator Lujan. Appreciate that. And I echo the concerns 
raised by Chair Murray about better data collection by race and 
ethnicity. Dr. Becker, you mentioned challenges faced by tribes 
in collecting data. How can these challenges be overcome?
    Mr. Becker. Thank you, Senator. Yes, in the State of 
Washington we have 29 tribal Government affiliations, and that 
is not represented in the data systems as we collect them. And 
right now what happens is our epicenters and our tribal 
partners go in and correct that data and accurately reflect it. 
But that is a labor intensive processes and we need to design a 
system that allows us to collect it right up front.
    Senator Lujan. My understanding is IHS is still not 
releasing the data they have state by state. That has also 
created challenges and us being able to understand where 
progress is made and where it is not and how we can refocus our 
efforts. I very much appreciate your attention and response in 
that area, Mr. Becker. Dr. Janz, New Mexico faces a significant 
health care workforce shortage. As a result, caring for the 
mental health of our providers is especially important. How can 
we better support the mental health needs of our health care 
workforce?
    Dr. Janz. I think we first need to engage with these 
frontline staff to understand what their exact needs are. I 
think every individual is going to have different needs, 
especially when they have been dealing with the stress of 
taking care of a high volume of COVID-19 patients. And thinking 
that one solution for every hospital in the country is going to 
meet all those needs is probably an inadequate response. We 
need to engage the stakeholders here, which are those frontline 
workers, and figure out what are their needs and how can we 
best develop systems to fill those needs.
    For example, if one particular hospital, the nurses in that 
hospital and the physicians have a greater need for mental 
health resources, those resources should be made readily 
available. They should not be difficult for them to seek out 
and obtain those resources. If a different hospital has a 
different need, for example, among their workforce, then the 
system should be nimble enough to respond to that need.
    But there needs to be response everywhere, because in this 
time of COVID, what happens in someone else's hospital affects 
my hospital, affects the hospital next to it and around the 
country. And so if one hospital is suffering, all of them will 
continue to suffer.
    Senator Lujan. Appreciate that. And Chair, I do have a line 
of questioning around Project Echo. I will submit them into the 
record. As well, just very much appreciate the panelists for 
being here today. And with that, I yield back.
    The Chair. Thank you.
    Senator Tuberville.
    Senator Tuberville. Thank you, Madam Chair. Thank you for 
being here today. And this is for the whole group, just a short 
answer would be great. We spent trillions of dollars, the 
Federal Government has on COVID relief legislation. I am a firm 
believer that just throwing money sometimes is not the proper 
answer. What we need is people and a plan. Aside from spending 
more money, what would you do differently, Mr. Becker, on our 
next go around for whatever we have coming our way?
    Mr. Becker. Thank you, Senator. And I completely agree that 
just throwing money at the problem is not going to solve it. 
What I suggest is actually having the partners sit down at the 
table and help design systems that are localized to their 
community. And that is why I talk about having the local 
partners there, the state partners there, but also our Federal 
partners there not just as funders that send off a contract and 
say get it done, but to help us knock down those roadblocks and 
barriers that come up as you implement a plan, because the plan 
is never going to be what you wrote on paper when you begin 
with. But we don't have that Federal partnership on the other 
side to help knock down those roadblocks.
    Senator Tuberville. Thank you.
    Mr. Arthur.
    Ms. Arthur. Thank you, Senator. I would actually make sure 
that all the data we are getting as we are learning about the 
disease is very quickly disseminated to both the academic and 
industry sector. I think that was a place where there was some 
delays and particularly small and medium sized companies didn't 
necessarily have access quickly to the natural history data, 
all the different science, the outcomes which could have 
allowed them to move even faster in their development of 
products.
    Senator Tuberville. Thank you.
    Dr. Janz.
    Dr. Janz. I would echo the statements by my colleagues in 
this panel. There isn't a day that we don't use data generated 
by public health experts to plan what we are going to do in the 
hospital that day, the next week, the next month, and over the 
next few months. Public health infrastructure and data obtained 
in real time from these experts has been vital in our response 
to the current pandemic and any future pandemic.
    Senator Tuberville. Thank you.
    Ms. Cicero. Senator, I agree wholeheartedly with the 
comments that are made by my fellow panelists. So I will pick a 
different issue. And that is, again, I think we need to be much 
more proactive in getting ready. But we are not going to be 
able to scale up contact tracers, have lots of different 
therapeutics, etcetera, in the midst of a surge during a 
pandemic.
    We have to prepare in the future to do that. I think for 
medical countermeasures in particular, we need a strong PHEMSE, 
as Ms. Arthur said, we also need a very strong ASPR that is 
able to be nimble and flexible and have the authorities that it 
needs to work quickly and deploy resources effectively in the 
middle of a crisis.
    Senator Tuberville. Thank you. This is another question for 
the whole group. We will start with you again, Mr. Becker. We 
spent $41 billion on COVID research, $41 billion. And kids are 
getting ready to head back to school. Are any of you all aware 
of any studies that we have focused on for the effectiveness of 
masks for kids under 12 years old? That is getting ready to be 
a huge topic. Mr. Becker?
    Mr. Becker. Thank you, Senator. That is outside my lane of 
expertise.
    Senator Tuberville. Okay.
    Ms. Arthur. Me as well. I don't know of any----
    Senator Tuberville. Dr. Janz.
    Dr. Janz. It is also outside my line of expertise.
    Ms. Cicero. Senator, thank you for that question.
    Senator Tuberville. Found somebody that knew something 
about it. Good.
    Ms. Cicero. I think that opening schools and how safe our 
kids are in schools in the fall is on everyone's mind right 
now. And I am not aware of a study that focuses on the 
effectiveness of masks for children under 12. But again, this 
is an area where we shouldn't--we need to develop better masks 
that are reliable, that fit different kinds of faces, that are 
wearable all day, that kids can communicate through.
    I do think that it is very reasonable in states and 
localities where cases are surging, and hospitalizations are 
beginning to fill up to maybe reimpose some mask mandates in 
those areas. And certainly for our kids in school, for now, it 
would be important that they wear those masks indoors.
    Senator Tuberville. I hope that what we have just gone 
through for the last year and a half, that if we start to wear 
these masks again, God forbid, heaven help us, that we would 
come up with a mask that everybody understands it actually 
works to some degree. Because you see people wearing masks that 
obviously they don't work. They are just wearing something put 
over their face. I heard very early from doctor friends of mine 
that said, listen, nothing but N95 really helped. Everything 
else is kind of shut the door. Is that your thoughts?
    Ms. Cicero. Thank you, Senator. Not completely. They--I 
believe that wearing the cloth masks that we have had available 
has helped to reduce transmission, especially indoors when we 
know the risk of COVID transmission is much higher. And we--but 
we can do better. And I think that we haven't innovated in this 
area, and we haven't really tried hard.
    I know that BARDA has recently had a massive innovation 
challenge. That is a good thing. I think we can do a lot more 
in this area to get better masks for the general public and 
also to be able to generate them quickly. I think when people 
buy masks in the CVS, they should know, first of all, they are 
available and second, they are certified. And so they are 
effective at reducing the risk of infection.
    Senator Tuberville. That is a good idea, certification. 
Thank you, Madam Chair.
    The Chair. Thank you.
    Senator Murphy.
    Senator Murphy. Thank you very much, Madam Chair. Thank you 
for convening this hearing. I would have hoped for a little bit 
more robust answer from the panel with respect to the efficacy 
of masks. I mean, we have enormous amounts of pretty well 
reliable data telling us that this is an incredibly effective 
means of controlling the virus. We have to look no further than 
the story of influenza in 2020 to know what a difference it 
makes, even if you are not all wearing N95 masks. We 
essentially eliminated the flu over the course of the past 
year. Why? Because the flu is much less contagious than COVID-
19.
    I share my--the hopes of Senator Tuberville, that we can 
get to a point where we are not required to wear masks in any 
setting. But I think it is important to tell the American 
public that they work. I wanted to turn to you, Ms. Arthur, to 
talk to us for a second about the issue of intellectual 
property protections.
    The United States has some of the strongest IP protections 
for medicine in the world. We should be proud of that because 
we save a lot of people's lives through the innovations that we 
create in the United States. But our IP protections were really 
never envisioned for a setting like this. They were never 
envisioned to provide protection in the case of a pandemic with 
a massive built in Government marketplace buying technology or 
medicines that every single American is going to need or 
desire.
    The risk here is pretty obvious that the amount of profits 
that could be made by private industry in this case is 
potentially limitless. And the question is whether, especially 
as we enter a world in which we may be needing annual booster 
shots, essentially get potentially paid for by the US 
taxpayers, guaranteeing a marketplace for decades for the small 
number of companies that have produced the vaccine, whether we 
need to sort of step back and have a conversation about perhaps 
modifying the level of IP protection specific for these 
technologies.
    Obviously, we have had this conversation internationally 
through the WTO. But make the case as to--I assume BIO is 
probably very protective of IP protections. So make the case as 
to why from a taxpayer standpoint, we shouldn't be worried 
about the amount of money that can be made in the out years 
when it comes to vaccines and boosters.
    Ms. Arthur. Thank you, Senator, for that question. I will 
say yes, indeed, at BIO we are very protective of the 
intellectual property our companies work hard to arrive at. I 
think that actually you should think of these products as an 
investment, not just in COVID, but all the other things that 
these technologies will be able to do that will save lives both 
in the short term and the long term. And that intellectual 
property is the base of that ability for companies to continue 
to do the R&D they should do for, commercial and of course 
future pandemic indications.
    From many of our companies, particularly small and medium 
sized companies, this intellectual property that they have 
garnered for this technology they have worked on is the 
foundation of the valuation of that company. I think it is 
extremely important to understand that moving or loosening the 
intellectual property protections we have in the U.S. could 
have a number of negative effects. It could certainly limit 
companies' willingness to respond to the next pandemic. I think 
that is extremely important to understand.
    But in addition, it could actually devalue some of those 
companies for some of the other uses they have for that 
technology as investors worry about them losing the 
intellectual property rights. And then I think last, it could--
it really does devalue the great--the great exercise--the great 
abilities of the U.S. Government and the U.S. as a leader in 
biotechnology. I do think, however, that in the future, 
remember that the commercial value of these products will 
actually lead to more competition, not less.
    There are companies behind the three that have vaccines on 
the market now who are going to have better innovations. Maybe 
it is lower dosing, maybe it is less dosing, maybe higher 
efficacy, better safety. This actually will spur more companies 
to work on great vaccines and therapeutics for COVID.
    Senator Murphy. I don't know that--I appreciate the answer 
and I want to give you the chance to make the case, but I am 
not sure I agree. I think that given the exceptional nature of 
this moment and what it will hopefully be the exceptional 
historical nature of this pandemic, it is not a danger to the 
overall bottom line of any individual company or the industry 
writ large to create some special set of rules for these 
technologies, given the fact that we are spending trillions of 
dollars in a way that we don't for any other comparable disease 
or virus on an annual basis. So I look forward to continuing 
this conversation. And I appreciate the chance to talk about 
this. Thank you, Madam Chair.
    Ms. Arthur. Thank you, Senator.
    The Chair. Thank you.
    Senator Scott.
    Senator Scott. Thank you, Madam Chair. At a risk of 
continuing the conversation with Senator Murphy. I am prepared 
to ask the question. I am unwilling to ask the question, so I 
am going to do it anyway, Ms. Arthur. I believe that had it not 
been for our ability to partner with the private sector, we 
might not be sitting here today. I believe that if we were 
unable or unwilling to recognize that perhaps the greatest 
economic engine, the greatest engine of innovation our Nation 
has seen and health care doesn't come from the Government, it 
comes from the private sector. But if, in fact, we had not had 
Warp Speed partnering with the private sector, we would not be 
having a conversation in person in this Nation and maybe in the 
world, and that the death toll would be multiple times higher 
than it is today. Am I in the realm of possible?
    Ms. Arthur. I firmly agree. I think what was really strong 
about Operation Warp Speed was the collaboration and the skills 
that were deployed by industry with the help and advice of 
Government, but really, the U.S. Government relied on what our 
decades of experience with experienced and small and medium 
manufacturers to really deploy the best of science for a really 
important goal. And doing it in--I still marveling because I 
have been in the vaccine business 25 years. I am still 
marveling that we made these extremely important, efficacious 
and safe vaccines in a year and deployed them in 6 months. It 
is incredible what we have done.
    Senator Scott. I remember sometime in April, May 2020, when 
I think it was NBC that said that the theory that we were going 
to have a vaccine within a year would take more than a miracle. 
It was nearly impossible to have any appreciation or 
expectation that somehow, some way, with all the great minds in 
the world working together, we could do what we have done. And 
so I do think we should have a longer conversation about the 
power of partnership and the synergy of public private-
partnerships in many areas of Government. I think we could 
easily miss the point of why we are having this hearing and why 
we are able to have this hearing.
    However, I have questions about virtual health and 
telehealth, and I will get to those prepared questions. So 
thank you for that. When I think about the pandemic, I don't 
find many silver linings at all. The death toll is devastating. 
The number of folks who have recovered but not fully is just 
mind boggling. But I do see, however, as the possibility of a 
silver lining is that perhaps the telehealth conversation 
accelerated forward five or six or 7 years. But in that silver 
lining, I think about in rural America or rural South Carolina, 
where one out of four people don't have the ability to connect 
because they have a flip phone, no phone or not a smartphone, 
15 percent of Americans find themselves in the same category as 
one out of near--almost one out of four rural Americans.
    The telehealth platform is so important that we probably 
need to spend more time investigating audio only in that 
telehealth delivery system with integrity in the system to make 
sure that we are talking to the patient if you can't see the 
patient. I think this platform needs greater investigation, and 
frankly, more resources. Thoughts on that? Let's start with 
you, Mr. Becker.
    Mr. Becker. Thank you, Senator. Yes, absolutely. I think 
telehealth has advanced because of the pandemic and there is 
infrastructural problems to getting it to the last mile in 
rural areas. When we were at public health in Harris County, we 
put the mobile telehealth on mobile vans and drove them out to 
communities of need that didn't have access. And we found 
community centers with extra space to set up the private room 
so patients can come into the community centers they were 
already visiting and have access to those services while they 
were there. So there are solutions, Senator. But I think, 
again, coming back to your previous--we need to work with our 
local partners, but also our private partners to figure out how 
to get that technology and those services out.
    Senator Scott. Thank you. My last 30 seconds here. Dr. 
Janz, my mother has worked in the hospital for the last 47 
years. And I think about all of our emergency responders who 
are willing to stick around and do their jobs in the face of 
losing their lives. And I know that the importance of PPE and 
obtaining the drugs that were necessary--did your hospital 
encounter any problems or challenges with PPE or drugs?
    Dr. Janz. Thank you, Senator. And thank you to your mother 
for her service over all those years. We obtained and 
maintained adequate supplies of PPE and medicines during the 
pandemic. It did require lots of work and effort, asking lots 
of other hospital systems around the state and country to help 
us out with those items. But we were able to maintain those 
items. And by just the generosity of our community. In spring 
of 2020, community members were dropping off N95 masks in the 
lobby of our hospital for us to use on the scale of hundreds to 
thousands of them a day. It took a village, but it worked.
    Senator Scott. I will say, as my time has run out, Madam 
Chair, that the excellence that we have seen in America's 
health care system is a marvel of the world. And I think bills 
like my Made in America Act that would provide more reasons to 
bring your PPE home and your generic drugs being made here in 
America is a necessary component of what I consider resiliency. 
Our Nation needs to be more resilient when it comes to 
challenges. And one of the ways for us to get there is for us 
to work in a bipartisan fashion together to bring home some of 
those really important resources to our Nation. Thank you for 
the extra minute.
    The Chair. Thank you.
    Senator Baldwin.
    Senator Baldwin. Thank you, Chair Murray. I have long 
prioritized the need to prepare for a pandemic influenza and 
have worked with Members of this Committee and back in my House 
days on the Energy and Commerce Committee on that mission. And 
we have made progress. But I think we can build on this 
progress as we plan for unknown disease threats. I will soon be 
introducing the Disease X Act to do exactly that. Specifically 
the Disease X Act would provide BARDA with the additional 
resources needed to stand up a medical countermeasures program 
aimed at developing responses to unknown viral threats or 
disease x.
    Ms. Cicero, you noted in your testimony that there are 
certain viral families that are more likely than others to lead 
to a large scale outbreak. What do we know about these viral 
families that are cause for concern? And why is it critical 
that we make an investment sooner rather than later in a 
disease x model?
    Ms. Cicero. Thank you for that question, Senator. When we 
look at the characteristics of pandemic pathogens that are most 
likely to result in a large scale outbreak, first of all, we 
look at the viral families that have been known to infect 
humans in the past, and then those that have the kinds of 
characteristics like high transmissibility, high lethality, and 
also asymptomatic spread.
    When you pair that with the fact that you don't have 
existing countermeasures already in the stockpile and ready to 
go, that is a terrible brew for the kinds of viruses that will 
cause a problem. And the handful of viral families that we 
would recommend is important to start with are things like the 
paramyxovirus family, which has deadly viruses in it, like 
Hendra and Nipah.
    Surely the coronavirus family, which is SARS-1, SARS-CoV-2, 
as we have seen, and also MERS, the orthomyxoviridae families, 
which avian flu is a member of that, as well as the poxvirus 
family. So it is those types of families that we know could 
produce a member that could become a pandemic. The reason why 
we need to invest now and not wait for the pandemic pathogen du 
jour to present itself is because it takes a long time to 
develop the kinds of platforms and technologies that will work 
well and could be quickly adapted into effective and safe 
vaccines and therapeutics and even diagnostics.
    I think it is a wonderful success story that Operation Warp 
Speed has produced in less than a year three different vaccines 
that Americans are able to use. But we must remember that 
coronavirus research started after SARS-1 in 2003. And then 
there was MERS, which is also part of the coronavirus family.
    That research also. So if you look back, it is almost, 
research since--15 years of research and over $12 billion that 
were invested to allow us to be able to generate these vaccines 
quickly. So we need to prepare in advance.
    Senator Baldwin. Thank you. Like many of you, I view this 
pandemic as an opportunity to reset and make us better prepared 
going forward. But I want to caution that we have planned 
before. It has been widely reported that the Obama 
administration left behind a pandemic playbook intended to 
inform the work of the incoming Administration. When I was 
serving on the Energy and Commerce Committee in the House, I 
remember working with George W. Bush administration for the 
pandemic influenza implementation plan.
    When I look at how little of that guidance in these two 
documents was put to use by the previous Administration, it 
makes me wonder how we can reset, provide guidance moving 
forward, and expect that won't be gathering dust in a 
department somewhere around Homeland Security or HHS.
    I don't know, it's not fair to ask you this, but Ms. 
Cicero, how can we best equip our public health preparedness 
infrastructure to really build on what already exists and use 
it, and then chart out a path to responding to future 
pandemics?
    Ms. Cicero. Yes. Thank you for that question, Senator. And 
it is true that these playbooks have existed in the past. We 
don't think just because they weren't deployed and used and 
followed strictly during this pandemic that playbooks aren't 
useful. It is very useful. Coordination across different 
agencies and sectors is so difficult that kind of coordinating 
playbook of who is doing what, who is responsible for what is 
very, very important. At the same time, we can't just live by 
the playbook. We have seen that we have had a lot of curveballs 
thrown at us during this pandemic and we have to have some 
flexibility and nimbleness baked into the system so that we are 
able to pivot as necessary.
    Our Center for Health Security at Hopkins over the years 
has done a number of tabletop pandemic exercises to test 
capabilities, and we would never have done something so 
dastardly as having a delta variant in the middle of kind of 
the recovery from COVID. I mean, it would just be unheard of--
but that has happened to us. And so a playbook can't give us 
everything, but it is fundamental to be the basis of the 
planning.
    We have seen too, even if we had followed the Obama 
playbook, I believe that we--our public health infrastructure 
is still woefully under-resourced and not quite in the 21st 
century. So we have to get those capabilities so that they can 
be deployed according to national plans that makes sense.
    Senator Baldwin. Yes. But the fact is, we didn't use the 
playbook, so----
    Ms. Cicero. I don't think so.
    Senator Baldwin. Alright. Thank you.
    The Chair. Thank you.
    Senator Braun.
    Senator Braun. Thank you, Madam Chair. In observing this 
journey from the beginning, I would like to reflect what 
Senator Scott said. I think it is amazing how the private 
sector--I remember early on CDC, FDA kind of maybe arguing 
about who was going to control the dynamic. Thank goodness it 
went the way it did and a modern miracle that we got the 
vaccines done that quickly. I am more concerned about this. We 
got the delta variant. When you look at vaccinations, it has 
got to be 80, 85 percent of the world, technically.
    I was in the logistics business before I got here. It seems 
like mission impossible, and I think we need to keep pushing to 
do the best we can. Begs the question, though, that this is so 
disproportionately affected, 1 percent or under of our 
population. And I would like you to each take maybe a minute or 
less, I would like to hear all four opinions, doesn't it make 
more sense to put resources into where you really go after the 
therapeutics to focus just--because of the numbers, where you 
got to focus on maybe 1 percent to have something that looks 
like it is already eluding vaccinations.
    I think you have got to do both. But I have not heard 
enough conversation about putting disproportionate resources 
into therapies that when you do get critically ill, and 
especially focused on the data we have got on who does get 
critically ill, shouldn't we be pivoting to putting more effort 
and resources on therapy while doing vaccines? Start with Mr. 
Becker.
    Mr. Becker. Thank you, Senator. I think we are going to 
have to do both. And I think you have to leverage and triage 
what the immediate need is of the virus at the time. And that 
is going to require pivoting at multiple points, probably the 
way this virus has handled itself.
    Ms. Arthur. Thoroughly agree. It is extremely important, 
Senator, that we have therapies not just that can potentially 
treat early stage disease, which I think we are now, but the 
new therapies that we see coming that could treat the more 
serious consequences and get you out of the hospital faster 
will save lives and save money as well.
    Dr. Janz. I completely agree that a combination approach is 
going to be vital. The ad coming out added and the therapy 
front, though, is remember all of the therapies developed to 
date to treat patients with COVID, especially critically ill 
adults with COVID, none of them are curative. They may save 
some lives, but many patients will still die, even with these 
new therapies that have been developed. So I don't think that 
only a therapeutic approach here is an answer. The preventive 
approach is still vital.
    Ms. Cicero. Thank you, Senator. I agree with Dr. Janz. I 
agree that we need to do both, but we also should remember what 
vaccines are intended to do. When we talk about vaccine 
effectiveness, it doesn't mean effectiveness against any 
infection at all of the virus. Instead, it is effectiveness 
against clinically apparent disease.
    We have seen, while cases are still rising, that as 
compared to last year, hospitalizations, deaths are about half 
of what they were before. And that really is due in large part 
to vaccination. But certainly we support the development of 
therapeutics as well because they have an important role to 
play.
    Senator Braun. Then I will be more specific. Do you think 
that we can outmaneuver this devious virus through vaccinations 
only? And I know you have just said you would like a combined 
approach. And do you think conferred immunity from infection is 
an ally in the effort as well? Mr. Becker.
    Mr. Becker. Thank you, Senator. I would just say that is 
probably outside my lane of expertise so I will pass to my 
colleagues.
    Ms. Arthur. I think that it is extremely important to 
actually focus on the vaccination campaign because I think it 
is the longest term way to protect us. The vaccines are showing 
that they work against the variance. And I think innovation 
will actually allow us to keep up majestically.
    Senator Braun. Logistically we can actually pull that off 
across the world?
    Ms. Arthur. I think we can. I think the industry, GAVI, the 
countries that are working hard to get--do just what we did in 
the U.S., get these vaccines as close to----
    Senator Braun. My comment would be that logistically it 
looks like we are not even though I wish we could. Even when 
you look at the most kind of agile country in the world 
ourselves, with the difficulties we are running into, and this 
has nothing to do with the anti-vaccine because we are lucky we 
got a vaccine. It is just the mechanics of pulling it off.
    Ms. Arthur. I agree, Senator. It is definitely complicated, 
but you have seen a lot of innovation in the way we are doing. 
And for treatments, I think what is hard is, is that some of 
the treatments have a very complex way of being given. So we 
could probably have the same logistics issue there. If we had a 
simple pill we could give, I agree with you that might help us 
save lives. But I think vaccination has an infrastructure 
globally where once we get the vaccines there, they can be 
deployed.
    Dr. Janz. I would point us toward all the pandemics and 
diseases of the past. Fortunately, they have been eradicated by 
vaccines around the world. This has been done before. This can 
be done again. We need to root cause analyze why it hasn't 
happened yet. Figure out what those reasons are, why we haven't 
had as much vaccine uptake, and then address those causes and 
attack this from that angle.
    Senator Braun. Seems to be most of the other ones have not 
been that transmissible and they haven't looked like they turn 
into variants that quickly.
    The Chair. Senator Braun, we have a vote called and we have 
got a few more Senators here. I am going to ask you if we can 
please wrap quickly.
    Senator Braun. Thank you.
    The Chair. Thank you.
    Senator Rosen.
    Senator Rosen. Thank you, Chair Murray. And thank you, 
everyone, for being here and testifying. As Dr. Janz just said, 
no therapy is curative yet. I do hope that we get there, but it 
will take time. And so I want to talk about booster shots. We 
continue to work toward fully vaccinating our Country. We have 
to plan ahead, and we have to ensure a robust and effective 
system for any booster shots that might be needed in the 
future, particularly for some of our vulnerable populations. 
So, Dr. Janz, some early research is showing promise for immune 
compromised patient patients such as organ transplant 
recipients. We have increased--they need to have increased 
antibodies to fight COVID after a third dose possibly of the 
vaccine. More reporting has just recently come out about this. 
So has the research determined what is sufficient antibody 
level would be to provide protection? And is there currently a 
standard testing protocol for health care providers to test 
their patients, especially the most vulnerable, to see what 
those levels are, and if, in fact, they might need the booster?
    Dr. Janz. I am aware of the recent research that was 
published that in patients specifically solid organ transplant 
patients, where they--when they received a third vaccination 
dose, that they had almost a 50 percent increase in their 
antibody response. What level is protective is outside of my 
area of expertise.
    My specific environment that I work in University Medical 
Center in New Orleans, which serves an underserved patient 
population, and patients that are immunocompromised, we need 
the answer to these questions to know how to take care of these 
patients better. And we look toward the experts in giving us 
those answers.
    Senator Rosen. Yes, I think it is really important for us 
to be able to have the scientists tell us what those levels are 
so we can determine the next case, and if we need a booster, 
when we need it.
    Ms. Arthur. Senator, I will say that there is a lot of 
really great research going on as we analyze the small number 
or the small number of breakthrough cases to existing vaccines 
that will help us establish what that correlate is. They will 
test people, have a breakthrough, and see where their 
antibodies are. That data taken together allows us to see what 
the number is we should watch for that tells us what protection 
will be long term.
    Senator Rosen. Yes, that will be helpful all around the 
world, I think. And do you have any information, anybody on the 
panel for the latest research on a possibly a universal 
booster, so regardless of what vaccination you may have 
received, you can just go ahead and get a booster?
    Ms. Arthur. There are several studies going on. There are 
studies going on with what we call heterozygous boosting where 
they are looking at if you got J&J, you get boosted with Pfizer 
or Moderna and other products that are right behind that are 
also in those studies like Novavax's product.
    We will certainly see whether we can boost across the 
various platforms. I think, in addition, companies are looking 
at what we call the cross protection across new variants. And a 
lot of this data we are seeing on whether or not you work 
against delta or lambda is part of that assessment of how these 
products work long term. And then some companies are looking at 
actually adding more virulent strains to their existing 
product. You may have what we call like a pan-corona vaccine in 
the future.
    Senator Rosen. Right. No, that is right. Thank goodness the 
scientists are working so fast with the modern computing. It is 
going to hopefully save the world. And speaking of computing 
and everyone going around the world, we have supply chain 
issues sometimes. So our domestic supply chain, I would like to 
talk about that and the role of non-profits. I recently 
introduced Expanding Access to Affordable Prescription Drugs 
and Medical Devices Act, because we have to do more to shore up 
our domestic supply chain.
    Hopefully this is going to reduce drug costs and drug 
shortages and buildup our domestic manufacturing capacity 
through support of nonprofit drug and medical device 
organizations. So Ms. Cicero, could you talk about the impact 
that increased domestic supply of affordable critical drugs and 
devices would have in our ability to strategically plan while 
still going on in this pandemic, or God forbid, any future 
pandemics.
    Ms. Cicero. Thank you, Senator Rosen. And I do not have the 
adequate background to talk in detail about the supply chain 
issues for low cost drugs versus other kinds of drugs. But I 
can reiterate your concern, and I agree that one of the major 
lessons that we have learned from this pandemic is that we did 
not have a resilient enough supply chain. We need to do more to 
bring manufacturing into the United States. We need to know 
where our supplies are coming from.
    We need to make that more reliable so that it will be able 
to surge in the middle of--if some kind of public health 
emergency and have the supplies we need rather than losing 
control of that and not being able to get lifesaving drugs to 
people. And also PPE and other medical supplies that we need in 
the middle of a pandemic.
    Senator Rosen. Thank you. I appreciate all of your answers 
and being here today.
    The Chair. Senator Hassan.
    Senator Hassan. Well, thank you, Madam Chair and Ranking 
Member Burr. Thanks to all of our panel for being here today. I 
want to start with a question to you, Ms. Cicero. You are very 
familiar with the challenges we faced during this pandemic, 
including the inability to manufacture and distribute essential 
medical supplies and personal protective equipment to health 
care workers. I recently introduced bipartisan legislation with 
Senator Cassidy to help address these challenges.
    You have spoken generally about the importance of being 
prepared. But specifically, our bill would improve transparency 
into the strategic national stockpile, authorize transfers of 
expiring products, assist states in establishing and 
maintaining their own stockpiles, and incentivize domestic 
manufacturing.
    Can you speak generally or if there are specific issues we 
haven't addressed yet to the importance of investing in our 
preparedness infrastructure, including the strategic national 
stockpile?
    Ms. Cicero. Thank you for that question, Senator. And as 
Senator Burr referenced earlier, our strategic national 
stockpile really was created with a bioterrorism mindset. And 
it is time to break out of that, not to leave that behind, have 
that to be included, but go beyond that. And I think that is 
partially what resulted in the lack of transparency now in 
understanding what is in the stockpile. People seem to know 
little bits and pieces, but a lot of it is classified. And so 
we should do what we can to increase the transparency.
    Also I think it is appropriate to have a deep assessment of 
the stockpile. Do we have what we need? How do we get what we 
need? I agree with you that having stockpiles in states or 
other locations to add on, not replace, our strategic national 
stockpile would be a good thing.
    I also think we should be thinking creatively about how to 
make sure all our products in the stockpile don't sit on the 
shelf and expire and then be thrown away. We could recycle or 
we can give PPE and masks, etcetera, to hospital systems to 
make sure they are being used and then replenish the stockpile 
as we go rather than holding on to it all. So, thank you for 
introducing that legislation. I think that would be an 
improvement.
    Senator Hassan. Thank you very much. Mr. Becker, the 
clinical lab at Dartmouth Hitchcock Medical Center in New 
Hampshire has been conducting COVID-19 test sequencing in 
partnership with public health officials. Sequencing COVID-19 
test samples helps us stay ahead of potential outbreaks, which 
is especially important given the emergence of several 
variants, including the delta variant that we are dealing with 
right now.
    The size of the sequencing data files can make data 
exchange between hospital systems and public health officials 
more difficult, which limits the ability of states to identify 
emerging variants in real time. What specific steps can we take 
now to ensure that labs and public health departments are able 
to quickly and efficiently exchange data in support of their 
efforts to track the delta variant?
    Mr. Becker. Thank you, Senator. I think having the CDC set 
standards and a secure system to allow that to happen like they 
do in other disease sets would be an initial first step that we 
should take.
    Senator Hassan. Thank you. And then a question for you, Ms. 
Arthur. Over the past year, companies have struggled to source 
active pharmaceutical ingredients and Americans have struggled 
to access essential medications. And this is really kind of a 
follow-up on Senator Rosen's line just now. The Federal 
Government has made significant investments through BARDA and 
the National Institutes of Health to support development of new 
medical countermeasures over the past year, including vaccines 
and therapeutics.
    However, our limited domestic manufacturing of essential 
medications, including generics, leaves us vulnerable to 
potential shortages of critical drugs during future public 
health emergencies. What specific steps should we be taking to 
increase domestic manufacturing of essential medications? And 
how do we incentivize competition within this space in order to 
improve supply chain resiliency?
    Ms. Arthur. Thank you, Senator, for the question. So I 
think that it is important to understand the reasons why 
different types of companies are no longer manufacturing in the 
United States. So in the biologics space that--the companies we 
work with, there is actually lots of investment in footprints 
of manufacturing here in the U.S., although there certainly 
could be more, and there is many legislative actions to do 
that.
    For essential medicines, I think we need to look at what 
are the different laws around the environmental impact, how do 
they source the chemicals that they need in the U.S., and some 
of--fixing some of these things could indeed encourage 
companies to return some of their manufacturing for essential 
generic medicines to the United States.
    Senator Hassan. Thank you very much. And thank you, Madam 
Chair and Ranking Member Burr.
    The Chair. Thank you. Senator Burr, do you have a final 
comment?
    Senator Burr. Just ending comments, Madam Chair. All of you 
highlighted BARDA, ASPR, a number of other things. 20 years 
ago, they didn't exist. These are new entities and thank 
goodness we have shown a little bit of vision at updating them 
every 5 years to reflect what we have learned. Ms. Cicero, the 
challenge with SNS is the Federal Government purchases 4 
percent of PPE. The private sector purchases 96 percent of all 
PPE. The Federal Government probably won't buy every time China 
dumps.
    We are going to rely on domestic manufacturing, and we are 
going to incentivize. We don't have the control of making the 
private sector buy the 96 percent. And if the N95 mask is being 
dumped by China, 3M, Honeywell, all those manufacturers are 
out. The only option is a payment for warming those facilities 
that will only be outstripped by Congress's memory and they 
will not fund it forever. So something that is sustainable is 
got to be what we are shooting for.
    Mr. Becker, your state received $154 million in 2020 and 
2021 for vaccine preparedness, which can be used to upgrade 
your data systems. That has nothing to do with the $1 billion 
that Senator Cassidy alluded to. So I would love for you to go 
back and look at that and see if, in fact, the state shared all 
of that with our public health entities. There has been a lot 
of criticism toward previous Administrations playbooks that 
weren't used. Let me just make two statements. One, Congress 
deserves as much criticism as any Administration out there, 
period. End of sentence.
    It doesn't have to be that way going forward. But we do. 
Second, I remember vividly in Ebola when that Administration 
didn't use the playbook that was written, we wrote it in 
statute. The ASPR, Dr. Laurie was relegated over to run the 
hospital, domestic hospital structure, not to be in charge of 
this global outbreak and the coordination of treatment. That 
was all taken out of her hands. Every Administration has 
recreated the wheel and Congress 20 years ago had a vision of 
what we needed, and we put it in place.
    The last Administration followed most of it that was in 
statute, so they deserve a little bit of credit for having 
accomplished something that none of us thought they could do. 
Senator Lujan talked about broadband and the need to stretch it 
out. I have been having that conversation up here for 20 years. 
I have no firm belief today that if we appropriate X amount of 
money that last mile, Mr. Becker, is going to get covered and 
that community health center is going to be covered. But I will 
tell you this, if we stop focusing on putting cable in the 
ground and we start funding the technology that is available 
today, Starlink, the sister company to SpaceX, started by Elon 
Musk, can deliver broadband delivery anywhere in the United 
States today.
    High speed, $50 a month average, and we don't have to put a 
thing in the ground. So this belief that America has to sit 
with or without, we can turn on the without tomorrow. It just 
takes Federal Government coordinating with the technologies 
that are out there. And Amazon is going to have a competing 
satellite network up in 2 years. So we are going to have two 
people delivering satellite direct broadcast competition. Last 
thing I want to say is, if there is a takeaway, if there is a 
headline today or tomorrow on what this hearing is about, I 
would suggest to it is this, if you are not vaccinated, get 
vaccinated.
    We can work out all of the challenges that each one of you 
have expressed to us because we are that good. But what we 
can't do is we can't overcome bad decisions by people that sit 
at home and say, even though this benefits my children, even 
though this benefits my parents, this happened too fast, so I 
am scared of it. Boy, that is a cop out. If Americans would get 
vaccinated at the same rate they started when vaccines became 
available, yes, we would be talking about breakthrough 
infections--breakthrough infections, are 0.004 percent of the 
individuals who have been vaccinated. Infections for the 
population of the United States is a little over 10 percent.
    Breakthroughs are just a speed bump in a parking lot 
compared. What does it tell us? It tells us every American owes 
it to everybody to get vaccinated. So my hope is that we are 
well on the way to doing that. Thank you, Madam Chair.
    The Chair. Thank you, Senator Burr. Especially want to echo 
that last comment. That will end our hearing today. I really 
want to thank all of our colleagues and I especially want to 
thank our witnesses today, Mr. Becker, Ms. Arthur, Dr. Janz, 
Ms. Cicero. We learned a lot. Very thoughtful discussion and I 
appreciate all of your contributions.
    For any Senators who wish to ask additional questions, 
questions for the record will be due in 10 business days, 
August 10th at 5 p.m.. The hearing record will also remain open 
until then for Members who wish to submit additional material 
for the record. This Committee will next meet Tuesday, August 
3rd, for an executive session. Committee stands adjourned. 
Thank you.

                          ADDITIONAL MATERIAL
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

                          QUESTIONS AND ANSWERS

         Responses by Les Becker to questions of Senator Braun

                             senator braun
    Question 1. As we look toward future disease outbreaks, even 
localized ones, how important is it that hospitals be able to quickly 
trace contacts so we can learn how a disease is spread?

    Answer 1. Case investigation and contact tracing (CICT) is the gold 
standard approach recommended by the Centers for Disease Control and 
Prevention (CDC) for investigation, mitigation, and containment of 
cases and outbreaks. CICT is typically conducted by the local public 
health disease detective staff who initially interview a case, or 
cases, to gather critical information to further educate the individual 
and inform broader public health action at workplaces, congregate 
settings, and the community-at-large.

    While the notion is enticing to have CICT closer to patient/
provider interactions, three core issues could be detrimental to 
community health. Those issues are (1) a duplicative workforce, (2) 
complications with integration of data systems, and (3) coordination 
and resource connections.

    Duplicative workforce: While a hospital may hire staff to perform 
CICT, it would require a robust and flexible workforce coupled with an 
epidemiology workforce to ensure proper investigation considerations, 
data integrity, and reporting. This workforce would only cover 
potential cases that intersect with that particular hospital system and 
not necessarily all the provider clinics throughout the state that 
interact with potential cases. Therefore, one would still need to 
maintain a similar workforce at the local public health department to 
ensure statewide coverage. With two workforces providing similar 
functions, this would lead to larger coordination issues and would 
complicate the autonomies of local health departments prescribed by 
state statues in ``home rule'' states--especially in healthcare systems 
that span county lines.

    Integration of data systems: With an additional workforce would 
also come the burden on hospitals to work with public health on 
universal data systems. Hospitals would need to ensure their systems 
can cater to the ongoing local needs but also mesh with local and state 
public health systems. This work is already conducted at the state 
level to ensure continuity between all county health departments. 
Adding an additional layer of hospitals to the mix will further 
complicate technology upgrades to these data systems. Additionally, as 
outbreaks and emerging diseases occur, they require rapid modification 
and maintenance to existing systems critical to rapid, coordinated 
response.

    Coordination and resource connections: This workforce would need to 
be continually trained and aware of public health actions and resources 
available at the local level that is consistent with local public 
health. There are pre-existing and ever-evolving partnerships 
maintained at the local health department level to ensure current and 
future response lessons are learned across all settings. Partnerships 
and coordination are key to the day-to-day public health work. Care 
coordination and connection are other aspects conducted by public 
health. Adding another workforce that would need to maintain similar 
relationships and knowledge could create scenarios of inconsistent 
knowledge and messaging between local health departments and hospitals 
that could confuse a situation.

    Current state and moving into the future: There is always room for 
improvement for better coordination between hospitals and public 
health. There is tremendous public health value in improving 
partnerships with healthcare providers. Providers are the trusted 
messengers and often the first responder to a potential case in an 
emerging situation. While notifications to public health through 
electronic lab reporting are instantaneous, the information a patient 
with potential disease receives while waiting for a test result can 
impact the trajectory of an outbreak. Providers can let a patient know 
what to expect from public health and what to do while waiting for a 
test result. Public health and healthcare also need to continually and 
rapidly identify communications and tools to be used for patient-
provider interactions for emergent situations. This includes some 
education on the patient's role in protecting their loved ones and 
their community.

    Question 2. At the onset of the COVID-19 pandemic, the Trump 
administration took swift action to expand health care accessibility 
across the country to meet Americans' health care needs. Through the 
temporary expansion of virtual medicine, our country has had the 
opportunity to innovate as well as collect and analyze data around the 
value and utilization of virtual medicine.

    Qustion 2(a). A survey by the Harris Poll recently found that ``87 
per cent of Americans receiving telehealth services during the pandemic 
were satisfied with the services they received''. Yet, 82 percent of 
participants in this study ``agreed that telehealth appointments were a 
great option during the pandemic but doctors' visits are best in 
person.'' While increased virtual medicine flexibilities has been one 
silver lining of the pandemic, there are many factors--such as the real 
value of health care services via video or phone and the potential for 
fraud and abuse and duplicative services--that Congress must consider 
before taking legislative action.

    These are some of the immense considerations that Congress is 
grappling with.

    Question 2(i). What are the most salient lessons learned in the 
virtual medicine space over the pandemic, and how do you recommend 
Congress respond?

    Answer 2(i).

    1. Invest heavily in broadband access. U.S. Department of Health 
and Human Service's recent announcement that Health Resources and 
Service Administration invested $19 million will support expansion of 
telehealth nationwide and improve access in rural and other underserved 
communities; \1\ however, Congress must increase investment in 
broadband across America. Broadband policy is critical to making 
telemedicine a success. One of the largest equity issues we still face 
as a Nation is lack of access to services due to lack of access to 
reliable high-speed internet. Coverage and policy changes do not help 
if patients cannot use the service due to structural limitations. 
Consumers of telehealth need high speed and unbiased access, which will 
allow smaller firm innovation to drive effective competition. Consumers 
of health care via telemedicine should not be penalized with speed 
reduction, data caps, or prioritized services based on which company 
can afford to purchase prioritization of their services.
---------------------------------------------------------------------------
    \1\  https://www.hhs.gov/about/news/2021/08/18/biden-harris-
administration-invests-over-19-million-expand-telehealth-nationwide-
improve-health-rural.html.

    2. Payment methods and policies must support health care 
practitioners. Working in a remote environment, the treating 
practitioner does not have direct access to ancillary health care 
providers (e.g. nurses, medical assistants or scribe support). This 
raises general productivity issues for practitioners as they must 
accomplish all support work for the visit, and in some cases American 
with Disability Act compliance issues if those staff serve as an 
accommodation. Some doctors anecdotally shared that productivity was 
lessened by telehealth in systems that did not have adequate support 
---------------------------------------------------------------------------
for the peripheral aspects of medicine.

    3. Bring back the home office tax deduction. Many practitioners are 
operating from home for telemedicine purposes and this additional 
fiscal incentive could help maintain adoption.

    4. Congress and U.S. Department of Health and Human Services must 
lift CMS restrictions on telemedicine/telehealth treatments, and make 
sure these coverage standards are identical in Tri-Care and Medicaid 
where possible. Variation in coverage standards reduces adoption by 
patients and practitioners and could lead to exploitation by private 
insurance.

    5. The Office of Management and Budget (OMB) may want to more 
broadly consider how we assess the value and savings of telemedicine in 
proposed legislation. The savings, while not always direct to the 
encounter, are quantified for the patient in other ways such as travel, 
quicker access and potential referral/intervention, the prevention of 
critical escalation due to the frequency of basic care, reduced 
potential for transfer injuries, and savings to those supporting the 
patient.

    6. Congress must consider policies to review use of artificial 
intelligence to reduce the potential for large scale unintended 
consequences and disparate outcomes. As larger data sets are gathered, 
due to the increase in telemedicine and expanded use in Electronic 
Medical Records, the application of artificial intelligence is growing. 
With this progression we are seeing documented results nationally 
showing significant unintentional bias against marginalized 
populations. Federal agencies must be given funding to evaluate and 
approve use of artificial intelligence tools in health care settings to 
reduce the potential for large scale unintended consequences and 
disparate outcomes.

    7. Authority for the practitioner, housed in state law or policy, 
to reject the visit as not appropriate for telemedicine. In Washington 
State, the Washington Medical Commission has adopted a policy that 
explicitly stated this discretion for doctors and physician assistants. 
\2\ To a large degree health system operators also adhered to that 
standard.
---------------------------------------------------------------------------
    \2\  https://wmc.wa.gov/sites/default/files/public/documents/
TelemedicineAndContinuityOfCarePOL2018-01.pdf.

    8. Respect and encourage license portability through new and 
existing compacts between the states. Medical doctors (allopathic and 
osteopathic) have what is arguably the most successful compact with 35 
member states and seven more under consideration in state legislatures. 
This compact was heavily utilized throughout the pandemic and is 
---------------------------------------------------------------------------
considered an essential portability tool.

    Question 2(ii). Does the data available support the permanent 
extension of certain virtual medicine services, or do we need more 
before we discuss permanency of pandemic virtual medicine 
flexibilities?

    Answer 2(ii).

    1. With obvious exceptions, health systems in Washington activated 
near total telehealth systems for the majority of patients during the 
early days of the pandemic. The overwhelming results show telemedicine 
can work for most patients, but it is not perfect. It was clear that 
practitioners need certain support. Those specific supports are 
discussed above.

    2. Harris polling data. Based on health care provider complaints we 
have received thus far in the pandemic, some patients are simply not 
comfortable with telemedicine visits and will never opt for them. This 
is acceptable and should be allowable going forward. With that in mind, 
it is possible the Harris poll cited is accurate in both statistics. 
Polling answers are likely not mutually exclusive depending on the 
question asked and demographic polled. Similarly, our demographic data 
indicates there will be a subset of practitioners, independent of 
specialty area or age, that simply will not participate in telemedicine 
as a modality unless forced. This avoidance should also be allowable 
going forward.

    3. Notably, we did not see increased allegations of fraud regarding 
telemedicine since the onset of the pandemic.

    4. Reduced costs through telemedicine are frequently only 
experienced by the patient's side of the equation but not the 
practitioner or the system. Patients, and to some degree the system, 
benefit from earlier intervention at a basic level which reduces costs. 
Chronic disease management and monitoring is a classic example of this. 
On the practitioner side however, the savings are not significant 
enough to warrant a deviation from payment parity. Direct to Consumer 
telemedicine companies may benefit from reduced overhead, but they 
offer limited services to patients and are more beneficial to contract 
with larger systems to offer those limited services as an extension. 
The practitioner did not go to 75 percent of their medical school, the 
system is not paying for 75 percent of practitioner service, and the 
brick and mortar system and IT infrastructure did not cost 75 percent 
less to build.

    Where is the reduced overhead? By paying practitioners less, there 
is less incentive to try a new modality and that will prevent 
appropriate telemedicine expansion.

    5. Overall, the permanent extension of certain pandemic 
flexibilities is likely warranted. Many groups such as Center for 
Telehealth and e-Health Law (CTeL) and regional health systems have 
gathered data showing increased adoption by patients and practitioners. 
What that data supports comes down to how OMB scores the bills that 
establish the changes. As discussed previously, it is not always about 
direct savings, but downstream savings as well, which are sometimes not 
considered or more difficult to quantify. A reasonable approach may be 
to have Centers for Medicare and Medicaid Services (CMS) expand their 
trial and assessment of extension of virtual medicine services so 
relevant data may be gathered where little currently exists in those 
use cases where it is needed.

    6. Care should be taken to harmonize making pandemic flexibilities 
permanent. There needs to be suitable messaging and clear understanding 
of what is possible by CMS or others. For example, when CMS lifted 
geographic restrictions on treatment of beneficiaries via telemedicine. 
There was significant confusion that this change only applied to 
reimbursement as opposed to legality of practice, which is retained by 
the states.

    7. The most difficult part of this conversation is appropriate 
treatment vs. appropriate modality. This usually comes down to audio 
only and asynchronous or message interaction. However, certain 
modalities simply are not conducive to effective assessment, diagnosis, 
and treatment for specific conditions and use by certain professions. 
Again, CMS determination of effectiveness and coverage could assist in 
clarifying the landscape on a Federal level and many others would 
likely follow suit. Mandating reflective standards in Tri-Care and 
others could further that goal.
                                 ______
                                 

       Responses by Phyllis Arthur to questions of Senator Braun

                             senator braun
    Under the direction of the Trump Administration, HHS established 
Operation Warp Speed, a public-private partnership that accelerated 
vaccine, therapeutic, and testing development, all while maintaining 
proper safety and efficiency standards. As devastating as the COVID 
pandemic has been, a positive outcome has certainly been greater 
efficiency in medical countermeasure innovation.

    Question 1. In your testimony, you discussed the importance of 
public-private partnerships in facilitating efficient medical 
countermeasure research and development--what are the most important 
lessons that BIO has extracted from the pandemic in the therapeutics 
space?

    Answer 1. Senator Braun, thank you for the thoughtful question. I 
want to agree with your assessment that Operation Warp Speed (OWS) was 
highly successful in its goal of partnering with industry to rapidly 
develop and distribute medical countermeasures during the pandemic. 
Much of that success is due to companies in the countermeasure space, 
large and small, stepping up and dedicating resources to combating the 
pandemic. It is also a credit to the design of OWS which combined the 
industry leadership and expertise in Dr. Slaoui's role along side 
General Perna and HHS's know-how and capabilities. OWS was effective at 
quickly identifying potential successful countermeasures, contracting 
with the companies, accelerating their trials, and scaling up 
production of the final product.

    From the perspective of industry, the initial pathways for products 
were clear. OWS had the needed resources to ``take multiple shots on 
goal'' and support many different products and types of products in 
both the vaccine and therapeutics space. With OWS the NIH established 
the Accelerating COVID-19 Therapeutic Interventions and Vaccines 
(ACTIV) program, which coordinated research strategy for prioritizing 
and speeding development of the most promising treatments and vaccines. 
The Administration through OWS identified there were numerous products 
in development, all competing for patients to participate in clinical 
studies. ACTIV worked to coordinate and streamline processes to make 
the best use of biomedical research resources and testing of 
preclinical and clinical compounds. It also worked to prioritize the 
most promising candidates and move them into clinical trials in a way 
that was safe and efficient. This system was successful in streamlining 
the development process, and the well-funded OWS was able to contract 
with companies and purchase products as they were finishing 
development.

    Ultimately, OWS became a supercharged version of what many had 
envisioned the ASPR role to be. It was a clear leader in planning the 
response that drove product development and procured products from 
their private sector partners. OWS showed that given the resources and 
authority, the Public Health Emergency Medical Countermeasures 
Enterprise (PHEMCE) and industry can rally to respond to any health 
security threat.

    As OWS went along, eventually a decision was made to focus on 
vaccines. Therapeutic funding and opportunities began to disappear, and 
that culminated in the COVID therapeutic BAA being pulled from BARDA. 
BIO has expressed its disappointment in that decision, and with a 
sizable portion of the population still unvaccinated and variants on 
the rise, the need for therapeutics is more important than ever. 
Additionally, we are now able to look at COVID with a more long-term 
view and see the need for a second generation of COVID products, but as 
of now there are limited pathways for the companies working in this 
space to partner with the Government. I would urge Congress to continue 
to invest in COVID therapeutics. Those investments will pay dividends 
not only by saving lives from COVID but may also better prepare us for 
the next pandemic.
                                 ______
                                 

         Response by Anita Cicero to questions of Senator Rosen

                             senator rosen
    As we have seen, this pandemic has had a significant impact on most 
aspects of our medical and public health systems. As we work to 
strengthen our critical safety-nets and better prepare for the future, 
we must not overlook the importance of safeguarding our Nation's blood 
supply. There have been shortages throughout the country. Just last 
month, an urgent call for donations went out to residents in the Las 
Vegas area to help with blood donation shortages so cancer patients 
could receive the treatment they needed.

    Question 1. It's not just the volume of blood donations, but also 
the supplies needed and the staff who are essential both for collecting 
the blood donations but also managing the supply at our blood banks. 
Ms. Cicero what are your recommendations for how to include 
consideration of safeguarding our blood supply as we look at improving 
other critical public health infrastructure and our medical domestic 
supply chain? Dr. Janz, please comment if you have anything to add as 
well.

    Answer 1. Thank you for that question, Senator Rosen. We are 
experiencing a blood and platelet shortage in the United States. I 
agree that our country needs to be able to sustain the infrastructure 
necessary to maintain a sufficient supply of blood donations and other 
essential medical services even during pandemics and other public 
health emergencies. It is important to understand that hospital 
preparedness and pandemic preparedness extend well beyond the hospital 
walls, into communities with other vital healthcare related facilities 
and services, such as blood banks. In order to minimize the disruption 
of services during shocks to the healthcare system, blood banks need to 
ensure that they have appropriate emergency staffing plans in place. 
Employees of blood banks, including nurses and phlebotomists, must be 
appropriately supported and supplied with personal protective 
equipment, training, and infection control practices that ensure their 
safety and their willingness to continue working even during times of a 
surge in cases. Blood banks should also join and play an active part in 
regional healthcare coalitions. Healthcare coalitions facilitate 
information sharing among participating organizations, promote 
situational awareness, provide a way to share resources among members, 
and serve as a link with regional authorities. During `peace times', 
healthcare coalitions also support pandemic exercises and drills, so 
that members such as blood banks can pressure test their procedures and 
pandemic plans, including plans for successfully handling the complex 
logistics of managing the blood supply during infectious disease 
outbreaks. As we continue to digest lessons learned during the COVID-19 
pandemic, it will be important to assess the role and performance of 
healthcare coalitions in the response. If the assessment determines 
that healthcare coalitions did not play a beneficial or proactive role 
during the COVID response, measures should be taken to address any 
limitations or challenges that inhibit their performance. Apart from 
healthcare coalitions, public health authorities should take into 
account the critical role that regional blood banks play and ensure 
that public health strategies and communications (including those 
related to `stay at home' recommendations) do not inadvertently 
discourage donations or the provision of other daily health needs.
                                 ______
                                 

  Responses by David Janz to questions of Senator Rosen, and Senator 
                                 Braun

                             senator rosen
    Throughout the pandemic, we have seen the important role mobile 
clinics have played in delivering lifesaving health care and COVID-19 
vaccines to our most vulnerable patients, particularly those in rural 
communities. I was incredibly grateful to FEMA for sending two mobile 
trailers on vaccination routes across rural Nevada, where volunteer 
nurses and doctors were successfully able to deliver over 7,600 COVID-
19 shots into arms. Allowing providers the flexibility to meet patients 
where they are is especially vital in our rural communities. That's why 
I've introduced bipartisan legislation with Senator Collins to expand 
access to mobile health clinics and ensure that our small and rural 
communities are not left behind.
    Question 1. Dr. Janz, how can we use lessons learned from the 
COVID-19 pandemic and utilize mobile clinics on a more permanent basis 
going forward, to ensure patients receive regular, routine care, rather 
than on an emergency basis?''

    Answer 1. I thank Senator Rosen for this important question and I 
agree that increased access to preventative healthcare is vital to 
improve the health of the Nation. I believe each community will have 
unique needs and challenges and recommend engaging community leaders to 
learn what these may be and which type of healthcare outreach will 
address these issues.

    Question 2. As we have seen, this pandemic has had a significant 
impact on most aspects of our medical and public health systems. As we 
work to strengthen our critical safety-nets and better prepare for the 
future, we must not overlook the importance of safeguarding our 
Nation's blood supply. There have been shortages throughout the 
country. Just last month, an urgent call for donations went out to 
residents in the Las Vegas area to help with blood donation shortages 
so cancer patients could receive the treatment they needed.

    It's not just the volume of blood donations, but also the supplies 
needed and the staff who are essential both for collecting the blood 
donations but also managing the supply at our blood banks. Ms. Cicero 
what are your recommendations for how to include consideration of 
safeguarding our blood supply as we look at improving other critical 
public health infrastructure and our medical domestic supply chain? Dr. 
Janz, please comment if you have anything to add as well.

    Answer 2. I thank Senator Rosen for this excellent question on a 
vital and limited resource. I think it is important for the Nation to 
take an accounting of all the potentially lifesaving but limited 
resources in healthcare and learn how we can bolster these resources as 
a response to current and future crises. The blood supply is certainly 
one of these resources. However, as discussed in my original testimony, 
the shortage of healthcare providers, including nurses, respiratory 
therapists, and physicians looms as a larger threat to our 
preparedness. An ample blood supply without a nurse to infuse the blood 
in a timely manner would not benefit our patients.
                             senator braun
    Question 1. COVID increased attention on the safety for patients 
and staff in hospitals while also intensifying demands on health 
leaders to act more efficiently and decisively. Can technology--
including faster and more accurate data collection--be the bridge 
between these two priorities?

    Answer 1. I would like to thank Senator Braun for this important 
question. The backbone of a Learning Healthcare System, discussed in my 
original testimony, includes collecting data and disseminating these 
data in real-time. These data can be important to a variety of 
stakeholders: patients, healthcare providers, healthcare systems, and 
leadership in these systems. Historically, data would be collected, 
analyzed, and disseminated over the course of years, which resulted in 
very slow advances in healthcare delivery. A Learning Healthcare System 
aims to integrate clinical research infrastructure with the 
infrastructure of the hospital system to collect high-quality data and 
not only disseminate these data in real-time, but also have the backing 
of hospital leadership to make changes in patient care and hospital 
function. This can occur on the scale of weeks rather than years. 
Hospital leadership should look toward this model of integration of 
clinical research infrastructure into the daily function of the 
hospital to improve every aspect of healthcare delivery.
                                 ______
                                 
    [Whereupon, at 12 p.m., the hearing was adjourned.]

                                   [ALL]