[Congressional Record Volume 163, Number 177 (Wednesday, November 1, 2017)]
[House]
[Pages H8381-H8383]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                 ADVOCATING FOR PATIENTS' RIGHT TO TRY

  The SPEAKER pro tempore. Under the Speaker's announced policy of 
January 3, 2017, the Chair recognizes the gentleman from Arizona (Mr. 
Biggs) for 30 minutes.


                             General Leave

  Mr. BIGGS. Mr. Speaker, I ask unanimous consent that all Members have 
5 legislative days in which to revise and extend their remarks and 
include extraneous material on the topic of this Special Order.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Arizona?
  There was no objection.
  Mr. BIGGS. Mr. Speaker, I am here this evening, along with my friend 
and colleague, Representative Brian Fitzpatrick, as we advocate for the 
passage of the Right to Try Act. This bill, which we introduced 
together, has dozens of bipartisan cosponsors, including Members here 
tonight.
  We are both supportive of Senator Ron Johnson's efforts to champion 
Right to Try in the Senate. He has been a tireless advocate of Right to 
Try for years, and his bill has already passed the Senate with 
unanimous consent. If you are watching the Senate very closely, you 
will know that nothing comes out of there, and certainly nothing with 
unanimous consent; so that tells how strong the sentiment is in favor 
of this bill.
  Our legislation allows terminally ill patients who have no further 
options left--I repeat that, no further options left--the opportunity 
to try experimental drugs that could save their own lives.
  Yes, there are also provisions in our bill to protect both the 
patients, as well as the pharmaceutical companies who want to 
participate, but those provisions are secondary to the primary purpose 
of this legislation. The primary purpose of the Right to Try Act is to 
give brave patients across this country some choice over their own 
destinies, when all other avenues are gone.
  We want to give hope to these Americans, and we should all share that 
same goal of doing everything we can for patients fighting to save 
their lives. This policy has significant bipartisan support. The Trump 
administration strongly supports Right to Try, and President Trump has 
indicated he would likely sign this bill into law.
  Time is of the essence, for time is one thing a terminally ill 
patient does not have. And the status quo is not the answer. The FDA 
and other agency officials claim that their own expanded access program 
is working and continues to improve. There may be some truth to that, 
but the program is simply not enough; and I know that because I have 
talked to dozens and dozens of patients, family members, and advocates 
who tell me it is not enough. They come to my office, they call me on 
the phone, they write me impassioned letters.
  These same advocates have ensured that Right to Try has become law in 
38 States. Think about that for a moment. With one more State, you 
could actually ratify a Constitutional amendment. And in half of those 
38 States, Right to Try laws passed with unanimous support. In my home 
State of Arizona, voters approved that initiative by 80 percent of the 
popular vote.
  At a time when pundits are claiming that our politics are broken, and 
Republicans and Democrats can't come together on anything, here is a 
cause that Americans of all political stripes can unite in.
  Mr. Speaker, I yield to the gentleman from Pennsylvania (Mr. 
Fitzpatrick).
  Mr. FITZPATRICK. Mr. Speaker, I want to thank my friend and 
colleague, Andy Biggs, for him joining all of us in this fight to stand 
up for terminally ill patients across this country.
  Mr. Speaker, each year, more Americans receive the devastating news 
of a terminal diagnosis. Even with the amazing work done in American 
medical research and development, for too many families, access to 
these potentially lifesaving treatments will come too late or not at 
all.
  Thousands of terminally ill patients, like my constituent, Matt 
Bellina, suffer needlessly while awaiting final approval for drug 
therapies and other medical technologies.
  In April 2014, at age 30, Matt was diagnosed with ALS, otherwise 
known as Lou Gehrig's disease. ALS attacks nerve cells in the brain and 
spinal cord, causing those with ALS to lose control of their muscles.
  Although this disease stopped Matt's career as a U.S. Navy aviator in 
its tracks, he persisted and actively involved himself in the ALS 
community as a strong advocate for Right to Try legislation.
  While the Food and Drug Administration carries out its three-phase 
approval process, which can take years and cost billions of dollars, 
many patients simply want the chance to try treatments that have 
already been demonstrated to be safe.
  A bill that was unanimously passed by the Senate will offer them a 
chance to extend their lives. The Right to Try Act, S. 204, would 
ensure that terminally ill patients, together with their physicians and 
pharmaceutical manufacturers, can administer investigational treatments 
where no alternative exists. In fact, this bipartisan idea is already 
the law in 37 States.
  A Federal Right to Try law would prevent the government from blocking 
access to potentially lifesaving medications. It would require patients 
to first try all other available treatments and be unable to 
participate in clinical trials.
  I want to note that these provisions only apply to terminally ill 
patients. It does not undo the FDA approval process but provides a 
potential lifeline for those who cannot wait. Moreover, it requires a 
physician to certify that other options are either exhausted or 
unavailable.
  This bill requires that a product meet a demonstrated level of safety 
by attaining FDA phase I approval. We have worked with the drug 
companies to ensure adverse outcomes are not used against the ongoing 
application for approval. Additionally, patients, doctors, and 
manufacturers do not assume any additional liability under this act.
  For those patients caught in between the traditional drug approval 
delays, a clinical trial process for which they do not qualify, and 
limited time, the Right to Try simply establishes the freedom for 
patients and their doctors to try therapies where the benefits far 
outweigh the risks. It gives them the option of trying to save their 
life.
  Mr. Speaker, whether it is a father like Matt courageously battling 
ALS, or a brave child living with Duchenne muscular dystrophy, they 
deserve the right to try.

                              {time}  2100

  Mr. BIGGS. Mr. Speaker, I thank Mr. Fitzpatrick; I appreciate all 
that he has done and continues to do in this cause, this important 
cause. He is a great leader in this, and I am grateful for all of his 
effort here.
  At this point, Mr. Speaker, I am pleased to yield to the gentleman 
from Florida (Mr. Gaetz).
  Mr. GAETZ. Mr. Speaker, I thank the gentleman for yielding. I thank 
him for

[[Page H8382]]

his leadership on this issue on behalf of the terminally ill. I would 
also like to thank Senator Johnson for marshaling together the 
resources of the Senate to bring this legislation to a head.
  I ran for public office because I was tired of the government playing 
too large a role in the decisions people make in their private lives, 
in their homes, and in their businesses. We live in a world today where 
the government wants to tell you where you have got to send your kids 
to school, what kind of healthcare plan you have got to buy, what 
regulations you have to comply with, and how much money they are going 
to take out of your paycheck each and every month.
  I certainly don't think the government ought to play a role in 
deciding how someone deals with treatment at the end of life. That is 
why I am a proud cosponsor of the Right to Try Act with Representative 
Biggs, Representative Fitzpatrick, and so many others. My frustration 
lies with any regime, regulatory or otherwise, that would impair a 
patient's decision to use any medication to be able to alleviate their 
symptoms or improve their quality of life in their final days.
  It is absolutely ludicrous to me that, in today's world, we don't 
allow terminally ill people in every corner of this great country to be 
able to use medical cannabis to alleviate their pain and suffering, 
particularly at the end of life.
  It is so frustrating to me that the Federal Government has lied to 
this country for a generation about medical cannabis, saying that it 
has no medical value. Well, I can tell you, Mr. Speaker, that is 
absolutely not true. I have met with patients in my district who have 
received terminal diagnoses, who have been told by their doctors not to 
buy green bananas, and yet those folks courageously move forward trying 
to be a part of their own treatment and to be a part of their own 
clinical plan moving forward.
  Too often, doctors, whether it is at the VA or in private practice, 
aren't able to counsel their patients and give them advice and comfort 
that there is a substance in medical cannabis which has proven in some 
circumstances to have medical value.
  Stage IV of terminal cancer includes symptoms like loss of appetite, 
which can be helped by cannabis, chronic pain, shortness of breath, 
difficulty breathing, chemotherapy-induced nausea. All of these things 
can be helped by medical cannabis.
  Those who are in stage III of AIDS have sleeplessness and weight loss 
that can be helped by medical cannabis.
  Cannabis has shown great promise in the treatment of Alzheimer's, 
Crohn's Disease, multiple sclerosis, and epilepsy, where there are 
refractory seizures, at times, 30 or 40 seizures a day.
  Mr. Speaker, in this great country, we will have people who will 
receive terminal diagnoses each and every day. I say let's get the 
government out of their way. Let's let the decisions that impact the 
healthcare of patients be made by those patients and their family 
members and their doctors, not a bunch of politicians and bureaucrats 
in Washington.
  As people fall ill, it is my position that this Right to Try Act can 
help them, and certainly the inclusion of medical cannabis into this 
legislation would make it a great deal more useful and a great deal 
better for those in pain.
  I thank the gentleman from Arizona for yielding.
  Mr. BIGGS. Mr. Speaker, I thank the gentleman from Florida for his 
impassioned speech, his position, his comments regarding the bill, and 
his desire to see it altered, but I do appreciate his support of the 
bill.
  Mr. Speaker, I am certainly grateful to have this opportunity to 
yield to the gentleman from Pennsylvania (Mr. Smucker).
  Mr. SMUCKER. Mr. Speaker, I would like to thank my colleague from 
Arizona (Mr. Biggs) for hosting tonight's Special Order. I also thank 
Mr. Fitzpatrick, as well, for his leadership in this bill. I am really 
glad to be part of this effort.
  We could stand here tonight and talk about the FDA's process for 
approving drugs. We could talk about the countless patients across the 
country who struggle to get accepted into a clinical trial for a drug 
that could save their life. We could even stand up here tonight and 
share with you one of the uplifting stories of a patient who received a 
lifesaving drug because of a State's right-to-try law. But we have 
heard this, and we know all of this.
  We know the FDA's approval process takes years. We know there are too 
few spots in clinical trials for patients in dire need of help. We know 
that right-to-try laws give families hope and can save lives. What I 
would like to talk about tonight is the moral imperative we face on 
this right-to-try legislation.
  America is home to the world's greatest doctors and medical experts. 
It is home to the world's greatest medical schools and hospitals. We 
have cured diseases that were once a death sentence. We have directed 
our national resources to fight epidemics that have saved lives here at 
home and overseas. We don't give up.
  What we do here in this Chamber, Mr. Speaker, speaks volumes. What we 
do here shows the Nation and the world where our priorities are.
  Is our priority the bureaucracy of this city that too often misses 
opportunities simply because of its inability to act, or is our 
priority the patients and families whom we represent to consult with a 
doctor and decide for themselves how they choose to fight against 
illnesses for which we continue to search for a cure?
  For me, the choice is clear, Mr. Speaker. I choose my constituents. I 
choose life, and I urge every single Member of this body to do the 
same. We cannot afford the cost of inaction.

  Mr. BIGGS. Mr. Speaker, I thank Mr. Smucker; I appreciate his 
comments and his willingness to participate this evening.
  Mr. Speaker, I am pleased to yield to the gentleman from Arizona (Mr. 
Gosar).
  Mr. GOSAR. Mr. Speaker, I thank my friend from Arizona for yielding.
  What a great issue. As a conservative, I am an outspoken defender of 
one's right to life. But being pro-life doesn't mean that I am just 
antiabortion. It also means that I support the right to try, because 
life at all stages is worth fighting for.
  Every year, over 1 million Americans die from terminal illnesses, 
many of whom pass away while waiting for the FDA to approve a drug that 
could dramatically change their prognosis, while others die in the 
hopeless cycle of trying and trying again to gain acceptance into a 
medical trial.
  Think about that: we are losing millions of Americans at the hands of 
government red tape.
  Now, as a healthcare provider for 25 years, I know firsthand how 
important innovation is to the medical community. The Right to Try Act, 
if made into law, will give hope to the child with leukemia whose 
doctors have exhausted all other treatment options. It opens previously 
locked doors by allowing healthcare providers to try experimental drugs 
as a last-ditch effort for survival.
  The experiments that the Right to Try Act will allow for have the 
potential to lead to many more birthdays, more piano recitals, and more 
camping trips, and offer hope for our future, hope for years to come.
  But don't take my word for it. Emily Whitehead was merely 5 years old 
when she was diagnosed with acute lymphoblastic leukemia, and her 
doctors quickly realized that she was among a small percentage of 
patients whose disease was seemingly untouchable by chemotherapy. The 
Whiteheads were at the end of their rope. The little girl's body was 
resisting chemotherapy, and the window for many more birthdays, more 
piano recitals, and more camping trips was wearing thin. Their only 
option was to join a clinical trial that experimented with T-cell 
therapy, where Emily could be the first pediatric patient to undergo 
this treatment.
  And do you know what? It worked. Three years later, a groundbreaking 
study was conducted where 63 patients received T-cell therapy for 1 
year, and 52 of them became cancer free, an absolutely unheard-of 
statistic with this deadly strain of leukemia.
  Think about that: 52 lives were saved; 52 families were given another 
birthday, another piano recital, and another camping trip. What a waste 
it would have been had they not had the right to try.
  Mr. BIGGS. Mr. Speaker, I thank all of my colleagues who have joined 
us tonight to champion the cause and inquire how much time I have 
remaining.

[[Page H8383]]

  The SPEAKER pro tempore. The gentleman from Arizona has 15 minutes 
remaining.
  Mr. BIGGS. Mr. Speaker, in closing, I want to mention how I came to 
really be converted to the cause of right to try.
  I served in the Arizona State Legislature with Laura Knaperek, who 
was also serving in the legislature when I first met her. By 2014, she 
was no longer serving in the State legislature. She was an advocate. 
That year, Laura was in the fight of her life against ovarian cancer, 
and her mission was to see right-to-try legislation passed into law.
  In the end, her efforts for this cause succeeded beyond everyone's 
wildest expectations when 80 percent of the electorate in Arizona voted 
to enact right to try. But, unfortunately, Laura is not with us because 
she lost her brave battle with cancer last year. Her legacy as a 
tireless patient advocate lives on.
  I will continue to carry on the fight not just for Laura Knaperek, 
but for all those patients across this country who are battling against 
the odds every day.
  I am joined by those who are here tonight, those who have cosponsored 
this bill, and many other advocacy groups, such as the Goldwater 
Institute in Arizona that continues to fight for this.
  I fight for Bertrand Might. Bertrand is a very special little boy. He 
was the first person ever to be diagnosed with a rare, fatal genetic 
disorder called NGLY1 that has left this 7-year-old paralyzed. Because 
the disease was only identified by scientists in 2012 and only a few 
people worldwide have been diagnosed with it, there is no cure and no 
treatment available. Because the disorder is so rare, a drug may never 
be developed to treat it.
  But scientists have found that Bertrand responds to certain 
investigational therapies. So Bertrand's family will have to rely on 
trying those new investigational medications as long as they have 
access to them. That is why we need this right-to-try legislation.
  I fight for Jordan McLinn. Seven-year-old Jordan says he wants to 
grow up to be a firefighter so he can save lives. He has Duchenne 
muscular dystrophy, which could leave him paralyzed within 5 years and 
shortens his life expectancy to only 20 years. There is a drug now 
being used in clinical trials that is helping young people like Jordan, 
but it could take another 7 years for that drug to be available on the 
market. His parents cannot afford to wait for the FDA to give that drug 
its final approval. He could be in a wheelchair by then. This 
investigational drug could add years to Jordan's life, which would give 
him the chance to save others.
  We have already heard, when Representative Fitzpatrick discussed Matt 
Bellina, his needs and his advocacy. We fight for him, and we fight for 
Mikaela Knapp.
  At 24, Mikaela was diagnosed with a deadly form of kidney cancer that 
had already migrated into her bones before she even knew she was sick. 
She went through every known treatment in a matter of months and 
nothing worked. Her high school sweetheart, Keith, heard about a drug 
under development that was successfully treating people with this same 
cancer, but Mikaela was not allowed to enroll in the clinical trial. 
Mikaela and Keith launched a social media campaign to try to get access 
to the drug, but it wasn't enough. The FDA didn't help.

  Mikaela died on April 24, 2014. Five months later, on September 4, 
the FDA gave final approval to the drug that might have saved her.
  I fight for Diego Morris. When he was 10 years old, Diego woke up 
with a sore leg that his mom thought was just another sports injury, 
but the pain didn't go away. They knew something was wrong, but they 
never expected osteosarcoma, a rare form of bone cancer.
  After exhausting all treatments available, Diego's doctors 
recommended he try mifamurtide, which wasn't available in the United 
States but was being safely used and had been given the Prix Galien 
Award, the gold medal for pharmaceutical development in England. The 
Morris family wasted no time and made the move abroad to try to save 
Diego's life. The treatments worked. Now Diego is back home in Phoenix 
and back to playing his favorite sports.
  We fight unitedly for the countless other patients who deserve a 
right to try. We must act without further delay. Again, I thank those 
who have been here to testify tonight.
  Mr. Speaker, I yield back the balance of my time.

                          ____________________