[Congressional Record Volume 164, Number 44 (Tuesday, March 13, 2018)]
[House]
[Pages H1521-H1528]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




 TRICKETT WENDLER, FRANK MONGIELLO, JORDAN McLINN, AND MATTHEW BELLINA 
                        RIGHT TO TRY ACT OF 2018

  Mr. WALDEN. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 5247) to authorize the use of eligible investigational drugs 
by eligible patients who have been diagnosed with a stage of a disease 
or condition in which there is reasonable likelihood that death will 
occur within a matter of months, or with another eligible illness, and 
for other purposes.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 5247

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Trickett Wendler, Frank 
     Mongiello, Jordan McLinn, and Matthew Bellina Right to Try 
     Act of 2018''.

     SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY PATIENTS 
                   DIAGNOSED WITH A TERMINAL ILLNESS.

       (a) In General.--Subchapter E of chapter V of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 
     amended by inserting after section 561A (21 U.S.C. 360bbb-0) 
     the following:

     ``SEC. 561B. INVESTIGATIONAL DRUGS FOR USE BY ELIGIBLE 
                   PATIENTS.

       ``(a) Definitions.--For purposes of this section:
       ``(1) The term `eligible patient' means a patient--
       ``(A) who has been diagnosed with an eligible illness;
       ``(B) who has exhausted approved treatment options and is 
     not eligible to participate in (for a reason such as the 
     patient not meeting inclusion criteria) a clinical trial 
     designed to evaluate an investigational drug for the 
     treatment of such eligible illness with which the patient has 
     been diagnosed, including one involving the eligible 
     investigational drug, or for whom participation in such a 
     clinical trial is not feasible (for a reason such as a lack 
     of geographic proximity to the clinical trial), as certified 
     by a physician, who--
       ``(i) is in good standing with the physician's licensing 
     organization or board; and
       ``(ii) will not be compensated for so certifying; and
       ``(C) who has provided to the treating physician written 
     informed consent, as described in part 50 of title 21, Code 
     of Federal Regulations (or any successor regulations), 
     regarding the eligible investigational drug, or, as 
     applicable, on whose behalf a legally authorized 
     representative of the patient has provided such consent.
       ``(2) The term `eligible investigational drug' means an 
     investigational drug (as such term is used in section 561)--
       ``(A) for which a phase 1 clinical trial has been 
     completed;
       ``(B) that has not been approved or licensed for any use 
     under section 505 of this Act or section 351 of the Public 
     Health Service Act;
       ``(C)(i) for which an application has been filed under 
     section 505(b) of this Act or section 351(a) of the Public 
     Health Service Act, as applicable, that is active; or
       ``(ii) that is under investigation in a clinical trial 
     that--
       ``(I) is intended to form the primary basis of a claim of 
     effectiveness in support of approval or licensure under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act; and
       ``(II) is the subject of an active investigational new drug 
     application under section 505(i) of this Act or section 
     351(a)(3) of the Public Health Service Act, as applicable; 
     and
       ``(D) the active development or production of which--
       ``(i) is ongoing;
       ``(ii) has not been discontinued by the manufacturer; and
       ``(iii) is not the subject of a clinical hold under the 
     regulations implementing section 505(i) or section 351(a)(3) 
     of the Public Health Service Act, as applicable.
       ``(3) The term `phase 1 trial' means a phase 1 clinical 
     investigation of a drug as described in section 312.21 of 
     title 21, Code of Federal Regulations (or any successor 
     regulations).
       ``(4) The term `eligible illness' means--
       ``(A) a stage of a disease or condition in which there is 
     reasonable likelihood that death will occur within a matter 
     of months; or
       ``(B) a disease or condition that would result in 
     significant irreversible morbidity that is likely to lead to 
     severely premature death.
       ``(b) Alternative Pathway for Eligible Patients With a 
     Terminal Illness.--
       ``(1) In general.--Eligible investigational drugs provided 
     to eligible patients in compliance with this section are 
     exempt from sections 502(f), 503(b)(4), and subsections (a) 
     and (i) of section 505 of this Act, and section 351(a) of the 
     Public Health Service Act so long as the conditions specified 
     in paragraphs (2), (3), and (4) are met with respect to the 
     provision of such investigational drugs.
       ``(2) Compliance with certain regulations.--The conditions 
     specified in this paragraph, with respect to an eligible 
     investigational drug referred to in paragraph (1), are that--
       ``(A) the eligible investigational drug is labeled in 
     accordance with section 312.6 of title 21, Code of Federal 
     Regulations (or any successor regulations); and
       ``(B) the provision of such eligible investigational drug 
     occurs in compliance with the applicable requirements set 
     forth in sections 312.7 and 312.8(d)(1) of title 21, Code of 
     Federal Regulations (or any successor regulations) that apply 
     to investigational drugs, subject to paragraph (5).
       ``(3) Notification.--The condition specified in this 
     paragraph, with respect to an eligible investigational drug 
     referred to in paragraph (1), is that the sponsor of such 
     eligible investigational drug notifies the Secretary of the 
     provision of such eligible investigational drug for use by an 
     eligible patient pursuant to this section. Such notification 
     shall be submitted within 7 business days of the provision of 
     such eligible investigational drug as correspondence to the 
     investigational new drug application described in subsection 
     (a)(2).
       ``(4) Adverse event reporting.--The condition specified in 
     this paragraph, with respect to an eligible investigational 
     drug referred to in paragraph (1), is that the sponsor or 
     manufacturer of such eligible investigational drug has 
     required, as a condition of providing the drug to a physician 
     for use by an eligible patient pursuant to this section, that 
     such physician will immediately report to such sponsor or 
     manufacturer any serious adverse events, as such term is 
     defined in section 312.32 of title 21, Code of Federal 
     Regulations (or any successor regulations), associated with 
     the use of the eligible investigational drug by the eligible 
     patient.
       ``(5) Application.--For purposes of this section, the 
     requirements set forth in sections 312.7 and 312.8(d)(1) of 
     title 21 of the Code of Federal Regulations (or any successor 
     regulations) are deemed to apply to any person who 
     manufactures, distributes, prescribes, dispenses, introduces 
     or delivers for introduction into interstate commerce, or 
     provides to an eligible patient an eligible investigational 
     drug pursuant to this section.
       ``(c) Use of Clinical Outcomes.--
       ``(1) In general.--Notwithstanding any other provision of 
     this Act, the Public Health Service Act, or any other 
     provision of Federal law, the Secretary may not use a 
     clinical outcome associated with the use of an eligible 
     investigational drug pursuant to

[[Page H1522]]

     this section to delay or adversely affect the review or 
     approval of such drug under section 505 of this Act or 
     section 351 of the Public Health Service Act unless--
       ``(A) the Secretary makes a determination, in accordance 
     with paragraph (2), that use of such clinical outcome is 
     critical to determining the safety of the eligible 
     investigational drug; or
       ``(B) the sponsor requests use of such outcomes.
       ``(2) Limitation.--If the Secretary makes a determination 
     under paragraph (1)(A), the Secretary shall provide written 
     notice of such determination to the sponsor, including a 
     public health justification for such determination, and such 
     notice shall be made part of the administrative record. Such 
     determination shall not be delegated below the director of 
     the agency center that is charged with the premarket review 
     of the eligible investigational drug.
       ``(d) Reporting.--The manufacturer or sponsor of an 
     eligible investigational drug that provides an eligible 
     investigational drug pursuant to this section shall post on 
     the same publicly available internet website used by the 
     manufacturer for purposes of section 561A(b) an annual 
     summary of any provision by the manufacturer or sponsor of an 
     eligible investigational drug under this section. The summary 
     shall include the number of requests received, the number of 
     requests granted, the number of patients treated, the 
     therapeutic area of the drug made available, and any known or 
     suspected serious adverse events, as such term is defined in 
     section 312.32 of title 21, Code of Federal Regulations (or 
     any successor regulations), associated with the use of the 
     eligible investigational drug.
       ``(e) Rule of Construction.--Nothing in this section shall 
     be construed as limiting the authority of the Secretary to 
     require manufacturers or sponsors of investigational drugs to 
     review and report information relevant to the safety of such 
     investigational drug obtained or otherwise received by the 
     sponsor pursuant to part 312 of title 21, Code of Federal 
     Regulations (or successor regulations).''.
       (b) No Liability.--Section 561B of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), is amended by 
     adding at the end the following:
       ``(f) Liability.--
       ``(1) Alleged acts or omissions.--
       ``(A) Manufacturer or sponsor.--No manufacturer or sponsor 
     (or their agent or representative) of an investigational drug 
     shall be liable for any alleged act or omission related to 
     the provision of such drug to a single patient or small group 
     of patients for treatment use in accordance with subsection 
     (b) or (c) of section 561 or the provision of an eligible 
     investigational drug to an eligible patient in accordance 
     with this section, including, with respect to the provision 
     of an investigational drug under section 561 or an eligible 
     investigational drug under this section, the reporting of 
     safety information, from clinical trials or any other source, 
     as required by section 312.32 of title 21, Code of Federal 
     Regulations (or any successor regulations).
       ``(B) Physician, clinical investigator, or hospital.--
       ``(i) No licensed physician, clinical investigator, or 
     hospital shall be liable for any alleged act or omission 
     related to the provision of an investigational drug to a 
     single patient or small group of patients for treatment use 
     in accordance with subsection (b) or (c) of section 561, as 
     described in clause (ii), or the provision of an eligible 
     investigational drug to an eligible patient in accordance 
     with this section, unless such act or omission constitutes on 
     the part of such physician, clinical investigator, or 
     hospital with respect to such investigational drug or 
     eligible investigational drug--

       ``(I) willful or criminal misconduct;
       ``(II) reckless misconduct;
       ``(III) gross negligence relative to the applicable 
     standard of care and practice with respect to the 
     administration or dispensing of such investigational drug; or
       ``(IV) an intentional tort under applicable State law.

       ``(ii) The requirements described in this clause are the 
     requirements under subsection (b) or (c) of section 561, 
     including--

       ``(I) the reporting of safety information, from clinical 
     trials or any other source, as required by section 312.32 of 
     title 21, Code of Federal Regulations (or any successor 
     regulations);
       ``(II) ensuring that the informed consent requirements of 
     part 50 of title 21, Code of the Federal Regulations (or any 
     successor regulations) are met; and
       ``(III) ensuring that review by an institutional review 
     board is obtained in a manner consistent with the 
     requirements of part 56 of title 21, Code of the Federal 
     Regulations (or any successor regulations).

       ``(2) Determination not to provide drug.--No manufacturer, 
     sponsor, licensed physician, clinical investigator, or 
     hospital shall be liable for determining not to provide 
     access to an investigational drug under this section or for 
     discontinuing any such access that it initially determined to 
     provide.
       ``(3) Limitation.--
       ``(A) In general.--Except as set forth in paragraphs (1) 
     and (2), nothing in this section shall be construed to modify 
     or otherwise affect the right of any person to bring a 
     private action against a manufacturer or sponsor (or their 
     agent or representative), physician, clinical investigator, 
     hospital, prescriber, dispenser, or other entity under any 
     State or Federal product liability, tort, consumer 
     protection, or warranty law.
       ``(B) Federal government.--Nothing in this section shall be 
     construed to modify or otherwise affect the authority of the 
     Federal Government to bring suit under any Federal law.''.

  The SPEAKER pro tempore (Mr. Curtis). Pursuant to the rule, the 
gentleman from Oregon (Mr. Walden) and the gentleman from New Jersey 
(Mr. Pallone) each will control 20 minutes.
  The Chair recognizes the gentleman from Oregon.


                             General Leave

  Mr. WALDEN. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous material into the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Oregon?
  There was no objection.
  Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise today on behalf of the patients who face terminal 
diagnoses but have exhausted all available treatment options. These are 
patients like Jordan McLinn, who is with us today.
  Jordan is a tireless fighter who self-advocates for others living 
with Duchenne muscular dystrophy. He is a namesake of this bill we are 
considering, like Matt Bellina, who testified before the Health 
Subcommittee last year. Because of folks like Jordan and Matt, we have 
a chance to increase patient access to experimental therapies.
  Thirty-eight States across our great land have right-to-try laws, 
including my home State of Oregon. Wisconsin, with a bill on its way to 
Governor Scott Walker's desk, will soon make it 39. While the State 
policies vary, they have a common goal: helping vulnerable patients.
  President Trump praised the movement during the State of the Union, 
saying: ``People who are terminally ill should not have to go from 
country to country to seek a cure. I want to give them a chance here at 
home.''
  Now, today, there is an existing process for patients to access 
unapproved drugs. The FDA oversees expanded access, commonly known as 
compassionate use. This program has been critical in helping patients 
access experimental drugs.
  Commissioner Scott Gottlieb and the Agency, the FDA, should be 
commended for their continued work to improve the expanded access 
program for patients.
  To improve this successful program, the bill before us today also 
provides liability protections for manufacturers, sponsors, physicians, 
clinical investigators, and hospitals that participate in the existing 
expanded access program and the new alternative pathway created under 
this legislation.
  This provision removes one of the biggest hurdles that patients have 
faced in getting access to these medicines, in gaining access to 
experimental therapies, as identified by the Government Accountability 
Office: manufacturer hesitancy to participate. That is the big hurdle. 
We seek to overcome it with this legislation.
  The bill also creates a new alternative pathway for patients who do 
not qualify for a clinical trial. This legislation strengthens patient 
protections with clearer informed consent and adverse event reporting.
  The bill also ensures the FDA, the Food and Drug Administration, is 
notified when a patient receives an unapproved drug through the new 
alternative pathway to ensure there is proper oversight.
  Mr. Speaker, I want to thank the House sponsors of this legislation 
who have worked tirelessly to bring this to a good place today: Brian 
Fitzpatrick, our colleague from Pennsylvania;  Andy Biggs from Arizona; 
and Morgan Griffith from Virginia. I also thank the Vice President, 
with whom Jordan and I met today. I am grateful for their work on 
behalf of these courageous patients, and I urge all my colleagues in 
the House to support this legislation.
  Mr. Speaker, I reserve the balance of my time.

                              {time}  1745

  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  I rise today in strong opposition to H.R. 5247, or the Right to Try 
Act of

[[Page H1523]]

2018. Supporters of this legislation, Mr. Speaker, have claimed that it 
will provide seriously ill patients, who have exhausted all of their 
available treatment options, access to experimental therapies free from 
the barriers of FDA oversight.
  While it is understandable that someone suffering from a disease who 
has no more options would want to try anything that could help them 
fight their disease, this legislation delivers the false hope to 
patients and their families that they will receive a cure to their 
underlying disease or condition.
  In fact, this legislation provides patients and their families 
nothing more than the right to ask a manufacturer for access to early 
stage, unproven treatments. Like other so-called right-to-try 
proposals, H.R. 5247 is based on the false premise that patients are 
not receiving access to the investigational treatments as a result of 
the Food and Drug Administration, and this simply not the case.
  Through the FDA's existing expanded access program, seriously ill 
patients are able to request access to investigational products. The 
FDA approves 99 percent of all requests for investigational drugs or 
biologics that it receives through this program.
  Last year, FDA received more than 1,500 requests, and only 9 were not 
approved. Despite this high-approval rate, supporters of right-to-try 
laws have argued that the process is too slow and burdensome, but I 
have not seen evidence that this is the case, Mr. Speaker. In fact, FDA 
often grants emergency requests for expanded access immediately over 
the phone, and nonemergency requests are processed in an average of 4 
days.
  FDA has even made improvements to streamline the process. For 
example, FDA has revised the application for physicians to ensure that 
it now takes less than an hour to complete. FDA has also released 
additional guidance to industry, outlining the expanded access 
program's requirements and addressing common questions related to the 
different programs and submission process, and how outcomes will be 
considered as part of the review process.
  Last fall, FDA Commissioner Gottlieb testified on right-to-try 
efforts and told our committee that: ``There is a perception that 
certain products that aren't being offered under FDA expanded access . 
. . will be offered under right-to-try. I don't see that,'' the 
commissioner said. As I have said, the review process is working well, 
but this legislation would completely take FDA out of the review 
process. This is dangerous and could put patients at serious risk.
  FDA is part of the process for a reason. It protects patients from 
potentially bad actors or from experimental treatments that might do 
more harm than good. While FDA approves 99 percent of the treatments it 
reviews, it also revises applications for 11 percent of patients to 
improve patient safety protections.
  In order to protect patients, this review should continue. We must 
protect patients from bad actors or from dangerous treatments that 
would make their lives worse. I am extremely concerned that the 
legislation we are considering today is advancing a solution to address 
barriers to investigational treatments that do not exist and could 
expose seriously ill patients to greater harm instead of the greater 
access that they are looking for.
  The true barrier to any expanded access is the determination by the 
manufacturer as to whether or not they will provide access to their 
products that are under development. But nothing in the legislation 
before us today would compel a manufacturer to grant access upon 
request.
  Further, H.R. 5247 would allow patients access to investigational 
treatments that have only completed a phase I clinical trial. That is 
an extremely small trial. It does not determine the effectiveness, or 
the potential side effects of a drug. Access at this stage in the 
development could expose patients to untested products, further harm, 
and result in delaying access to a treatment that may be more 
appropriate and more beneficial for their underlying disease or 
condition.
  H.R. 5247 also erodes important patient safeguards. It limits FDA's 
ability to use clinical outcomes associated with the use of an 
investigational product when reviewing a product for approval if it 
could adversely impact its review. It also prevents any entity from 
being held liable for use of the treatment.
  And while I appreciate, Mr. Speaker, the intent of this bill, I can't 
support it. The last thing I want to do is give patients false hope and 
to potentially put them at risk by completely removing FDA from the 
review and approval process.
  Finally, Mr. Speaker, it is outrageous, in my opinion, that a bill of 
this magnitude is being considered under a suspension of the rule. As 
my Republican colleagues well know, bills considered under suspension 
are traditionally bipartisan bills that have worked their way through 
the appropriate committees with overwhelming bipartisan support.
  This bill was never considered by the Energy and Commerce Committee. 
In fact, it was only introduced today. A bill with such critical 
patient safety implications should not be considered in this fashion. 
So I urge my colleagues to oppose this misguided legislation and stand 
with the more than 100 organizations that have come forward expressing 
their concern for patients and the unnecessary risk this legislation 
could expose our Nation's most vulnerable to.
  Mr. Speaker, I reserve the balance of my time.
  Mr. WALDEN. Mr. Speaker, I now have the honor of yielding 3 minutes 
to the gentleman from Pennsylvania (Mr. Fitzpatrick), who has been, 
even before he got to the Congress, an extraordinary advocate for this 
cause and for the patients with terminally ill conditions.
  Mr. FITZPATRICK. Mr. Speaker, I want to thank Chairman Walden; Mr. 
Burgess; Mr. Griffith; my friend,  Andy Biggs; and Senator Ron Johnson 
for their resolute commitment to see the Right to Try Act brought to a 
vot today.

  Mr. Speaker, each year, thousands of Americans receive the 
devastating diagnosis of a terminal illness. And 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. As their Representatives, we should each 
endeavor to support these individuals in their time of need as well as 
support new pathways to potentially lifesaving treatment.
  That is what the right to try is all about. As the chairman 
indicated, 38 States have passed this bill with near unanimous, 
bipartisan support. A version of this bill unanimously passed the 
United States Senate.
  However, we know Congress cannot legislate miracles. That is why, 
when talking about the right to try, we are careful not to represent it 
as a cure itself. The reality is that, while passing this measure is a 
step, the families and advocates we have worked closely with for years 
know that the right to try isn't a guarantee. It is about protecting 
hope and protecting opportunity--hope and opportunity for those like my 
constituent, Lieutenant Commander Matthew Bellina, a retired naval 
aviator and father of three, who was diagnosed with ALS in 2014.
  Following the onset of his symptoms, Matt was grounded from flying. 
He eventually moved back home to Bucks County with his wife, Caitlin, 
and his three children to be surrounded by family and friends.
  Although this disease stopped Matt's military service, he quickly 
picked up the fight with his new battle, involving himself in the ALS 
community and becoming a strong advocate for right-to-try legislation. 
Together with Jim Worthington and the Have a Heart Foundation, Matt 
advocated for the right to try across the Nation.
  While the FDA has a program that allows terminally ill patients to 
apply for early access to promising treatment, the right to try is 
needed because the FDA's compassionate use process doesn't help enough 
people. Only about 1,200 people a year can make it through the current 
time-consuming and expensive application process. Comparatively, Mr. 
Speaker, in 2014, more than 12,000 people in France were using 
investigational treatments through that government's equivalent 
program.
  If a country with one-fifth of the population of the United States 
can help 900 percent more people, the FDA program clearly is not 
working. This bill

[[Page H1524]]

does not gut the FDA or fundamentally change the relationship between 
doctor and patient. What it does is give Americans facing a terminal 
diagnosis a new pathway for treatments undergoing clinical trials.
  I want to read something in closing, Mr. Speaker, that I received 
from Matt Bellina, who is with us today. ``Please let them know that I 
have had ALS too long to meet the exclusion criteria for any promising 
trials. No drug company will offer me treatments under the current EAP 
guidelines. Two reputable companies have already indicated that they 
would try to treat me under the rules of this bill. A vote against this 
is essentially a vote to kill me. It is a vote to make my wife a widow 
and leave my boys fatherless. I can't stop anyone from voting that way, 
but please ask them to have the respect to look my family in the eye 
when they cast'' that vote.
  Mr. Speaker, when a life hangs in the balance, the Federal Government 
should not stand in the way of access to potentially lifesaving 
treatment.
  Mr. PALLONE. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Texas (Mr. Gene Green), who is the ranking member of our 
Subcommittee on Health.
  Mr. GENE GREEN of Texas. Mr. Speaker, I thank my ranking member for 
allowing me to speak tonight.
  Mr. Speaker, I rise in opposition to the Right to Try Act, 
legislation that would bypass the Food and Drug Administration's 
longstanding review and oversight of drug treatments and endanger 
patients with life-threatening diseases.
  My heart goes out to the families of loved ones who are terminally 
ill and desperate for a breakthrough treatment. I, too, have lost loved 
ones and wished there was an experimental therapy available to save 
them.
  FDA has decades of experience dealing with experimental therapies 
that have not received final approval. In 1987, the FDA created 
expanded access, better known as compassionate use, and gives 
terminally ill patients access to therapies still under clinical 
trials. FDA approves nearly all requests for investigational drugs. For 
the last 5 years, the FDA approval rate for this expanded access is 
over 99 percent. In fact, FDA physicians are available 24 hours a day 
to approve emergency requests.
  My daughter is an infectious disease physician at the University of 
Nebraska Medical Center. They used the FDA's compassionate pathway to 
provide experimental therapy for an American doctor, a U.S. citizen, 
who had contracted Ebola while in Africa in 2014. FDA approved that 
request for that experimental treatment over the telephone in less than 
24 hours. There is a solution other than this bill.
  The new path created in this legislation is not necessary, and, in 
fact, may endanger the health and safety of terminally ill patients by 
bypassing FDA's oversight and expertise.
  Mr. Speaker, I also want to speak on the importance of following 
regular order. The House Energy and Commerce Committee has been working 
with stakeholders and Federal agencies for years on creating incentives 
and pathways for the new generation of breakthrough therapies.
  Two years ago, these efforts culminated with the passage of the 21st 
Century Cures Act, which I am proud to be a champion of. The 21st 
Century Cures Act went through regular order, including hearings; 
Member discussions; and compromises between regulators, stakeholders, 
and regulators.
  It is not easy or quick, but regular order works because it gives the 
committees of jurisdiction the opportunity to debate and refine the 
legislation. This legislation we are currently considering did not go 
through regular order. In fact, it was just introduced earlier today, 
purposely avoiding consideration before our Energy and Commerce 
Committee due to its shortcomings.

  I hope we can agree on the importance of following regular order and 
observe our Chamber's rules and traditions. The American people deserve 
nothing less. I ask my colleagues on both sides of the aisle to stand 
up for Americans facing these serious and life-threatening diseases by 
opposing this unnecessary and potentially dangerous legislation.
  Mr. WALDEN. Mr. Speaker, I yield 2 minutes to the gentleman from 
Texas (Mr. Barton), the former chairman of the full committee and the 
current vice chairman.
  (Mr. BARTON asked and was given permission to revise and extend his 
remarks.)
  Mr. BARTON. Mr. Speaker, I have listened to my friends on the 
minority talk about the reasons they are opposing this bill, and a 
normal piece of legislation that would have some merit didn't go 
through regular order, things of this sort. But, Mr. Speaker, when the 
house is burning down and you need the fire department, you don't ask 
if they followed proper procedure to get somebody out there to put out 
the fire.
  My brother had liver cancer at the age of 44. He had tried every 
conventional therapy known to modern medicine, and it wasn't working. 
Now, he had a brother, myself, who was a subcommittee chairman of the 
committee of jurisdiction over the FDA. I contacted the FDA, and we got 
him in a special protocol for an investigational drug that was under 
approval. It wasn't approved. And the doctors and the people at the FDA 
told my brother and his family: If it works, it is going to really help 
you. But if it doesn't, you are going to die sooner.
  Well, he was going to die anyway, Mr. Speaker. So he signed the 
informed consent and he took the drug and it didn't work, but he had 
that last shot. Now, I don't know what this debate about false hope is. 
When you have no hope, perhaps false hope is better than none at all.
  All this bill does is let people who have no other hope for 
conventional therapy, if a drug has at least passed stage one at the 
FDA approval process, and their doctor thinks it will help them, if 
they give an informed consent, they can try it.
  Now, my friends on the Democratic side are correct that, most of the 
time under the existing protocol, the FDA approves it without a 
problem. But why should the FDA approve it if you are about to die 
anyway? That is what this bill does. By the way, it passed the Senate 
with unanimous consent. Now, that is a miracle in itself.
  Let's pass it here in the House and give hope a chance for these 
patients who are terminally ill and have no hope at all today.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
California (Ms. Matsui).
  Ms. MATSUI. Mr. Speaker, I thank the ranking member for yielding to 
me.
  Mr. Speaker, I rise in opposition to this proposed right-to-try 
legislation. This bill offers patients false hope. It proposes a 
pathway to experimental drugs that offers absolutely no guarantee of 
access, while stripping patients of any legal or financial recourse, 
and places clinical trials at risk.

                              {time}  1800

  Last week, I am sure like everyone else, I heard from many 
constituents on behalf of their families and communities with 
devastating diseases, like multiple sclerosis.
  When a family member is faced with a devastating diagnosis, you would 
do anything and try anything to improve their quality of life. I know. 
I have been there with family members in such heartbreaking situations. 
But this bill would not necessarily make it easier to get experimental 
treatments and it would definitely make it harder for patients in the 
future to get treatments. We need clinical trials to ensure drugs are 
safe and effective and to find real cures and treatments for these 
patients.
  Because this bill would be dangerous for patients both today and in 
the future, many disease groups oppose the bill, including the National 
Organization for Rare Disorders, the American Cancer Society, the 
Cystic Fibrosis Foundation, and more.
  Rushing this bill without proper bipartisan oversight places the 
American people in the way of real harm. Rescinding FDA oversight on 
unproven therapies is a perilous proposition.
  Mr. Speaker, I urge my colleagues to oppose this bill.
  Mr. WALDEN. Mr. Speaker, I yield myself 5 seconds.
  Mr. Speaker, the last two speakers from California and Texas, two of 
our biggest States, a grand total of two legislators voted ``no.'' 
Otherwise, it was unanimous in both those States to do what we are 
doing here today.

[[Page H1525]]

  Mr. Speaker, I yield 2 minutes to the gentleman from Arizona (Mr. 
Biggs), an incredible advocate of this legislation.
  Mr. BIGGS. Mr. Speaker, I thank Chairman Walden for yielding. I am 
grateful for the work he has done on this. I am also grateful to my 
friends, Representatives Fitzpatrick and Griffith, as well as Senator 
Johnson, for their advocacy here.
  I don't want to get this crucial point lost: it is not us; it is the 
courageous patients and their friends and their families who deserve 
the most recognition about how far we have come to get this bill 
passed. Today is for them, not for us.
  Thirty-eight States, soon to be 39 States, have passed this bill. 
That is enough to amend the U.S. Constitution, but here we stand 
because some have come and said we shouldn't give people false hope.
  There is no such thing as false hope. You either have hope or you 
have no hope. In this instance, this bill gives tens of thousands, 
perhaps hundreds of thousands, or millions even, the hope that they can 
avail themselves of medication that might prolong their life or maybe 
even be a cure. These people who have advocated are fighters.
  I hear about patient groups who oppose this, yet the States, our 
employers, they approve this. Every day, Laura McLinn, the mother of 
Jordan McLinn, receives countless emails from people similarly 
situated, saying: We need to pass the Right to Try Act. I need that 
right to try.
  I am told: Oh, well, we take care of 1,500 a year.
  Mr. Speaker, 1,500 a year, when there are literally tens of thousands 
of people who need their opportunity.
  We are not mandating even. We are providing an opportunity. We are 
providing an option both for the patient and even the pharmaceutical 
company.
  Now, I heard in the opening statement from my friend across the aisle 
that we are not compelling them to do it.
  Would he feel more comfortable if we compelled pharmaceutical 
companies to provide those potential lifesaving medications?
  We need to recognize that this bill is not for us in this Chamber. It 
is for Matt Bellina, Jordan McLinn, and Laura McLinn. It is for those 
who are similarly situated.
  We have waited long enough. Let's get this done.
  Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from 
Illinois (Ms. Schakowsky).
  Ms. SCHAKOWSKY. Mr. Speaker, I rise in opposition to H.R. 5247 
because it actually creates a dangerous back door around the Food and 
Drug Administration approval process and it ignores that there is a 
safe pathway for terminally ill patients to get the treatment that they 
need.
  This bill denies patients what they really need, which is safe and 
effective treatments.
  This bill strips away important safeguards in the name of helping 
patients. It is not patient friendly. That is why 78 patients and 
doctor groups are all opposed to this legislation, like the American 
Cancer Society, the National Brain Tumor Society, the Leukemia and 
Lymphoma Society, and the Vietnam Veterans of America.
  Mr. Speaker, I include in the Record this 5-page list of the opposing 
groups.

              Groups Opposed to Right to Try Legislation,

       ADNP Kids Research Foundation, AIDS Action Baltimore, 
     Alliance for Aging Research, Alliance for Regenerative 
     Medicine, American Academy of Neurology, American Association 
     of Justice, American Cancer Society Cancer Action Network, 
     American Lung Association, American Society of Clinical 
     Oncology, American Syringomyelia and Chiari Alliance Project, 
     Amyloidosis Support Groups, Association for Creatine 
     Deficiencies, Benign Essential Blepharospasm Research 
     Foundation, Biomarin, Bonnie J. Addario Lung Cancer 
     Foundation, Breast Cancer Action, Bridge the Gap--SYNGAP 
     Education and Research Foundation, CancerCare, Cancer 
     Prevention and Treatment Fund, Charlotte and Gwenyth Gray 
     Foundation to Cure Batten Disease, Children's Cause for 
     Cancer Advocacy, Children's Cardiomyopathy Foundation, 
     Congenital Hyperinsulinism International, CurePSP.
       Cutaneous Lymphoma Foundation, Cystic Fibrosis Foundation, 
     Defeat MSA, The Desmoid Tumor Research Foundation, The 
     Disability Rights Legal Center, Dupl5q Alliance, Dysautonomia 
     Foundation, Equal Access for Rare Disorders, Fight Colorectal 
     Cancer, FORCE: Facing Our Risk of Cancer Empowered, Former 
     FDA Commissioner Margaret Hamburg, Former FDA Commissioner 
     Robert Califf, Friedreich's Ataxia Research Alliance (FARA), 
     Friends of Cancer Research, Georgia State University College 
     of Law, The Global Foundation for Peroxisomal Disorders, 
     Glutl Deficiency Foundation, The Guthy-Jackson Charitable 
     Foundation, Hemophilia Federation of America, Hematology/
     Oncology Pharmacy Association, HLRCC Family Alliance, Hope 
     for Hypothalamic Hamartomas, Hyper IgM Foundation, Inc., 
     International Fibrodysplasia Ossificans Progressiva (FOP) 
     Association, International Myeloma Foundation.
       International Pemphigus and Pemphigoid Foundation, 
     International Society for Stem Cell Research, International 
     Waldenstrom's Macroglobulinemia Foundation (IWMF), The Isaac 
     Foundation, Jack McGovern Coats' Disease Foundation, The LAM 
     Foundation, The Leukemia & Lymphoma Society, Lymphoma 
     Research Foundation, Li-Fraumeni Syndrome Association (LFS 
     Association / LFSA), LUNGevity Foundation, Max Cure 
     Foundation, M-CM Network, Mattie Miracle Cancer Foundation, 
     MitoAction, MLD Foundation, Moebius Syndrome Foundation, The 
     MSA Awareness Shoe, Mucolipidosis Type IV Foundation, The 
     Myelin Project, Myotonic Dystrophy Foundation, National Brain 
     Tumor Society, National Coalition for Cancer Survivorship, 
     National Comprehensive Cancer Network, National Consumers 
     League, National Health Council.
       National MPS Society, National Niemann-Pick Disease 
     Foundation, National Organization for Rare Disorders (NORD), 
     National Patient Advocate Foundation, National Physicians 
     Alliance, National PKU Alliance, National PKU News, National 
     Women's Health Network, Neurofibromatosis Northeast, NYU 
     Langone Health, Operation ASHA, Our Bodies Ourselves, PRP 
     Alliance, Inc., Prevent Cancer Foundation, Public Citizen, 
     Rare and Undiagnosed Network (RUN), Sarcoma Foundation of 
     America, Scleroderma Foundation, The Snyder-Robinson 
     Foundation, Sofia Sees Hope, SSADH Association, Susan G. 
     Komen, TargetCancer Foundation, Treatment Action Group, The 
     Turner Syndrome Society.
       TMJA (Temporomandibular Joint Disorders patient 
     organization), United Leukodystrophy Foundation, United 
     Mitochondrial Disease Foundation (UMDF), University of 
     Pennsylvania Perelman School of Medicine, Veterans Health 
     Council, Vietnam Veterans of America, VHL Alliance, 
     Washington Advocates for Patient Safety, Woody Matters, 
     Worldwide Syringomyelia & Chiari Task Force, Yale School of 
     Public Health.

  Ms. SCHAKOWSKY. Mr. Speaker, it opens the door for bad actors to take 
advantage of terminally ill patients. It is the FDA's job to ensure 
that drugs are safe and effective. We can't trust manufacturers to act 
as a gatekeeper.
  The important thing to know is there is already a safe process for 
terminally ill patients to access experimental treatments. Under the 
Expanded Access Program, 99 percent of applications are approved, and 
they are done in a speedy way.
  This process is not merely a rubber stamp. The FDA plays a vital role 
in ensuring these experimental treatments are safe.
  Even more important, in 19 States that have passed right-to-try laws, 
patients using an investigational drug can lose their hospice care; and 
in 6 States, they can be denied home healthcare. These are the very 
people who depend on hospice and home care, and they could lose those 
services.
  This is not a humane, patient-centered bill for people who are facing 
death. It is just a dangerous pathway for bad actors to exist.
  Let's go with the positive ability right now that we have. Ninety-
nine percent of those desperate people looking for hope will get it 
from the Food and Drug Administration. So I urge my colleagues to 
oppose H.R. 5247.
  Mr. WALDEN. Mr. Speaker, when Illinois took this up, they approved it 
169-1 in their assembly.
  Mr. Speaker, I yield as much time as he may consume to the gentleman 
from Virginia (Mr. Griffith).
  Mr. GRIFFITH. Mr. Speaker, I thank Chairman Walden for yielding.
  Mr. Speaker, I have heard people say that this bill gives folks a 
false hope. There is no false hope.
  They know it is a Hail Mary pass. They know it is unlikely to 
succeed, but they are willing to make the decision and the choice to 
take that chance.
  I have heard that patients will be at risk, that they lose their 
safeguards. They have received a terminal diagnosis. They know they are 
at risk. They don't care about safeguards. They want to fight for life. 
They know they have that terminal disease or diagnosis and they may 
lose a few weeks, as we heard from my colleague, but they may gain 
years, and they are willing to take that risk.

[[Page H1526]]

  Mr. Speaker, I have to tell you, if I had a terminal diagnosis, I 
would even consider injecting monkey urine if I thought it would give 
me a few more months or a few more years with my children, who are 
currently 18, 12, and 10. Others may choose not to try something. They 
may not want the right to try. They may not want to try the Hail Mary 
pass, but they should have the choice. They should have the right to 
try.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, as I have said, I have great concerns that H.R. 5247 
would expose our most vulnerable and desperate patients to unnecessary 
risk.
  Supporters of this legislation have argued that those patients who 
are suffering from a terminal illness deserve the right to take their 
health and treatment into their own hands, as they are faced without 
any other treatment options. Some have even asked: What risk could be 
worse than the risk of death?
  As Arthur Caplan, a bioethicist from NYU, has pointed out: ``There 
are things worse than death; being made to die faster, being made to 
die more miserably.''
  These are all very real scenarios that patients could be exposed to 
under the misleading and ill-conceived right-to-try pathway.
  As I stated before, while the FDA approved 99 percent of the requests 
it received, of those, they revised 11 percent in order to protect 
patients. If this bill becomes law, the FDA no longer will have the 
opportunity to make those revisions and to protect vulnerable patients.
  We must protect patients from bad actors or from dangerous treatments 
that might make their lives worse. That is why more than 100 
organizations have written in opposition to this legislation, including 
83 patient organizations like the National Organization for Rare 
Disorders, the Friends of Cancer Research, the American Cancer Society, 
Cancer Action Network.
  In a letter to the Speaker and the Democratic leader, the patient 
organizations noted that ``the alternative pathway in the latest 
version of the legislation is still less safe for our patients than the 
current expanded access process'' that the FDA uses.
  Dr. Ellen Sigal, the chair and founder of Friends of Cancer Research, 
said: ``In its current form, the proposed legislation does nothing for 
patients other than provide false hope by allowing them to request a 
drug with no evidence of efficacy they may never receive and, should 
they receive it, may do more harm than good.''
  So I think we should all be concerned about protecting patients. 
Rather than rushing this bill through today, I would urge my colleagues 
to oppose this legislation and to come back to the table to find a 
solution that will streamline Expanded Access Programs while protecting 
patients from unnecessary harm.
  Mr. Speaker, I reserve the balance of my time.
  Mr. WALDEN. Mr. Speaker, I yield 2 minutes to the gentleman from 
Texas (Mr. Burgess), the chair of our Health Subcommittee. Texas voted 
unanimously for the Right to Try Act.
  Mr. BURGESS. Mr. Speaker, I thank the chairman for yielding.
  Mr. Speaker, just a little over a month ago, President Trump stood 
here at this podium behind me and told us: ``People who are terminally 
ill should not have to go from country to country to seek a cure.''
  Along with President Trump, I want to give patients a chance right 
here at home.
  A little over a year ago, this House passed the 21st Century Cures 
Act, made unprecedented acceleration of discoveries. Thanks to our 
researchers and our academic institutions, and those working in the 
pharmaceutical and medical device companies, Americans have access to 
more and more innovative treatments. However, I continue to hear from 
patients with serious life-threatening conditions, including my 
constituents in north Texas, who are frustrated with what they see as 
regulatory barriers from trying and experimenting with new therapies 
when everything else has failed.

  When potentially lifesaving treatments exist but remain unavailable 
to patients, we have an opportunity to move past what has long been a 
dilemma towards delivering a hopeful message.
  Since 2014, 38 States, including Texas, have passed a version of 
right-to-try laws.
  I am pleased that the House of Representatives is considering right-
to-try legislation that gives patients a chance at life by improving 
access to experimental treatments.
  Mr. Speaker, a lot of people deserve thanks for getting this bill to 
us today, but, in particular, I want to thank the President of the 
United States, President Trump, and Vice President Pence for their 
leadership in this effort.
  Mr. Speaker, I urge my fellow Members to support this bill.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, there are a lot of reasons to oppose this bill today, 
and I have given a number of them, but the primary reason being the 
need to continue protecting patients by ensuring that the FDA remains a 
part of the process.
  While we are speaking about process, I have to also oppose this 
legislation based on the inappropriate way the Republican majority is 
bringing this bill to the floor. Bills considered under suspension have 
traditionally gone through the committee process with overwhelming 
bipartisan support, and neither of those things is the case with this 
bill.
  It was introduced today.
  Does the majority really believe they are giving Members the 
appropriate time to view this bill when it was introduced at 2 p.m.?
  Patient access and patient safety should be shared goals among 
Democrats and Republicans, goals that could be achieved if this 
legislation was not being rushed to the floor under an arbitrary 
deadline.
  Legislation such as this, that carries such great risk of patient 
harm, should be considered carefully, with attention paid to the 
unintended consequences that could follow.
  Mr. Speaker, I would urge my colleagues to oppose this unnecessary 
and risky legislation, and to return to the regular order of the 
committee to consider legislation that would protect both patients from 
harm and the FDA from the weakening of the agency's role in our drug 
approval process.
  We should not be voting on a bill of this consequence that was 
introduced this afternoon.
  Mr. Speaker, I reserve the balance of my time.

                              {time}  1815

  Mr. WALDEN. I yield 2 minutes to the gentleman from Georgia (Mr. 
Carter), a distinguished member of our committee and a pharmacist by 
training and trade.
  Mr. CARTER of Georgia. Mr. Speaker, I rise today in support of the 
Right to Try Act because this legislation will improve access to 
potentially lifesaving treatments for patients with terminal diseases 
or conditions.
  Currently, patients can only receive drugs that are undergoing FDA 
review through clinical trials, through compassionate use, or expanding 
access. They access these unapproved treatments exclusively through the 
FDA but not through the drug sponsor. This critical legislation would 
establish informed consent for patients to access unapproved drugs that 
could save their lives.
  This bill still guards patients from manufacturers misbranding or 
mislabeling drugs and specifies that any unapproved drug used in the 
alternative pathway must have an active application and is not the 
subject of a clinical hold.
  I thank my good friend Chairman Burgess and the rest of my colleagues 
on the committee for moving this legislation forward and working with 
the administration and stakeholders on all sides of these issues. This 
is a great step forward towards ensuring our patients get to take 
advantage of the incredible pharmaceutical therapies that our 
manufacturers are known for.
  I applaud the Energy and Commerce Committee for their work in moving 
this legislation forward, and I urge my colleagues to support this 
legislation.
  Mr. PALLONE. Mr. Speaker, may I ask the gentleman how many speakers 
he has left.
  Mr. WALDEN. Mr. Speaker, we have two, I believe, left.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.

[[Page H1527]]

  Mr. Speaker, I just want to talk about two other aspects of this bill 
that I haven't so far. One is the fact that States have actually 
implemented right-to-try laws that have done little to expand access to 
investigational treatment. Although 17 States and the District of 
Columbia have enacted right-to-try laws, there is no evidence that 
anyone has obtained an investigational treatment via these laws that 
couldn't have been obtained through FDA's expanded access program.
  Right-to-try laws do not compel companies to provide patients access 
to investigational treatments. Therefore, under these State laws, 
patients still do not have a right to try, only the right to request 
the treatment from the company. State right-to-try laws do not address 
the fundamental barriers of cost and accompanying restrictions.
  Neither the FDA nor States require insurers or pharmaceutical 
companies to cover the cost or reduce the cost of these expensive 
treatments. Instead, these laws put patients at a higher risk by 
prohibiting or weakening FDA oversight of investigational treatments.
  With regard to clinical trials, the legislation could also expose 
patients to unnecessary risk by allowing access to investigational 
drugs that have only completed a phase I clinical trial. Phase I trials 
are extremely small trials, in the range of 20 to 80 patients, and are 
used primarily to determine toxicity. They do not determine 
effectiveness or potential side effects. Patients could suffer from 
harmful side effects or delay enrolling in a clinical trial program for 
a treatment that actually has evidence of efficacy for their disease or 
condition.
  Finally, the bill would weaken the FDA's ability to oversee the 
adverse events or other clinical outcomes from the use of 
investigational drugs and provide broad liability protections for 
manufacturers, leaving patients with no recourse in the case of an 
adverse effect.
  I just wanted to mention those.
  Mr. Speaker, I reserve the balance of my time.
  Mr. WALDEN. Mr. Speaker, I yield 2 minutes to the gentleman from 
Georgia (Mr. Allen).
  Mr. ALLEN. Mr. Speaker, I rise today to urge my colleagues to join me 
in supporting the Right to Try Act.
  When those we hold dearest are diagnosed as terminally ill, the last 
thing we want to hear is that all treatment options have been 
exhausted. This is why I have been a longtime supporter of the Right to 
Try Act. Currently, 38 States have already passed right-to-try 
legislation to assist vulnerable patients, including my home State of 
Georgia.
  By allowing terminally ill patients the access to unapproved drugs 
and therapies, we are giving them a fighting chance for their God-given 
right to life. Although these drugs cannot guarantee a road to 
recovery, they can provide a better alternative in many hopeless 
situations and pave the way for more scientific breakthroughs.
  Congress should keep breaking down regulatory barriers. Like the 
bill's name says, patients have a right to try. All Americans should 
have the right to choose.
  Mr. Speaker, I thank the Energy and Commerce Committee for passing 
this important legislation out of committee, and I urge my colleagues 
to join me in supporting this bill on the House floor.
  How in the world could anyone oppose the right to choose life?
  Mr. WALDEN. Mr. Speaker, may I inquire as to how much time remains 
for each side.
  The SPEAKER pro tempore (Mr. Weber of Texas). The gentleman from 
Oregon has 3 minutes remaining. The gentleman from New Jersey has 1 
minute remaining.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I just want to conclude, if I could, in opposition to 
this bill by quoting some of the former FDA Commissioners.
  This is from Dr. Margaret Hamburg, who said:

       I am deeply concerned by the draft legislation 
     being considered to remove the FDA from the proposals 
     around right to try. Excluding the FDA will not benefit 
     those patients and would be a mistake. There is no need to 
     create a new potentially dangerous paradigm by passing 
     this legislation which does not address the real issues at 
     hand and could have unintended negative consequences, 
     leading to a possible impediment of the development and 
     approval of safe and effective therapies.

  And then, finally, is the former FDA Principal Deputy Commissioner, 
Joshua Sharfstein, who said:

       FDA review allows doctors and patients to tell the 
     difference between a medication that works and one that does 
     not. Evidence also orients the pharmaceutical market towards 
     developing products that produce meaningful benefits for 
     patients instead of just hope. Undermining FDA review by 
     giving a right to patients to try anything at any time will 
     leave more patients in desperate situations with fewer 
     options and less understanding of what could really make a 
     difference.

  Again, Mr. Speaker, I would urge opposition to this legislation.
  Mr. Speaker, I yield back the balance of my time.
  Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, when the Energy and Commerce Committee took up this 
issue in its broadest form, we heard from the FDA Commissioner, we 
heard from patients, we heard from family members, and what we heard 
was that there are barriers in States that preclude these State laws 
from working.
  That is what the Government Accountability Office told us. They 
identified two issues--liability and use of outcomes--as the two 
barriers as to why these laws passed in 38, soon to be 39, States. And 
in many cases--most cases, I would say--these laws have passed 
unanimously, with Republicans and Democrats back home supporting them, 
including in my own State. I think it was unanimous in both the house 
and the senate, all controlled by Democrats, in Oregon.
  We have listened to our constituents; we have observed what has 
happened in our States--great laboratories--and we are acting here 
today to allow those who have been given this wretched, wretched 
prescription that their life is about to end to have a chance and a 
choice. That is what we are doing today. We are overcoming the barriers 
that exist at the State level. We are doing it in a reasonable and 
thoughtful way that protects patient safety and creates this new 
alternative pathway for them.
  This is important legislation. It is not often in this body we get 
this opportunity to make this kind of a change and provide chance and 
hope for those who see their loved ones dying before their eyes.
  I met with Jordan McLinn and his mother, Laura, earlier today. They 
have been incredible advocates for this cause. And they had just come 
from a meeting with Vice President Pence, who, with the President, has 
been an extraordinary supporter of this effort.
  From his Bible, Jordan showed me the Parable of the Lost Sheep, which 
is one of his favorites. It is a parable he had shared with the Vice 
President.
  That Parable of the Lost Sheep tells us that not a single sheep 
should be lost, that the shepherd cares about them all. That same 
sentiment is what brings us here to right to try today.
  Every opportunity to save a life matters, and every patient deserves 
that right to try. That is the legislation before us today, Mr. 
Speaker. It is well conceived, it is well thought out, and it will make 
a difference in saving lives.
  I encourage my colleagues to vote ``yes'' and pass this legislation 
and give people a right to try.
  Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Oregon (Mr. Walden) that the House suspend the rules and 
pass the bill, H.R. 5247.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. PALLONE. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this motion will be postponed.

[[Page H1528]]

  

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