[Congressional Record (Bound Edition), Volume 163 (2017), Part 9]
[Senate]
[Pages 12505-12506]
[From the U.S. Government Publishing Office, www.gpo.gov]




                         RACE FOR CHILDREN ACT

  Mr. RUBIO. Mr. President, I come to the floor today to voice my 
support for the FDA Reauthorization Act. Within this legislation is a 
very important measure that will support the development of innovative 
and promising cancer drugs--the RACE for Children Act, which is a law 
that I introduced with Senator Michael Bennet of the State of Colorado.
  RACE for Children is sorely needed, as it would close a loophole that 
exists in current Federal law and prompt companies--pharmaceutical 
companies--to examine the safety and the efficacy of powerful cancer 
drugs and how they work on children. This, in turn, will provide 
doctors with the necessary information to properly treat children 
battling cancer.
  Pediatric cancer is a leading cause of death by disease among 
children. A startling statistic: One in every 285 children is diagnosed 
with cancer before the age of 20. While the good news is that 
researchers are continuing to make significant advances to treat and 
cure cancer for adults, the progress to develop safe drugs for 
pediatric cancer sadly lags far behind.
  One of the problems is that current law, the way it is today, directs 
pharmaceutical companies to study the safety and the efficacy of adult 
drugs on children. So if you develop a drug on diabetes or heart 
disease or anything for adults, it also requires you to do some of that 
on children because you want to make sure that it works on both 
populations and you don't want to keep a drug out of the market for 
children that could work for them. Of course, this requirement is only 
in place if the FDA believes that there is a pertinent need--in 
essence, a condition that children suffer from. There are some 
conditions that are unique to adults; there are few, if any, pediatric 
populations who have that disease, so maybe they would decide it wasn't 
pertinent to require it.
  However, this provision in the law specifically exempts cancer drugs. 
In essence, it says to a pharmaceutical company: If you are going to 
study the safety and the efficacy of a drug on adults, if there is a 
pertinent need, if there is a real population out there that suffers 
from the same condition in children, you have to test it on children, 
as well, except if it is a cancer drug. One of the reasons that 
exemption is in there is because technology--medical technology at the 
time that law was put in place--didn't allow researchers to target the 
genetic structure of cancer. In essence, at the time, it didn't allow 
them to say: We can go in and find the genetic markers of a specific 
cancer and test against it. That is why it didn't have that 
requirement.
  Now, however, we do have that capability. Today, the technology 
exists to pinpoint the similarities in adult and childhood cancer 
genomes. So the technology has now reached a point where you can treat 
the specific genome of a cancer whether it is in an adult or in a 
child. That is how far the technology has advanced, but the law has not 
been updated to keep up with it. The result is that there are a lot of 
adult advances being made, and we don't know if they work on children 
because they haven't been forced to test it.
  So the RACE for Children's Act, which is a law that Senator Bennet 
and I offered and is included in the FDA reauthorization, closes that 
loophole.
  Let me say that getting to this point here on the floor was not easy. 
So I do need to take a moment to thank the chairman, Senator Alexander 
of Tennessee, and obviously Senator Bennet, but also the pediatric 
cancer community, including organizations like the Live Like Bella 
Foundation in my hometown of Miami, Lambs for Life, the Alliance for 
Childhood Cancer, St. Jude's, St. Baldrick's, Nemours Children's 
Hospital, Arnold Palmer Hospital, the American Cancer Society, and so 
many others that came together to the table to address this important 
issue in a way that would not limit future innovations for cancer 
treatment. It has taken over a year and a half to reach this point, and 
I am grateful to all of them for their participation because I would 
not be standing here giving this speech without it.
  Suffice it to say that, tragically, many of my colleagues in 
Congress, here in the Senate but also across the country, have been 
affected by cancer.

[[Page 12506]]

Whether you are fighting cancer yourself or it is your child, your 
sister, your brother, your cousin, your friend, I want to make one 
thing clear: You are not alone in your struggle.
  I would venture to say that I do not know anyone who has not been 
impacted by pediatric cancer. I have it in my own family, and some have 
confronted it in theirs, in loved ones and children who went to school 
with your kids. In fact, Live Like Bella Foundation was founded for a 
young girl by the name of Bella from Miami. She was a classmate of my 
nephew in grade school, and she lost her battle with cancer. Her father 
has been a tireless advocate for this cause. He moved Heaven and Earth 
to try to reach a point where they could find a cure for her. That did 
not come in time. He has now made it the mission of his life to honor 
her life by continuing this work. So we have all been impacted in some 
way.
  As I said, unfortunately, across this country this disease is a 
reality. I want to share some stories of a few of the children who have 
been impacted by cancer and who have impacted our office and helped us 
to make this a priority over the last year and a half.
  The first is the story of a young boy named Jeremy. He is only 5 
years old and has been in treatment for 4 of those 5 years. He has had 
more than 150 surgeries so far, and ultimately had to have his eyes 
removed because of cancer, which left him completely blind, obviously.
  Then there is Tatum, who was diagnosed with a rapidly developing 
brain tumor just before she was supposed to start kindergarten. Her 
parents were told by the doctors that they should take her home and 
they should enjoy the little time they had with Tatum because they had 
no options to treat her.
  There is Princeton, who was diagnosed with cancer when he was 5 years 
old. He is now 7. In those 2 years he has undergone 6 chemo cycles, a 
bone marrow transplant, 9 surgeries, 12 rounds of radiation, and 6 
cycles of immunotherapy. Because of this intense and time-consuming 
treatment schedule, Princeton built friendships with others who were 
also in the hospital for treatment. Sadly, he has lost many of these 
friends.
  Princeton's best friend was Trevor. Trevor passed away right before 
Princeton's birthday party. Princeton came to my office asking the 
Senate to do more for kids like them. Here is what 7-year-old Princeton 
said: ``I don't want my friends to die, and I don't want me to die.''
  There is the story of Derek. He was a healthy, happy baby until he 
developed an aggressive form of cancer and it produced tumors all over 
his body. His body was literally taken over by tumors. At only 5 months 
of age, baby Derek lost his battle against cancer.
  These are real stories. They are real, heartbreaking stories--stories 
of our neighbors, friends, and family and what they have endured.
  But with the developments in medicine today, there is no reason these 
children shouldn't have a second chance. Yet the treatment options for 
children with cancer is much more limited than it is for adults, and 
some of the reasons why are the issues we are trying to address about 
this law here today.
  Recent advancements in cancer treatment enable oncology drugs to 
specifically target the genetic structure of the cancer, and that makes 
it possible to transition certain adult cancer drugs for pediatric use. 
However, the basic information you need to do that--about dosing and 
safety--needs to be determined to guide the doctors responsible for 
treating these children. These treatments, these advances are providing 
new-found hope for cancer patients, but mostly only for adult cancer 
patients.
  Fortunately, we have a chance and an opportunity to change this, and 
that is the goal of the RACE for Children Act.
  The House recently passed the RACE for Children Act as part of the 
FDA user fee reauthorization bill that is before us here today. It is 
now our turn to do so and to send this important and potentially 
lifesaving legislation to the President for his signature.
  In a place where we have had some heated debates over the last 7 
years, since I have been here--6\1/2\, and more to come--sometimes it 
feels as though, perhaps, our service here doesn't make much of an 
impact. But from time to time, we have unique opportunities to vote on 
laws and legislation that slightly alter the arc of history and 
potentially help people. Standing here today, I can't tell you if there 
will be 1,000 children, 100,000 children, or 5 children who will 
benefit from a cancer treatment because of this new requirement in 
which these adult drugs will have to be tested on children. We don't 
know.
  Standing here today, believing that we all walk on Earth and our days 
are numbered to the glory and grace of God, frankly, we don't know if 
one of our own children, God forbid or someone we deeply love or one of 
our children's classmates will be impacted by pediatric cancer. But we 
know that 1 in about 300 children will be. So the chances are that at 
some point, we will once again have someone we care deeply about 
impacted. We hope that when that moment comes, if it does, that there 
will be options for their parents and their doctors and that they will 
have the opportunity to use for them treatments that perhaps would not 
have been available, had this requirement not been in the law. That is 
why I hope and I urge my Senate colleagues to join me in supporting 
this initiative.
  In fact, sometimes we give these speeches with a sense of mystery: If 
this passes; if it doesn't pass; there is no reason this isn't going to 
pass. We all expect the FDA reauthorization bill to pass. I imagine 
when people vote on this tomorrow, they will read the title of the 
bill, ``FDA Fee Reauthorization.'' It sounds like taking care of the 
normal course of business--it is important in its own right, by the 
way--that this is just this bureaucratic exercise to reauthorize an 
expiring law. Embedded in that law is a very important law, one that I 
hope will lead to real life-changing innovation in a way that will 
impact lives, change and save the lives of children here in our country 
but ultimately in other parts of the world as well.
  That is why I felt it was important to come to the Senate floor and, 
obviously, urge my colleagues to support this initiative but also to 
urge my colleagues to be proud of it.
  We are about to go home, whether it is tomorrow or next week, and 
answer to our constituents for all the things we didn't do. There are 
some significant issues we have not confronted and solved for the 
country, but this is a significant issue. There aren't going to be a 
lot of articles written about it; there aren't going to be blaring 
headlines on the websites about it, mailers and campaign commercials. 
That doesn't mean it isn't important. We live in a society where 
oftentimes good news doesn't draw ratings, and good news doesn't drive 
eyeballs and clicks to a website. It doesn't make it unimportant. It 
doesn't make it insignificant.
  This is significant. This is an opportunity. This is evidence that 
more often than perhaps people realize, fellow Americans of different 
points of view, representing diverse States and communities, who 
approach the political process with very different ideologies and aims, 
come together to make a difference. I am pleased that while there are 
many things we have not done, we will leave here tomorrow or next week 
knowing that at least we did one thing that will matter. It is an 
important thing because these children whom we are trying to help do 
not have the time to continue waiting for us to step up and take 
action.
  I thank the Chair.
  With that, I yield the floor.
  I suggest the absence of a quorum.
  The PRESIDING OFFICER (Mr. Tillis). The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. McCONNELL. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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