[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]


                      IMPROVING ACCESS TO CARE: LEGISLATION TO 
                      REAUTHORIZE KEY PUBLIC HEALTH PROGRAMS

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

                            VIRTUAL HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 29, 2020

                               __________

                           Serial No. 116-123
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

                   govinfo.gov/committee/house-energy
                        energycommerce.house.gov
                        
                                __________

                   U.S. GOVERNMENT PUBLISHING OFFICE                    
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-----------------------------------------------------------------------------------                         

                    COMMITTEE ON ENERGY AND COMMERCE

                     FRANK PALLONE, Jr., New Jersey
                                 Chairman
BOBBY L. RUSH, Illinois              GREG WALDEN, Oregon
ANNA G. ESHOO, California              Ranking Member
ELIOT L. ENGEL, New York             FRED UPTON, Michigan
DIANA DeGETTE, Colorado              JOHN SHIMKUS, Illinois
MIKE DOYLE, Pennsylvania             MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois             STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina    ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California          CATHY McMORRIS RODGERS, Washington
KATHY CASTOR, Florida                BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland           PETE OLSON, Texas
JERRY McNERNEY, California           DAVID B. McKINLEY, West Virginia
PETER WELCH, Vermont                 ADAM KINZINGER, Illinois
BEN RAY LUJAN, New Mexico            H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York                 GUS M. BILIRAKIS, Florida
YVETTE D. CLARKE, New York, Vice     BILL JOHNSON, Ohio
    Chair                            BILLY LONG, Missouri
DAVID LOEBSACK, Iowa                 LARRY BUCSHON, Indiana
KURT SCHRADER, Oregon                BILL FLORES, Texas
JOSEPH P. KENNEDY III,               SUSAN W. BROOKS, Indiana
    Massachusetts                    MARKWAYNE MULLIN, Oklahoma
TONY CARDENAS, California            RICHARD HUDSON, North Carolina
RAUL RUIZ, California                TIM WALBERG, Michigan
SCOTT H. PETERS, California          EARL L. ``BUDDY
DEBBIE DINGELL, Michigan             CARTER, Georgia
MARC A. VEASEY, Texas                JEFF DUNCAN, South Carolina
ANN M. KUSTER, New Hampshire         GREG GIANFORTE, Montana
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
A. DONALD McEACHIN, Virginia
LISA BLUNT ROCHESTER, Delaware
DARREN SOTO, Florida
TOM O'HALLERAN, Arizona
                                 ------                                

                           Professional Staff

                   JEFFREY C. CARROLL, Staff Director
                TIFFANY GUARASCIO, Deputy Staff Director
                MIKE BLOOMQUIST, Minority Staff Director
                         Subcommittee on Health

                       ANNA G. ESHOO, California
                                Chairwoman
ELIOT L. ENGEL, New York             MICHAEL C. BURGESS, Texas
G. K. BUTTERFIELD, North Carolina,     Ranking Member
    Vice Chair                       FRED UPTON, Michigan
DORIS O. MATSUI, California          JOHN SHIMKUS, Illinois
KATHY CASTOR, Florida                BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland           H. MORGAN GRIFFITH, Virginia
BEN RAY LUJAN, New Mexico            GUS M. BILIRAKIS, Florida
KURT SCHRADER, Oregon                BILLY LONG, Missouri
JOSEPH P. KENNEDY III,               LARRY BUCSHON, Indiana
    Massachusetts                    SUSAN W. BROOKS, Indiana
TONY CARDENAS, California            MARKWAYNE MULLIN, Oklahoma
PETER WELCH, Vermont                 RICHARD HUDSON, North Carolina
RAUL RUIZ, California                EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan             GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire         GREG WALDEN, Oregon (ex officio)
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
LISA BLUNT ROCHESTER, Delaware
BOBBY L. RUSH, Illinois
FRANK PALLONE, Jr., New Jersey (ex 
    officio)
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, opening statement...............................     2
    Prepared statement...........................................     3
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     4
    Prepared statement...........................................     5
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     6
    Prepared statement...........................................     8
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     9
    Prepared statement...........................................    10

                               Witnesses

Linda Goler Blount, M.P.H., President and CEO, Black Women's 
  Health Imperative..............................................    12
    Prepared statement...........................................    14
Robert Boyd, M.C.R.P., M. Div., President, School-Based Health 
  Alliance.......................................................    16
    Prepared statement...........................................    18
    Answers to submitted questions...............................   160
Nancy Goodman, M.P.P., J.D., Founder and Executive Director, Kids 
  V Cancer.......................................................    25
    Prepared statement...........................................    27
Aaron Seth Kesselheim, M.D., J.D., M.P.H., Professor Of Medicine, 
  Harvard Medical School.........................................    30
    Prepared statement...........................................    33
Brian Lindberg, Chief Legal Officer and General Counsel, National 
  Bone Marrow Donor Program......................................    43
    Answers to submitted questions...............................    46
    Prepared statement...........................................   164
Travis T. Tygart, Chief Executive Officer, U.S. Anti-Doping 
  Agency.........................................................    53
    Prepared statement...........................................    55
    Answers to submitted questions...............................   168

                           Submitted Material

H.R. 2075, School-Based Health Centers Reauthorization Act of 
  2019...........................................................   106
H.R. 4078, EARLY Act Reauthorization of 2019.....................   108
H.R. 4439, Creating Hope Reauthorization Act.....................   110
H.R. 4764, Transplant Act of 2019................................   112
H.R. 5373, United States Anti-Doping Agency Reauthorization Act 
  of 2019........................................................   116
Statement of July 13, 2020, from the National Marrow Donor 
  Program, submitted by Ms. Eshoo................................   121
Letter of July 28, 2020, to Mr. Pallone and Mr. Walden, from 
  Council of State Bioscience Associations, submitted by Ms. 
  Eshoo..........................................................   123
Letter of July 28, 2020, to Mr. Pallone and Mr. Walden, from Rep. 
  Mike Thompson, submitted by Ms. Eshoo..........................   126
Statement of July 29, 2020, Joanna Kurtzberg, President, Cord 
  Blood Association, submitted by Ms. Eshoo......................   128
Report of January 2020, ``Drug Development: FDA's Priority Review 
  Voucher Programs''\1\
Article of February 2019, ``Impact Of the Priority Review Vouches 
  Program on Drug Development For Rare Pediatric Diseases,'' from 
  Thomnas J. Hwang, et al., Pharmaceuticals and Medical 
  Technology, submitted by Ms. Eshoo.............................   135
Letter of July 23, 2020, to Mr. Pallone and Mr. Walden, from the 
  Bone Marrow, PBSC, Cell Therapy, and Cord Blood Transplant 
  Coalition, submitted by Ms. Eshoo..............................   142
Letter of July 29, 2020, to Ms. Eshoo and Mr. Burgess, by Rachel 
  Sher, J.D., M.P.H., Vice President, Policy and Regulatory 
  Affairs, National Organization for Rare Disorders, submitted by 
  Ms. Eshoo......................................................   146
Letter of July 28, 2020, to Ms. Eshoo and Mr. Burgess, by 
  Victoria A. M. Wolodzko, Senior Vice President, Mission, Susan 
  G. Kome, submitted by Ms. Eshoo................................   148
Letter of July 28, 2020, to Mr. Pallone and Mr. Walden, 
  Biotechnology Companies Coalition, submitted by Ms. Eshoo......   150
Letter of July 22, 2020, to Mr. Alexander, et al., from Coalition 
  Pediatric Medical Research, submitted by Ms. Eshoo\2\
Letter on July 29, 2020, to Mr. Pallone and Mr. Walden, by Nancy 
  Houlihan, MA, RN, AOCN, President, Oncology Nursing Society, 
  submitted by Ms. Eshoo.........................................   152
Slides of July 29, 2020, by Robert Boyd, President, School-Based 
  Health Alliance, submitted by Ms. Eshoo \3\
Guide, School-Based Health Alliance, submitted by Ms. Eshoo......   153
Addendum, Slide Presentation--Written Testimony for the Record, 
  submitted by Ms. Eshoo.........................................   154

----------
\1\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF14/
  20200729/110949/HMTG-116-IF14-20200729-SD007.pdf.
\2\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF14/
  20200729/110949/HMTG-116-IF14-20200729-SD013.pdf.
\3\ The information has been retained in committee files and also 
  is available at https://docs.house.gov/meetings/IF/IF14/
  20200729/110949/HMTG-116-IF14-20200729-SD015.pdf.

 
IMPROVING ACCESS TO CARE: LEGISLATION TO REAUTHORIZE KEY PUBLIC HEALTH 
                                PROGRAMS

                              ----------                              


                        WEDNESDAY, JULY 29, 2020

                       House of Representatives,

                    Subcommittee on Health,
                  Committee on Energy and Commerce,
                                            Washington, DC.
    The subcommittee met, pursuant to call, at 10:00 a.m., via 
Cisco Webex online video conferencing, Hon. Anna G. Eshoo 
(chairwoman of the subcommittee) presiding.
    Members present: Representatives Eshoo, Engel, Butterfield, 
Matsui, Castor, Sarbanes, Schrader, Kennedy, Cardenas Welch, 
Ruiz, Dingell, Kuster, Kelly, Barragan, Blunt Rochester, Rush, 
Pallone (ex officio), Burgess (subcommittee ranking member), 
Upton, Guthrie, Griffith, Bilirakis, Long, Bucshon, Brooks, 
Mullin, Carter, Gianforte, and Walden (ex officio).
    Also present: Representatives O'Halleran and Johnson of 
Ohio.
    Staff present: Joe Banez, Professional Staff Member; Billy 
Benjamin, Systems Administrator; Jeffrey C. Carroll, Staff 
Director; Kimberly Espinosa, Professional Staff Member; Waverly 
Gordon, Deputy Chief Counsel; Stephen Holland, Health Counsel; 
Aisling McDonough, Policy Coordinator; Meghan Mullon, Policy 
Analyst; Joe Orlando, Staff Assistant; Kaitlyn Peel, Digital 
Director; Tim Robinson, Chief Counsel; Rebecca Tomilchik, Staff 
Assistant; Kimberlee Trzeciak, Chief Health Advisor; C. J. 
Young, Press Secretary; Nolan Ahern, Minority Professional 
Staff, Health; Mike Bloomquist, Minority Staff Director; S. K. 
Bowen, Minority Press Secretary; William Clutterbuck, Minority 
Staff Assistant; Theresa Gambo, Minority Human Resources/Office 
Administrator; Caleb Graff, Minority Professional Staff, 
Health; Tyler Greenberg, Minority Staff Assistant; Tiffany 
Haverly, Minority Communications Director; Peter Kielty, 
Minority General Counsel; Ryan Long, Minority Deputy Staff 
Director; James Paluskiewicz, Minority Chief Counsel, Health; 
Brannon Rains, Minority Policy Analyst; Kristin Seum, Minority 
Counsel, Health; Kristen Shatynski, Minority Professional Staff 
Member, Health; and Everett Winnick, Minority Director of 
Information Technology.
    Ms. Eshoo. OK. I am going to gavel in, and the Subcommittee 
on Health will now come to order.
    Due to COVID-19, today's hearing is being held remotely, 
and all members and witnesses will be participating via video 
conferencing.
    As part of our hearing, the microphones--as you know, but 
it is a reminder--the microphones will be on mute to eliminate 
background noise, and members and witnesses will need to unmute 
your microphone each time you wish to speak. So that is every 
time. So turn it on when you go to speak. Turn it off so that 
there isn't any background noise when you are not speaking.
    Documents for the record can be sent to Meghan Mullon at 
the email address that we have provided your staff with, and 
all documents will be entered into the record at the conclusion 
of the hearing.
    The Chair now recognizes herself for 5 minutes for an 
opening statement.

 OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Today our subcommittee is considering five bills to 
reauthorize important public health programs that support and 
improve the health and well-being of children in our country, 
as well as adults.
    While so much of our subcommittee's focus and work is on 
the COVID-19 pandemic that has taken the lives of 150,000 
Americans, we also have to continue our essential work during 
the crisis, which means making sure that health programs 
nearing their expiration are continued, that they are improved, 
and in some cases expanded.
    So today we are going to hear testimony on five bipartisan 
reauthorization bills. Several of these bills support 
individuals in the fight against cancer.
    The Creating Hope Reauthorization Act, sponsored by 
Representatives Butterfield and McCaul, help children access 
pediatric cancer drugs.
    Pediatric cancer is the number one disease killer of 
American children, but pharmaceutical companies often avoid 
developing pediatric cancer drugs because of the very small 
market and the high risks that are associated with studying and 
testing drugs for children.
    The Creating Hope Act provides incentives for the research 
and development of pediatric cancer drugs by providing the 
developers with the valuable priority review vouchers which 
allow the recipient to speed up the FDA review of any one of 
its new drug products.
    The next bill, the TRANSPLANT Act, sponsored by 
Representatives Matsui and Bilirakis, helps those with blood 
cancers, like leukemia and lymphoma, to be matched with a 
potential bone marrow and cord blood donor.
    Through this matching program, over 100,000 lives have been 
saved, so clearly this works. And that law is a source of pride 
to all of us.
    The EARLY Act, sponsored by Representatives Wasserman 
Schultz and Brooks, increases funding for the successful CDC 
outreach and education campaign that informs young people about 
breast cancer risks.
    Each year, over 300,000 women are diagnosed with breast 
cancer. I have spent my entire service in Congress to make sure 
women have access to breast cancer treatment, including 
reconstructive surgery after mastectomies, and I am really 
pleased to consider this important program today.
    Now, outside of public health programs that help in the 
fight against cancer, we are also considering a bill to 
reauthorize the School-Based Health Center Program, sponsored 
by Representatives Sarbanes and Stefanik.
    About 2,500 school-based health centers serve 3.6 million 
American children. These health centers provide children with 
immunizations, mental health support, asthma, and allergy 
screenings, and many other vital services. It really is a 
terrifically effective program.
    And finally, we are considering a bill to make sure that 
the U.S. Anti-Doping Agency is prepared for the 2028 Olympics 
in Los Angeles. The sponsors are Representatives Mike Thompson, 
Diana DeGette, and Mr. Johnson.
    The Agency is an independent body that manages the anti-
doping program for America's athletes to ensure they are 
playing clean.
    So as we struggle with the pandemic, with COVID-19, and the 
crisis that it is in our country, we have to keep up our work 
for the American people, those with cancer, our Nation's 
children, and our athletes training for future events, and that 
is exactly what we are doing today. So I stand ready to work 
with each of you to make sure that these programs are 
reauthorized.
    [The prepared statement of Ms. Eshoo follows:]

                Prepared Statement of Hon. Anna G. Eshoo

    Today our Subcommittee will consider five bills to 
reauthorize important public health programs that support and 
improve the health and wellbeing of children and adults.
    While so much of our Subcommittee's focus and work is on 
the COVID-19 pandemic which has killed 150,000 Americans, we 
also have to continue our essential work during the crisis, 
which means making sure that health programs nearing their 
expiration are continued, improved, and in some cases expanded.
    Today we will hear testimony on five bipartisan 
reauthorization bills.
    Several of these bills support individuals in the fight 
against cancer.
    The Creating Hope Reauthorization Act sponsored by 
Representatives Butterfield and McCaul helps children access 
pediatric cancer drugs.
    Pediatric cancer is the number one disease killer of 
American children, but pharmaceutical companies often avoid 
developing pediatric cancer drugs because of the small market 
and the high risks associated with studying and testing drugs 
for children.
    The Creating Hope Act provides incentives for the research 
and development of pediatric cancer drugs by providing the 
developers with the valuable Priority Review Vouchers which 
allow the recipient to speed up the FDA review of any one of 
its new drug products.
    The TRANSPLANT Act sponsored by Representatives Matsui and 
Bilirakis helps those with blood cancers like leukemia and 
lymphoma to be matched with a potential bone marrow and cord 
blood donor. Through this matching program, over 100,000 lives 
have been saved.
    The EARLY Act sponsored by Representatives Wasserman-
Schultz and Brooks increases funding for the successful CDC 
outreach and education campaign that informs young people about 
breast cancer risks. Each year, over 300,000 women are 
diagnosed with breast cancer.
    I've spent my entire service in Congress to make sure women 
have access to breast cancer treatment, including 
reconstructive surgery after mastectomies, and I'm pleased to 
consider this important program today.
    Outside of public health programs that help the fight 
against cancer, we're also considering a bill to reauthorize 
the School-Based Health Center program sponsored by 
Representatives Sarbanes and Stefanik. About 2,500 school-based 
health centers serve 3.6 million children. These health centers 
provide children with immunizations, mental health support, 
asthma and allergy screenings, and many other vital services.
    Finally, we're considering a bill to make sure that the 
U.S. Anti-Doping Agency is prepared for the 2028 Olympics in 
Los Angeles. The sponsors of this bill are Representatives 
Thompson, DeGette, and Johnson. The Agency is an independent 
body that manages the anti-doping program for America's 
athletes to ensure they're playing "clean."vAs we struggle with 
the COVID-19 crisis, we have to keep up our work for Americans 
with cancer, our nation's children, and athletes training for 
future events.
    I stand ready to work with my colleagues to make sure these 
programs are reauthorized.

    Ms. Eshoo. And with that, I will yield back my time. And 
the chair now recognizes Dr. Burgess, the ranking member of our 
subcommittee, for 5 minutes for his opening statement. And 
please remember to unmute.
    Thank you, colleagues.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. Very well. I thank the Chair. I trust I have 
successfully unmuted.
    This is an important hearing today to discuss the 
reauthorization of five public health programs: the school-
based health centers, the young women's breast health education 
and awareness, the Stem Cell and Therapeutic Research Act, and 
the United States Anti-Doping Agency Reauthorization Act, and 
perhaps most importantly, the Pediatric Priority Review Voucher 
Program.
    All five of these bills provide tools for individuals in 
all stages of life to stay healthy and to save lives. So I am 
grateful that the committee has organized this discussion on 
these important measures of expiring reauthorizations and 
potentially providing hope and reassurance to many Americans in 
what has turned out to be a very difficult time.
    Often serving as a lifeline for access to care to many 
children, H.R. 2075 would reauthorize Federal support for 
school-based health centers, while also including federally 
qualified health centers as eligible providers.
    Generally administered as a partnership between hospital, 
schools, and local organizations, school-based health centers 
provide comprehensive care for students through important 
services, such as primary medical care, behavioral care, and 
even substance disorder counseling.
    These services are offered in school, a setting with which 
students are familiar and comfortable. This convenient setting 
makes these services more accessible for many students, 
especially those high risk, and certainly underscores the 
importance of opening schools.
    Furthermore, ensuring access to preventive care allows for 
early intervention and treatment before a condition might 
worsen.
    This was first authorized in 2010. The EARLY Act 
reauthorizes the Young Women's Breast Health Education and 
Awareness Requires Learning Young Act. This piece of 
legislation provides women with meaningful information, 
teaching women, especially young women, the importance of 
breast health and the risk factors associated with breast 
cancer, education and awareness, and the critical steps in 
preventive care.
    With a history starting in the 1980s, the C.W. Bill Young 
Cell Transplantation Program has supported over 92,000 blood 
stem cell transplants. With 12,000 Americans diagnosed with 
blood cancer and disorder every year, H.R. 4764, the TRANSPLANT 
Act, would reauthorize the C.W. Bill Young Transplantation 
Program and the National Cord Blood Inventory, providing 
resources and support to those who need a donor or a cord blood 
unit.
    Diseases like sickle cell anemia or blood cancer often rely 
on bone marrow or cord blood transplant for treatment. However, 
70 percent of those with a blood disorder or cancer do not have 
a matched donor. H.R. 4764 will help maintain that program.
    And I do want to acknowledge over the years this program 
has been one that has been championed by Representative Chris 
Smith of New Jersey, and certainly he has been responsible for 
getting us to where we are today with the cord blood industry.
    In 1999, the U.S. Olympic Committee launched the United 
States Anti-Doping Agency to oversee and enforce anti-doping 
programs for our Nation's athletes. The Anti-Doping Agency 
Reauthorization Act would ensure that the USADA has the 
resources needed to encourage healthy sportsmanship among 
American athletes, especially as sports teams begin playing 
again.
    Our athletes often serve as role models for our children, 
making the mission of USADA all the more significant. Our 
children must learn the value and importance of clean 
sportsmanship.
    Parenthetically, it is interesting that in 2014 one of the 
earliest attacks of Russian interference was in the anti-doping 
agency that was actually administered through, it turned out to 
be, the Russian military.
    Finally, I am encouraged to see H.R. 4439, the Creating 
Hope Reauthorization Act, included in today's hearing. It is an 
important bill that would make permanent the Pediatric Rare 
Disease Priority Review Voucher Program, an incentive program 
to encourage American drug innovation for rare and pediatric 
diseases.
    Because of the complexity and expense required to invest in 
pediatric drugs, the FDA had only approved two pediatric 
oncology drugs in 22 years leading up to the Creating Hope Act, 
which was first signed into law in 2012.
    Since the enactment of this program, the FDA has approved 
22 drugs. Unfortunately, the program does expire on September 
30 of this year, so it does require our immediate attention.
    So I hope we can continue to work on these bills in a 
bipartisan manner and get these reauthorizations across the 
finish line. They are all critical.
    I thank our witnesses for sharing their time and expertise 
today.
    And I will yield back the balance of my time.
    [The prepared statement of Mr. Burgess follows:]

             Prepared Statement of Hon. Michael C. Burgess

    Thank you, Madam Chair. Today we are here to discuss the 
importance of reauthorizing five public health programs: 
School-Based Health Centers, the Young Women's Breast Health 
Education and Awareness Requires Learning Young Act, the Stem 
Cell Therapeutic and Research Act, the United States Anti-
Doping Agency Reauthorization Act, and the Pediatric Priority 
Review Voucher Program. All five of these bills provide various 
tools for individuals in all stages in life, to stay healthy 
and even save lives. I am grateful that the committee organized 
this discussion on these important measures, potentially 
providing hope and reassurance to many Americans depending on 
these programs in this difficult time.
    Often serving as lifeline for access to care for many 
children, H.R. 2075, would reauthorize federal support for 
School-Based Health Centers while also including Federally 
Qualified Health Centers as eligible providers. Generally 
administrated as a partnership between hospitals, schools, and 
local organizations, school-based health centers provide 
comprehensive care for students through important services such 
as primary medical care, behavioral care, and even substance 
disorder counseling to 3.6 million k-12 students nationwide. 
These services are offered in school, a setting with which 
students are familiar and comfortable, this convenient setting 
makes these services more accessible for many students, 
especially those of high-risk.
    Furthermore, ensuring access to preventative care allows 
for early intervention and treatment before the condition 
worsens. First authorized in 2010, The EARLY Act reauthorizes 
the Young Women's Breast Health Education, and Awareness 
Requires Learning Young Act. This piece of legislation provides 
women with meaningful information, teaching women, especially 
young women, the importance of breast health and the risk 
factors associated with breast cancer. Education and awareness 
are a critical steps in preventative care, and with the breast 
cancer survival rate averaging 93 percent if detected at an 
early stage, we know it can help save lives.
    With a history starting in the 1980s, the C.W. Bill Young 
Cell Transplantation Program has supported over 92,000 blood 
stem cell transplants. With 12,000 Americans diagnosed with 
blood cancer and disorders every year, H.R. 4764, the 
TRANSPLANT Act, would reauthorize the C.W. Bill Young Cell 
Transplantation Program and the National Cord Blood Inventory, 
providing resources and support to those who need a donor or 
cord blood unit. Diseases like sickle cell anemia or blood 
cancer often rely on bone marrow or cord blood transplant for 
treatment; however 70 percent of those with a blood disorder or 
cancer do not have a matched donor. H.R. 4764 will help 
maintain this program.
    In 1999, the U.S. Olympic Committee launched the United 
States Anti-Doping Agency, or USADA, to oversee and enforce 
anti-doping programs for our Nations' athletes. The Anti-Doping 
Agency Reauthorization Act would ensure that the USADA has the 
resources needed to encourage healthy sportsmanship among 
American athletes, especially as sports teams begin playing 
again. Our athletes often serve as role models for our 
children, making the mission of the USADA all the more 
significant. Our children must learn the value and importance 
in clean sportsmanship, and what better way to learn about 
these values than through the athletes they so admire.
    Finally, I am encouraged to see H.R. 4439, the Creating 
Hope Reauthorization Act, included in today's hearing. This 
important piece of legislation would make permanent the 
pediatric rare disease priority review voucher program, an 
incentive program to encourage American drug innovation for 
rare pediatric diseases. Because of the complexity and expense 
required to invest in pediatric drugs, the FDA had only 
approved two pediatric oncology drugs in the twenty years 
leading up to the Creating Hope Act, which was first signed 
into law in 2012. Since the enactment of this program, the FDA 
has approved 22 drugs for rare pediatric diseases. Consider all 
the young lives this program has helped improve and maybe even 
save. Clearly these outcomes signal success and the importance 
in passing this piece of legislation.
    I do hope we can continue to work in a bipartisan manner to 
get these reauthorizations across the finish line in a timely 
manner. I thank our witnesses for sharing their time and 
expertise today.

    Ms. Eshoo.
    Mr. Pallone. I couldn't hear Anna. Am I supposed to speak 
now?
    Ms. Eshoo. Yes. I just introduced you.

OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. All right. Thank you.
    Mr. Pallone. So today we continue the committee's ongoing 
work to improve the health and well-being of Americans by 
discussing legislation that will reauthorize five important 
public health programs.
    While we continue to prioritize the critical response to 
the COVID-19 pandemic that is devastating our Nation, it is 
also essential that we continue our work to improve access to 
care.
    So we are going to hear from public health experts about 
what is working and what considerations this committee should 
take into account as we move forward on the five bills. I know 
that Chairwoman Eshoo has already described the bills, but let 
me just a say little more about them.
    The first bill, H.R. 2075, the School-Based Health Centers 
Reauthorization Act, authored by Representatives Sarbanes, 
Tonko, and Upton, would reauthorize these centers.
    Those health centers are a powerful tool for achieving 
health equity among children and adolescents who unjustly 
experience disparities in outcomes because of their race and 
family income. The authorization for school-based health 
centers lapsed in 2014, and it is important that we strengthen 
those programs with additional Federal funds.
    The next bill, H.R. 4078, The EARLY Act Reauthorization was 
introduced by Representatives Wasserman Schultz and Brooks, and 
it authorizes the Centers for Disease Control and Prevention to 
develop initiatives to increase knowledge of breast cancer 
among women, particularly for women under the age of 40 and 
those at heightened risk for developing the disease.
    Breast cancer, we know, has impacted too many families, and 
it is important that the CDC continue its work.
    We are also going to bring up H.R. 4439, the Creating Hope 
Reauthorization Act, cosponsored by many members of the 
committee. This bill would permanently authorize the Rare 
Pediatric Disease Priority Review Voucher Program.
    This program has provided value to pharmaceutical companies 
who have made investments in rare disease programs, but it also 
places a strain on the FDA. So we have to keep in mind that we 
should think carefully about whether a permanent authorization 
makes sense as opposed to shorter term.
    Next, H.R. 4764, the TRANSPLANT Act of 2019, reauthorizes 
the C.W. Bill Young Transplantation Program. This provides 
patients who need life-saving bone marrow and umbilical cord 
blood transplants with info and support as they go through the 
process. It also maintains an efficient process for identifying 
donor matches, increases the number of nonfamilial donors 
available for transplant, and expands data and research to 
improve patient outcomes.
    Our colleagues Representatives Matsui and Bilirakis have 
authored this and worked to secure funding for this program for 
many years.
    And finally H.R. 5373, the U.S. Anti-Doping Agency 
Reauthorization Act. The Anti-Doping Agency is the national 
organization in the U.S. for Olympic, Paralympic, Pan American, 
and Parapan American sports. This reauthorization would not 
only promote clean sports through testing, education, and 
research, but also use a portion of its funding to promote a 
positive youth sport experience.
    So I want to thank all the witnesses, and I would like to 
yield the time that remains to Representative Sarbanes.
    [The prepared statement of Mr. Pallone follows:]

                   Prepared Statement of Mr. Pallone

    Today we continue this Committee's ongoing work to improve 
the health and wellbeing of Americans by discussing legislation 
that will reauthorize five important public health programs. 
While we continue to prioritize the critical response to the 
COVID-19 pandemic that is devastating our nation, it is also 
essential that we continue our work to improve access to care.
    Today we will hear from public health experts about what is 
working and what considerations this Committee should take into 
account as we move forward on these five bills.
    The first bill, H.R. 2075, the "School-Based Health Centers 
Reauthorization Act," which is authored by Representatives 
Sarbanes, Tonko, and Upton, would reauthorize school-based 
health centers. These health centers are a powerful tool for 
achieving health equity among children and adolescents who 
unjustly experience disparities in outcomes because of their 
race and family income. The authorization for school-based 
health centers lapsed in 2014, and it is important that we 
strengthen these programs with additional federal funding.
    The next bill, H.R. 4078, the "EARLY Act Reauthorization," 
was introduced by Representatives Wasserman Schultz and Brooks. 
The EARLY Act authorizes the Centers for Disease Control and 
Prevention (CDC) to develop initiatives to increase knowledge 
of breast cancer among women, particularly for women under the 
age of 40 and those at heightened risk for developing the 
disease. Breast cancer is a tragic disease that has impacted 
too many families and it is important that the CDC continues 
this work.
    We will also discuss H.R. 4439, "The Creating Hope 
Reauthorization Act," which is cosponsored by many Members of 
this Committee. This legislation would permanently authorize 
the Rare Pediatric Disease Priority Review Voucher Program. 
While this program has provided value to some pharmaceutical 
companies who have made investments in rare disease programs, 
it also places a strain on the Food and Drug Administration 
(FDA). We must keep that in mind and we should think carefully 
about whether a permanent reauthorization makes sense at this 
time.
    Next, H.R. 4764, the "TRANSPLANT Act of 2019," will 
reauthorize the C.W. Bill Young Transplantation Program. This 
important program provides patients who need life-saving bone 
marrow and umbilical cord blood transplants with information 
and support as they go through this process. It also maintains 
an efficient process for identifying donor matches, increases 
the number of non-familial donors available for transplant, and 
expands data and research to improve patient outcomes. 
Representatives Matsui and Bilirakis, who have authored this 
legislation, have worked to secure funding for this program for 
many years.
    Finally, we have H.R. 5373, the "United States Anti-Doping 
Agency Reauthorization Act of 2019." The U.S. Anti-Doping 
Agency is the national anti-doping organization in the U.S. for 
Olympic, Paralympic, Pan American, and Parapan American sports. 
This reauthorization will not only promote clean sport through 
testing, education, and research efforts, but it will also use 
a portion of its funding to promote a positive youth sport 
experience.
    I want to thank all of the witnesses for joining us today, 
and I would like to yield the remainder of my time to 
Representative Sarbanes.

    Mr. Sarbanes. Thanks, Mr. Pallone.
    I want to just thank Chairwoman Eshoo and Chairman Pallone 
for having this very important hearing today regarding 
reauthorization of all these key public health programs.
    I have been working on the School-Based Health Centers 
Reauthorization Act for a very long time, and I am very 
appreciative that that is a bipartisan bill, and we certainly 
have bipartisan sponsorship of it within the committee.
    And it would authorize, as you have indicated, Federal 
support for school-based health centers through 2024, which 
provide critical primary and mental health services to 
vulnerable and youth, certainly very important in this moment.
    I have seen it in Maryland for sure, and I know that the 
witness we have today, Robert Boyd, who is president of the 
School-Based Health Alliance, will certainly be able to testify 
to this as well. And that is that when a student has access to 
school-based health centers the negative health outcomes, such 
as asthma, morbidity, rate of hospital admissions, those 
decrease, while the educational outcome, such as school 
performance and graduation rates, increase.
    And now, of course, the services of school-based health 
centers are needed more than ever given the coronavirus 
pandemic, young people grappling with changes in their lives, 
the uncertainty. And being able to get care in a familiar and 
supportive setting is very important.
    So I look forward to the testimony today. Again, thank you, 
Chairwoman Eshoo, Chairman Pallone, and my colleagues, for 
support of this bill. And I yield back.

    [The prepared statement of Mr. Sarbanes follows:]
    Ms. Eshoo. The gentleman yields back.
    The Chair now has the pleasure of recognizing Mr. Walden, 
the ranking member of the full committee, for his 5 minutes for 
an opening statement.

   OPENING STATEMENT OF HON. GREG WALDEN A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you very much, Madam Chair. Thanks for 
having this hearing. As we have heard, these are really 
important pieces of legislation. I am glad we are having the 
hearing on them.
    Obviously, there is a lot of uncertainty about the 
authorizations as they are due to lapse or expire in just a 
matter of months. So reauthorizing the funding of these public 
health programs could be literally life-saving for Americans, 
and because of that it is critical. I hope we swiftly move 
these bills.
    And as we have heard, the first bill, H.R. 2075, the 
School-Based Health Centers Reauthorization Act of 2019, by 
Representatives Sarbanes, Upton, Tonko, and others, 
reauthorizes funding for school-based health center programs, 
which support health centers operating as a partnership between 
a school and a community health organization in order to 
provide quality healthcare for our students.
    H.R. 4078, the EARLY Act Reauthorization of 2019, sponsored 
by Representatives Wasserman Schultz and Brooks, reauthorizes 
programs related to breast cancer outreach, on which you have 
been a real leader, Madam Chair, on this effort, and other 
education initiatives, along with survivor support services at 
the Centers for Disease Control and Prevention.
    H.R. 4764, the TRANSPLANT Act of 2019, spearheaded by 
Representatives Matsui and Bilirakis, reauthorizes the C.W. 
Bill Young Cell Transplantation Program. That provides critical 
support and life-saving treatments to patients in need of bone 
marrow or umbilical cord blood transplants.
    There are approximately 7,000 rare diseases affecting an 
estimated 30 million people. It is also estimated about half of 
these diseases affect children. That is why I am glad that we 
are also considering H.R. 4439, the Creating Hope 
Reauthorization Act. This bipartisan legislation makes the 
Priority Review Voucher Program permanent for rare pediatric 
diseases.
    The PRV was first created in 2012 with the passage of the 
Food and Drug Administration Safety and Innovation Act to 
incentivize the development of therapies to treat rare 
pediatric diseases.
    While progress has been made in the development of 
pediatric therapies, in fact, 22 therapies have been approved 
for the treatment of 18 rare pediatric diseases since the 
inception of the pediatric PRV program, we all know we still 
have a long way to go. Nearly 95 percent of all rare diseases 
do not have an FDA-approved treatment, leaving many patients 
and their families with no options.
    Research and development for rare disease therapies is 
often scarce because each drug is only intended to serve a very 
small population, and of course the opportunity to recoup 
investments is limited.
    Drug development is extremely costly, as we all know. It is 
often time-intensive and often requires billions of dollars and 
nearly a decade before receiving FDA approval, if it makes it 
all way through the process.
    The permanent reauthorization of the pediatric PRV program 
would provide some certainty to drug developers considering 
whether to invest in therapies for rare pediatric diseases as 
they evaluate the feasibility of devoting significant resources 
to products that may not provide a return on significant 
investments given the limited population of patients, but that 
could be life-changing for those that receive them.
    So again I want to thank all of our witnesses for 
participating in our hearing today, and I want to thank the 
chairwoman for having this hearing and helping move these bills 
along. They are commonsense, they are bipartisan, and we hope 
to get them through the markup quickly and on down to the White 
House.
    So with that, Madam Chair, I yield back the balance of the 
time.
    [The prepared statement of Mr. Walden follows:]

                 Prepared Statement of Hon. Greg Walden

    Madam Chairwoman, I am glad we are convening this hearing 
to discuss the reauthorization of several important public 
health programs, many of which face uncertainty as their 
authorizations have either lapsed or will expire in just a 
matter of months. Reauthorizing the funding of these public 
health programs could be life-saving for many Americans and 
because of that it is critical that we swiftly move these 
bills.
    The first bill, H.R. 2075, the School-Based Health Centers 
Reauthorization Act of 2019, sponsored by Reps. Sarbanes, 
Upton, and Tonko, reauthorizes funding for the school-based 
health center program, which supports health centers operating 
as a partnership between a school and community health 
organizations in order to provide quality health care services 
to students. H.R. 4078, the EARLY Act Reauthorization of 2019, 
sponsored by Reps. Wasserman Schultz and Brooks reauthorizes 
programs related to breast cancer outreach and education 
initiatives, along with survivor support services at the 
Centers for Disease Control and Prevention (CDC). H.R. 4764, 
the TRANSPLANT Act of 2019, spearheaded by Reps. Matsui and 
Bilirakis, reauthorizes the C.W. "Bill" Young Cell 
Transplantation Program, which provides critical support and 
life-saving treatment to patients in need of bone marrow or 
umbilical cord blood transplants.
    There are approximately 7,000 known rare diseases affecting 
an estimated 30 million people. It is also estimated that about 
half of these diseases affect children. That is why I am glad 
that we are also considering H.R. 4439, the Creating Hope 
Reauthorization Act. This bipartisan legislation will make the 
priority review voucher (PRV) program permanent for rare 
pediatric diseases. The PRV was first created in 2012 with the 
passage of the Food and Drug Administration Safety and 
Innovation Act (FDASIA) to incentivize the development of 
therapies to treat rare pediatric diseases. While progress has 
been made in the development of pediatric therapies--in fact, 
22 therapies have been approved for the treatment of 18 rare 
pediatric diseases since the inception of the pediatric PRV 
program--we still have a long way to go. Nearly 95-percent of 
all rare diseases do not have an FDA-approved treatment, 
leaving many patients without options.
    Research and development for rare disease therapies is 
often scarce because each drug is only intended to serve a 
small number of patients, meaning the opportunity to earn a 
profit is limited. Drug development is extremely costly and 
time-intensive, often requiring billions of dollars and nearly 
a decade before receiving FDA approval--if it makes it through 
the approval process at all. The permanent reauthorization of 
the pediatric PRV program would provide some certainty to drug 
developers considering whether to invest in therapies for rare 
pediatric diseases as they evaluate the feasibility of devoting 
significant resources to products that may not provide a return 
on the significant investment given the limited population of 
patients, but that could be life-changing for those that 
receive them.
    I thank the witnesses for being here today and look forward 
to hearing their testimony. I hope we can move these 
commonsense, bipartisan bills through the mark up process as 
quickly as possible. I yield back.

    Ms. Eshoo. The Chair thanks the ranking member for his good 
comments, and he yields back.
    The Chair would now like to remind members that pursuant to 
committee rules, all members' written opening statements shall 
be made part of the record.
    I now would like to introduce our witnesses that are with 
us today.
    First, Ms. Linda Blount. She is the President and CEO of 
the Black Women's Health Imperative.
    Welcome to you. We are thrilled that you are here with us 
today.
    Mr. Robert Boyd, the president of the School-Based Health 
Alliance.
    Thank you, Mr. Boyd, for your willingness to testify today.
    Ms. Nancy Goodman. She is the founder and executive 
director of Kids v Cancer.
    Thank you for your extraordinary work, and we are thrilled 
to have you as a witness.
    And Dr. Aaron Kesselheim. He is a professor of medicine at 
Harvard Medical School.
    Welcome, Doctor, and thank you for your willingness to be 
here with us.
    Mr. Brian Lindberg is the chief legal officer and general 
counsel of the National Bone Marrow Donor Program.
    Welcome to you.
    And Travis Tygart is the chief executive officer of the 
U.S. Anti-Doping Agency.
    So welcome to each one of you. Thank you for being willing 
to share your time, your important time, with us on these 
important bills.
    I now will recognize Linda Blount.
    You are recognized for 5 minutes. And please remember to 
unmute. Welcome. It is wonderful to see you.

STATEMENTS OF ROBERT BOYD, M.C.R.P., M.DIV., PRESIDENT, SCHOOL-
 BASED HEALTH ALLIANCE; LINDA GOLER BLOUNT, M.P.H., PRESIDENT 
   AND CEO, BLACK WOMEN'S HEALTH IMPERATIVE; NANCY GOODMAN, 
 M.P.P., J.D., FOUNDER AND EXECUTIVE DIRECTOR, KIDS V CANCER; 
    AARON SETH KESSELHEIM, M.D., J.D., M.P.H., PROFESSOR OF 
 MEDICINE, HARVARD MEDICAL SCHOOL; BRIAN LINDBERG, CHIEF LEGAL 
    OFFICER AND GENERAL COUNSEL, NATIONAL BONE MARROW DONOR 
 PROGRAM; AND TRAVIS T. TYGART, CHIEF EXECUTIVE OFFICER, U.S. 
                       ANTI-DOPING AGENCY

                STATEMENT OF LINDA GOLER BLOUNT

    Ms. Blount. Thank you very much. Good morning, Chairwoman 
Eshoo, Ranking Member Burgess, members of the Committee on 
Energy and Commerce. Thank you for the opportunity to appear 
before this committee to discuss the EARLY Act Reauthorization 
of 2019, introduced by Representatives Wasserman Schultz and 
Brooks.
    I am testifying today as president and CEO of the Black 
Women's Health Imperative. And this week, we celebrate our 38th 
year as the only national organization solely focused on 
improving the health and wellness of our Nation's 21 million 
Black women and girls.
    We are proud to work with Congresswomen Robin Kelly, Yvette 
Clarke, and Lisa Blunt Rochester, members of the Congressional 
Black Caucus and of this committee.
    In this role, and as a Black woman, I see every day how 
young Black women are disproportionately impacted by this 
terrible disease, and I know we can do more to prevent needless 
suffering and death from breast cancer through early education 
and screening.
    Black women develop breast cancer on average 5 to 7 years 
younger than White women, and until recently, the good news was 
that Black women got breast cancer at lower rates than White 
women. But as of 2015, that is no longer the case.
    But that is where the good news ends. Black women are 40 
percent more likely than White women to die of breast cancer. 
This is, in part, for three reasons.
    First, Black women are more likely than other racial and 
ethnic groups to have an aggressive breast cancer subtype.
    Second, they are less likely to receive the most effective 
therapeutics for their cancers.
    The first is an issue of biology, and the second is an 
issue of behavior.
    The third reason is why we are here today. Black women die 
at such high rates because their breast cancers are too often 
detected at late stages when treatment of any kind is less 
effective. And researchers know that most breast cancers are 
detectable long before a woman gets a mammogram.
    Consider that 30 percent of all breast cancers in Black 
women occur under the age of 50; 18 percent occur under the age 
of 45. The CDC projects that for this year roughly 30,000 
breast cancers will be diagnosed in women under 45. That is 
5,000 among Black women under 45.
    We know that early education, awareness, and screening 
saves lives. When breast cancer is detected early and quality 
treatment is received, the 5-year survival rate is 100 percent 
for all women. If we just increase the rate of screening 
mammography by 50 percent among women 45 and under, the 
survival rate would be increased by an additional 3,000 women 
every year, and that is 700 to 1,000 more Black mothers, 
daughters, and sisters. That is good news.
    Younger women are less likely to undergo breast cancer 
screening than women age 50 to 74, and they are less likely to 
have access to the latest digital breast screening 
technologies, including 3D tomosynthesis, which have been shown 
to detect breast cancers earlier.
    We must do better to educate and improve access, which is 
where the EARLY Act comes in. The EARLY--Breast Cancer 
Education and Awareness Requires Learning Young--Act, sponsored 
by Representatives Wasserman Schultz and Brooks, would 
reauthorize and increase funding originally authorized in 2010, 
giving needed attention to the education of younger and high-
risk women about their breast health.
    The program not only educates women ages 45 and younger on 
breast cancer risk, but it supports initiatives and research to 
identify high-risk women, collect family histories, and educate 
healthcare providers.
    The EARLY Act has already benefited women. Mortality rates 
from breast cancer have dropped in the past ten years, in large 
part due to early detection.
    The need for earlier screening and diagnosis is critical 
for women with inherited genetic mutations, such as BRCA genes, 
Ashkenazi Jewish women, and women who were treated with 
radiation therapy for cancer as children.
    I add Black women to this list not because of biology or 
genetics, but because of the systemic racism that has limited 
their access to preventive care.
    The COVID-19 pandemic is yet another example of disparities 
in our public health approach to the Black community. Black 
people are at much higher risk of contracting COVID-19, and 
they are much more likely than White people to die from the 
virus.
    We are on the verge of a seismic shift in this country when 
it comes to valuing Black lives and health. I see a future when 
we can stop talking about how Black women disproportionately 
and needlessly die from breast cancer. Reauthorize the EARLY 
Act and make 2020 the year we do what we know works and save 
lives.
    Thank you.
    [The prepared statement of Ms. Blount follows:]
    [GRAPHIC] [TIFF OMITTED] T5868.008
    
    [GRAPHIC] [TIFF OMITTED] T5868.009
    
    Ms. Eshoo. Thank you very much for your excellent 
testimony, Ms. Blount.
    The Chair now recognizes Mr. Robert Boyd.
    You are recognized for 5 minutes for your statement.

                    STATEMENT OF ROBERT BOYD

    Mr. Boyd. Thank you, Congresswoman Eshoo. Good morning to 
you and to Ranking Member Burgess and to members of the Health 
Subcommittee. Thank you for inviting me to speak with you this 
morning on H.R. 2075.
    I would like to thank Congressman Sarbanes for being the 
tireless champion for school-based health centers. Without your 
leadership and your dedicated staff, we wouldn't be here today.
    My name is Robert Boyd, and I am the son and nephew of 
public school teachers. I am here today as the President of the 
School-Based Health Alliance, a nonprofit organization based 
here in Washington, DC. Since 1995, the Alliance has served as 
the national voice for more than 2,500 school-based health 
centers that collectively provide healthcare for over 3.6 
million children, youth, and others from predominantly low-
income families from across the country.
    School-based health centers have been located in public 
schools since the early 1970s. As you all know, schools are 
more than just places of learning. Schools are pillars of the 
community, whether located in large cities, suburbs, or rural 
America.
    For millions of low-income students, school-based health 
centers are their sole source of healthcare. They allow parents 
to remain at work and students to stay in school while getting 
the healthcare that they need.
    Now, the data is clear: Healthy kids learn better, healthy 
kids earn better grades, and healthy kids achieve higher 
promotion and graduation rates. Healthy kids also grow up to be 
healthy adults. School-based health centers sit at the critical 
intersection of education and healthcare.
    Currently, we hear extensive discussion about how schools 
will operate this fall. It will be difficult to safely resume 
in-person learning. Many schools will continue remote learning 
or in some hybrid combination.
    But what cannot be up for debate is the ability of school-
based health centers to continue providing essential healthcare 
services to our most vulnerable students.
    Many people do not realize it, but even during the pandemic 
many school-based health centers are still delivering ongoing 
care.
    Throughout the pandemic, school-based health centers have 
continued to provide health services to K-12 students directly, 
sometimes onsite at the school, sometimes at school-linked 
clinics, via mobile vans, even drive-through visits in school 
parking lots.
    Some students have been able to receive life-saving 
medications, immunizations, and even participate in socially 
distanced counseling sessions.
    Unfortunately, far too many have not.
    We also provide care through telehealth services. As a 
result of the pandemic, the U.S. Centers for Medicare and 
Medicaid Services has given State Medicaid programs increased 
authority and flexibility to expand telehealth services, 
including telephonic and video conference care, and has removed 
some cross-State licensing requirements.
    Going forward, telehealth will remain an important strategy 
for increasing access to care, allowing us to reach the 
students and families with the greatest needs, including almost 
one-third of school-based health centers located in rural 
communities.
    Telehealth is not a substitute for in-person care. It is a 
technological enhancement in the tool chest of healthcare 
providers.
    Ladies and gentlemen, please be clear, the School-Based 
Health Alliance believes in a comprehensive definition of 
health that includes protecting the mental, emotional, and 
social health needs of students.
    Even as education and health leaders are urgently 
purchasing hand sanitizer and marks, we cannot forget to care 
for the entire student. We are here to help.
    The mental and emotional health of students is an issue 
that has too often been overlooked in the current debate about 
reopening school buildings. It is more important than ever that 
we think comprehensively and act with urgency. We must treat 
this pandemic as we would a mass incident, like tornadoes, 
hurricanes, or school shootings, that wreak multiple levels of 
havoc on an entire community.
    As with a mass incident, some of the pandemic's harm is 
visible and immediately apparent. But other damage may be less 
visible, such as increases in depression, anxiety, sleep 
problems, hunger, and stress, caused by children's struggles 
with online learning and social isolation.
    A lingering concern is the potential for child abuse to 
remain unchecked, given that the primary reporters of violence 
and neglect are educators and healthcare workers.
    Communities need maximum flexibility to ensure that the 
doors of school-based health centers, both our literal doors as 
well as our virtual online gateways, remain open to deliver 
critical primary and mental healthcare services to students.
    By passing the bipartisan School-Based Health Centers 
Reauthorization Act, you will recognize the critical role that 
school-based health centers play in both the immediate and 
long-term health needs of our Nation's schoolchildren.
    Thank you, and I am happy to answer questions.
    [The prepared statement of Mr. Boyd follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you very much, Mr. Boyd, for your 
excellent testimony.
    The chair now recognizes Ms. Nancy Goodman for 5 minutes 
for your testimony.
    Welcome again, and thank you.

                   STATEMENT OF NANCY GOODMAN

    Ms. Goodman. My name is Nancy Goodman, and I am here as 
founder and executive director of Kids v Cancer, a nonprofit 
that has been the driving force of the Creating Hope Act, as 
well as the RACE for Children Act, which requires novel 
therapies to be studied in children's cancers.
    Kids v Cancer promotes programs that are in the best 
interest of seriously ill children, regardless of whether the 
pharmaceutical industry supports or opposes them. Toward that 
end, we do not accept donations from drug companies.
    In addition, I have drafted and am solely responsible for 
the following comments.
    I am here not only in my capacity as the executive director 
of Kids v Cancer but also as a mother. More than a decade ago, 
I lived in Manhattan with my husband and sons, Jacob and 
Benjamin.
    When Jacob was eight years old, he began waking up with 
nausea and headaches. We went to our pediatrician again and 
again, and on a Sunday morning, sitting on an examination bed, 
wearing a Mickey Mouse tie, our pediatrician told us Jacob 
might have a brain tumor.
    We learned Jacob had medulloblastoma, a rare pediatric 
cancer. The drugs available to treat Jacob were 40 years old, 
and they were unlikely to work. How could that be, I wondered, 
when there are so many exciting innovations in adult cancer 
therapies?
    Jacob died in the early hours of a wintry Friday morning. 
He was ten years old. That day I founded Kids v Cancer.
    We started with drafting the Creating Hope Act. The 
challenge we sought to address was that there were inadequate 
market incentives to bring drug companies to develop drugs for 
small children with life-threatening illnesses. Yet we wanted 
to create a program largely funded by major pharmaceutical 
companies.
    So let me repeat that. The Creating Hope Act basically 
transfers value from large pharmaceutical companies to smaller 
and oftentimes more innovative biotech companies to facilitate 
their investment in creating drugs for seriously ill children.
    Since the passage of the Creating Hope Act, the Pediatric 
Voucher Program has been very successful and has created a 
pathway for companies to develop many drugs for children with 
life-threatening illnesses. So let me review some of these 
measures of success.
    The first measure of success is the value of the vouchers. 
The Pediatric Voucher Program has mobilized well over $1 
billion in incentives in the form of payments for vouchers, 
creating opportunities for market-based, risk-adjusted returns 
on investment, and rare pediatric disease drug development.
    A second measure of success is the number of new drugs that 
have been approved for seriously ill kids since the Creating 
Hope Act's passage, more than 20 so far.
    A third mark of success is the number of drugs in the 
development pipeline. As measured by the number of rare 
pediatric disease designations, this number is increasing by 
leaps and bounds, from 3 in 2013 to over 60 today.
    Fourth, as Dr. Kesselheim, my co-witness, notes in his 
Health Affairs article, drugs qualifying for a pediatric 
voucher are more likely to proceed through the phases of drug 
development and at the speed at which it would do so.
    Fifth, and perhaps the most important, at the time of 
Jacob's illness there were no companies whose core mission was 
pediatric cancer drug development. Now there are several.
    The Creating Hope Act has been a great success, but its 
short duration has created uncertainty and limited its impact. 
Since 2012, the program has been reauthorized three times, each 
for 1 to 4 years. However, this time horizon for drug 
development from idea to FDA approval can be 7 to 10 years or 
longer.
    The start of the drug development process is a critical 
moment. It is when developers choose whether to develop a drug 
for kids. If we reauthorize the Pediatric Voucher Program on a 
permanent basis, we can affect this early stage of drug 
development as well.
    The Creating Hope Act has increased the number of reviews 
in the FDA's Priority Review Program. That is why, when 
originally drafting the Creating Hope Act, we were careful to 
include a provision by which the FDA could compensate itself 
for any additional burden, allowing the FDA to set voucher user 
fees.
    In 2020, voucher user fees are $2.1 million on top of a 
$2.9 million user fee. If there are remaining issues around the 
management of this program, I thank the FDA leadership as they 
work to address them head on so that we do not have to abandon 
or shorten a program that promises hope to so many critically 
ill children.
    All evidence available indicates that the Pediatric Voucher 
Program is effective. I urge you to support its permanent 
reauthorization by passing the Creating Hope Reauthorization 
Act.
    Thank you for including me in today's hearing, and I am 
happy to take your questions.
    [The prepared statement of Ms. Goodman follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you very much, Ms. Goodman. I can't help 
but think that, as a mother myself, out of the extraordinary 
tragedy and loss of your son, your work is nothing short of 
remarkable. And it is so important for us to take up this 
reauthorization and that it be made permanent, as you 
indicated. So thank you very, very much. You are a source of 
inspiration to us.
    Next, Dr. Aaron Kesselheim, you are recognized for 5 
minutes for your testimony. And thank you again for your 
willingness to be with us today.

                 STATEMENT OF AARON KESSELHEIM

    Dr. Kesselheim. Thank you. Chairwoman Eshoo, Ranking Member 
Burgess, members of the subcommittee, thank you for this 
opportunity to talk today.
    I am an internal medicine physician and lawyer, and I lead 
the Program on Regulation, Therapeutics, and Law, one of the 
largest and most prolific nonindustry-funded research groups in 
the country that focuses on the pharmaceutical market.
    My remarks today will cover the rare pediatric disease 
priority review voucher, or PRV, why it is a poor way to 
support research into rare pediatric disease treatments, and 
what some better options are.
    A PRV entitles drugmakers to speed FDA review of the 10-
month timeframe it applies to standard drugs that lack any sort 
of special innovative or clinical qualities to the priority 
review 6-month timeframe reserved for drugs representing 
therapeutic advances, like those meeting unmet medical needs.
    Economists assume that drugmakers would value reaching the 
market four months sooner, so Congress created the voucher in 
2012 to stimulate investment into rare diseases affecting 
children, unquestionably an important public health issue.
    Unfortunately, it hasn't turned out that way. There are 
four major problems: It doesn't work, it wastes public and FDA 
resources, it is potentially dangerous, and it isn't very 
valuable.
    First, from 2012 to 2018, the FDA awarded 14 rare pediatric 
disease PRVs, which is more treatments than in years before 
2012, but the important question is whether the initiation of 
the PRV program changed the research trajectory.
    To study this question, in a study led by my colleague here 
at Harvard, Thomas Hwang, we compared how drugs treating rare 
pediatric diseases progressed through development in the years 
before and after the voucher program with drugs treating rare 
adult diseases, which would not earn a voucher.
    We found no variation in the rate at which drugs eligible 
for a rare pediatric PRV were introduced into clinical testing. 
That is, the baseline trajectory didn't change. Rather, there 
has been an increase in recent years in rare diseases of all 
kinds, pediatric and adult. That is obviously great, but it 
doesn't mean that the PRV works, and I would be happy to submit 
this paper for the record.
    Second, the voucher wastes public resources. It derives its 
market value from the prospect that manufacturers with more 
likely run-of-the-mill drugs would come to market sooner and 
start selling those drugs at high prices to be reimbursed by 
payers like Medicare and Medicaid.
    It also wastes regulatory resources. FDA officials have 
raised concerns that the PRV interferes with the way it 
prioritizes drugs by hastening review of unremarkable products 
that would not otherwise merit an expedited timeline, straining 
resources since the FDA cannot quickly hire and train new staff 
with the necessary expertise to review the drugs.
    Third, the voucher is dangerous, since too speedy FDA 
review may lead to bad decisionmaking. For drugs that are a 
major advance in treatment, accelerating FDA review is 
reasonable, but one study showed the risks of imposing 
arbitrarily short deadlines on FDA review times for drugs that 
did not deserve such acceleration, such as increased risk of 
subsequent safety-related withdrawals or botched warnings.
    And finally, the vouchers' value has plummeted. Because 
vouchers can now be earned for FDA-approved drugs for neglected 
tropical diseases and medical countermeasures, as well as rare 
pediatric diseases, there are a lot of vouchers available on 
the market.
    In recent years, vouchers have sold for approximately $80 
to $110 million, a far cry from the lofty values predicted by 
the economists who devised this scheme.
    One way to try to address these issues would be to make 
necessary improvements in the voucher program. For example, 
drugs qualifying for the voucher could be limited to first-in-
class products or products meeting unmet medical need.
    Manufacturers should also not be allowed to earn a voucher 
immediately for drugs approved via the "special accelerated 
approval" pathway, since accelerated approval of drugs has not 
yet demonstrated meaningful patient benefits.
    Most importantly, rare pediatric disease manufacturers 
earning a voucher should be required to ensure that the product 
is sold to U.S. patients at value-based prices, or at no higher 
than prices sold to rare pediatric disease patients in other 
high-income countries, to help ensure that the children who 
need the drug can be assured of access to it.
    A better pathway forward for Congress would be to consider 
more direct ways of encouraging drug development for such 
medical conditions. For example, the U.S. Government supports 
pharmaceutical innovation with substantial amounts of taxpayer 
dollars each year, mostly through the NIH. One study found that 
all new drugs approved from 2010 to 2019, or their molecular 
targets, could be linked back to this government-funded 
research.
    The U.S. Government also offers various tax concessions and 
refunds directed at research and development spending by 
private firms. Thus, greater upfront funding, or tax credits, 
could be offered for research into rare pediatric diseases. And 
unlike the PRV, this method of stimulating innovation has a 
track record of success.
    Another approach would be to provide greater support for 
late-stage development, perhaps through nonprofit organizations 
via public-private partnerships. Recent funding through BARDA 
to support vaccines for COVID-19 is related to this model.
    Naturally, such partnerships should include guarantees 
about affordable access to the rare pediatric disease drugs 
that emerge because of the public's involvement in reducing the 
risks and costs of drug research and development.
    Children with rare diseases need more investment in 
scientific discovery and clinical trials to get them the 
treatments that they deserve. It is time to move past the 
pediatric rare disease priority review voucher mistake and let 
it sunset, and instead direct efforts towards better solutions 
known to lead to transformative drugs, including direct public 
investment in research and development for treatments for rare 
pediatric diseases.
    Thank you very much.
    [The prepared statement of Dr. Kesselheim follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you very much, Doctor.
    Now we will recognize Brian Lindberg.
    Thank you again for being with us today, and you have 5 
minutes for your testimony.

                  STATEMENT OF BRIAN LINDBERG

    Mr. Lindberg. Madam Chair, Ranking Member Burgess, and 
distinguished members of the subcommittee, I am Brian Lindberg. 
I have the honor to serve as chief legal officer and chief 
policy officer of National Marrow Donor Program/Be The Match.
    For over three decades, through public-private partnership 
with the Federal Government, we have been entrusted to operate 
the C.W. Bill Young Cell Transplantation Program, which 
provides life-saving bone marrow and umbilical cord blood 
transplants to patients in need.
    As you know, this is the program that houses the national 
registry of volunteer bone marrow donors, as well as the 
National Cord Blood Inventory and the Stem Cell Therapeutics 
Outcomes Database.
    On behalf of the entire team at NMDP/Be The Match and the 
patients we serve, I would also like to thank all the members 
of the Health Subcommittee for the opportunity to speak with 
you today and for allowing me the privilege to share with you 
the successes of the program over the past 5 years, but more 
specifically during the current crisis of the global pandemic.
    Finally, I would also like to extend my special thanks to 
Congresswoman Matsui and Congressman Bilirakis for their 
leadership in introducing H.R. 4764, to reauthorize the program 
for another five years. Ms. Matsui and Mr. Bilirakis have been 
tireless champions for patients whose only chance at life is 
bone marrow transplant.
    Today, I am so pleased to be able to tell you that this 
past December, NMDP/Be The Match marked the 100,000th time it 
facilitated a transplant in which a heroic volunteer donor 
stepped up to save the life of a person they had never met by 
making this life-giving gift of bone marrow donation.
    This is because 35 years ago the founders of our program 
refused to accept the conventional wisdom that a national 
registry wouldn't work because, after all, who would do this, 
who would step up to donate their marrow for a stranger.
    They persevered because they knew that a national registry 
would work, that this must work, and needed to be established 
by Congress.
    I can say without hesitation that this same spirit, that 
refusal to take "no" for an answer, has served this program 
well over the past year. In addition to celebrating our 
100,000th transplant in 2019, we have facilitated more 
transplants than in any other year in our history.
    And then global pandemic arrived, and it threatened the 
very foundational underpinnings of our ability to fulfill our 
obligation to those patients. And that is specifically why I am 
here before you today.
    As you are no doubt aware, the success of this program and 
the lives of the patients we serve rely on our ability to move 
couriers who carry donated cells, not only across the country 
but also across the world.
    The complexity of matching patients and donors results in 
half of these cellular donations crossing an international 
border. Domestic and international travel bans, border 
closings, declining availability of passenger airline service, 
quarantine and shelter-in-place orders, and an ever-changing 
patchwork of State and local restrictions during the COVID 
pandemic have created near catastrophic barriers to our ability 
to facilitate timely transplant and threaten to impede every 
one of these life-or-death missions at multiple points along 
what is now a tenuous path from donor to waiting patient.
    But despite all of that, I am thrilled to be able to report 
to you today that throughout the course of the pandemic, NMDP/
Be The Match, through innovation and determination, has since 
March delivered more than 2,500 life-saving therapies to 
patients who are relying on them without a single failure. Not 
one patient prepped for transplant has gone without.
    Everyone associated with this program understands the 
consequences of failure are the direst consequences of all.
    But these successes have been hard-earned, and in many 
cases involve days-long, around-the-clock, extraordinary 
interventions across multiple Federal agencies, as well as 
State and foreign governments.
    Due in material part to the national program status awarded 
us under the authorizing statute, over the past few months we 
have been granted a waiver in the national interest by the CDC 
to the European travel ban, allowing international bone marrow 
couriers to deliver products to U.S. patients.
    We have designated our couriers and donors as essential 
critical infrastructure by the Department of Homeland 
Security's CISA.
    We have leveraged private aircraft, donated for use by HHS, 
to deliver life-saving cells to patients when commercial 
flights were no longer available.
    We have accessed support from U.S. embassies and consulates 
to obtain from foreign governments timely travel authorizations 
for donor and courier travel and to coordinate private and 
humanitarian flights in and out of countries that had otherwise 
closed their borders.
    And we have been granted clearance from Customs and Border 
Protection that ensures donations coming from Canada to 
American patients will have uninterrupted transport into the 
country.
    The examples I have just described share two common but two 
extraordinarily important threads. First, this would not have 
been achieved without our national program status. And second, 
patients in the U.S. would have died had these things not 
happened.
    And that is why I am before you today, urging your help to 
ensure timely reauthorization of the program to mitigate any 
unnecessary risk to patient life.
    Thank you again for the opportunity to submit this 
testimony and for the committee's longstanding support of this 
program that has given so many a second chance at life.
    On behalf of those whose lives have been extended, those 
who are searching the registry for a match donor today, and 
those who will need to look to the program for help in the 
future, we urge to once again reauthorize the C.W. Bill Young 
Cell Transplantation Program, and we would respectfully ask you 
do so prior to the program lapsing at the end of September.
    Thank you.
    [The prepared statement of Mr. Lindberg follows:]
   [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you so much, Mr. Lindberg. What a powerful 
story, given all the challenges of COVID that you have had to 
deal with.
    Each one of you has a powerful story in your testimony, and 
Mr. Lindberg's was as well. Thank you.
    I served with Bill Young, and I think that he would be 
very, very proud. Very proud.
    Mr. Lindberg. Thank you.
    Ms. Eshoo. He was a gentleman, a lovely, good man.
    Next, the chair recognizes Travis Tygart.
    Mr. Tygart, you are recognized for 5 minutes for your 
testimony, and thank you for being with us today. Welcome.

                 STATEMENT OF TRAVIS T. TYGART

    Mr. Tygart. Thank you. Chair Eshoo, Ranking Member Burgess, 
members of the subcommittee, good morning. My name is Travis 
Tygart. I am the CEO of the United States Anti-Doping Agency, 
or USADA. Thank you for inviting me to appear before you today 
to discuss our reauthorization and our important mission.
    It is a huge honor to be here representing our North Star, 
which are our clean athletes. We greatly appreciate the ongoing 
support of Congress and the President's Office of National Drug 
Control Policy, or ONDCP, to protect, along with us, the 
health, safety, and rights of clean athletes to a fair and 
level playing field.
    USADA, as you know, is charged with implementing a robust, 
fair program, which includes both in- and out-of-competition 
testing, results management, and athlete education for all U.S. 
Olympic, Paralympic, and Pan Am athletes.
    Importantly, we also contribute to the advancement of all 
clean sport through scientific research and education 
initiatives focused on values and healthy and safe competition.
    Chair Eshoo, members of the subcommittee, we cannot perform 
this essential mission without your support. As many of you 
know, we opened our doors in late 2000, thanks to the 
bipartisan efforts of Congress in recognizing the need to 
create an independent anti-doping system.
    Throughout the 1990s, many viewed the U.S. and our athletes 
as dirty. There was no independent effort, because the Olympic 
sports movement, whose job it is to promote sport, was also 
handling the anti-doping program. It was the epitome of the fox 
guarding the henhouse.
    As a result, Congress took action and established an 
independent organization to implement a fair and robust 
national program.
    This landmark decision literally changed the game for U.S. 
athletes for the good. This independence is our lifeblood, and 
it is possible only through government support that we receive 
each year.
    We received Federal funding in the fall of 2000 and every 
year since. We were first formally authorized by the committee 
and Congress in 2006, and we were reauthorized in 2014. Our 
congressional funding comes through ONDCP and is combined with 
our private funding to achieve our mission.
    Since we opened, we have educated tens of thousands of 
athletes and others on the reason that playing fair is the only 
way. Our True Sport Partner program has reached over 13.8 
million since its founding in 2017.
    Deterrence is the foundation of the entire program, and we 
have conducted approximately 175,000 drug tests. In 2019, we 
completed a total of 7,300 blood and urine tests.
    We have also earned the trust that we fairly enforce the 
rules even when not easy or popular to do so. This is essential 
to our success. In 2019, we received 533 tips to our Play Clean 
whistleblower line and resolved 49 cases.
    Importantly, when we were sued by Lance Armstrong, a 
Federal court ruled that the USADA process provides due 
process. This will likely be the most important legal legacy 
ever, that due process is afforded our Olympic and Paralympics 
athletes.
    The final component is our scientific and research efforts. 
Along with others, we have advanced the science to now have 
reliable laboratory methods to detect and, thus, deter things 
like EPO or human growth hormone or designer steroid use.
    We also joined forces and raised additional private money 
with Major League Baseball and the National Football League to 
establish a scientific research entity that has become a world 
leader.
    Of course, you can see from our independent audit that we 
send to Congress every year we are efficient and we are good 
stewards of the funding. We are lean and mean, and for just a 
small amount of government funding we have changed the game for 
the good.
    Comparatively, the U.S. Government is funding less on 
average per athlete than many other countries. As one example, 
the U.K. Government provided its agency a million dollars more 
in funding than us, yet they have less than half the athletes 
we do.
    USADA's reauthorization, as was mentioned by the chair, is 
even more important this time around since the Summer Olympic 
and Paralympic Games are coming to the United States in L.A. In 
2028. By passing this reauthorization, you can help make sure 
the 2028 Olympic Games are the cleanest games ever.
    Finally, our authorization strengthens our ability to 
influence globally. Congress' backing gives us the standing to 
advocate so that our athletes' rights are also protected when 
they compete abroad. USADA's independent model has become a 
beacon to others, and we are humbled to be in the position to 
lead within the global community.
    Just last month, at the request of Congress, ONDCP sent a 
report to Congress detailing the World Anti-Doping Agency's 
governance problems, including its lack of independence and 
failure to provide fair athlete and U.S. representation.
    We applaud ONDCP for its work on this issue. And hopefully 
you all have seen that several leading athlete groups from 
Canada, the United States, Germany, and others have come out 
strongly in favor and support of these principles.
    Chair Eshoo, Ranking Member Burgess, members of the 
subcommittee, Congress did the right thing almost 20 years ago 
by establishing an independent anti-doping organization, and 
you all have continued to support this model to this day.
    Along with the millions of athletes we represent, we thank 
you for your ongoing support and hopefully for the swift 
passage of H.R. 5373, and I look forward to taking any of your 
questions.
    [The prepared statement of Mr. Tygart follows:]

    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Ms. Eshoo. Thank you for your wonderful testimony and for 
being with us today.
    We will now move to member questions, and I recognize 
myself for 5 minutes. To the witnesses that I don't get to with 
questions, it doesn't mean that I don't respect your program. 
You have all given superb testimony. They are very important 
programs.
    I want to zero in on the Creating Hope Reauthorization Act, 
because we have some differing views here.
    So to Dr. Kesselheim, the GAO found that drug developers 
said the voucher program plays a major part--has played a major 
part in their decision to invest in the development of rare 
pediatric drugs, but your research found no increase in the 
development of rare pediatric drugs after the voucher program 
began.
    So my first question to you is--and I want to get my 
questions in first and then take the answers--how do you 
explain the differences in these findings?
    To Ms. Goodman, Dr. Kesselheim's research paper used drug 
development for rare adult diseases as the comparison group for 
rare pediatric diseases. But in your experience, how is the 
drug development process different for pediatric drugs versus 
adult drugs?
    And to both of you, do you believe that the Pediatric 
Voucher Program has existed long enough to prove whether it is 
beneficial or harmful, and if so, what benefits have you seen, 
and what harm?
    And so why don't we start with Dr. Kesselheim. Please try 
to keep your comments brief so that I can get all of the 
answers to my questions.
    Dr. Kesselheim. I will do my best, Chairwoman, to be brief.
    I would say that the difference is that the GAO report was 
based on anecdotal interviews with individual companies, and 
the study that we did was a comprehensive study that looked at 
all new drug development. And so it would be possible for, in 
subjective interviews, for companies to say, sure, why not, but 
if you actually look at the data across the board, it doesn't 
look like there is any difference.
    Ms. Eshoo. Well, I represent Stanford University, the 
Stanford Medical Center, and Dr. Crystal Mackall, she is the 
leading cancer researcher at the Stanford Medical School, and 
she is a clinician. She said the voucher program has been 
remarkably impactful for childhood cancer. She said before the 
program, she used to go with her hat in hand to beg investors 
to consider a potential drug, and now people take a second look 
and are interested in developing drugs. And she named them. She 
said something very interesting, that a bean counter may be 
disappointed by the sheer numbers of approved pediatric drugs. 
But she said that that disregards the lengthy drug development 
cycle, and it is more important to look at the impact of the 
approved drugs. And then she named them. So I just wanted to 
insert that.
    When you say the GAO interviewed people and it was 
anecdotal, the GAO usually does very thorough work. So I don't 
know how you--how did you get to identify the GAO's report as 
anecdotal?
    Dr. Kesselheim. Because that is how the GAO describes it in 
its report. It says that the way that they identified the--how 
drug companies thought--what drug companies thought about it is 
by interviewing some of them.
    Ms. Eshoo. OK. Ms. Goodman, can you answer my questions, 
please, and anything else you want to add?
    Ms. Goodman. Yes, and thank you so much for giving me this 
opportunity. Look, I think there is a lot of evidence that this 
has been a very successful program. There are more approved 
drugs. There are loads of new drugs in the development pipeline 
which we can measure by designation. And how do we explain that 
away? Even Mr.--Dr. Kesselheim, in his health affairs piece, 
notes that the program has been--you know, has shown that for 
drugs that qualify for vouchers, they speed through the drug 
development process faster, and they are more likely to go from 
one phase to the other.
    It is true that the program's weakest point of 
effectiveness is, at the very start, when drug developers 
decide will I develop a drug for seriously ill children or for 
some other indication, right?
    And so I agree with Mr. Kesselheim--Dr. Kesselheim, in part 
on that point. But the reason there is this problem is that 
drug development takes, you know, ten or more years, and we 
keep on reauthorizing this program for very short periods of 
time. If we reauthorize it for permanent length of time, we are 
going to see Dr. Kesselheim very happy about the effect of this 
program on early drug decisions.
    Dr. Kesselheim. If I could just clarify, just a mentioned 
mistake about the way that my--what my study actually shows. So 
my study didn't show any difference in the ways that drugs 
progressed from phase 2 to phase 3, or phase 3 through 
approval. Although, it did show that there was a statistically 
significant effect on the progress from phase 1 to phase 2. 
Phase 1 is also--tends to be the shortest phase of clinical 
trials and drug development, so it is unclear of how meaningful 
that is overall. The most important finding was that it doesn't 
appear that there are any new drugs that come into the system 
before or after the voucher program as compared to rare adult 
diseases. And I will just point out that over the last couple 
of decades----
    Ms. Eshoo. Doctor, my time has run out. But I think it is 
important to note of the drugs that have been approved, as Dr. 
Mackall says at Stanford Medical School, and she also works out 
of Lucile Packard Children's Hospital in my district.
    It is now--let's see, we go to--who is next? Who is? To the 
ranking member of the subcommittee, Dr. Burgess, for his 
questions, 5 minutes.
    Mr. Burgess. I thank the chair. Maybe we can continue this 
discussion that we just started a little bit. Dr. Kesselheim, 
Ms. Goodman mentioned in her testimony that the number of rare 
pediatric disease drugs approved by the FDA since the enactment 
of the Creating Hope Act--the Creating Hope Act has increased 
by over 120 percent. Do you have a sense of how the United 
States compares to other nations when it comes to rare 
pediatric drug development?
    Dr. Kesselheim. Well, I believe that the United States is--
you know, helps contribute substantially to rare pediatric 
disease drug development because of the substantial amount of 
money through the NIH that goes into the discovery and 
development of the--of some of the key, you know, drugs that--
that emerged for all kinds of conditions, including rare 
pediatric diseases. And I--my presumption is, is that those 
drugs also are available in other countries around the world, 
although, I haven't studied that.
    Mr. Burgess. But as far as development for a drug to treat 
a rare pediatric cancer--I would suspect that it is likely, 
more likely to happen in the United States than other 
countries. But perhaps we can find that out on our own.
    Ms. Goodman. If I could intervene?
    Mr. Burgess. Yes, yes. Sure.
    Ms. Goodman. Yes, you know, the vast predominant--the vast 
majority of drugs developed for seriously-ill kids are right 
here in the United States. And if we don't get our incentives 
right, kids all over the world are going to suffer. And so I 
think this is a real issue. I think you hit it right on the 
head.
    Mr. Burgess. So let me just ask you, because you brought up 
the point about the reauthorization date, and I don't know if a 
lot of people are aware of--this program was started in a Food 
and Drug Administration reauthorization act back in 2012, but 
it is not linked to the reauthorization or the FDA 
reauthorizations that we do every five years. So this program 
expires September 30th kind of all on its own--talk about an 
orphan--and it is out there by itself. And you may have an 
excellent point that it ought to be reauthorized, but perhaps 
the permanence or a longer period of time because we do have a 
long time horizon with these products that are in development.
    Ms. Goodman. That is correct. Look, the first drug to get a 
voucher for pediatric cancer is the Dinutuximab by Unituxin, 
and this drug was in development for 30 years. So even if we 
do--even if we extend this program by 7 or 10 years, there is 
still going to be a large portion of drugs that we don't 
incentivize and we can't support.
    Mr. Burgess. You know, as I was listening to you and one of 
the earlier witnesses, of course, we are so fortunate on this 
committee, the full committee, to have worked on the 21st 
century CARES Act and championed and got through. Also pointed 
out to me in 2015, having been no new therapeutic for sickle 
cell disease approved for 40 years, FDA approved therapy for 
sickle cell for 40 years, very reminiscent of your comments 
about no new children's drugs developed for 40 years. So we 
don't--we don't always do things perfectly in this committee, 
but sometimes we can make things a priority that actually do 
make a difference in people's lives. And from time to time, we 
have to acknowledge that, celebrate that success, and recognize 
that that is equity that we can push forward if we are willing 
to do that. So definitely making things a priority, thumbs up. 
That is an important point.
    Now, Mr. Lindberg, just before my time runs out, I had 
signed up to be a donor. I have been in the donor program to 
see if I can be a donor match, because there was some drive 
going on in my community, long before I ever came to Congress. 
I have been here for a while. Is that--is that enlistment still 
active? Does a citizen need to reup that from time to time? 
What can you tell us, as we are here highlighting your program, 
what the people need to know about signing up and the length of 
time that they may be signed up for a marrow donor program?
    Mr. Lindberg. Thank you, Ranking Member Burgess. So--thank 
you for signing up to join the registry. Our criteria--
eligibility criteria do state that once a volunteered registry 
member reaches the age of 61, that person ages off the 
registry. That is a cell efficacy issue.
    Mr. Burgess. What difference does it make? I object.
    Mr. Lindberg. We like people objecting to aging off. One 
thing that we know is that over 30 years of this program and 
our work with outcomes database, we know that--we know that 
despite a very good HLA or DNA match, that as a donor ages, 
that there are poorer outcomes for the recipient. So we know 
that our network transplant physician community looks for 
young, healthy donors, and will prioritize those over those--
like me--who are a bit more aged than others.
    Mr. Burgess. OK. Well, I actually did not know that. So 
that is useful information that came in this morning. I didn't 
realize it had been so insensitive as to bump me off for being 
old.
    Thank you, Madam Chair. Again, I have learned something 
this morning. I will yield back.
    Ms. Eshoo. The gentleman yields back.
    The chair is now pleased to recognize the chairman of the 
full committee, Mr. Pallone, for his 5 minutes of questions.
    The Chairman. Thank you, Madam Chair. I wanted to ask my 
questions of Dr. Kesselheim and they are all about the Rare 
Pediatric Disease Priority Review Voucher. I wanted to say 
that--while I believe that we--while I think we all agree that 
more has to be done to expand research into treatments and 
cures for diseases that affect children and adolescents, and 
that those treatments and cures should be accessible to those 
who need it, I think the committee needs to carefully consider 
whether the Rare Pediatric PRV Program is tailored to achieve 
those ends. And that requires an analysis of the cost and 
benefits.
    And when making policy decisions to reauthorize programs, 
generally, we have to analyze how they have worked in the past, 
and that can be particularly challenging when we are looking at 
an incentive program, we have to determine whether the desired 
effect would have happened without the incentive provided by 
Congress.
    So, Dr. Kesselheim, with that, by way of background, I 
interested in the portion of your testimony when you described 
how you do an empirical study into how the Rare Pediatric PRV 
program acted an incentive. Could you describe the way or the 
methods you used in your study in your findings in that regard?
    Dr. Kesselheim. Sure. So what we did was we identified all 
new drugs that are coming into the pipeline, not drugs that are 
FDA-approved, drugs that coming into the pipeline, and we 
identified whether or not they were directed towards pediatric 
rare diseases and adult rare diseases. And then we looked to 
see in the years before the Pediatric Review Voucher Program in 
2012 was extended to rare pediatric diseases, and in the years 
after, whether or not there was a difference between the number 
of new rare pediatric drugs entering into the pipeline and the 
number of new adult rare drugs entering into the pipeline, 
which theoretically wouldn't have been incentivized at all, 
because they wouldn't have gotten--they wouldn't have been 
eligible to get a voucher. We found no difference in the 
trajectory before and after.
    What we did notice was that the trajectory has been 
increasing, which is a good thing, but what it just means is 
that, it just means that rare diseases, in general, are a point 
of a lot of research for drug companies and the--and public 
funding, and we are just getting a lot more new drugs for rare 
diseases across the board over the last couple decades. The 
Rare Pediatric Disease Voucher Program was extended to rare 
pediatric diseases in 2012 doesn't seem to have affected the 
trajectory at all.
    Mr. Pallone. Well, now, let me ask you this: I know the 
program does not have a budget score or really cost the Federal 
Government any money, but there may be, you know, other costs 
associated with this. So in that regard, can you describe how 
the program affects FDA resources?
    Dr. Kesselheim. Sure. And I will actually disagree that the 
program doesn't cost the government any money. The government--
the program does cost the government a lot of money, because 
what the program does is it lets run-of-the-mill, non-
innovative drugs onto the market sooner so that they can start 
being charged extremely high prices to Medicare and Medicaid, 
which, of course, are government-funded insurance programs. 
That is where the voucher gets its value from.
    But in terms of the FDA, yes, in those--in that same GAO 
study where they interviewed drug companies, they also 
interviewed people at the FDA, and the people of the FDA said, 
Look, this is a real burden on our resources, even though there 
is an additional user fee associated with it, it is just not 
something that it--you know, it strains our ability to 
prioritize what we think are important public health drugs and 
put those at the top of the queue.
    Mr. Pallone. Well, let me ask you one last question. The 
bill before us would fully remove the sunset and authorize the 
program indefinitely. I know in your testimony you said it 
would prefer to see this program expire. But if the program 
were to continue, which I think is likely, what improvements 
would you recommend?
    Dr. Kesselheim. Well, so first of all I would say, I would 
say, first of all, that the PRV should not be able to apply to 
drugs that are--that it should only be able to apply to drugs 
that are first in class or to drugs that meet an un-medical 
need. I would say that the PRV should not be able to apply to 
drugs that are approved via the accelerated approval pathway, 
because those drugs do not have a demonstrated effect on actual 
patient outcomes. And I would say that any drug that gets a PRV 
should be required to make the drug available to patients at a 
value-based price that is consistent with the same price for 
which it is available to pediatric rare disease patients in 
other countries, so that patients can have access to the drugs 
that they really need.
    Ms. Goodman. Congressman, if I may jump in here for a 
moment. And I am going to also say that I would disagree with 
Dr. Kesselheim on every single point he has made. Let's just 
start with the pricing issue.
    You know, there are two kinds of ways to provide access to 
drugs, access to drugs for patients. And there are two groups 
of patients. One are patients who already have drugs. And so 
for those patients, of course, we would like the drugs to be as 
low as--the pricing as low as possible. But the other group of 
patients don't have the therapies to treat their illnesses yet, 
and that includes my son, Jacob. And we can't expect that we 
are going to give that class of patients best access to drugs 
if we are going to be suppressing prices of therapies that 
haven't even been developed yet.
    The second point I just want to make is with respect to, 
you know, we are talking a lot about this health affairs 
article. I think Dr. Kesselheim is, you know, playing fast and 
loose with a bunch of numbers. If you look at his charts, there 
are notable deltas, which means pediatric and adults, the adult 
curves. And, of course, the weakest point in the efficacy of 
the program is right at the start when people--when developers 
decide do they want to develop drugs for kids? That is why we 
need a permanent program.
    Mr. Pallone. My time has expired, but--what did you say, 
Doctor? I am sorry.
    Thank you, Madam Chair.
    MS. Eshoo. Yes, well, I know that it went over by almost a 
minute, but it is a very important discussion, and perhaps 
other members will follow up on the--on the points that are 
being made.
    It is a pleasure to recognize the gentleman from Michigan, 
the former chairman of the full committee, Mr. Upton, for his 5 
minutes of questions.
    Mr. Upton. Thank you. Thank you, Madam Chair, and I am 
delighted to be here. And I also just want to say, I want to 
thank Mr. Sarbanes and others--Republicans and Democrats that 
are a cosponsor of this important legislation on school-based 
health centers, something that we need to reauthorize. For me, 
I have been terribly supportive of this program. I would note 
that in my district I have a number of these facilities. And I 
am very concerned that, particularly, as schools are going to 
have limited openings, it appears, from e-learning, limited 
days, how exactly are we going to make sure that our kids, and 
school kids and their families then are able to benefit from 
these school-based clinics? And I guess that question is for 
Mr. Boyd--Dr. Boyd, if you mind commenting on that. I will put 
the earphones back on. Thank you.
    Mr. Boyd. Yes, Congressman, it is "Mr."
    Schools did not close. They went to remote learning. 
School-based health centers, to the best of their abilities, 
did not close, they went to remote operations through 
telehealth. Our dilemma--and I am not an alarmist, I worked 
with Congresswoman Brooks for a number of years on school 
safety--we have a pending healthcare crisis coming in our 
schools that is shared by all of the major education groups, 
all of the major school-based health partners that we have, and 
the nurses, the psychologists, the counselors, and the social 
workers. And it is not just mental health. Kids are not getting 
their vaccines. They are not getting their lifesaving 
medications for diabetes and treatments for asthma. We have to 
address these issues.
    The school-based health centers are going to continue to 
try to serve their students. I know anecdotally, we don't have 
a lot of good data, but we have been in close touch with 
school-based health centers around the country. I know 
anecdotally of stories of clinicians asking school resource 
officers and educators to go check up on children that they 
haven't heard from. We don't know how many Title 1 school kids 
have not been served by the continuing of education through 
remote learning, or the continuing of healthcare through 
telehealth. We just don't know what the numbers are yet.
    So, I want to make clear that--that we are going to 
continue to operate to the best of our abilities, whether 
school buildings reopen or not.
    One of our great concerns at the Alliance is the ability of 
school-based health centers to reopen. A number of them are 
sponsored by federally qualified health centers, some by public 
health agencies, some by hospital systems, some by school 
districts.
    In the cases where they could take those workers and put 
them back on the front line, keep them on the front line, in 
the primary community health center or the primary hospital, 
they did just that. The question will be whether or not they 
will be able to move them back to the schools should that 
building reopen.
    And so, we have a pending crisis and, you know, we are 
going to be right there on the front lines with our partners in 
education to address the needs of the students that we serve, 
but the resources are short. The resources are scant.
    Mr. Upton. So a quick question to finish up on my time. So 
schools in Michigan pretty much closed in March, in March, and 
they were shut down through their Easter break. And it is 
somewhat unclear as schools struggle--I talked to a number of 
our superintendents--my superintendents this past week as they 
are trying to prepare for opening up at some point in the next 
number of weeks. Usually, the end of August is when they do it.
    Do we have any sense of how many children in any of the 
States actually missed a vaccination, or perhaps got into--any 
even anecdotal evidence of kids running into trouble because 
their health needs were unmet as it related not only to the 
school closings in the spring, but, also, the preparations as 
they--they have to include that when they begin to open up this 
fall?
    Mr. Boyd. Yes, it is only anecdotal at this point, Mr. 
Upton. It is--it is not--there is no data at this point for us 
to be able to know how many children have missed vaccinations 
and how many children have--that no one has even heard from.
    Anecdotally, I have heard from colleagues at the Coalition 
of Community Schools that it could be as many as a third of 
Title 1 school children that no one has heard from in some 
districts. That is a scary number, because it is not just the 
education side that we are not hearing from them, they are not 
getting their healthcare because the school-based health center 
was their health home. We may see that start to turn up in 
reports from emergency rooms, because that is where they would 
seek help if they are not getting it at the school. But we 
don't have those kinds of numbers. They have got their hands 
full right now just with the coronavirus.
    We do know that we are all very concerned, as I said in my 
remarks, about abuse. That we have no idea what the numbers are 
of--going on with school children around abuse. We just don't 
know.
    Mr. Upton. Thank you. I know my time has expired. I yield 
back. Thank you very much.
    Mr. Boyd. Thank you, sir.
    Ms. Eshoo. The gentleman yields back.
    A pleasure to recognize the gentleman from North Carolina, 
Mr. Butterfield, for his 5 minutes of questions.
    Mr. Butterfield. Thank you very much, Ms. Eshoo, for 
convening this hearing today, and thank you for your passionate 
leadership, not just on these issues, but so many issues that 
we have dealt with as a committee. Thank you to our full 
committee chairman, my friend, Frank Pallone, I thank you, 
Frank, for your leadership. I certainly respect your views on 
PRVs and just look forward, look forward to working with you to 
get this right. I know you have a strong conviction for helping 
young children who are affected with cancer, and I know we 
will--we will find some common ground to get this thing right.
    And, finally, thank you to the six witnesses, thank you so 
very much for your passion. I can literally feel your passion 
as you testify today.
    Let me just hone in on Ms. Goodman, and I have met you 
before, Ms. Goodman, and just thank you for your strength and 
what you bring to this debate.
    Ms. Goodman, your testimony indicates that the Rare 
Pediatric Disease Priority Review Voucher--of course, we call 
it PRV--that this program is working as intended. You mentioned 
that both the number of rare pediatric disease designations and 
the number of drugs approved for these conditions actually 
increased after the creation of the program.
    A scientist at Duke University, which is located in my 
congressional district in North Carolina, whose invention is in 
clinical trials in children with brain tumors, this, this doc 
told my office that even though brain tumors are the most 
common cause of death from cancer in children and infants, they 
are still rare. And for most children, there is no effective, 
safe therapy available. He said that this program serves a 
very, very unique role in assuring continued clinical research 
efforts on behalf of a vulnerable and underserved patient 
community.
    And so, Ms. Goodman, it has been eight years, eight long 
years since the rare pediatric disease, the PRV was created, 
yet we know that that--that it often takes a decade, ten years 
or more to develop the drug. My bill, which is cosponsored by 
16 members, and I think one more has joined us this morning, 17 
members of this committee, would permanently reauthorize this 
lifesaving program.
    How would a long-term extension of the PRV impact research 
and drug development for children? Please help me with this, 
and put your comments in the record.
    Ms. Goodman. Thank you, Congressman Butterfield. Look, even 
though this program has been in effect for eight years due to 
your leadership, each time we have had to reauthorize the 
program, we have only had an opportunity to do reauthorizations 
of three months, one year, one year and four years. So drug 
developers, at the very beginning of the drug development 
process, when they are looking 10 or 15 years out, they don't 
have any assurance that the program is going to be there for 
them. And so they may or may not be persuaded by the existence 
of the Pediatric Voucher Program, and they may or may not use 
the possibility of getting the voucher if the program is 
reauthorized to start developing drugs for seriously-ill 
children.
    If we have a permanent program, we are going to see many, 
many more drugs for seriously ill kids.
    Mr. Butterfield. Well, you know, as legislators, we are 
always concerned about the cost of a program to the taxpayer. 
Can you tell me if this program has cost our taxpayers any 
money at all?
    Ms. Goodman. No, sir. No money at all. The CBO scored this 
program at zero.
    Mr. Butterfield. Very good. Ms. Goodman, as Jacob's mom, 
and as the founder of Kids Versus Cancer, do you think--do you 
think that the Rare Pediatric Disease Program should be 
permanently reauthorized, not only your view, but the viewpoint 
of our stakeholders and our friends that you associate with 
every day?
    Ms. Goodman. I do. I believe that permanent reauthorization 
will ensure that this incentive has maximum effect. And I have 
not received a cent from any of these vouchers, but I don't 
mind if other biotechs are well-funded so that they develop 
drugs for seriously-ill kids.
    Mr. Butterfield. And, finally, let me close out by speaking 
directly to Mr. Boyd. Dr. Boyd, thank you very much for your 
testimony today. I realize that COVID is different in every 
State, in every jurisdiction. But does it matter that a school 
district has insufficient funding? The tier 1 school systems 
that I specifically have in mind, has funding become a factor 
in the decision to reopen?
    Mr. Boyd. Yes, as of right now, sir, we don't receive any 
funding from educational sources. Our funding is through grants 
that help get the school-based health center open, and then 
from reimbursements from, primarily, Medicaid and SHIP. 
Although, some are set up to take private health insurance. But 
for the most part, the kids we serve don't--don't have private 
insurance.
    We are hopeful in the Senate bill that is being considered, 
the Republican Senate bill that school-based health centers 
will become an eligible use, so we would hope that you would 
consider that if it comes before the House so that we can have 
money to reopen and restart.
    Mr. Butterfield. Thank you very much. Those negotiations 
are taking place as we talk. Thank you very much.
    Ms. Eshoo. Am I unmuted?
    Mr. Butterfield. I yield back.
    Ms. Eshoo. The gentleman yields back.
    A pleasure to recognize the gentleman from Kentucky, Mr. 
Guthrie, for his 5 minutes of questions.
    Mr. Guthrie. Thank you, Madam Chair. Thanks for having this 
and hosting this meeting.
    And to Ms. Goodman, thanks for being here and honoring your 
son Jacob with your effort. I guess, we are--according to your 
timeframe, so when I was in junior high, which was about 40 
years ago, I lost a friend. And every time I see St. Jude ads, 
I always think of her. We were from the South, and so she went 
to St. Jude. And in this day and with her category, she 
probably would have survived. So what we are doing here is 
important, and research really changes family's lives. So 
thanks for that.
    My question, though, is for Mr. Lindberg. And I am on the 
registry as well. We had a big bone marrow drive for someone in 
our community's son, there was a young person too that needed 
bone marrow, so I had a huge drive. And I didn't match him, but 
later on, I matched and got called and went and did all of the 
process. It is a lot when you--when you donate, actually. And I 
got right to the point where I was supposedly scheduled to go 
donate, and it was cancelled. And I always hoped and prayed 
that it was because they found a better match. They wouldn't 
tell me why. That is what I always kind of wondered, who that 
other person was. We never were able to get that far down the 
process.
    But, hopefully, he or she found a better match and is still 
with us today. I just would love to know that, but I know there 
is no way to know.
    But during June, what is remarkable is that the bone--your 
program facilitated more transplants in June than ever before, 
and it was encouraging just to see during the pan--in the 
middle of a global pandemic.
    So my questions are, could you please speak to your work 
with the Health and Human Services in order to ensure these 
transplants were possible in June? And moving forward, what 
needs to be done to ensure transplants can continue during the 
coronavirus pandemic, and how do we--how can we prepare better? 
So you--as you work at HHS, to ensure that we can continue 
moving forward, and then what do you think we can do to make it 
better during--if another pandemic comes to be better prepared? 
Thank you.
    Mr. Lindberg. Thank you, Congressman Guthrie. And thank you 
for going through the process, almost getting to that point 
where you donated.
    I can tell you that after 15 years of working with this 
program myself, just that hope that having a donor, a 
potentially matching donor available for a patient, that hope 
means an awful lot. And, like you, I will hope that there was 
just simply a better DNA match donor for that patient out 
there.
    Thanks for your question. With respect to HHS, we have 
enjoyed so, so many decades of public private partnerships with 
our colleagues at HRSA and HHS. They have been extraordinarily 
helpful to us throughout the course of pandemic. We work 
shoulder to shoulder with them.
    One example that I will provide is that as we were very 
much struggling with commercial flights being cancelled, one of 
the things that I will mention to the committee quickly is that 
we take these courier trips so seriously, many times, many, 
many times patients have been mild-like, meaning their immune 
systems have been removed before a product that is collected 
internationally can be delivered to their transplant center. So 
if we--if we miss, that has very, very dire consequences. So we 
can't miss.
    We take--our couriers take these products in coolers, and 
they enter into the passenger compartment of a commercial 
airline many times and fly overseas to bring those products 
back to the patient's bedside.
    As those commercial flights started to dry up, as schedules 
started to be eviscerated as the pandemic hit, one of the 
things that we have worked with HHS around was they had 
received an in-kind donation of private flight time from an 
entity that I can't name because they have added--a private 
entity that has asked to remain confidential.
    But those--those flight hours were donated to us, and we 
were able to work through HHS to procure these private flights 
to move donors and couriers overseas, so that we didn't miss--
like I said, we didn't miss one time. I think that is a 
remarkable thing. And it is just--it is grit and determination 
and incredible help.
    So I am so proud of my colleagues here at National Marrow 
Donor Program/Be the Match, and I am proud of our partnership 
with the government over 30 years. It has been extraordinary.
    In terms of what we can do going forward, this program 
reauthorization and doing it in a timely way is of immediate 
importance to us. And my colleagues here at the NMDP, so much 
of our success over the course of the last four months has 
pivoted on our national program status.
    I fear that if a program lapses, we may lose some of that 
really important leverage that we have had with foreign 
governments, in particular. If we lose the full force of the 
Federal Government behind us, all of a sudden we are a 
nonprofit here sitting here in Minneapolis, Minnesota. It is a 
really great profit----
    Mr. Guthrie. I am about out of time.
    Mr. Lindberg. Yes. Thank you.
    Mr. Guthrie. I am out of time. Thank you very much. I am 
56. So, hopefully, I will get called within the next 5 years.
    Mr. Lindberg. Thank you, sir.
    Mr. Guthrie. So I appreciate it very much. And thank you 
all for everybody else, and I am sorry I didn't get to your 
questions. I yield back.
    Ms. Eshoo. The gentleman yields back.
    It is a pleasure to recognize our wonderful colleague from 
California, Ms. Matsui, for her 5 minutes of questions.
    Ms. Matsui. Thank you very much, Madam Chair, for having 
this important hearing. And I thank the witnesses for being 
here today. These are all important bills, and we all want them 
to pass. And a special thank you to Mr. Lindberg for testifying 
today about the importance of the National Bone Marrow Program 
and Cord Blood Inventory. You can tell it is a popular subject, 
because many people have already talked about it, and some of 
the questions have already been covered. But I think we should 
keep talking about it more, because the bone marrow program is 
really very critical.
    In fact, my late husband, Bob Matsui, had MDS, and there 
was a time, I guess, 15 years ago or more, when he was ill, 
when it wasn't really possible for him to get the bone marrow 
that he needed. So the more we have, the better it is.
    Every three minutes, we know that someone is diagnosed with 
blood cancer. And for patients and families facing these fatal 
diseases, a bone marrow or cord blood transplant may be the 
best treatment or only potential for a cure.
    Congress recognized a need to coordinate these lifesaving 
transplants in creating the C.W. Bill Young Cell 
Transplantation Program, a strong bipartisan public health 
priority. I am proud to say that in working with my colleagues, 
the program's authorization has never lapsed since it was first 
enacted in 2005.
    Because most patients diagnosed do not have a suitable 
donor in their family, the program's national registry known as 
the Be The Match which matches patients in need with possible 
unrelated volunteer bone marrow, or cord blood donors, is truly 
a lifeline. We have to continue to encourage donors and give 
these patients with otherwise fatal blood cancers a second 
chance at life. And that is why I was pleased to join 
Representatives Bilirakis and Pingree to introduce the 
Transplant Act of 2019, legislation to reauthorize the C.W. 
Bill Young Cell Transplantation Program and the National Cord 
Blood Inventory for another five years.
    So, anyway, just to continue on, you mentioned in your 
testimony some of the roles that the National Marrow Donor 
Program plays in addition to running the national registry. Can 
you elaborate a bit on the work that Be The Match and NMDP 
plays?
    Mr. Lindberg. I would be thrilled to do that, Congresswoman 
Matsui. And thank you, again, for unwavering support over the 
years. I see a direct line of sight between your advocacy for 
this program and thousands of patients' lives saved here, so 
thank you for that.
    NMDP/Be the Match, is the largest, I would argue, most 
sophisticated registry of volunteered bone marrow donors in the 
world. We have, I think, been now, again, a world leader over 
the course of the last four months as the globe has been hit 
with a pandemic. We have been able to, with the help of you and 
your colleagues, pull levers that we would not have been able 
to pull otherwise, with the State and foreign governments in 
order to continue to move these lifesaving products in a timely 
way all across the world. And we continue--and we intend to 
continue to do that.
    Ms. Matsui. OK. You know, the number of transplants of 
racial and ethnic minority patients has increased substantially 
in the year 2000 to today. What effort is Be The Match making 
continue to expand the diversity of the registry to ensure that 
minority patients can find matches?
    Mr. Lindberg. Yes. Thank you for that question, 
Congresswoman Matsui. I was about to go there and decided that 
I would hold a moment. I wanted to mention that our 5-year 
strategic plan--our mission is to save lives through self-
therapy. Our vision to do that is--we talk about democratizing 
self-therapy. And what we mean by that when we say that, is 
that no matter who you are, no matter your race, your 
ethnicity, your religion, your creed, your economic status, 
that it is our obligation to find for you that match and to 
deliver that match to you and hope that your life can be saved.
    And what we know today is that because of the peculiarities 
of our DNA and our HLA, that it is unfortunately far more 
difficult for those who are in historically underserved 
populations to find that good match.
    So we have doubled down on our efforts to serve underserved 
communities, and we have set up a metric that we are moving 
well towards to double the number of transplants in ethnic 
populations in five years.
    Ms. Matsui. Well, thank you very much. I appreciate your 
hard work. And we know this has to be reauthorized. It is such 
important work. So, thank you very much, and I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    The gentleman from Virginia, Mr. Griffith, is recognized 
for his 5 minutes of questions. We are so happy to see you and 
know that you are doing well.
    Mr. Griffith. Thanks. I am glad to be with you all. And, 
yes, things are going very well. It is really interesting, I 
was the 17th member who signed on to continuing and permanently 
funding Chairman--Mr. Butterfield's bill. And I will just 
relate to you what happened. Sometimes timing is important. I 
was at the pool within the last couple of days with my boys who 
are 14 and 12. And I was talking to a dad whose son is entering 
the 6th grade, and he has just gotten over leukemia, or is at 
least in remission. We were talking about this very program, 
and I reiterated to him my support for it. I couldn't think of 
a better way to show that support than signing onto the bill, 
and, hopefully, we can get this through and we were very 
pleased to have done that. But we all know somebody who is 
affected, or might be affected by this, and it just brings it 
all home.
    That being said, and I appreciate that. I do want to go 
to----
    Mr. Butterfield. Thank you, sir. Thank you.
    Mr. Griffith. Thank you. I appreciate you carrying it. I do 
want to go to the Anti-Doping Agency, and I want to talk a 
little about that.
    Mr. Tygart, are you available for a question there, or I 
guess you are somewhere----
    Mr. Tygart. I sure am. Yes, sir.
    Mr. Griffith [continue]. In the internet? In your written 
testimony you talk about the World Anti-Doping Agency, and you 
reference that the United States is not able to be on the 
executive committee. What is the stated reason for that? 
Because we have been leading and pushing hard to make the 
Olympics better. Why aren't we on that executive committee of 
the World Anti-Doping Agency?
    Mr. Tygart. Yes, the process for selection of the countries 
around the executive committee, we fall into the Americas 
region, which is 43 countries in South Latin, the Caribbean, 
North America as well. And they had a rule change that says the 
chair of a council of sports ministers gets the seat at the 
WADA executive committee. And you may know, we don't have a 
sports minister in the United States. So while you know there 
may be some technical ability to take that position, I think 
the reality is that no way the U.S. is going to have that seat. 
Both us and Canada have been extremely disappointed because we 
are the two largest funders to WADA as well.
    Mr. Griffith. And do you think the rules change, 
specifically, to exclude Canada and the U.S. because of our 
strong anti-doping position?
    Mr. Tygart. It is a--certainly, that suggestion has been 
put out there. I don't have the--as a lawyer, I don't have the 
proof that I would want to prove it, but certainly that 
skepticism and question has to be asked.
    Mr. Griffith. But what you are saying is, is that it is not 
just a conspiracy theory, there might be a little something 
there, if there is smoke, there might be some fire?
    Mr. Tygart. It is just hard for me to believe that the 
largest funder and one of the powerful sport countries as well 
as a country that has been leading with an independent model 
since 2000 does not have a seat at the most powerful committee 
at the World Anti-Doping Agency, and, realistically, does not 
look to have one in the near future.
    Mr. Griffith. And that is very disappointing. While I 
certainly hope that we will continue to fund your agency, is 
there any action we should be taking to, as a Nation, to 
express our disappointment and perhaps roll back our funding to 
that World Anti-Doping Agency if they are going to exclude us?
    Mr. Tygart. I think what ONDCP and we, as I said in my 
testimony, applaud the effort that they went to, at the request 
of congressional appropriators for ONDCP to provide them a 
report, they lay it out perfectly well, and they ask for the 
opportunity to have discretion in their funding. I think up 
until now, they have seen it only as a contract that they had 
to pay, regardless of what WADA did, reform-wise or otherwise. 
And so we would--we would love--and we were thrilled that the 
House Appropriations Subcommittee FSGG has given them, in its 
markup, the discretion that they asked for, and we hope that 
the Senate does the same, and then allow ONDCP, who has the 
status within WADA's eyes, to be able to sit down with WADA and 
negotiate before just removing the money. But at the end of the 
day, without any leverage, money being the biggest leverage, 
the likelihood of change there is not realistic.
    Mr. Griffith. Well, and I think that is important as well. 
As many members of this committee may recall, and I don't 
remember if it was this subcommittee or not, but we had Michael 
Phelps and a number of others in a couple of years ago talking 
about this very issue. And I think it is important--I think it 
is extremely important, and I think this committee thinks it is 
important that we make sure that we don't have doping in our 
sports in the United States, or in our sports across the world 
as our athletes compete. But I think do appreciate your hard 
work. Is there anything else that you want us to know before I 
finish my questioning?
    Mr. Tygart. I think you are absolutely right, and there is 
no better testament to the number of household names in the 
Olympic movement, Paralympic movement who stand beside us, arm 
in arm, to fight for their right to clean and healthy and safe 
sporting. And we really appreciate the government's effort on 
this to give them the hope that they can compete in the right 
way.
    Mr. Griffith. Well, I appreciate that. I see my time is up. 
Madam Chair, I yield back.
    Ms. Eshoo. The gentleman yields back.
    It is a pleasure to recognize the gentlewoman from Florida, 
Ms. Castor, for her 5 minutes of questions. Nice to see you, 
Kat.
    Ms. Castor. Nice to see you. Thank you, Chairwoman Eshoo. 
This is an important hearing with a lot of terrific bills, so 
thank you. And thanks to our witnesses who are here today. We 
need more school-based, safe health centers across America, so 
I want to thank my colleagues, Representative Sarbanes, 
Representative Tonko, for leading that effort. I am a cosponsor 
of that bill. I also appreciate the focus on rare pediatric 
diseases and Creating Hope for Families, and what else we need 
to do in stem cells and then anti-doping sphere as well.
    I want to focus on the EARLY Act. I am a cosponsor of the 
Early Act, and I am grateful to Congresswoman Debbie Wasserman 
Schultz and Congresswoman Brooks for joining together to stand 
up for young women.
    Ms. Blount----
    Ms. Blount. Yes.
    Ms. Castor [continue]. Congratulations to you. I understand 
the Black Women's Health Imperative is celebrating 38 years of 
advocacy----
    Ms. Blount. We are.
    Ms. Castor [continue]. Advocacy for health equity for Black 
women and girls across the country. I am hopeful that the EARLY 
Act will help improve the diagnosis rates for African American 
women contracting breast cancer. And I hope the EARLY Act would 
also help--help improve their care after they are diagnosed.
    In your testimony, you cite a number of very troubling 
statistics. Black women develop breast cancer typically 5 to 7 
years younger than White women. And African American women are 
40 percent more likely to die after a breast cancer diagnosis. 
That is not acceptable in this country. Would you mind walking 
us through the reasons for that, and what else we should be 
doing about it?
    Ms. Blount. Yes, thank you for your question and your 
concern, Congresswoman, I appreciate that. There are a number 
reasons, as you might imagine. A lot of researchers will point 
to obesity rates, they will point to underlying chronic 
conditions, they will point to childbearing patterns among 
Black women as an explanation for why they are getting breast 
cancer younger. And that may be true, to some degree, but that 
can't explain it all, because if you look at Black women and 
White women in control for obesity rates, control for 
childbearing patterns, age at when they had their first child, 
that doesn't explain the difference in breast cancer rates.
    So the answer is, we don't know exactly. There is something 
going on. And what a lot of researchers are now exploring, and 
frankly, have been for quite a number of years is looking at 
the impact of elevated cortisol levels. Black women have, on 
average, about 15 percent more cortisol in their bloodstream 
than White women. And we know a lot about what that does to the 
body. It triggers our inflammatory response, which, in fact, 
raises our risks for chronic disease. But we also now know that 
elevated--chronically elevated cortisol also raises our risk 
for things like incompetent cervixes. Infant mortality and 
maternal mortality have been demonstrated for years.
    So what we need to understand more about is what this--what 
is happening, because we know it is not biology, we know it is 
not genetics, but what is happening in the lived experiences of 
the Black woman that actually raises their risk for chronic 
diseases, particularly, breast cancer?
    Ms. Castor. So what is the most effective--what successful 
outreach initiatives have you seen that you would recommend to 
us?
    Ms. Blount. Well, I have seen a number of community-based 
outreach initiatives. I mean, our organization, is of course, 
among many to make sure to educate Black women on the 
importance of screening mammography, in particular, and 
starting at age 40. This is very much a grassroots kind of 
activity where we have got to make sure that providers 
recommend screening mammography. You would be amazed at the 
percentage of providers who don't suggest that their patients 
get the screening mammogram, starting at age 40, and to explain 
the process.
    So we and other organizations have been involved working 
with federally qualified health centers, and with the NMA and 
other medical associations to help educate Black women on the 
importance--and Latinas on the importance of getting that first 
mammogram, understanding your family history, and getting that 
early mammogram so that you know what your risks might be, and 
can take the proper steps.
    Ms. Castor. That would save lives.
    Ms. Blount. It would indeed.
    Ms. Castor. Thanks for your important work.
    Ms. Blount. Thank you, Congresswoman.
    Ms. Eshoo. The gentlewoman yields back.
    It is a pleasure to recognize--oh, God, every time I say 
Representative Brooks, my heart sinks because we don't want you 
to leave. But I am going to recognize you for your questions. 
It is wonderful to see you.
    Mrs. Brooks. Thank you, Madam Chairwoman, And thank you so 
much for those kind words. But thank you to all of the 
witnesses for your passionate testimony. All of these bills are 
critically important in ensuring that we reauthorize all of 
these very important five public health bills.
    It is also good to see you, Mr. Boyd. We have done work 
together in the past on school safety. And as the mother of a 
Title 1 teacher, all that you said about the concerns for our 
school-based programs, health centers are critically important.
    I want to focus my time today, though, and continue to 
follow up on what my colleague, Ms. Castor, was just talking 
about with respect to breast cancer. It is not just another 
disease. It is personal for so many of us. I think it is safe 
to assume that everyone in this hearing has been impacted in 
one way or another by someone who suffered from breast cancer. 
And, in fact, our colleague and dear friend, Debbie Wasserman 
Schultz, suffered from early breast cancer at the age of 41 
back in 2007, and she has been a passionate advocate, as has 
the chairwoman in fighting to make sure that young women have 
access to screening.
    And I want to continue to talk about the importance of 
early detection, because we know that--we know that the higher 
chance a woman has in getting detected, they will beat that 
cancer.
    And, then, Ms. Blount, you stated in your testimony, I 
think it is worth repeating, that if we can increase breast 
cancer screenings in women under 45 by just 50 percent, 3,000 
more women per year will survive their diagnosis. Yet, I think 
many young women, in particular, don't think about the 
importance of getting screened. And as you have said, the 
providers often don't encourage them to get screened.
    So while we are--let's talk a little bit further about what 
is the state of our Nation's public awareness and education 
efforts, in your opinion, particularly focused on younger 
women? Can you please share with us what you view as the state 
of our Nation's public awareness campaigns and education 
efforts?
    Ms. Blount. I can. And thank you for that question, 
Representative Brooks. It is certainly not where it needs to 
be. You know, young people often feel invincible, as we have 
seen with COVID-19 recently, and, you know, a young woman 
doesn't want to think about breast cancer. I understand it. I 
understand it completely. But we have got to do more about 
making sure that she understands her risk and, particularly, 
her family history.
    So, you know, we have got the National Breast and Cervical 
Cancer Early Detection Program which helps, but we also know 
there are funding challenges with that program. In some States, 
the program may run out of money 6, 7, 8 months into the year. 
And while there is outreach that is done, and we hope treatment 
occurs when there is a suspicious finding, you know, there is 
not the resources to reach all the women and, particularly, 
young women, frankly, in the way they need to hear the message. 
Our public health conversation, our public health programs, the 
kind of language, imagery we use is, frankly, fairly old 
school.
    So, a lot of what we in my organization are trying to do is 
use modern-day images, terminology, communications mechanisms 
to make this message relevant to where women are today. And if 
we can do that, we can get them into screening early.
    Mrs. Brooks. Thank you very much. Can you actually discuss 
a few of the strategies that your organization, Black Women's 
Health Imperative, is using to educate these women? What kind 
of strategies, specifically, is your organization using, and 
how can we ensure that these young women get the access that 
they need?
    Ms. Blount. We are, of course, using social media. We are 
going right to where these young women are on Instagram to talk 
about the importance of breast health. We have launched what we 
call Black & Well TV where we have conversations with notable 
influencers and celebrities and medical professionals and 
public health professionals to talk about the importance of 
early screening. It is, you know--it is delivered via 
streaming. And we hope in the not-too-distant future to 
actually have a partnership where we can have a more national 
spokesperson convey this kind of information in the way Black 
women need to hear it in order to act on it, so that they 
understand that this is important, but, most importantly, that 
they don't need to be afraid.
    We are particularly concerned now that COVID-19 may 
actually keep women out of mammography centers, and that 
screening rates may go down. So we have got to make sure that 
Black women understand that it is still important to do, and 
that there are safe ways to do it.
    Mrs. Brooks. Well, thank you. Thank you for your important 
advocacy, and we do know that early detection works and will 
save lives. So thank you for your important work. I yield back.
    Ms. Blount. Thank you.
    Ms. Eshoo. The gentlewoman yields back.
    It is a pleasure to recognize our colleague from 
California, Mr. Cardenas, for his 5 minutes of questions. You 
need to unmute. Mr. Cardenas?
    Mr. Cardenas. Yes. Thank you. Can you hear me? I am on. OK. 
Thank you. Thank you, Madam Chair, and Ranking Member Burgess, 
for holding this important legislative hearing. Reauthorizing 
critical public health programs is very, very important to our 
country, and I hope people understand that critical need, 
especially during this pandemic. And a big thank you to our 
witnesses. I really appreciate your expertise and your opinions 
today.
    My first question has to do with schools. So I am going to 
ask Mr. Boyd a question. I am a longtime supporter of the 
School-Based Health Centers Program, and I am very glad to see 
prioritizing legislation today to reauthorize this program that 
provides healthcare for 3.6 million youth, predominantly from 
low-income families.
    I am very, very proud to say that I grew up in the second 
largest school district in the country. And the school-based 
health clinic--I think it was the first one in the entire 
district, was at San Fernando High School, my high school. And 
what is really important in all aspects of healthcare is 
cultural competency, and especially when it comes to linguistic 
differences.
    So that school was very--and that clinic that sponsored it 
was very smart in carrying my brother, who was a clinical 
psychologist of linguistics and competent in two languages, 
Spanish and English, and also culturally competent as well. He 
grew up in that neighborhood. He and my ten brothers and 
sisters went to that high school. So he was able to really 
provide a service above and beyond what he learned in college 
to get his degrees.
    So I worry about the massive wave of behavioral health 
issues experts warn about when we are talking about this 
pandemic, staying-at-home orders, virtual learning, and more. 
People having to educate their own children, that in and of 
itself is a big issue these days.
    My question has to do with how could additional school-
based health funding support students with mental health and 
substance abuse disorders? Like I said, my brother, the 
psychologist, was at the school-based clinic. So it was mental 
and physical health provided there. Mr. Boyd?
    Mr. Boyd. Yes, Congressman, you raised two important 
issues: one, access. The number of school-based health centers 
from my perspective, from our organization's perspective is 
unacceptable. There are few within 3,000 of us pre-pandemic, 
and we have got 25,000 fully eligible Title 1 schools. So we 
have got to grow the number. That then poses a human capital 
problem. We can't take people out of the--out of colleges and 
just throw them to work in school-based health centers. They 
have got to licensed, certified, trained professionals. So over 
the next ten years, we have to address that human capital 
issue, and it has to address cultural competence.
    In seminary, I was always taught to look for the good news. 
The good news in the pandemic is that a lot of behavioral 
health specialists have said, OK, we accept the fact that 
telehealth is here to stay. Now the opportunity that that 
presents is how do we get culturally competent mental health 
professionals to the schools that need them, potentially using 
telehealth? And that is something that a number of us are 
working on right now, trying to put together a strategy to 
bring to the Federal agencies to say, we have the capability of 
doing this through telehealth. We have got to address the State 
licensing issues post-pandemic. Right now, it is not as much of 
an issue.
    But you are right on point: Human capital is the number one 
issue as we look to expand the number of school-based health 
centers over the next ten years.
    Mr. Cardenas. Thank you, Mr. Boyd. And I just want to state 
for the record: Tomorrow, I am introducing the bipartisan bill 
with some of my NC colleagues, behavioral health technical 
assistance and training centers for schools within SAMHSA. 
SAMHSA, for those who don't--who are viewing this, is the 
Substance Abuse and Mental Health Service Administration. This 
would help schools and school systems better support students 
with mental health and substance use disorders.
    I hope this important legislation gains momentum and would 
welcome support from the School-Based Health Alliance.
    Mr. Boyd, what impact do you think COVID-19 will have on 
the health and well-being of our students? And, also, how can 
we better help prepare you all to address this in the coming 
school year?
    Mr. Boyd. It is--like I said, it is a disaster. It is a 
disaster on the mental health side. It is going to be a 
disaster for the children that need daily medicine management 
and behavioral health services. We need more of us. The 
opportunity using telehealth is a great one because the cost of 
privacy-protected platforms have come down, and the cost of 
equipment that primary care providers use has come down 
literally 90 percent in the last 18 months. Where it was 
$23,000 a unit this time last year, it is $2,300 a unit for 
that primary care equipment.
    So, you know, to those of you on Energy and Commerce that 
are also on Communications, turning to the FCC and saying, Use 
some of the universal services fund to enable us to buy that 
equipment and provide those platforms through school-based 
health centers, is critical. We need those resources. We simply 
don't have them. It is one thing to get reimbursed, but if you 
don't have the capacity to be there and you don't have the 
trained professionals to serve, it is not going to matter. We 
have got to have the equipment, and we have got to have that 
kind of funding.
    Mr. Cardenas. Thank you, Mr. Boyd.
    Madam Chair, if you will allow me a point of personal 
privilege about our colleague, Mrs. Brooks. I agree with your 
sentiment, sad to see her leave. And I just want to quote my 2-
year-old granddaughter who is bilingual. Every time I leave, 
she touches me by saying, "No te vayas, no te vayas." That is 
"Don't go. Don't go." Take care.
    Ms. Eshoo. That is beautiful. Thank you. And the gentleman 
yields back. Pleasure to recognize the gentleman from Montana, 
Mr. Gianforte, for his 5 minutes of questions.
    Mr. Gianforte. Yes, thank you, Madam Chair.
    Ms. Eshoo. Oh, I am sorry. I am sorry, I am sorry. I need 
to withdraw that. I was wrong.
    Mr. Mullin, our colleague from Oklahoma, I am sorry. I 
apologize to you, Mark. You are now recognized for 5 minutes.
    Mr. Mullin. Madam Chair, thank you so much.
    Ms. Eshoo. Mr. Gianforte, promise you.
    Mr. Mullin. Well, Madam Chair, thank you so much. I would 
have gladly yield to hopefully the next Governor of Montana, 
Greg Gianforte. But I got to say this, Tony, you said that you 
hate to see Susan go, I am mixed feelings because I don't want 
her to go, but at the same time, I get to move up on the dais 
as she does. So I am kind of mixed on this one. No, I thank you 
so much for having this important hearing, Madam Chair.
    Ms. Goodman, my question is going to be referred to you, 
and I just got to--reading your story about your son, I just 
want to tell you how much I appreciate you continuing, even a 
decade later, advocating for these important causes. Literally, 
I just ran out of where I am staying temporarily. I am not even 
at my house or in the office, because my son had a major brain 
injury, and I had to just drop him off with specialists at the 
Centre For Neuro Skills in Bakersfield and ran back in here to 
answer questions.
    And as you know with pediatric care, there is a disconnect 
between adult care and pediatric care; what is available to our 
children, versus what is available to adults, and it is 
disproportionately wrong. And, so, I just want to tell you how 
much I appreciate your advocacy, but not just on medication, 
but on rehab and development, and the encouragement of biotech 
companies to be involved in this area.
    So personally, Ms. Goodman, I just want to tell you, thank 
you so much for being such an advocate for all of our kids.
    In your testimony, you mentioned pediatric rare disease 
drug development is mostly done by small biotech companies, 
which is true. Can you comment on how Rare Pediatric Disease 
Priority Review Voucher Program works to get more funding to 
these small inventors?
    Ms. Goodman. Sure. Thank you so much, Congressman Mullin, 
and first of all, we are all keeping your son in our thoughts 
and our prayers for a, you know, a full and speedy recovery.
    Mr. Mullin. Thank you.
    Ms. Goodman. So the voucher program is really critical for 
biotech, many of which are thinly capitalized, because the 
opportunity for them to create a voucher, it gives them a 
chance to attract additional investors and even to sell their 
designation early in the drug development process and monetize 
the designation, you know, phase 1 or phase 2, as soon as they 
receive it, so that they can use that funding for development 
of the drugs for kids who really need these novel therapies.
    Mr. Mullin. How is the program funded to support the FDA 
reviewers as needed to review products on the expedited 
timeline? Are you familiar with that?
    Ms. Goodman. Yes, sir. Thank you for that question. So 
every year, the FDA calculates what the expense was to the FDA 
of this program, and the FDA sets a new pediatric voucher user 
fee for the following year. And the current user fee is $2.1 
million, and that is on top of the PDUFA user fee that a 
sponsor would pay, which is about $2.9 million.
    Mr. Mullin. Do you know if the program has a CBO score on 
either what it costs or what it saves the American taxpayers?
    Ms. Goodman. Yes. The score is zero.
    Mr. Mullin. And I think, obviously in asking these 
questions, I know the answer, but I think a lot of people need 
to understand that, that we are not--we can invest in this 
without costing us anything because of the return.
    And once again, your advocacy on this is something that I 
think every parent that has been through what you have been 
through, commends you on, and I just can't thank you enough.
    What measures does the FDA have in place to ensure that the 
safety and the efficiency of these drugs go through the 
expedited approval process?
    Ms. Goodman. So, I think your question is, how can we be 
sure that the FDA approves drugs in a safe manner?
    Mr. Mullin. Yes.
    Ms. Goodman. Is that your question?
    Mr. Mullin. Yes. Absolutely, yes.
    Ms. Goodman. Look, I think that people who choose to work 
at the FDA are just smart and incredibly impassioned and 
dedicated people, and they make sure that any drugs that they 
approve, you know, meet their rigorous standards. The targets 
they need to meet under this, or any other PDUFA program, are 
not required. They are not mandatory on the FDA, they are 
optional. They are only--FDA is only going to approve drugs if 
they are safe.
    Mr. Mullin. Right. And I, once again, know the answer to 
this, but without congressional action, the Pediatric Rare 
Disease Priority Review Voucher is set to expire at the end of 
this year. What would that mean to you, and to parents that are 
going through the same things that you went through?
    Ms. Goodman. Thank you. You know, we have had almost two 
dozen new drugs for seriously ill kids approved in the past 
eight years since the program was developed, and I think it is 
going to dry up.
    Mr. Mullin. Right. Well, Ms. Goodman, thank you again for 
your time and for being here.
    Madam Chair, thank you for holding this important hearing, 
and with that, I yield back.
    Ms. Eshoo. The gentleman yields back. It is a pleasure to 
recognize the gentlemen from Maryland, Mr. Sarbanes, for 5 
minutes, for his questions.
    Mr. Sarbanes. Thank you very much, Madam Chair. Can you 
hear me?
    Voice. Yes, sir.
    Mr. Sarbanes. OK. Appreciate all of the bills that we are 
discussing here today. Again, very gratified that among them is 
the School-Based Health Center Reauthorization bill, and I want 
to thank my colleagues for their support of it and their 
interest in the topic.
    And Mr. Boyd, I want to thank you for your leadership at 
School-Based Health Alliance and the testimony that you have 
given us today. I can say, having visited many, many school-
based health centers over the last few years, trying to 
understand all the dimensions in which they can provide support 
for children and families, that some of the most impressive 
practitioners and health professionals I have ever met are the 
people that staff these school-based health centers.
    The amount of support they give to the school, to the 
students, to the families, and to the community, really can't 
be overstated. So you are representing a very proud and 
resourceful group of people, and we thank you for being with us 
today.
    The school-based health centers, I kind of look at them as 
having two basic functions, or opportunities. One is obviously 
to serve what is a captive audience, which are the children 
that are located in that school, and to take full advantage of 
the fact that you have them there, or that you are connected to 
them if we look at it now through the lens of the pandemic and 
what that is doing to kind of change the status quo.
    But the other is that through children who come to these 
school-based health centers, or are served by them, they act as 
a link to the families of those students and can help connect 
families to healthcare resources that are more broadly 
available. Sometimes that is through actual partnerships with 
community health clinics, including federally qualified health 
centers. Other times it is more through referral to other 
providers that are in the community.
    But maybe you could speak a little bit to that, how the 
health centers in these schools can be a gateway of opportunity 
to access broader health supports, whether it is physical 
health or mental health, emotional health, that are needed in 
those communities?
    Mr. Boyd. That is a great question, Congressman. Pre-
pandemic--and I have to keep speaking of that because we don't 
know how many school-based health centers are going to have the 
resources to reopen--but pre-pandemic, the majority, over 51 
percent of the school-based health centers were sponsored by 
federally qualified health centers. So that gave a tremendous 
link between the families' overall healthcare needs and 
addressing the healthcare needs of the students.
    The NACHC, the National Association of Community Health 
Centers, has identified, and put in their strategic plan for 
this next year, an interest and a direction for federally 
qualified health centers to look more carefully at school-based 
health centers as an opportunity for them to expand their 
business models.
    You speak to the quality of the people that work in the 
school-based health centers. Clearly, they could make more 
money. This is their calling. They are like teachers. They are 
not there because it is the best-paying job in the world; they 
are there because of their dedication and their commitment to 
serve, and particularly to serve children, and in particular, 
to serve children in low-income communities because that is 
where most of the SBHCs are located.
    So, yes, absolutely, and pre-pandemic, we were in process 
of arranging a visit, for us to go with you to visit some of 
those centers in your district, and hopefully we will get the 
opportunity to do that in the future.
    Mr. Sarbanes. Well, I look forward to that, and I 
appreciate very much your raising the issue of compensation for 
those who staff the school-based health centers. If you think 
about it, there is no more important position, given all of the 
different dimensions that can be brought to bear by those 
professionals. And we got to make sure that we recruit them 
with the opportunity to, you know, make a good living, and that 
we keep them.
    Because that is critical as well, because they build 
relationships. That was one of the most powerful testimonies I 
got from a most recent visit to a school-based health center, 
was the relationship that that center had built with certain 
students--this was a high school--over the course of their 
time. And it meant when those students had issues and stresses, 
they felt like it was a place to turn, there was a relationship 
there. That is exactly what we need to provide for our young 
people.
    So thank you for your testimony, we appreciate it very 
much, and I yield my time back.
    Mr. Boyd. Thank you, sir.
    Ms. Eshoo. The gentleman yields back. A pleasure to 
recognize the gentleman from Montana once again, Mr. Gianforte, 
5 minutes for questions.
    Mr. Gianforte. Thank you, Madam Chair. I appreciate the 
committee meeting today to advance several bipartisan 
reauthorization bills. As we know, we are reauthorizing the 
School-Based Health Center Program, a program to promote 
awareness and education about breast cancer in younger women, 
the Cord Blood Inventory and Bone Marrow Transplant Programs, 
and the U.S. Anti-Doping Agency. This is the entity that 
ensures that Olympic and Paralympic athletes are not using 
performance-enhancing drugs. I know we are all looking forward 
to having the Olympics next year and cheering for the Americans 
that will be competing.
    The piece of legislation we are working on today that I am 
most appreciative of is the Creating Hope Reauthorization Act. 
This bill reauthorizes the Rare Pediatric Disease Priority 
Review Voucher Program. This program creates an incentive for 
drug companies to develop therapies for rare pediatric 
diseases.
    If we develop a therapy for one of these diseases affecting 
children, they get a voucher to speed the FDA review of another 
drug. This program has already led to the development of 22 
therapies. I have heard from Montanans dealing with the loss of 
their children from DIPG, a currently untreatable brain tumor. 
DIPG is the second most common cause of child cancer deaths. 
Encouraging more therapies and treatments for these rare 
pediatric diseases is something we should all support.
    Ms. Goodman, thank you for sharing your story with us 
today, and you were very articulate in your response to 
Markwayne Mullin's questions. Is there anything else you would 
like to add about the reauthorization of this program and the 
impact it has been having for children in this country.
    Ms. Goodman. Thank you, Congressman Gianforte for that 
question. I would just really like to just emphasize that this 
program has, as you said, 22 new drugs, many new drugs in the 
pipeline. The FDA has the opportunity to incorporate all of the 
costs of executing this program in their user fee, and so, I 
hope we can find a way to reauthorize it on a permanent basis.
    Mr. Gianforte. Well, I think we have strong bipartisan 
support, and you being here today and telling your story has 
had quite an impact. I want to thank you for that.
    I look forward to supporting these pieces of legislation, 
and with that, Madam Chair, I yield back.
    Ms. Eshoo. The gentleman yields back. A pleasure to 
recognize the gentleman from Massachusetts, Mr. Kennedy, for 
his 5 minutes of questions.
    Mr. Kennedy. Madam Chair, thank you, and thank you for 
holding this important hearing, as always.
    Mr. Boyd, in your testimony, you mentioned that it is still 
unclear how and if students will be able to go back at in-
person learning in the fall. It is a hard thing to balance--the 
importance of in-person education, while also ensuring the 
health and safety for our children, their families, and their 
communities.
    Because opening schools will not just impact students, it 
impacts everyone around them. Because of this, we need to 
ensure that if schools do allow for in-person learning, we 
follow scientific guidelines, learn from other countries that 
either began too soon, or took a more strategic approach, and 
ensure we have all the necessary stakeholders at the table in 
making these decisions.
    So Mr. Boyd, I want to ask you if you can talk a little bit 
about how you think school-based health centers should be 
involved in these decisions and the planning processes for the 
re-open.
    Mr. Boyd. That is a great question. Thank you, Congressman. 
We are part of a series of networks in Washington that include 
all of the major organizations on the education side, including 
the unions, the superintendents, the principals, as well as on 
the health delivery side, in the nurses, the counselors, the 
psychologists, the social workers, and us. Everybody, across 
the board, sees the value of the work that we do. We don't see 
ourselves in competition with each other. We see ourselves in 
full support of each other.
    We are not sure how schools should open. We think that is a 
local decision that is going to have to be made on a scientific 
basis, case by case. But again, I want to come back to the 
point that schools are--schools, for the most part, remained 
open. The question was the ability of the school to deliver 
their services. It was the buildings that closed.
    I don't think that most school districts today are looking 
necessarily at not reopening. They are looking at whether or 
not to reopen their buildings. School-based health centers have 
to be a part of that conversation, and we are, at the national 
level; it has to filter down to the district level. School 
districts can't put out plans that don't include parents, and 
in some situations, students, as well as major employers in 
their communities, as well as all of the disciplines that I 
have referenced.
    Mr. Kennedy. And I wanted to build on that a little bit, 
Mr. Boyd, because you spoke about the importance of mental 
health and emotional well-being of children during this 
pandemic, and it has been a big area of focus of mine, as 
perhaps you know. We have seen how the pandemic has highlighted 
the gaps in our own health system when it comes to mental 
health, and now what has happened with the need to shelter in 
place, with additional isolation and diminished care 
connections and how that can negatively impact one's mental 
health.
    We have seen the devastating impacts of a far increased 
need for mental and behavioral health services, increasing 
rates of suicide, long-standing racial inequities that still 
exist between Black, Native, and Latinx children and families.
    So just walk me through how you are thinking of providing--
meeting that need for mental/behavioral health services for our 
children and in our schools?
    Mr. Boyd. Yes, I think there is several challenges. 
Telehealth does provide that opportunity. For many mental 
health care providers throughout this pandemic, that has been 
the telephone. And while children are left--schoolchildren are 
left reluctant to do that kind of a telehealth visit, it has 
been the adults that have resisted it. I think many have gotten 
past that.
    Our dilemma then is to make sure that we protect the 
privacy of those students. It is to give them a greater 
opportunity to participate, but make sure that when they are 
participating, they are doing it in an environment that allows 
them to be honest and open without sharing confidences or the 
invasion of their privacy because someone's able to hear it, or 
someone's able to hear the healthcare provider on the other 
end.
    We have got to come up with technological solutions and 
platforms that work for the kids but also protect their privacy 
and work for the practitioners. That is going to be the major 
challenge and the major opportunity for us going forward if we 
wind up being in this situation for an extended period of time, 
as it seems we are going to. We are going to have to use 
technology.
    Mr. Kennedy. Time is limited, so I might follow up with a 
question for the record for you, but I am grateful for your 
time and your willingness to highlight these issues as we try 
to navigate our way forward. Thank you very much, sir.
    I yield back.
    Mr. Boyd. At your convenience, sir.
    Ms. Eshoo. The gentleman yields back. The chair now 
recognizes the gentleman from Florida, Mr. Bilirakis, for his 5 
minutes of questions.
    Mr. Bilirakis.
    Ms. Eshoo. Are you unmuted, Mr. Bilirakis?
    Mr. Bilirakis.
    Ms. Eshoo. Mr. Bilirakis, you need to unmute. I guess if I 
sing it, it doesn't make any difference, right?
    Mr. Bilirakis.
    Ms. Eshoo. Let's see, how are we going to get his 
attention? Unmute.
    Voice. Looks like he is trying to unmute.
    Ms. Eshoo. Let's see if we have--why don't we go to 
Congressman Ruiz of California, and then circle back with Mr. 
Bilirakis, because I think he has some technological issues 
there.
    Mr. Ruiz. OK.
    Ms. Eshoo. Somebody is laughing. I don't know.
    Mr. Ruiz. My good friend, Gus, you are going to have to go 
get a staffer to help you, my friend. I have been there. It is 
a black hole for sure.
    So thank you, everybody, for being here. School-based 
health centers are essential for many families in my district 
and around the country. I grew up in an underserved community 
with poor access to healthcare. It is a farm worker community 
of Coachella, California. In fact, my alma mater, Coachella 
Valley High School, has a school-based health center.
    While some of these, quote/unquote, health centers consist 
of one exam room, limited supplies, and are often in a tiny 
trailer on campus, they are critical to a child's health and 
well-being, providing services such as dental prevention and 
treatment, health education, mental health services, and 
preventative health screenings.
    Not only that, but they also serve the families of the 
students, providing important continuity of care within the 
family. Students and their families rely on school-based health 
centers for their healthcare, because oftentimes, that is the 
only access to healthcare that the family has.
    These facilities tend to serve families in otherwise 
underserved areas where health disparities are acute, where 
people might not have insurance, or maybe can't find a doctor 
who takes Medicaid, or can't take off work in the middle of a 
Tuesday to take their child to the doctor. School-based health 
centers fill this need, and they are critical to families who 
have limited access to care.
    My question to Mr. Boyd, how do school-based health centers 
address health equity and the needs of underserved children and 
adolescents?
    Mr. Boyd. Thank you, Congressman. You raised three 
important issues, and the first one I want to speak to is the 
infrastructure. The average age of a public school building in 
the United States of America is north of 50 years--I have built 
a lot of buildings in my life--and the guts, the roofing 
systems, the HVAC, et cetera, are built with a 20- to 30-year 
life. So they are holding them together with nothing, and the 
reason you probably had a trailer was, there was no room in the 
school building for them to put that school-based health 
center, but they really wanted one.
    The other issue you raise is access, and I am a believer 
that if you took all of the rural schools in America and you 
put them into one school district, you would probably have the 
poorest school district in America. So even if there was a 
desire to build out space for that school-based health center 
in your community, they probably did not have the resources.
    The pandemic has given us an interesting opportunity, 
technology, to be able to expand the reach and beam into that 
trailer other kinds of services that might not be available 
readily in the community, is a unique one for this time that we 
are in. That is why I say to those of you that sit on the 
Communications Subcommittee, make the FCC give us money for 
telehealth. It is critical--
    Mr. Ruiz. Thank you.
    Mr. Boyd [continue]. If we are going to continue to serve 
and expand. It is all about what Linda Blount said. It is all 
about equity.
    Mr. Ruiz. Thank you, Mr. Boyd. You said in your testimony 
that there is an intersection between education and health. 
What are the health outcomes of these centers, and can you 
expound on the correlation between health and education 
outcomes?
    Mr. Boyd. I love--thank you for that. I love when people 
ask questions that other people have answered. Included in your 
written testimony is a document from the Community Preventative 
Services Task Force of the CDC, and they list access to all of 
their findings, but they point out two major ones.
    School-based health centers led to improved educational 
outcomes, including school performance, grade promotion, and 
high school completion. School-based health centers also led to 
improved health outcomes, including the delivery of 
vaccinations and other recommended preventative services, and 
decreases in asthma morbidity, and emergency department and 
hospital admission rates.
    Mr. Ruiz. That is very interesting, because, oftentimes, in 
poor communities, the rate of asthma is high, and that is 
particularly true in my desert, rural community with farm 
workers.
    It seems like a lot of people will refer to cost-
effectiveness of these programs. Are there any data that shows 
the cost effectiveness of these school-based health centers?
    Mr. Boyd. I may have to get back to you on that one. 
Understand that school-based health centers don't cost the 
schools any money. They are reimbursed by Medicaid, and 
oftentimes, if that child is not being seen by a school-based 
health center, they may not be seen by anybody. They are not 
necessarily going to the local, federally qualified health 
center or to an independent pediatrician.
    Mr. Ruiz. Well, I think we can agree that if we have 
preventative services, mental health services, that we provide 
in the schools efficiently, then it lowers healthcare costs 
overall in the long run.
    Mr. Boyd. Absolutely. Healthy kids grow up to be healthy 
adults and are less of a drain on our financial system. 
Absolutely.
    Mr. Ruiz. Thank you very much. I yield back.
    Mr. Boyd. Thank you.
    Ms. Eshoo. The gentleman yields back. Let's circle back to 
our wonderful colleague, the gentleman from Florida. Mr. 
Bilirakis. Are you unmuted?
    Mr. Bilirakis. Can you hear me?
    Ms. Eshoo. Now I can. Now we can.
    Mr. Bilirakis. OK. Very good. Yes, we--I had to switch to 
my iPhone because the computer was not working. I did unmute 
several times, and I apologize for that, Madam Chair.
    Many of you know that the National Marrow Donor Registry 
was established more than 30 years ago by our former colleague 
and friend, Bill Young. You mentioned that, Madam Chair. What a 
wonderful man. Actually, my district was adjacent to his. He 
was passionate about this program, and often said it was his 
proudest accomplishment in Congress. That is saying something.
    Because of Bill Young and, of course, Chris Smith's 
passion, the gentleman from New Jersey, I am familiar with the 
work of the National Registry. However, what I didn't realize 
until I met with Mr. Lindbergearlier this year is the special 
requirement that bone marrow must be hand-carried by volunteer 
couriers from donor to patient.
    Because of this perishability, there are serious time 
constraints. Many times, marrow travels internationally. So 
again, the question is for Mr. Lindberg--by the way, an 
outstanding job on your presentation today, sir--the question 
is, can you discuss the challenges this creates for the 
program, especially during this pandemic, please? Thank you.
    Mr. Lindberg. Mr. Bilirakis, thank you. Thank you for 
cosponsoring H.R. 4764, and for picking up the torch that Mr. 
Young lit. We appreciate that so very much.
    You know, as you can imagine, the COVID pandemic has 
created incredible barriers for us, obstacles that perhaps back 
in March I wasn't sure we were going to be able to overcome. 
But I am so proud of my colleagues who have done incredible 
work to make sure that no patients have missed their 
transplant.
    I will share briefly, only anecdotally, things like, Mr. 
Bilirakis, there was a donor in the country of Colombia. That 
donor, because of inability to collect her cells in Colombia, 
needed to get to the United States. We needed to get her to the 
United States in a matter of days. I will share only briefly 
that on a Saturday afternoon at 2:00, I was told by an embassy 
official, Brian, it is impossible, this can't--we are not going 
to be able to make this work in time. And by 10:00 that 
evening, we had the authorization for her to leave the country. 
We had the authorizations to open up a closed airport. We 
brought in a private aircraft and flew this young woman out of 
the country of Colombia. She flew to your home State, Mr. 
Bilirakis, and donated her bone marrow just a couple of days 
later in time for that patient's life to be saved.
    So, yes, this has been an incredibly trying time, but I 
have been so thankful for my colleagues, and, frankly, the 
support of you, your colleagues, and the Federal Government 
agencies in allowing us to make that happen.
    Mr. Bilirakis. Well, that shows you, we should never give 
up. And I know Harry Glenn has been working on this as well. He 
is the former chief of staff for Bill Young.
    So let me go on to the next question. As referenced 
previously, the nonpartisan Government Accountability Office 
stated in their January 2020 report on Priority Review 
Vouchers, that all seven drug developers we speak to indicated 
that the vouchers were a factor in their decision.
    So this question is for Ms. Goodman. The bottom line, as a 
patient advocate, do you believe the Rare Pediatric PRV 
Program, has been effective at incentivizing the development of 
new target therapy and immunotherapy drugs for rare, pediatric 
cancers, to extend and save lives and provide hope to pediatric 
patients and their families?
    If so, can you also describe for this committee what would 
occur if this program failed to be reauthorized or reauthorized 
permanently? That is the question. And these are all great 
bills, I tell you what. This is a wonderful hearing. We hope we 
put them in the markup in September. But anyway, if you could 
answer, Ms. Goodman, I would appreciate that very much.
    Ms. Goodman. Thank you so much, Congressman Bilirakis, and 
thank you for your support on this bill throughout the past 10 
years. Look, the evidence that the program is successful goes 
from the 22 drugs that have been approved since it was passed, 
to the over 60 drugs in the development pipeline for seriously 
ill kids.
    You know, we don't want to lose this opportunity by letting 
this program lapse, and by making it permanent, we can hit the 
one area that we haven't--where we haven't maximized the 
incentive, and that is at the very earliest stage of drug 
development when drug developers say, am I going to develop a 
drug for seriously ill kids; they need to know the voucher is 
going to be out there whenever they get the drug approved so 
that they can develop those drugs for kids. Thank you.
    Mr. Bilirakis. Thank you.
    A question for Mr. Lindberg, for many diseases, including 
blood cancers and sickle cell anemia, cellular therapy offers 
the best hope for a cure. The question is for Mr. Lindberg. Has 
the calculated need for unrelated cellular transplants, in 
other words, non-family members increased? If so, what 
demographic has seen the largest increase in need? If you can 
share that with the committee, I would really appreciate it.
    Mr. Lindberg. Thanks, Mr. Bilirakis. I will do that with 
pace here. Yes. We know as the number of diseases that are 
treatable by bone marrow transplant, purple blood stem cell 
transplant, and other cell therapies increases, the need 
thereby increases as well.
    And we know that our largest obstacles are making sure that 
as we become more and more diverse as a country, that we are 
able to serve more and more diverse patients through more and 
more members of our registry of varying ethnic descents that 
are willing to step up and make those donations.
    Mr. Bilirakis. Thank you very much.
    I think my time is expired, Madam Chair. Is that correct? I 
believe so.
    Ms. Eshoo. Your time is expired----
    Mr. Bilirakis. Thank you very much. Appreciate it.
    Ms. Eshoo [continue]. And the gentleman yields back. Glad 
you got the----
    Mr. Bilirakis. Yes, we got it straightened out.
    Ms. Eshoo [continue]. Got it all straightened out there.
    Mr. Bilirakis. Thank you.
    Ms. Eshoo. OK. It is a pleasure to recognize the very 
patient gentlewoman from New Hampshire, Congresswoman Kuster, 
for your 5 minutes of questions.
    Ms. Kuster. Wonderful to be with you. Thank you, Madam 
Chair.
    Ms. Eshoo. Sure.
    Ms. Kuster. I want--can you hear me? We are good?
    Ms. Eshoo. Yes.
    Ms. Kuster. It is a very important discussion, and thank 
you for hosting this hearing today. While this committee has 
been keenly focused on the coronavirus pandemic, there are many 
public health programs that we need to continue to support, and 
one of those is school-based health centers. So I am a proud 
cosponsor of H.R. 2075, introduced by my colleague, Congressman 
Sarbanes.
    These health centers are critical in providing 
comprehensive care, including care to identify at-risk students 
before they develop substance dependence and addiction.
    In New Hampshire and communities across the country, we are 
battling two crises: the opioid epidemic and the COVID-19 
epidemic. In fact, preliminary data shows that COVID is 
worsening preexisting issues with substance misuse, and the 
current pandemic and resulting economic downturn are 
exacerbating behavioral health risk factors, such as social 
isolation and stress.
    Prior to COVID-19, I heard from teachers regarding the 
generational effects of the opioid epidemic and how children 
cope with adverse childhood events, or ACEs, outside of their 
home.
    As the COVID-19 pandemic continues, how can school-based 
health centers ensure that we continue to address adverse 
childhood events closer to the occurrence of the event, which 
increases the ability to treat an acute condition before it 
becomes chronic?
    And I am asking Mr. Boyd, if you could speak to the role of 
school-based health centers in nurturing age-appropriate 
resilience that is helpful to mitigate self-medication, and to 
further substance-use disorders in early adulthood?
    Mr. Boyd. Yes, this is another great question. We work very 
closely with youth as well. We have a youth advisory committee 
that, you know, feeds into our programmatic work, and actually 
a part of one of our Federal grants is to work with the youth.
    The dilemma right now, as you know, is that the pandemic 
has exponentially grown, potentially, the abuse and use of 
alcohol and drugs. We have seen it in liquor store sales. We 
don't have, you know, good numbers on any increases in sales of 
opioids, in particular.
    Our need right now is to get the school-based health 
centers that we have reopened, and to expand that reach. Part 
of expanding that reach is also expanding the services that are 
offered, and substance-abuse services are critical in school-
based environments. One of our----
    Ms. Kuster. Thank you. My time is limited. I am sorry to 
have to cut you off.
    Mr. Boyd. No problem.
    Ms. Kuster. I really find this very important, and I want 
to support you and your work and your colleagues all across the 
country, including here.
    Another program I want to focus on is the USADA, United 
States Anti-Doping Agency, recognized by Congress as the 
national anti-doping organization for our Olympic community, 
and I am the niece and cousin of Olympic alpine ski racers.
    And I wanted to ask you, Mr. Tygart, in your testimony, you 
discuss a culture change in terms of the way the United States 
was perceived on the international sports stage. Can you talk 
about this shift, and why it is so important for youth when 
they look up to Olympic athletes, to know that they are drug-
free?
    Mr. Tygart. Yes, ma'am, and thank you for the question. 
Well, it is absolutely critical to have true heroes today, and 
we may be more desperate today in the world of sport than we 
ever have been, to have people that our young kids can look up 
to and try to emulate and attempt to become.
    And so when Congress set up an independent organization to 
ensure that the fox was no longer guarding the henhouse, what 
it did was gave confidence to athletes that this independent 
organization is not there just to promote them, but is there to 
ensure that they follow the rules.
    And we know whether a young person becomes an Olympic 
athlete and becomes one of those heroes, or goes into any 
other, you know, industry or career in their life outside of 
sport, the lessons they learn on the playing field are 
important life lessons that they will take with them.
    And respecting the rule of law, respecting, yes, we want to 
win, but we want to win the right way, is absolutely essential. 
And our athletes today, you know, 20 years ago, since we were 
established, have embodied that notion and are truly the heroes 
that we want them to be. Not to say that some won't attempt to 
cut the rules, but we are here to have a fair program that 
ensures that their decision to do it right is enforced.
    Ms. Kuster. Well, my time is up, but I can certainly say as 
a parent, I appreciate the role that you play, and thank you 
again.
    Thank you, Madam Chair, and I yield back.
    Ms. Eshoo. The gentlewoman yields back. It is a pleasure to 
recognize the only pharmacist in the Congress, my colleague, 
Mr. Carter, from Georgia, for 5 minutes of questions.
    Mr. Carter. Thank you, Madam Chair, and thank everyone for 
being on this call. This is certainly important.
    I want to start with you, Ms. Goodman. There are those who 
have been somewhat critical, if you will, of the Rare Pediatric 
Disease Priority Review Voucher, and have said that it hasn't 
been successful in achieving what it was intended to. You cited 
some figures, I believe, when Congressman Mullin was asking you 
some questions. Could you repeat those and the number of drugs 
that have come out as a result of the PRV, and how you would 
respond to those claims, those critics who say that it hasn't 
operated like it should have?
    Ms. Goodman. Sure. You know, there have been 22 new drugs 
approved by the FDA--that is a very high bar, approval--since 
the program was enacted in 2012. I think that is pretty good 
proof that the program has been successful.
    Mr. Carter. How was it before the program? Can you compare 
it before and after?
    Ms. Goodman. Sure. Well, in the case of pediatric cancer, 
which is not all rare diseases of course, there had only been 
two drugs approved expressly for kids with cancer in the 25 
years leading up to the Creating Hope Act enactment. Just 
couldn't get funding.
    Mr. Carter. OK. Good. Obviously, the program has helped. 
Obviously, we have seen results.
    Ms. Goodman. The program has helped with small biotechs, 
with academics who want to get their ideas out into industry. 
It has just really been a very successful program.
    Mr. Carter. Well, staying on that, on the program itself 
and the vouchers that get the priority review by the FDA, and 
allowing them to be completed in six months, do you have any 
evidence that any of the drugs approved with a voucher under 
this program have had to be pulled from the market because it 
was unsafe? Have you seen any instances of that at all?
    Ms. Goodman. So that is a terrific question, Congressman 
Carter. I am going to have to get back to you on specifics, but 
I will say that, you know, because of the voucher program, 
because of the user fees charged for this program and for 
PDUFA, FDA has been able to almost double the number of 
employees working at the FDA on reviewing drug approvals from 
2008 until now. So we really have so many more people, so much 
more FDA technology, and better management practices reviewing 
these drugs. I really trust the FDA not to be--do a quick and 
dirty job. I really trust them to only approve drugs that are 
safe.
    Mr. Carter. Well, you know, I am one who believes. And 
listen, as was mentioned earlier, as a practicing pharmacist 
for over 30 years, I have seen this, and I have dispensed some 
of these medications, and I can tell you that they are needed, 
and we need to improve the process by which they are approved. 
And certainly, you know, we still need to be careful, there is 
no question about that, but I am still one who believes that, 
you know, no matter how long the process is, you still run that 
risk. There will be some that--and I have seen it over my years 
of practice--of drugs that have gone through a thorough review, 
that regardless of how good a review it was, we had to pull 
them from the market at some point. And that is going to 
happen, but to keep them from getting on the market, I think, 
is far worse than what we have experienced.
    Dr. Kesselheim, are you still with us? Yes.
    Mr. Kesselheim. I am. And happy to answer questions.
    Mr. Carter. Yes. Have you seen any instances where any 
drugs have had to be pulled back as a result of this 
accelerated approval program?
    Mr. Kesselheim. Yes. There was a study that was published 
in The New England Journal of Medicine about a decade ago that 
said that drugs that are approved within a short period of 
time, just before the FDA approval deadline, were more likely 
to be pulled from the market, were more likely to have boxed 
warnings added to it or other safety-related information added 
to it.
    And I think that study shows that if you impose arbitrarily 
fast deadlines on reviews, that that can increase the risk of 
those kinds of things happening. Again, I agree it doesn't 
happen very often, but we want to try to minimize it happening 
as much as possible.
    The FDA doesn't approve drugs--when the FDA approves a 
drug, it doesn't mean the drug is safe. It just means that the 
drugs benefits outweigh its risks, and we have a lot more to 
learn about those risks once the drug hits the market.
    Mr. Carter. Now, I am not going to dispute what you just 
said, but, again, as a practicing pharmacist for over 30 years, 
I can tell you, I have witnessed where no matter how long the 
review is, you are still going to have those instances, and I 
do think that the risk does outweigh--or the benefits do 
outweigh the risks in this particular case. That is why I do 
hope that the program is permanently renewed, and that we can 
move on from there.
    And Madam Chair, I see I am out of time, and I will yield 
back. Thank you both. Thank you all.
    Ms. Eshoo. The gentleman yields back. Thank you for your 
good questions. A pleasure to recognize the gentlewoman from 
Delaware, Ms. Blunt Rochester, and thank you for your patience.
    Ms. Blunt Rochester. Thank you. Thank you, Chairwoman, and 
thank you so much to all of our witnesses today.
    As a cosponsor of H.R. 2075, the School-Based Health 
Centers Reauthorization Act, H.R. 4078, the EARLY Act 
Reauthorization, and H.R. 4439, the Creating Hope 
Reauthorization Act, I am glad that the subcommittee is taking 
the opportunity to discuss legislation that would reauthorize a 
number of critically important public health programs.
    Delaware leads the Nation in rates of triple-negative 
breast cancer, an aggressive form of cancer that 
disproportionately affects young African American women. In 
fact, a 2019 study found that more than 21 percent of Black 
women were diagnosed with triple-negative cancer, compared to 
11 percent for all other types of breast cancer, and women 
under the age of 40 had twice the odds of a triple-negative 
breast cancer diagnosis than women aged 50 to 64 years.
    Ms. Blount, what are the unique challenges that young, 
Black women face in finding out about this type of cancer and 
what their risks might be?
    Ms. Blount. Thank you, Congresswoman. You actually 
highlight a very serious concern that we have in breast cancer 
as we think about what we can do to reduce our risk. The number 
one talent is information, is understanding their own risk, 
understanding their family history, understanding the need to 
go in for a screening mammography, and being in a system where 
their providers are likely to ask certain questions, and then 
make those recommendations. So this is really critical.
    The other really important point is, we don't quite 
understand why Black women have twice the rates in some 
States--as you mentioned in Delaware and others--nationally 
about 30 percent more triple-negative breast cancer. We need to 
do a large study to understand that, and I understand a large 
randomized control trial will take years. We need to do that, 
but in the meantime, what we need to make sure is that Black 
women get screened early. Because we know even if it is triple-
negative breast cancer, if we catch it in its earliest stages, 
Black women can have wonderful outcomes and die of old age, and 
not from breast cancer. So the important thing is to make sure 
that they know to get in and get screened early.
    Ms. Blunt Rochester. Thank you so much. And in your 
testimony, you also talked about access to the latest digital 
breast screening technologies. How does the EARLY Act improve 
access to better diagnostic care, and what more can Congress do 
to reduce disparities in access, in addition to the incredible 
work that you are doing?
    Ms. Blount. Well, the EARLY Act makes sure that women 
understand their risk, understand the need for screening 
mammography gets to providers so providers understand that, but 
the important thing is, Black women tend to have dense breast 
tissue, and so, if they have a lesion, 2D or standard film 
mammography is less likely to pick it up as compared with 3D or 
tomosynthesis.
    So as a part of that education program for providers and 
for women, to help them understand that if they have a choice, 
try to find a facility that will provide 3D mammography is 
going to be much better for them, more likely to pick up their 
cancer, more likely to pick it up early when it can be treated.
    Ms. Blunt Rochester. Thank you. Thank you so much for your 
work.
    Ms. Blount. Thank you.
    Ms. Blunt Rochester. I want to get to my questions to Dr. 
Boyd. I had the opportunity to serve over almost 30 years ago 
as a policy adviser to our current Senator, Tom Carper, who, at 
the time, was our governor, and he had a vision for making sure 
that every school in our State had a wellness center. We 
started off with all of the high schools, and now today, I can 
report that every public non-charter high school operates a 
wellness center in the State, and is looking to expand to 
elementary and middle schools.
    Dr. Boyd, how do early intervention services provided by 
elementary school wellness centers help improve health outcomes 
throughout a child's life and save healthcare dollars?
    Mr. Boyd. Great question, and Delaware has an extraordinary 
program. I am a former Delaware resident, so I am very 
appreciative of it.
    First, it gets the students used to understanding it is 
just health. Tearing down the barriers so that they are 
comfortable and confident in interacting with healthcare 
professionals, and learning to look after their health and 
speak up when there are issues addressing those.
    But two, that CDC guide I pointed to, we know that it has 
significant impact on the academic performance of the students. 
Time on task. It keeps them in front of the classroom longer 
than not having to leave school, and it solves the problem for 
the parent, often women, often low-income, that have to leave 
an hourly job to go take that child to a doctor. Nine times out 
of ten it doesn't happen.
    Ms. Blunt Rochester. Thank you so much. Thank you so much, 
Dr. Boyd. And also the mental health aspect of it is so 
important, especially now more than ever. Thank you.
    I yield back, Madam Chairwoman.
    Ms. Eshoo. The gentlewoman yields back. It is a pleasure to 
recognize the gentleman from Illinois, Mr. Rush, for his 5 
minutes of questions. You need to unmute.
    Mr. Rush. And thank you for that gentle reminder to unmute. 
Ms. Goler Blount, I want to thank you for the work that your 
organization does for Black women and girls all around this 
Nation. As a cancer survivor myself, it is heartening to hear 
the progress that is being made to prevent unnecessary deaths 
among Black women from cancer.
    As I listen to your testimony, the parallels to heart 
disease were overwhelming. As I am sure you know, more than 60 
percent of Black women are not aware that heart disease is 
their number one health threat.
    I recently wrote to the National Institutes of Health, 
asking that they create a Black women's healthy heart program, 
which would focus directly on increasing awareness among Black 
women about the risk of and the prevention to the variables for 
heart disease.
    What best practices, Ms. Goler Blount, from your work on 
raising breast cancer awareness could be applied to heart 
disease awareness, specifically for Black women?
    Ms. Blount. Well, thank you, Congressman Rush. You raise a 
very important point. Heart disease is the number one killer, 
and a lot of us don't know that. And heart disease is an issue 
of both lifestyle and circumstances. So the things that we 
know--for example, my organization, the Black Women's Health 
Imperative, has a program called Change Your Lifestyle, Change 
Your Life, which was originally conceived as diabetes 
prevention, but the risk factors for diabetes and heart disease 
and hypertension are the same. And so, we start with managing 
stress and how you eat, why you eat, what emotionally you bring 
to eating, and active living, moving around.
    We know if women can manage their stress--particularly 
Black women--manage their stress, and have access to fresh 
fruits and vegetables, and can get physical activity, this can 
significantly reduce their rates for all chronic diseases, and 
we also know that about 70 percent of chronic disease mortality 
is completely avoidable.
    So what we need are programs like this program implemented 
across the country--and we are in 12 States right now--and to 
partner with the CDC on its chronic disease awareness program, 
and to make sure women understand what they can do, and that, 
in fact, they can do things.
    And to your point, if women can manage their stress and 
their diet and their physical activity, that also lowers their 
risk for breast cancer.
    Mr. Rush. Right. Mr. Boyd, and also Ms. Goler Blount, this 
pandemic, the coronavirus, in my opinion, gives us an 
extraordinary opportunity to completely reimagine, and 
revitalize, and re-create a permanent health system. Do you 
agree, and what are some of the things that this Congress 
should be doing in order to really just create a whole new 
perspective, reimagining what a public health system could mean 
to all Americans, particularly the least of these?
    Ms. Blount. Yes. I agree with you. Our public health 
response was not, in any way, sufficient. What we need to do is 
listen to scientists. What we could have done to prevent where 
we are now with COVID-19 is to reflect back 40 years with HIV. 
We needed to do testing. We needed to do contact tracing and 
follow-up.
    We can still do that now, but what we have got to do is 
make sure that people have access to resources, that we are 
reaching out to people with the kinds of information and 
resources they need----
    Mr. Rush. Thank you.
    Ms. Blount [continue]. And make sure our providers and 
researchers are involved in the conversation.
    Mr. Rush. Thank you.
    Mr. Boyd, can you chime in with the few seconds that I have 
remaining?
    Mr. Boyd. Yes, Congressman. Access, access, access. People 
of low income don't have access to adequate care. It is that 
simple.
    Mr. Rush. Thank you very much.
    Madam Chair, I yield back the balance of my time.
    Ms. Eshoo. The gentleman yields back and thank him for his 
excellent questions.
    It is a pleasure to recognize the gentlewoman from 
California, very patient, Ms. Barragan, for your 5 minutes of 
questions.
    Ms. Barragan. Thank you, Madam Chairwoman, and thank you to 
all our panelists today. I appreciate the conversation and want 
to go back to continue to highlight the issue of breast cancer 
disparities that we continue to see.
    As with many other health conditions plaguing our 
communities, there are significant and unacceptable health 
disparities when it comes to breast cancer. My own sister got 
breast cancer at an early age, so it continues to be a concern, 
and in our communities, it is something that I don't hear of 
talked about a lot.
    Ms. Blount, as you have mentioned in your testimony, you 
know, African American women are almost 40 percent more likely 
to die from breast cancer compared to non-Hispanic, White 
women. In part, I think that is because they are screened less 
frequently, they are more likely to have advanced disease when 
a diagnosis is made, and have less access to medical care.
    You just mentioned something that I don't think a lot of 
people hear about, the 3D mammography availability. Is that 
something that a community clinic would have available if, 
let's say, I told my constituents to ask about it, or is that 
something they would have to have more advanced access to a 
different level of healthcare?
    Ms. Blount. Yes. Thank you for that question, 
Congresswoman. Right now, most 3D mammography is available in 
upper-income areas, I will just be honest with you, in suburban 
areas. And we need to make sure that all women have access to 
3D mammography. That is critically--particularly Black women, 
Latinas, particularly women who are going to have dense breast 
tissue. We have to make it more available. As Mr. Boyd said, 
access is critical.
    I do want to highlight one point, that screening rates, 
actually between Black and White women, are about the same, 
both annually and biannually. The problem is, Black women tend 
to get their cancers detected much later. So while about 60 
percent of us are screening every year, our cancers don't get 
diagnosed until much later, because we tend to wait later. So 
if we had access and we were screening at the same rates, our 
outcomes would be much better.
    Ms. Barragan. Well, thanks for pointing that out because I 
think what you just said about what is available in the upper-
income areas versus the lower-income areas goes to the 
disparities that we face, and really the different access to 
care that people have in this country.
    Can you elaborate on how the EARLY Act may help reduce the 
intolerable disparities that we are seeing in this area?
    Ms. Blount. I can. We have seen over the last ten years, 
particularly among younger women, a slight uptick in screening 
rates. I mean, we have gone from about--annual--from about 58 
percent to 62 percent, so I am going to declare success. But 
what the Act will do is make sure women understand the 
importance of screening mammography, and most importantly, that 
they don't need to be afraid of it.
    You know, women aren't being recommended, but also women 
are afraid to be screened. They are afraid, what happens if I 
have a breast cancer, and the fact is, you know, screening 
doesn't impact whether or not you are going to develop breast 
cancer, but it can impact how well you will do if a breast 
cancer is detected.
    So the EARLY Act is critical to help women understand that 
they need to get in early, starting at age 40, screen every 
year, and that if it so happens a breast cancer gets detected, 
you have had this experience, it can be treated in its earlier 
stages when outcomes are excellent.
    Ms. Barragan. Great. Thank you so much.
    Ms. Blount. Thank you.
    Ms. Barragan. The National Cancer Institute has also found 
that social economic status factors, like access to education, 
access to health insurance, living conditions, including 
exposure to environmental toxins, are associated with an 
individual's, or a group's risk of developing and surviving 
cancer.
    I have been advocating for investments in these social 
determinants of health, including introducing a bill called the 
Improving Social Determinants of Health Act which would give 
the CDC resources to invest in communities to tackle these 
issues. This would help lower health--would actually help 
improve health outcomes, especially for those who are low 
income and living in underserved communities.
    Can you discuss how investing in social determinants of 
health can help reduce the rate of breast cancer in underserved 
communities and also lead to better outcomes?
    Ms. Blount. Yes, I can. Thank you. And that is an important 
point. Social determinants covers a variety of things from 
community, to neighborhoods, to food, to transportation, 
housing. One of the things we can do is by focusing on social 
determinants is actually lower our risk. And another issue is 
to understand how environmental factors impact our--whether or 
not we are going to develop disease, and, critically, and I 
have to come back to this, access. Social determinants of 
health are the leading impediment to access to healthcare of 
any kind.
    Ms. Barragan Great. Thank you.
    Madam Chairwoman, I yield back.
    Ms. Blount. Thank you.
    Ms. Eshoo. The gentlewoman yields back.
    It is a pleasure to recognize the gentleman from Ohio, Mr. 
Johnson, who has, I believe, waived on to our subcommittee 
today, and one of the authors of the bills that we are taking 
up.
    Mr. Johnson. Well, thank you, Madam Chairwoman and Mr. 
Ranking Member for the opportunity to waive on to the Health 
Subcommittee today in support of H.R. 5373, the United States 
Anti-Doping Agency Reauthorization Act.
    Mr. Tygart, it is good to see you again as well. Thanks for 
your decades of tireless work to make USADA the gold standard 
across the world for its anti-doping efforts. You know, this 
bipartisan legislation, which I am proud to sponsor, along with 
my colleague, Congresswoman DeGette, will reauthorize funding 
for USADA, improve education to youth sports, and for both 
programs and coaches, and includes provisions to direct Federal 
law enforcement to coordinate with USADA to combat the 
trafficking and illicit use of performance enhancing drugs.
    With the summer Olympics in Tokyo next year, and the return 
of the Olympics to the United States in 2028 in Los Angeles, it 
is critical that USADA has the resources it needs to continue 
its work.
    So, Mr. Tygart, as we heard in your testimony, it is 
essential that America takes the global lead in anti-doping in 
clean sports. In the past, this has not always been the case. 
Can you explain the benefit to the standing of the United 
States abroad when we can demonstrate that our athletes compete 
and win the right way?
    Mr. Tygart. Thank you, Congresswoman Johnson. I really 
appreciate the question. You are absolutely right for the rule 
of law. We are a democracy that functions when all of us who 
agree to a set of rules that are designed to provide certain 
benefits for those that follow the rules and ensure that 
equality can be provided in the athletic context for our 
athletes who are competing. And so, when the United States 
sends athletes around the world and they demonstrate that, I 
think there is no better example of the values that this 
country stands for that our athletes abide by the rule of 
sport. They compete healthy. They compete clean. And you can 
actually look at them as the role models that they are, and 
that they represent this great country and the values that we 
espouse around the world like no other instrument we almost 
have. And that is kind----
    Mr. Johnson. It is kind of like they are ambassadors, 
right?
    Mr. Tygart. It is absolutely right. And not just to win, 
but importantly win the right way. And that is the difference 
between our athletes today and what the world saw back in the 
late 1990s, when the speculation--and there was some evidence 
to suggest it when our system was so poor that our athletes 
weren't winning the right way. Today, they know they are being 
held to the highest standards, and that they can upgrade 
confidence when they go and win medals at the games and 
represent this country that they are doing it to the right way.
    Mr. Johnson. Sure. Well, what does it mean for global 
sports more broadly to have an organization that does things 
the right way, like USADA does, and doesn't operate under 
malign influences like we have seen with countries like Russia 
and others?
    Mr. Tygart. It is critically important. That independent 
model has become a beacon to many around the world, and I think 
is demonstrated, as my written testimony that I submitted 
indicates, has shown. I mean, two whistleblowers inside of 
Russia, all benefits of the independent model, and specifically 
USADA's work, and it motivated them and said there are people 
outside of Russia, despite what they were being told, that do 
stand for these values. That the rules matter. That integrity 
in sport matters. And it motivated them and inspired them to 
come forward and ultimately expose a state that was abusing its 
own athletes, as we saw in the state-sponsored scandal that has 
been exposed now dealing with Russia.
    So, it is a beacon to many around the world that winning 
the right way is the only way to play.
    Mr. Johnson. OK. Well, I mentioned youth sports. You know, 
I have got a teenage son, Nathan, who is a competitive high 
school swimmer, and he has his dreams set on swimming in 
college and maybe even beyond. He is really very good. I am a 
little biased, I am his dad, but I think he is really, really 
good. His time sure reflects that. But he looks up to our 
incredible Olympians, and is looking forward to watching them 
compete in Tokyo next year.
    Can you explain how USADA's work is essential for the next 
generation of top athletes, why taking early action on 
educating them on the importance of competing fairly and 
ensuring clean drug-free sports in the future, why that is so 
important?
    Mr. Tygart. Well, it is critically important, and you 
should have confidence that your--he does have a number of role 
models that he can watch and be proud of and attempt to 
emulate.
    And can you imagine a young athlete, you know, first grade, 
second grade as they are growing up one day dreaming of making 
it to the elite level, only then to realize they have to inject 
themselves with dangerous performance enhancing drugs? You 
know, nobody goes into sport for that reason. And that is why 
to protect the value of sport, whether he ultimately becomes an 
Olympic level swimmer, or just goes into another profession, 
doing it the right way is the only way. And our program is to 
educate, but also provide true role models for him--are 
critically important to his future success.
    Ms. Eshoo. The gentleman's time has expired.
    Mr. Johnson. Thank you, Madam Chairman, I yield.
    Ms. Eshoo. Thank you. And we share your pride in your son, 
Mr. Johnson.
    Mr. Johnson. Thank you.
    Ms. Eshoo. It is a pleasure to recognize the gentleman from 
Arizona, Mr. O'Halleran, for his 5 minutes of questions. And I 
believe he is the last member, unless someone walks out and I 
see them on the screen.
    So, Mr. O'Halleran, you are recognized.
    Mr. O'Halleran. Thank you, Madam Chair, and thank you also 
ranking member, for allowing me to waive on. This issue speaks 
to a really important issue in rural America, not only in 
Arizona, but throughout America. And as school-based health 
centers provide a wide variety of potential health services to 
students and their families, many of them lack health 
insurance, and, otherwise, would have no ability to see a 
national provider. School-based health centers can treat 
chronic conditions like asthma and provide services like 
immunization and physical examination. School-based health 
centers play a critical role in providing care to children and 
families throughout Arizona.
    In fact, according to the Arizona School-Based Health 
Alliance, 45 percent of school-based health centers are located 
in rural areas. Rural America already is suffering from the 
lack of access to high quality and affordable healthcare. 
Additionally, 82 percent of the children who use these services 
are uninsured. That is why School-Based Health Centers 
Reauthorization Act of 2019 is so critical. I fear that if 
Congress fails to act, many children will lose access to the 
important services provided by these sectors.
    The COVID-19 pandemic has exploded, as those of us in rural 
America already know. Many of us lack affordable access to 
high-quality healthcare, in particular, and concern about the 
mental healthcare of students and families whose lives have 
been upended and whose social structure has completely changed 
in light of COVID-19.
    Dr. Boyd, thank you for your testimony here today and all 
the work you and your members do. In your testimony, you talked 
quite a bit about the importance of reimbursing mental health 
of our students and remembering. What changes have you and your 
members already seen in the mental health of our students given 
the COVID-19 situation? Also, what are the long-term health and 
educational paths of these sorts of mental health issues? And 
whether the students are going to go back into schools or stay 
home and do it virtually, this is having a profound impact on 
students across our country.
    Dr. Boyd?
    Mr. Boyd. This is a great question, Congressman. We are in 
process of putting some polls in field, but it is very, very 
difficult. As I said earlier, there are estimates that could be 
as many as a third of Title 1 students people haven't heard 
from. And so, knowing exactly what is happening in those 
households, we don't know. We are hopeful that as schools come 
back online, you know, after--after this summer break, that 
they will be able to give us more information. Our fear is that 
enough--we may lose a number of school-based health centers 
because their sponsoring agency does not have the resources for 
them to reopen.
    The impact we believe, along with our colleagues and the 
school psychologists and counseling areas and the nurses are 
going to be devastating. And students are going to be typecast 
when they come back and they show behaviors that to a student 
going through trauma is actually normal for a person going 
through trauma, but because they are acting out, may then get 
typecast and put into the system. That is a problem that we are 
really, really concerned about. And I don't think anybody at 
this point has good solutions to it. But we just, frankly, 
don't know what is happening with a lot of kids at home. And 
that is where the telehealth opportunity is great, and support 
from the FCC would be great to provide those kinds of platforms 
and resources to get out there and find out and communicate 
with the kids.
    Mr. O'Halleran. And, also, do school-based health centers 
look to serve as COVID-19 testing centers?
    Mr. Boyd. They would be if they had access to the test, 
yes, sir.
    Mr. O'Halleran. Madam Chair, I yield.
    Ms. Eshoo. Mr. O'Halleran yields back.
    I don't see any other members, so I think that we have 
heard from subcommittee members from both sides of the aisle, 
as well as our colleagues that waived on.
    I have documents to submit to the record, and I see my 
friend, Mr. Griffith, standing by. I have four pages. So I 
would like to ask for a unanimous consent request that all of 
the documents that are contained in this stack be entered into 
the record.
    Mr. Griffith. As long as it has been provided to our 
Committee staff as well, no objection.
    [The information appears at the conclusion of the hearing.]
    Ms. Eshoo. It all has. I haven't added anything to what was 
presented to the minority staff, and I thank the gentleman.
    Let me close on this note. First of all, our deepest thanks 
to each one of you. We have been together for 3 hours and 15 
minutes, not that you were counting the seconds or the minutes. 
But, boy, was it time well spent. These are such important 
programs, and you have taken a very deep dive into why they are 
so important, how they work, who has served, and really the 
original motivations for these programs. In the case of Ms. 
Goodman, it was the tragedy of losing her son.
    So I can't thank you enough for enlightening us. And these 
reauthorizations are very important. And for the--if anyone is 
listening in in the country to this virtual hearing, 
reauthorization means that we are going--we are reviewing the 
program, we may add, we may subtract, but we are renewing the 
contract on it, so to speak, so that the program can keep 
running.
    So from our children to the diseases that they--the rare 
diseases that they have, to saving lives through the--the 
donors and cord blood, to doping, and making sure that our 
sports are absolutely clean, to our friend from Harvard who has 
offered, I think, in a very clear way what his position is on 
some of the legislation--I hope I haven't missed anyone--but we 
appreciate you. We appreciate you and the testimony that you 
have given. Continue to work with us. We always need the expert 
advice. We are, bettered as a result of it.
    And with that, I will now adjourn the Health Subcommittee. 
And thank you all for your participation. The committee is 
adjourned.
    [Whereupon, at 1:16 p.m., the subcommittee was adjourned.]
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