Washington, D.C. – Speaking on the U.S. Senate floor today, Senator Marco Rubio (R-FL) pushed for the Race for Children Act, legislation that will provide children battling cancer with more innovative and promising treatment options. Rubio and Senator Michael Bennet (D-CO) introduced the legislation in February.The full speech can be watched here and a downloadable broadcast quality version is available for TV stations here. A full transcript of Rubio’s remarks is below.
U.S. Senator Marco Rubio
U.S. Senate Floor
August 2, 2017
RUBIO: I come to the floor today to voice my support for the FDA reauthorization Act and 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 was a law that I introduced by 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 efficacy of powerful cancer drugs, and how they work on children. And 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. Startling statistic - one in every 285 children is diagnosed with cancer before the age of 20. And while the good news is that researchers continue 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 under the current law, the way it is today - it 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 of that 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 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. So there are some conditions that are unique to adults. There are few of any pediatric populations that have that disease and so they would maybe decide it wasn’t pertinent to require it for that drug.
However, this law – this provision in the law - it 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 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’s a cancer drug.
And one of the reasons that provision because technology - medical technology at the time of the bill’s enactment 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 in the genetic markers of a specific cancer and test against it. And as a result, that’s why it didn’t have that requirement.
Even 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 a children. That’s where the technology has gone to. But the law has not been updated to keep up with it.
And the result is that there are a lot of adult advances being made and we don’t know if it works in children because they haven’t been forced to test it. And so The RACE for Children Act, which is the law that Senator Bennet and I offered and is included in the FDA reauthorization, it closes that loophole.
Now let me say that getting to this point here on the floor was not easy. And so I do need to take a moment to thank chairman, Senator Alexander of Tennessee. Obviously Senator Bennet. But also the pediatric cancer community – organizations like Live Like Bella Foundation in my hometown of Miami, Lambs for Life, the Alliance for Childhood Cancer, St. Jude’s, St. Baldrick’s, the Moffitt Cancer Center, Nemours Children’s Hospital, the Arnold Palmer Hospital, American Cancer Society, so many others –
Now 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 childhood cancer. Whether you are fighting cancer yourself, or it’s your child, your sister, your brother, your cousin or your friend, I want to make one thing clear - you are not alone in your struggle. I would venture to say I don’t know anyone who hasn’t been impacted by pediatric cancer.
I have it in my own family. And some have confronted it in theirs. And Loved ones and children that went to school with your kids. In fact, Live Like Bella foundation was founded on 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 on 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 and he’s now made it the mission of his life to honor her life by continuing this work. So we’ve all been impacted in some way.
As I said, unfortunately, across this country, this disease is a reality and 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 led us to make this a priority over the last year and a half.
The first is a story of a young boy named Jeremy. He is only five years old and he’s been in treatment for four of those five years. He had more than 150 surgeries so far. Five years old, 150 surgeries, and ultimately had to have his eyes removed because of cancer. It’s left him completely blind obviously.
Then there’s 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’s Princeton, who was diagnosed with cancer when he was five years old. He’s now seven and in those two years he has undergone six chemo cycles, a bone marrow transplant, nine surgeries, 12 rounds of radiation and six 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, and he came to my office asking the Senate to do more for kids like them. Seven year old Princeton, here’s what he told us. This is a quote. "I don't want my friends to die and I don't want me to die."
There’s the story of Derek, who 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 five months of age, baby Derek lost his battle against cancer.
These are real stories – the real heartbreaking stories. The stories of our neighbors, friends and family and what they have endured. With 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 with this law here today.
Recent advancements in cancer treatments 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 need to be determined in order to guide the doctors responsible for treating these children.
And these treatments, these advances, they are providing newfound hope for cancer patients. But, mostly only for adult cancer patients. Fortunately, we have a chance and an opportunity to change this, and that was and is the goal of the RACE for Children Act.
The House recently passed the RACE for Children Act as part of the FDA User Fees—the reauthorization bill that is before us here today. It is now our turn to do so, and to send this important and potentially life-saving legislation to the president for his signature. In a place where we’ve had some heated debates over the last seven years since I’ve been here, six and a half, and more to come. Sometimes it feels like perhaps our service here doesn’t make much of an impact. But from time to time we have these 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 a thousand children, a hundred thousand children, or five children who will benefit from a cancer treatment because of this new requirement, in which the adult drugs will have to be tested in children. We don’t know. Standing here today believing that we all walk on earth and our days are numbered through 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 their classmates will be impacted by pediatric cancer,
But we know that about one in three hundred children will be. And so the chances are that at some point we will once again have someone we care about deeply, impacted. And we hope that when that moment comes, if it does, that there will be options for their parents and their doctors.
And we hope that when that moment comes, if it does, that there will be options for their parents and their doctors. 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. And that’s why I hope and I urge my Senate colleagues here to join in me in supporting this initiative.
In fact, you know, sometimes we give these speeches with a sense of mystery, “if this passes,” “if it doesn’t pass”—there’s no reason why this isn’t going to pass, we all expect the FDA authorization bill to pass. And I imagine when people vote on this tomorrow they’ll read the title of the bill, “FDA fee reauthorization,” it just sounds like us taking care of the normal course of business. Important in its own right, by the way, but this is just some 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 and change and save the lives of children here in our country but ultimately in other parts of the world as well.
And that’s why I felt it was important to come to the Senate floor and obviously urge my colleagues to join me in supporting this initiative but also urge you to be proud of it.
We’re about to go home here, whether it’s tomorrow or next week and answer to our constituents for all the things we didn’t do, and there are some significant issues we have not confronted and solved for the country. But this is a significant issue. There isn’t going to be a lot of articles written about it, there isn’t going to be blaring headlines on the websites about it, mailers and campaign commercials. It 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’m 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, and it’s an important thing because these children that we’re trying to help, they do not have time to continue waiting for us to step up and take action.