[Congressional Record Volume 164, Number 84 (Tuesday, May 22, 2018)]
[House]
[Pages H4355-H4366]
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 2017
Mr. BURGESS. Mr. Speaker, pursuant to House Resolution 905, I call up
the bill (S. 204) to authorize the use of unapproved medical products
by patients diagnosed with a terminal illness in accordance with State
law, and for other purposes, and ask for its immediate consideration in
the House.
The Clerk read the title of the bill.
The SPEAKER pro tempore. Pursuant to House Resolution 905, the bill
is considered read.
The text of the bill is as follows:
S. 204
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 2017''.
SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY PATIENTS
DIAGNOSED WITH A TERMINAL ILLNESS.
(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act 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 a life-threatening
disease or condition (as defined in section 312.81 of title
21, Code of Federal Regulations (or any successor
regulations));
``(B) who has exhausted approved treatment options and is
unable to participate in a clinical trial involving the
eligible investigational drug, 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 directly by the manufacturer
for so certifying; and
``(C) who has provided to the treating physician written
informed consent 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; 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 is
ongoing and has not been discontinued by the manufacturer or
placed on clinical hold under section 505(i); and
``(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).
``(b) Exemptions.--Eligible investigational drugs provided
to eligible patients in compliance with this section are
exempt from sections 502(f), 503(b)(4), 505(a), and 505(i) of
this Act, section 351(a) of the Public Health Service Act,
and parts 50, 56, and 312 of title 21, Code of Federal
Regulations (or any successor regulations), provided that the
sponsor of such eligible investigational drug or 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 is in
compliance with the applicable requirements set forth in
sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code of
Federal Regulations (or any successor regulations) that apply
to investigational drugs.
``(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 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.--
``(1) In general.--The manufacturer or sponsor of an
eligible investigational drug shall submit to the Secretary
an annual summary of any use of such drug under this section.
The summary shall include the number of doses supplied, the
number of patients treated, the uses for which the drug was
made available, and any known serious adverse events. The
Secretary shall specify by regulation the deadline of
submission of such annual summary and may amend section
[[Page H4356]]
312.33 of title 21, Code of Federal Regulations (or any
successor regulations) to require the submission of such
annual summary in conjunction with the annual report for an
applicable investigational new drug application for such
drug.
``(2) Posting of information.--The Secretary shall post an
annual summary report of the use of this section on the
internet website of the Food and Drug Administration,
including the number of drugs for which clinical outcomes
associated with the use of an eligible investigational drug
pursuant to this section was--
``(A) used in accordance with subsection (c)(1)(A);
``(B) used in accordance with subsection (c)(1)(B); and
``(C) not used in the review of an application under
section 505 of this Act or section 351 of the Public Health
Service Act.''.
(b) No Liability.--
(1) Alleged acts or omissions.--With respect to any alleged
act or omission with respect to an eligible investigational
drug provided to an eligible patient pursuant to section 561B
of the Federal Food, Drug, and Cosmetic Act and in compliance
with such section, no liability in a cause of action shall
lie against--
(A) a sponsor or manufacturer; or
(B) a prescriber, dispenser, or other individual entity
(other than a sponsor or manufacturer), unless the relevant
conduct constitutes reckless or willful misconduct, gross
negligence, or an intentional tort under any applicable State
law.
(2) Determination not to provide drug.--No liability shall
lie against a sponsor manufacturer, prescriber, dispenser or
other individual entity for its determination not to provide
access to an eligible investigational drug under section 561B
of the Federal Food, Drug, and Cosmetic Act.
(3) Limitation.--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 under any State or Federal product liability, tort,
consumer protection, or warranty law.
SEC. 3. SENSE OF THE SENATE.
It is the sense of the Senate that section 561B of the
Federal Food, Drug, and Cosmetic Act, as added by section 2--
(1) does not establish a new entitlement or modify an
existing entitlement, or otherwise establish a positive right
to any party or individual;
(2) does not establish any new mandates, directives, or
additional regulations;
(3) only expands the scope of individual liberty and agency
among patients, in limited circumstances;
(4) is consistent with, and will act as an alternative
pathway alongside, existing expanded access policies of the
Food and Drug Administration;
(5) will not, and cannot, create a cure or effective
therapy where none exists;
(6) recognizes that the eligible terminally ill patient
population often consists of those patients with the highest
risk of mortality, and use of experimental treatments under
the criteria and procedure described in such section 561A
involves an informed assumption of risk; and
(7) establishes national standards and rules by which
investigational drugs may be provided to terminally ill
patients.
The SPEAKER pro tempore. The bill shall be debatable for 1 hour
equally divided and controlled by the chair and ranking minority member
of the Committee on Energy and Commerce.
The gentleman from Texas (Mr. Burgess) and the gentleman from New
Jersey (Mr. Pallone) each will control 30 minutes.
The Chair recognizes the gentleman from Texas.
General Leave
Mr. BURGESS. Mr. Speaker, I ask unanimous consent that all Members
have 5 legislative days to revise and extend their remarks and to
insert extraneous material into the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Texas?
There was no objection.
Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, here in the people's House, we reflect the will of the
American people. When the Right to Try Act is law in 40 States, it may
no longer just be a grassroots movement. It is a call to action from
Americans from coast to coast--many of the over 1 million Americans who
die from a terminal illness every year--to return choice and control
over treatment options to where it is most effective: with the patient,
with the doctor.
Today, the House is taking up the Right to Try Act for the third
time. But the reason we are here again debating this issue is because
of the Senate Democrats' refusal to take up the revised right-to-try
legislation that passed this House by a bipartisan vote 2 months ago.
That revised bill, H.R. 5247, was more narrowly crafted than this
version of S. 204.
This version, the Trickett Wendler, Frank Mongiello, Jordan McLinn,
and Matthew Bellina Right to Try Act of 2017, is before us today. S.
204 was authored by Senator Ron Johnson of Wisconsin and passed by
unanimous consent in the Senate last August.
I think it is important, so let me take a moment to lay out the
efforts by the Energy and Commerce Committee since that time.
First, the Energy and Commerce Health Subcommittee, which I chair,
held a hearing last October to consider right-to-try bills, including
this bill, S. 204, where Members heard from Dr. Scott Gottlieb, the
Commissioner of the Food and Drug Administration, from patients and
other groups that either support or oppose the concept of right to try.
For several months, our committee engaged in conversations with
patients, advocates, the administration, particularly the Food and Drug
Administration, and stakeholders on all sides of this complex topic.
Our aim was to open the door to innovative, experimental drugs for
terminally ill patients without necessarily compromising the vital work
and mission of the Food and Drug Administration. The product of that
aim was H.R. 5247, the revised House right-to-try bill.
Sadly, Senate Democrats said ``thanks, but no thanks'' to the House
bill. Frankly, I am perplexed by their decision, because not a single
Senate Democrat expressed any reservation when S. 204 passed their
Chamber by unanimous consent last August.
So House Republicans will show the American people that we hear you.
We will act to deliver on a promise made by the President in this House
before the joint session of the House and Senate during the State of
the Union address. He told us that we would pass the right-to-try
legislation. Well, today, we are doing just that.
You know, this was kind of a bold statement by the President, to
stand up in the State of the Union and say that he wanted to sign this
bill into law. So I am proud to boldly stand with him and stand with
the American people.
Mr. Speaker, we live in the greatest Nation in the world. An
unprecedented amount of innovation and scientific breakthrough is the
norm. We have innovative treatments at our fingertips because of the
valuable contributions of researchers in academia and the private
sector.
Despite these achievements, I still hear from patients with serious,
life-threatening conditions, including constituents from north Texas,
who remain frustrated with the current regulatory processes that
prevent them from trying or experimenting with new therapies when
everything else has failed them.
As a physician, I understand that access to investigational drugs and
therapies is a deeply personal priority for those seeking treatment for
their loved ones with serious terminal conditions.
To my friends on the other side of the dais in the committee and the
aisle here in the House, I have a simple question: Why do you not want
to allow these patients to exercise their right to fight for
their future?
Mr. Speaker, I am proud to support H.R. 5247, the House right-to-try
bill that currently remains in the Senate.
However, the right-to-try legislation before the House today is the
Senate bill, S. 204, so I am pleased that we are considering this
right-to-try bill so that terminally ill patients have a chance, maybe
a second chance, at life.
These patients are our constituents. They could be someone we know.
Let us take this opportunity to improve access to experimental
treatments for them and give them renewed hope.
S. 204 establishes an alternative pathway for terminally ill patients
to access certain investigational drugs that have successfully
completed a phase one clinical trial and have an active application at
the Food and Drug Administration. They also must be under active
development or production by the manufacturer.
It is important to note that, for these patients, they have exhausted
all FDA-approved treatment options and are unable to participate in a
clinical trial involving these investigational drugs.
The bill we will be voting out soon is about patients. It is about
having more
[[Page H4357]]
time with their loved ones. In the words of Vice President Mike Pence,
``It's about restoring hope and giving patients with life-threatening
diseases a fighting chance.''
With hundreds of thousands of Americans with a terminal illness and
their families looking for us to act, I urge Members of this House, the
people's House, to support restoring hope and giving them a fighting
chance at life.
I urge a vote in support of S. 204. Let us send this groundbreaking
legislation to the President's desk for his signature, and let it
become the law of the land.
Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in strong opposition to S. 204, the Federal
Right to Try Act. This is dangerous legislation that threatens FDA's
authority over ensuring that medical treatments are safe and effective.
This bill needlessly exposes vulnerable patients to the risks of
unproven medications.
{time} 1600
We heard last night in the Rules Committee from my Republican
colleagues that we must accept and pass this legislation because the
Senate is unable to pass a bill that passed the House earlier this
year. That House bill was bad enough, but this Senate bill is much
worse. I cannot fathom why my Republican colleagues are surrendering to
the Senate and agreeing to pass a more dangerous version of the right-
to-try legislation.
The Senate bill, like the House bill, establishes an alternative
pathway for experimental treatments that eliminates any review from the
Food and Drug Administration and scientific and medical experts of an
independent review board. This will provide fly-by-night physicians and
clinics the opportunity to peddle false hope and ineffective drugs to
desperate patients.
At a hearing before our committee, FDA Commissioner Scott Gottlieb
cautioned that S. 204 risked ``exposing people to unwanted side effects
from experimental therapies.''
Now, supporters of this bill would have you believe that this
legislation is targeted at those with terminal illnesses, but this is
simply not the case. S. 204 would, in fact, apply to a much broader
range of patients diagnosed with life-threatening diseases or
conditions. And the term ``life-threatening disease or condition''
could include chronic and often manageable diseases, such as diabetes
or chronic heart failure.
If all patients with diabetes and other chronic but manageable
illnesses were eligible, it would greatly expand the scope of the
legislation well beyond the scope of most State laws and FDA's expanded
access program. This exposes an even greater number of patients to risk
and undermines our clinical trial program by diverting patients from
trials that could support full approval to the alternate pathway.
Commissioner Gottlieb also cautioned Congress that this legislation
risked ``undermining a regulatory process that has been carefully
crafted over many years to strike a very careful balance.'' The
Commissioner noted that S. 204 would not subject all participants to
the alternate pathway to critical regulatory requirements, such as
labeling products as investigational, charging limitations, and
restrictions on promotion and commercialization of such treatments.
S. 204 could also impede the FDA from taking action against
manufacturers and others that violate other provisions of the Federal
Food, Drug, and Cosmetic Act. Under this bill, if a bad actor is not in
compliance with good manufacturing practices or does not protect
against intentional alteration--adulteration, I should say--or allows
dishonest or misleading labeling, the FDA will not be able to take any
enforcement action.
But, more importantly, Mr. Speaker, this Federal right-to-try bill
simply is not necessary, in my opinion. FDA has an expanded access
program and has an approval rate of nearly 100 percent.
To be clear, FDA's high approval rate is not just a rubberstamp for
these applications. Of the applications FDA receives and approves, it
also adjusts applications for 11 percent of patients to improve patient
safety protections. This could include modifying the dosing,
strengthening informed consent, or improving safety monitoring.
We must protect patients from bad actors or from dangerous treatments
that might make their lives worse. Without this critical review, there
will not be any oversight to ensure that patients are not being taken
advantage of or put in harm's way.
The main reason this bill is being pushed is to chip away at FDA's
authority to ensure the safety and effectiveness of our drugs.
FDA oversight of access to experimental treatment exists for a
reason: it protects patients from potentially snake oil salesmen or
from experimental treatments that might do more harm than good.
By removing the FDA oversight, you are counting on physicians and
manufacturers to serve as the gatekeeper and protector of our patients.
I simply don't buy that that is going to work.
Supporters of this bill want to blindly believe that there are no bad
actors out there, but imagine someone like Martin Shkreli promising a
dying patient a cure that could save their life. Under this bill, FDA
would play no role in determining whether or not Martin Shkreli could
provide that drug to that dying patient.
If S. 204 is signed into law, patients will be taken advantage of and
will be harmed. Bad actors exist, and this Republican bill gives them
the opportunity to prey on desperate people who are, understandably,
looking for any treatment that may help save their lives.
Now, let me also point out that the supporters of this bill claim to
be helping desperate patients who are looking for hope. If this is such
a patient-centered bill, why does every major patient organization
overwhelmingly oppose it? Where is the call from patients for this
legislation?
More than 100 patient organizations, including the National
Organization for Rare Disorders, Friends of Cancer Research, and
American Cancer Society Cancer Action Network, sent a letter to
Congress just yesterday opposing this legislation. In the letter, they
stated: ``The Senate version of the legislation is less safe than the
pathway proposed in the House version and is dangerous compared to the
current expanded FDA access process.''
Four former FDA Commissioners from both parties also oppose this
Republican legislation, noting: ``There is no evidence that either
bill''--that is the House or the Senate--``would meaningfully improve
access for patients, but both would remove the FDA from the process and
create a dangerous precedent that would erode protections for
vulnerable patients.''
Mr. Speaker, S. 204, I know, is a key agenda item for the President
and the Vice President; but I think it is dangerous for our patients,
and it is an unprecedented attempt to roll back FDA's oversight of
investigational treatments.
Mr. Speaker, I urge my colleagues to stand with more than 100
organizations that have come forward to oppose this misguided and, I
believe, harmful legislation.
Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield 5 minutes to the gentleman from
Oregon (Mr. Walden), the chairman of the full committee.
Mr. WALDEN. Mr. Speaker, today represents the third time this year
that the House has considered legislation to deliver hope to patients
who are battling terminal diseases. Twice already, a bipartisan
majority of Members has supported increasing patient access to
investigational drugs through a new pathway outside of the existing
expanded access program, and the bill before us today is deserving of
that same support.
Thirty-nine States have right-to-try laws, including my home State of
Oregon. While the State policies vary, they have a common goal: helping
vulnerable patients. President Trump praised the movement during the
State of the Union. He said: ``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.'' Those are the President's words. Since this
time, he has continued to feverishly advocate for this legislation.
For today's debate, I believe it is important to understand that it
is both
[[Page H4358]]
the background of this issue as well as the politics that have brought
us back to this floor.
Today, there is an existing process for patients to access unapproved
drugs. The FDA oversees the expanded access program, commonly known as
compassionate use. This program has been critical in helping patients
access experimental or investigative drugs.
As I previously said before in this Chamber, Commissioner Gottlieb
and the agency should be commended for their continued work to improve
the expanded access program for patients.
To improve this successful program, the bill this Chamber previously
passed 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 the legislation. That provision removes one of the
biggest hurdles patients face, as identified by the Government
Accountability Office, in gaining access to experimental therapies:
manufacturer hesitancy to participate. That is the obstacle. That same
bill creates a new alternative pathway for patients who do not qualify
for a clinical trial.
It is my view that the House-passed bill strengthens patient
protections with clearer informed consent and adverse event reporting.
The bill also ensures that the FDA is notified when a patient receives
an unapproved drug through the new alternative pathway to ensure proper
oversight.
But when a strong bipartisan majority of this Chamber, of the U.S.
House of Representatives, Mr. Speaker, delivered for patients and
answered President Trump's call to give Americans the right to try,
leaders in the Senate on the other side of the aisle objected, blocking
terminally ill patients from increasing access to investigational
drugs. But we will not allow them to play politics to delay this effort
any longer. That is why we are here today.
Mr. Speaker, across our great country, men, women, children, and
parents are desperately seeking a beacon of hope, and the Senate bill
we have before us today will provide it.
Mr. Speaker, I thank President Trump and Vice President Pence for
continuing to weigh in on this important issue; and the sponsors of
past and current legislation, including Senator Johnson and
Representatives Fitzpatrick and Biggs, who are here with us today. They
have all been tireless in their advocacy and their efforts for this
worthy cause. I am glad to see that, together, we are once again going
to deliver.
But, most importantly, I would like to acknowledge the individuals
this bill is named after: Trickett, Frank, Jordan, and Matthew. Jordan
was here on the House floor the first time we considered right-to-try
legislation, and Matthew testified at our hearing last fall. Jordan is
back with us today. It is through their advocacy and hope to find a
treatment or a cure that we have this chance to give patients the right
to try.
Mr. Speaker, it is time for the House to do what the entire United
States Senate did and pass this legislation. It is time to send a
right-to-try bill to President Trump's desk, where he is eager to sign
it.
Mr. Speaker, I urge all of my colleagues to support this legislation.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Florida (Ms. Castor), the vice ranking member of the Energy and
Commerce Committee.
Ms. CASTOR of Florida. Mr. Speaker, I thank the ranking member for
his leadership and for yielding me time.
Mr. Speaker, S. 204 is harmful legislation that offers a false hope
of access to investigational therapies and endangers patients who have
serious and life-threatening diseases. The bill establishes a dangerous
and unnecessary alternative pathway that is void of any FDA review or
oversight. It is opposed overwhelmingly by the patient community.
Mr. Speaker, I include in the Record a letter to the Speaker and
minority leader from 104 patient advocacy groups. It includes such
groups as the American Cancer Society Cancer Action Network, the
American Lung Association, the Cystic Fibrosis Foundation--all opposed
to this bill--the Leukemia & Lymphoma Society, and about 100 more.
May 21, 2018.
Hon. Paul Ryan,
Speaker, House of Representatives, Washington, DC.
The Hon. Nancy Pelosi,
Minority Leader, House of Representatives, Washington, DC.
Dear Speaker Ryan and Leader Pelosi: The undersigned
organizations collectively represent millions of patients
with serious and life-threatening diseases. We write to
express our strong opposition to the Trickett Wendler, Frank
Mongiello, Jordan McLinn, and Matthew Bellina Right to Try
Act (S. 204).
On March 21st, The House of Representatives passed a
version of the Right to Try Act (H.R. 5247), that
incorporated important patient safeguards such as more robust
informed consent and public reporting requirements,
additional Food and Drug Administration (FDA) oversight, and
a narrower definition of eligibility for this pathway. The
Senate version does not include these safeguards and
therefore could greatly increase the likelihood of our
patients being harmed by unsafe and ineffective experimental
therapies. Therefore, this version is substantially worse for
patients.
We reiterate our concern with creating a secondary pathway
for accessing investigational therapies outside of clinical
trials. This pathway removes FDA approval and consultation
and would not increase access to promising therapies for our
patients because it does not address the primary barriers to
access.
FDA's expanded access program, though imperfect,
facilitates access to investigational therapies for over a
thousand patients facing serious and life-threatening
conditions each year. FDA repeatedly approves over 99 percent
of requests while sometimes making important dosing and
safety improvements to proposed expanded use. Conversely, it
is often times the pharmaceutical company that denies access
to its investigational therapy outside of its clinical trials
for any number of reasons.
The Senate version of the legislation is less safe than the
pathway proposed in the House version and is dangerous
compared to the current expanded access process. The Senate's
bill would allow unproven therapies to be given to patients
without FDA notification for up to a full year and would not
establish any standards for informed consent.
Additionally, both versions prohibit FDA from halting
access to these experimental therapies short of placing a
clinical hold on all clinical research on the therapy in
question. Both House and Senate versions would also remove
FDA's consultation on dosing, route of administration, dosing
schedule, and other important safety measures available under
FDA's current expanded access program.
While we did not support the recent House passed version of
this legislation, the House legislation includes improved
patient safeguards compared to the Senate version. The Senate
version would negatively impact patient safety substantially,
and our collective organizations are strongly opposed. We
appreciate past efforts in the House to consider stakeholder
perspectives and desire to continue the dialogue, but
returning to the Senate version is simply not the way
forward.
Sincerely,
A Twist of Fate-ATS; ADNP Kids Research Foundation; Adult
Polyglucosan Body Disease Research Foundation; AIDS Action
Baltimore; Alliance for Aging Research; Alliance of Dedicated
Cancer Centers; American Cancer Society Cancer Action
Network; American Lung Association; American Society of
Clinical Oncology; American Syringomyelia and Chiari Alliance
Project; Amyloidosis Support Groups; APS Type 1 Foundation;
Association for Creatine Deficiencies; Association of
American Medical Colleges; Benign Essential Blepharospasm
Research Foundation; Bonnie J. Addario Lung Cancer
Foundation; Bridge the Gap-SYNGAP Education and Research
Foundation; CancerCare; Charlotte and Gwenyth Gray Foundation
to Cure Batten Disease; Children's Cardiomyopathy Foundation.
Congenital Hyperinsulinism International; cureCADASIL;
CurePSP; Cutaneous Lymphoma Foundation; Cystic Fibrosis
Foundation; Defeat MSA; The Desmoid Tumor Research
Foundation; The Disability Rights Legal Center; Dupl5q
Alliance; Dysautonomia Foundation; Dyskeratosis Congenita
Outreach, Inc.; Equal Access for Rare Disorders; Fight
Colorectal Cancer; FORCE: Facing Our Risk of Cancer
Empowered; Friedreich's Ataxia Research Alliance (FARA);
Friends of Cancer Research; The Global Foundation for
Peroxisomal Disorders; Glutl Deficiency Foundation; The
Guthy-Jackson Charitable Foundation; Hemophilia Federation of
America.
HLRCC Family Alliance; Hope for Hypothalamic Hamartomas;
Hyper IgM Foundation, Inc.; Incontinentia Pigmenti
International Foundation; Indian Organization for Rare
Disorders; 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; Li-Fraumeni Syndrome Association (LFS
Association/LFSA); LUNGevity Foundation; Lymphangiomatosis
[[Page H4359]]
& Gorham's Disease Alliance; 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 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 PKU Alliance; National PKU
News; Neurofibromatosis Northeast; The Oley Foundation;
Operation ASHA; Organic Acidemia Association.
PSC Partners Seeking a Cure; Platelet Disorder Support
Association; PRP Alliance, Inc.; Pulmonary Fibrosis
Foundation; Rare and Undiagnosed Network (RUN); Rothmund-
Thomson Syndrome Foundation; The Snyder-Robinson Foundation;
Sofia Sees Hope; SSADH Association; Susan G. Komen;
TargetCancer Foundation; Tarlov Cyst Disease Foundation; Team
Audrey; Treatment Action Group; The Turner Syndrome Society;
United Leukodystrophy Foundation; United Mitochondrial
Disease Foundation (UMDF); Vasculitis Foundation; Veterans
Health Council; Vietnam Veterans of America; VHL Alliance;
Wilhelm Foundation; Worldwide Syringomyelia & Chiari Task
Force; The XLH Network, Inc.
Ms. CASTOR of Florida. Mr. Speaker, this bill is a bill in search of
a problem. FDA has approved 99 percent of the expanded access requests
it receives. FDA's expanded access program approves nearly all requests
for investigational drugs or biologics it receives.
Physicians at the FDA are available 24 hours a day to approve any
emergency expanded access requests that the agency receives, and it
typically grants those emergency requests immediately over the phone
and nonemergency requests in a median time of 4 days and generally no
longer than 30 days. FDA has also taken actions to streamline this
entire process.
The process of clinical trials at FDA is vital to the protection of
the health of all of our neighbors and the folks we represent. In 11
percent of expanded access applications, FDA has raised a red flag and
said: Do you know what? You have got to change this.
That is who we are trying to protect here: the actual patients. The
patient groups across the country agree with us.
Many States have tinkered with right-to-try laws, but this is
different. Forty States have enacted right-to-try laws, but there is no
evidence that anyone has obtained the type of therapy via these laws
that couldn't have been obtained through the FDA's expanded access
program.
Right-to-try laws do not compel companies to provide patient access
to these treatments. Therefore, under these laws, patients still do not
have a right to try, only the right to request it from the company.
Sometimes those insurance companies will say: Do you know what? We
are not going to pay for it.
So that is going to be another barrier.
Mr. Speaker, in the end, these right-to-try laws put patients at
higher risk by prohibiting and weakening the FDA oversight, leaving our
neighbors on the hook to cover the cost of unproven treatments.
For all of these reasons, I urge a ``no'' vote on the bill. Join with
the patient advocates across America, who, in this letter, called this
a dangerous proposal.
Mr. BURGESS. Mr. Speaker, I am pleased to yield 3 minutes to the
gentleman from Texas (Mr. Barton), the vice chairman of the full
committee and chairman emeritus of the Energy and Commerce Committee.
(Mr. BARTON asked and was given permission to revise and extend his
remarks.)
Mr. BARTON. Mr. Speaker, when I was a little boy, I used to read
comic books, and one of them I read was Superman. In the Superman comic
books, way back in the 1960s, Superman had an alterego that lived on
Bizarro World.
{time} 1615
In Bizarro World, everything was a little bit off-kilter. When I
listen to my sincerely good friends on the minority side, I think they
are on Bizarro World. I know they mean well, but they are not seeing
the same planet I am seeing.
I have told this story a number of times about my brother John at the
age of 40 having liver cancer. He had exhausted all conventional
therapy. He was given less than 3 months to live.
Being a Member of Congress and on the Energy and Commerce Committee,
I had access to the National Institutes of Health and the FDA. I
called, and I said: Are there any experimental programs that you could
get my brother into that might help him?
They checked, and they had a clinical trial, I believe, in San
Antonio, Texas. We called down, and they got him into it. But they told
him: This is experimental. It has helped a lot of people so far, but it
doesn't help everybody. And if it doesn't help you, it accelerates your
disease.
He and his wife prayed about it, and his mother and myself and his
brother and sister, and we all decided, why not?
They put John in the trial, and it didn't help him, but we were at
peace because we had used every available remedy that we could to try
to help him.
This bill--which has passed the Senate, and if we pass it today, it
goes to the President and it is going to be signed this week--gives
patients, if their doctors approve, the right to try.
It has to be an investigational drug that is in an FDA clinical trial
that has passed phase one, which has proved that it is nontoxic.
It gives them the right to try. There is no downside to this. This
could become law. It would give a statutory right to try at the Federal
level.
Why in the world my friends on the minority side have a problem
with--it passed the Senate unanimously, which means, under the current
Senate, 49 Democrats voted for it by a voice vote.
There is no downside to it. The FDA is still in control of what drugs
are passed through this phase one clinical trial. And the doctor has to
recommend it, and the patient has to accept it.
So I hope we will vote ``yes.''
The SPEAKER pro tempore (Mr. Donovan). The time of the gentleman has
expired.
Mr. BURGESS. Mr. Speaker, I yield an additional 30 seconds to the
gentleman from Texas.
Mr. BARTON. Mr. Speaker, the bill has already passed the House on a
bipartisan vote. I think I am right that it passed with 261 votes the
last time we sent it.
The House bill is a little bit better bill than the Senate, but the
Senate bill is better than no bill. So please vote ``yes'' when the
time comes this afternoon.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
California (Mr. McNerney).
Mr. McNERNEY. Mr. Speaker, I thank the gentleman for yielding, and I
thank the Members of the House for talking about this issue.
Mr. Speaker, I rise in opposition to S. 204, the Right to Try Act. I
don't agree with my friend from Texas that there is no downside, and I
will go over that here in these 2 minutes.
The House took up this issue before, and I voted against it then.
This version is worse, so of course I am going to oppose it.
It would weaken the FDA's authority and provide broad access to
unproven treatments. The FDA's oversight of experimental treatment
plays a critical role in protecting patients from bad actors with
malicious intent or from drugs that are grossly untested. The FDA's
oversight protections protect patients from experimental treatments
that might do more harm than good.
Chipping away at the FDA's authority would put patients in my
district and around the country in great danger by providing liability
protections for manufacturers and weaken the FDA's oversight ability.
This legislation would leave patients with no recourse in the case of
harmful side effects.
This legislation is even more flawed, as I said, than the House bill
that I voted against back in March. Like the earlier bill, the Senate
bill contains the same dangerous, unnecessary pathways to experimental
treatments, but it exposes a much larger number of patients to serious
risk--not just terminal patients, but patients that would like to try
something that is not even tested. In fact, it is so broad, that it
exposes patients of all chronic conditions to the risk of experimental
treatments.
More than 100 major patient safety groups have voiced their strong
opposition to this bill.
Moreover, this bill is not even necessary. The FDA has an expedited
approval process for terminal patients.
[[Page H4360]]
Mr. Speaker, I urge my colleagues to stand up for patient safety and
vote against this flawed legislation.
Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from
Georgia (Mr. Carter), a valuable member of the Health Subcommittee.
Mr. CARTER of Georgia. Mr. Speaker, I thank the gentleman for
yielding.
Mr. Speaker, I rise today in support of S. 204, the Right to Try Act,
because this legislation will enhance access to potentially lifesaving
treatments for patients with terminal diseases or conditions.
Currently, patients can only receive drugs that are undergoing FDA
clinical trials through compassionate use or expanded access. At this
time, patients and their physicians can acquire unapproved treatments
through the FDA, not directly 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
new alternative pathway must have an active application that is not the
subject of a clinical hold
Mr. Speaker, I want to thank the Speaker and the majority leader for
recognizing the importance of right-to-try legislation and making sure
that we fulfill our duty to patients looking for any chance to survive
deadly conditions.
This is a great step forward toward ensuring our patients get to take
advantage of the incredible pharmaceutical therapies that are being
researched and developed in the United States.
Mr. Speaker, I urge my colleagues to support this legislation.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from New
York (Mr. Tonko).
Mr. TONKO. Mr. Speaker, I thank the gentleman from New Jersey for
yielding.
Mr. Speaker, I rise in strong opposition to the so-called Right to
Try Act.
This ideologically driven legislation is trying to solve a problem
that simply doesn't exist.
Every single Member of this body supports allowing terminally ill
individuals to seek access to experimental treatments that could be
potentially lifesaving. However, we have to do so in a structured way
that won't undermine the role of the FDA in guaranteeing that the
medications we all use are safe and are effective.
I believe the FDA's current expanded access program meets that test
by ensuring proper informed consent and adverse event reporting and
establishes the appropriate safeguards around access to experimental
drugs.
The legislation before us would take the FDA out of the process
completely and would allow a black market of snake oil salesmen to
emerge, with unscrupulous companies selling untested drugs to a broad
array of individuals, including those with manageable chronic
conditions like diabetes.
Make no mistake about it: this legislation offers false hope to
seriously ill individuals and will put patients at risk.
Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from
Arizona (Mr. Biggs).
Mr. BIGGS. Mr. Speaker, before giving my remarks, I include in the
Record a statement by Senator Johnson explaining the intent of S. 204.
Statement of Legislative Intent
(By Sen. Ron Johnson on S. 204 (as considered by the House of
Representatives))
In a recent article about pending right to try legislation,
FDA Commissioner Scott Gottlieb was quoted as saying: ``In
terms of making sure that it balances [access to experimental
drugs] against appropriate patient protections . . . with [S.
204], we'd have to do a little bit more . . . in guidance and
perhaps in regulation to achieve some of those goals, and I
think those are the goals that Congress wants us to
achieve.'' The article went on to quote Commissioner Gottlieb
as saying: ``We felt that there were certain aspects of [S.
204] that could be modified to build in additional patient
protections, but if you weren't able to do that
legislatively, that there [was] a pathway by which you do
that administratively and still remain consistent with the
letter and the spirit of this law.''
In response to this article, Commissioner Gottlieb tweeted
the ``FDA . . . stands ready to implement [right to try] in a
way consistent with the intent of Congress.''
As S. 204's primary author and lead sponsor, I want to make
this legislation's intent absolutely clear and remove any
ambiguity that the FDA could use to implement right to try in
a way contrary to its aim.
S. 204, as originally introduced, applied to patients
``with a terminal illness,'' as defined by State law. In
discussion with the FDA, the agency suggested it would prefer
a uniform federal definition, especially one that already
existed in federal statute or regulation, because an existing
federal definition would facilitate implementation of the
law. The FDA suggested defining terminal illness as an
``immediately life-threatening disease or condition.'' The
FDA disclosed that its suggested definition would exclude,
for example, patients with Duchenne muscular dystrophy--an
illness explicitly intended to be covered by the legislation.
To be clear, I rejected this proposed definition because I
believed it would inappropriately exclude patients with
certain diseases from accessing treatments. By contrast, the
legislation instead defines terminal illness as ``life-
threatening disease or condition'' (which exists in current
federal regulation), which the FDA confirmed would include
patients diagnosed with Duchenne muscular dystrophy.
Contrary to the preference of FDA official Dr. Janet
Woodcock, who expressed the FDA's desire to draft the
legislation ``to make sure we don't include patients we (the
FDA) doesn't intend to include,'' I replied and rejected that
notion by stating my intent was completely opposite hers:
``I wanted to make sure we didn't exclude any one we didn't
intend to exclude.'' My aim from the beginning was to be as
inclusive as possible such that as many patients as possible
who are facing no available alternatives could potentially
qualify.
S. 204 is fundamentally about empowering terminally-ill
patients and their doctors who, together with the cooperation
of the developers of potentially life-saving therapies,
should be in charge of making a determination about their own
course of treatment. The bill is not intended to further
empower any federal agency, including the FDA, to limit in
any way the ability of an individual facing a life-
threatening disease or condition from accessing treatment. S.
204 is about preserving a right to hope and about expanding
individual freedom. It is not meant to empower the FDA to
limit the right to hope by regulation or guidance.
S. 204 includes a provision ensuring the Secretary may not
use a clinical outcome associated with the use of an eligible
investigational drug to delay or adversely affect review or
approval of the drugs, unless use of such clinical outcome is
critical to determining safety. This language is in no way
intended to enable the FDA to expand the scope of existing
safety determinations regarding investigational drugs.
S. 204 requires, in certain circumstances, that an eligible
investigational drug be under investigation in a clinical
trial that is intended to form the primary basis of a claim
of effectiveness in support of approval or licensure.
According to the FDA, this language simply incorporates the
standard definition of a clinical trial. This language is not
in any way intended to enable the FDA to exclude any clinical
trial as a basis for precluding access to treatments under
right to try.
Mr. BIGGS. Mr. Speaker, I rise today in strong support of the Right
to Try Act and on behalf of the patients who are fighting each and
every day to try to save their own lives.
It has been a long ride, but we are in sight of our destination.
Mr. Speaker, I would like to take a brief moment to thank my friend
and colleague, Representative Fitzpatrick, for working with me on this
cause from the moment we both entered office last year, and to extend
my appreciation to Senator Johnson, whose efforts on behalf of right to
try have been extraordinary.
Mr. Speaker, I also thank Chairman Walden for his efforts and the
leadership of President Trump and Vice President Pence.
Mr. Speaker, I acknowledge and thank my predecessor, Congressman Matt
Salmon, for his tireless efforts to pass right to try.
But it is the patients themselves and their tireless advocates who
deserve the most recognition. I have said this before and I will
continue to say it: when the Right to Try Act passes this Chamber and
is signed into law by the President, it will be them, not us, who
deserve the most credit for this remarkable victory.
Everyone here has heard me speak about the Right to Try Act more than
a few times already and everyone here is aware of the widespread
support that this legislation has garnered. Forty States have already
passed right-to-try legislation, often with unanimous or overwhelming
support from Republicans and Democrats alike.
If we can't come together to support a commonsense cause such as this
one, I am not sure what effort we can unite behind.
[[Page H4361]]
Those on the other side of this debate--and they are a shrinking
minority--argue that this legislation is unnecessary. Well, if it is so
unnecessary, why do I receive phone calls and letters from patients
each week urging me to do everything in my power to get this
legislation passed?
I have no doubt the FDA's expanded access program helps patients, but
I also know that the agency's personnel, including Director Gottlieb
himself, want to help as many patients as possible, but their efforts
simply are not enough.
The Right to Try Act doesn't eliminate the expanded access program.
Far from it. We are merely providing another, more direct avenue for
patients to acquire potentially lifesaving medications from
pharmaceutical companies that don't require them to ask permission from
a bureaucratic middleman.
Another argument I hear from the naysayers, one that makes me angry,
is that we are peddling false hope. False hope? What is that?
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. BURGESS. Mr. Speaker, I yield an additional 30 seconds to the
gentleman from Arizona.
Mr. BIGGS. Mr. Speaker, to this tired argument, I respond that there
is no such thing as false hope. You either have hope or you don't.
I, for one, want those brave men and women who are fighting every day
against terrible illnesses and almost insurmountable odds to have a
choice, even if it is the last choice many of them will ever have the
opportunity to make. I trust them to weigh the pros and cons and choose
for themselves whether they wish to take a risk to try to save their
own lives.
Make no mistake: it is a choice. We are not offering a mandate,
merely an option.
Mr. Speaker, I urge all of my colleagues to vote ``yes'' on this
legislation.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I just want to respond briefly to the previous speaker
on the Republican side.
I don't understand how the gentleman can say that the expanded access
program will continue even under right to try.
The problem is, sure, on paper it will continue, but there wouldn't
be any reason for anyone to go to the FDA. If the FDA is now out of the
picture and all you have to do is find somebody who manufactures a drug
or treatment and get the doctor to say, ``Okay, I will administer it,''
then you don't need to go to the expanded access program.
You see, the problem is that the gentleman assumes that people will
go to the FDA and they will know that the expanded access program
exists. I think the very nature of this legislation, which basically
says that you don't have to go to the FDA, is going to mean that people
won't even know that that is an option. And if they can get somebody to
give them the drug without going to the FDA, they will just do it.
Let me just say this. I know the gentleman referred to the FDA's
bureaucrats. I guess you could say that the people at the FDA are
bureaucrats, but the FDA existed because, for many years before then,
in the 19th century and early 20th century, all kinds of snake oil and
things were advertised and promoted in the papers and in magazines,
saying that this is going to cure that, this is going to cure that, and
people demanded that there be some kind of Federal oversight as to
whether drugs or treatments actually are effective, whether they have
harm, whether they are toxic. That is why the FDA was started.
So I guess I just don't understand, because the bottom line is there
is very little evidence that there is any significant number of people
who are denied treatment or drugs because of the expanded access
program. At least then they know that some agency has looked at this to
see whether it is harmful, whether it has some negative impact.
The great concern that those of us on the other side of this issue
have is that without the FDA, there is no guarantee that what somebody
gets as a form of treatment is actually going to be meaningful, not be
harmful.
So I don't want to prolong my response to the gentleman, but I do
think that you have to understand that those of us on this side of the
aisle actually think that the FDA has a purpose and actually performs
an important function, and I don't think we should deny that. I think
it is unfortunate that there are those who think that somehow the FDA
is not doing its job.
Mr. Speaker, I reserve the balance of my time.
{time} 1630
Mr. BURGESS. Mr. Speaker, I yield 2 minutes to the gentleman from
Pennsylvania (Mr. Fitzpatrick), another principal author of the bill.
Mr. FITZPATRICK. Mr. Speaker, today is long overdue; long, long
overdue. I want to thank Leader McCarthy, Chairman Walden, Dr. Burgess,
Mr. Griffith, my friend and colleague, Andy Biggs, Senator Ron
Johnson, and all of the advocates who have had a relentless fight to
see right to try debated, passed, and signed into law once and for all.
And I want to thank the overwhelming bipartisan majority of my
colleagues here in the House who we had to work on, many of them, back
in March, who supported the Trickett Wendler, Frank Mongiello, Jordan
McLinn, and Matthew Bellina Right to Try Act and proved emphatically
that right to try is about more than politics. It is about hope.
For those patients caught in between traditional drug delay
approvals, a clinical trial process for which they do not qualify, and
limited time, the Right to Try Act.
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 saving their life.
Mr. Speaker, I want to acknowledge the Wendler, Bellina, Mongiello,
McLinn families, all who are here with us in this Chamber today to see
history be made.
Although the FDA has a program that allows terminal patients to apply
for early access to promising treatments, the Right to Try Act is
needed because the FDA's compassionate use process does not help enough
people.
While 99 percent of expanded access applications are approved, the
application process is complicated, it is time consuming, and it is
expensive.
Moreover, only about 1,200 people a year can make it through the
application process. By contrast, Mr. Speaker, in 2014, more than
12,000 people in France were using investigational treatments through
that government's equivalent program.
How is it, pray tell, that a country one-fifth the size of the United
States can help 900 percent more people? The FDA program clearly is not
working.
Mr. Speaker, the Right to Try Act gives people hope. And let me be
clear: This bill requires robust informed consent between the patient,
the doctor, and the manufacturer, while requiring notification be given
to the FDA after an unapproved drug becomes available to an eligible
patient, and requiring doctors and the manufacturers to report adverse
events.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. BURGESS. Mr. Speaker, I yield an additional 30 seconds to the
gentleman from Pennsylvania.
Mr. FITZPATRICK. Mr. Speaker, when life hangs in the balance, the
Federal Government must not stand in the way of this process. We have
to get this done once and for all.
Mr. Speaker, today, I urge my colleagues on both sides of the aisle,
appeal to the better angels of your nature. All the groups that they
say are opposed to this bill, I will tell you who is in favor of this
bill: Over 80 percent of the American people, and they are the ones who
have the power in this country, and they are the ones we have to listen
to.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, again, I would like to respond to the previous
Republican speaker. He made three comments that disturb me.
One, he said that people should be able to try things, try the drugs
or the treatment, when the benefits outweigh the risks. But how are
they going to know that when the FDA isn't involved?
When the FDA goes through various phases of clinical trial, not only
phase
[[Page H4362]]
one, which determines whether something is toxic, but beyond, to
determine whether it is effective or whether it has harmful effects,
then you do know. The FDA basically will tell you: Yes, the benefits
outweigh the risk, and that is why we have an approval process in
general for drugs, and that is why we have the expanded access, so that
the FDA can look at it and say: Okay. Maybe you are going to risk this,
but we want to make sure that you have some protection.
The gentleman said that the FDA process is complicated or time
consuming. First of all, there is an emergency process where you can
simply get on the phone or the doctor gets on the phone, and within 24
hours you can be approved.
But on the other hand, if it is not an emergency, the average
approval time is 4 days. So I don't know how he can say that this is
time consuming.
And then the last thing he said is that there is consent, that the
doctors and the manufacturers have to agree. But who is going to
enforce this?
Right now, because the FDA has to go through the expanded access
process, the FDA has the enforcement. They can say: We are going to
grant this; we are not; we are going to provide some safety or other
protections.
But if the doctor and some fly-by-night manufacturer decide that they
want to give you this drug or treatment, who is going to enforce that?
How do we know that the doctor is legitimate? How do we know that the
manufacturer is not selling snake oil?
Once the FDA is out of the picture, there is no way for the patient
to know whether the doctor is unscrupulous, whether the manufacturer is
unscrupulous. There is no review. There is no enforcement whatsoever.
So, again, this is the problem once you take the FDA out. I
understand there are some that don't like the FDA, don't think maybe
they should be involved. But in the absence of the FDA, I don't know
how you possibly could know whether this thing is going to help you,
whether the benefits outweigh the risk, whether there is a bad actor
involved, either with the doctor or the manufacturer.
Mr. Speaker, I reserve the balance of my time.
Mr. BURGESS. Mr. Speaker, I yield myself 1 minute.
Mr. Speaker, I want to read from the Statement of Administration
Policy that was put out by the Executive Office of the President.
The last paragraph:
Since the late 1980s, the Food and Drug Administration has
facilitated access to investigational drugs, devices, and biological
products for the treatment of seriously ill patients. Families in these
situations have sometimes found this process challenging, and the Food
and Drug Administration is constantly striving to make improvements to
its expanded access program. Some patients and their families, however,
still have challenges accessing investigational treatments. The
administration believes that the treatment decisions for those facing
terminal illnesses are best made by the patients with the support and
the guidance of their treating physicians. This legislation will
advance those principles.
Mr. Speaker, that is from the Statement of Administration Policy, and
I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I want my colleagues on the other side to understand why
so many of us over here have been so upset by this proposal today.
As I think I said before, the House bill was bad enough. The Senate
bill is worse for at least two reasons.
One is our concern, on the one hand, that rather than these drugs or
treatments without FDA approval would be handed to just terminally ill
patients, that the Senate bill says that it would apply to people who
have life-threatening situations.
And the FDA and the commissioner of the FDA have stated quite clearly
that they are concerned about the expansion from terminal to life-
threatening, because it could be that people who have diseases like
diabetes, severe diabetes, or chronic heart disease, for example, could
make the argument that their situation is life-threatening, and,
therefore, they can go and get these experimental drugs without FDA
approval.
So that is a huge loophole that is very disconcerting.
The second thing is that the prohibition, if you will, on promotional
activity with these investigational drugs is taken out by the Senate
bill.
So the worst thing of all, we talk about snake oil and advertising,
is now is some unscrupulous doctor or manufacturer now going to promote
this and say: Well, if you take this, this may save your life?
So that is why the Senate bill is worse.
But I want to go back to the whole idea. The problem that I have with
all this is that once you take out the FDA, and the FDA is not involved
anymore, the way this bill is set up, how do I know, if I am the
patient and I hear from some doctor or through some promotion or
whatever, that there is something that might help me, and I am
desperate, how do I know that the doctor that I go to or the
manufacturer who is promoting this drug, that this is actually not a
bad actor, not somebody who is taking advantage of the situation
because there is no FDA approval?
In other words, who is going to determine whether this person's life
is threatened or whether they are terminally ill? There is no FDA. Who
determines that?
Who is going to determine whether this drug has any effectiveness at
all?
Well, some of my Republican colleagues say: Well, it has to go
through phase one, but phase one clinical trials could have 20 or 30
people. They are sometimes very small.
The FDA doesn't really have any ability to control those clinical
trials. Sure, they have some oversight over clinical trials, but there
are clinical trials that take place all over the country with very few
people, and sometimes the drug manufacturers who are experimenting with
these trials, with these small groups, are not necessarily known
manufacturers or large ones that we know will be safeguarding these
drugs or treatments.
So I just think the problem is, when we talk about snake oil and bad
actors, it is almost as if the Republicans assume there are no bad
actors.
Because if you assume that there are, which I do, and there are bad
actors who are going to promote something that is not going to be
effective or is going to harm somebody, and that there is a
manufacturer who is not someone we know, who is going to determine
whether or not they are a bad actor or what they are doing?
You need to have some kind of enforcement. You need to have somebody
who is supervising this. Otherwise, it is any man for himself decides:
I will try this drug. It went through phase one. Maybe it is not toxic.
So I really worry that this debate on the other side of the aisle is
not taking into consideration that there always are going to be people
who want to take advantage of the situation and sell something that
they are going to make a buck on that is not necessarily going to have
any real oversight in this situation.
So that is my fear. That is my fundamental fear about this bill, that
these situations are going to arise, nobody is going to be in charge,
nobody is going to know what is going on, and then the person is going
to either die earlier or have some awful impact, and then they are
going to say: Oh, how come the FDA didn't approve it? Or maybe they are
going to assume the FDA approved it, and there is no FDA. They are
gone.
Mr. Speaker, in any case, I would urge my colleagues to oppose what I
consider very harmful legislation, and I yield back the balance of my
time.
Mr. BURGESS. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, on January 30 of this year, the President of the United
States came to this House and addressed a joint session of the House
and Senate in the State of the Union address, and he said, right from
that podium, ``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 right
here at home. It is time for Congress to give these wonderful Americans
the right to try.''
Mr. Speaker, I couldn't say it any better than the President has
already put it. The Right to Try Act is before us. It is a good bill.
The House needs to support it, and it will go to the President for his
signature.
[[Page H4363]]
Mr. Speaker, I yield back the balance of my time.
Ms. MATSUI. Mr. Speaker, this proposed ``Right to Try'' legislation
will make it possible for bad actors to take advantage of desperate
families.
The pill would allow companies to completely circumvent the FDA if
they claim to have a new drug or cure for a patient. And it dogs not
require the doctor or the company to even report to FDA, so we will
have no way of knowing who is trying which experimental drug. This
legislation really does encourage snake oil salesmen.
Currently, legitimate companies may have new experimental drugs that
have not yet been approved, but that could be helpful for patients who
have no other options . . . but this bill is not limited to that
situation. And, FDA does have an existing process to allow for patients
with life-threatening conditions to try experimental drugs before they
are approved.
And, this bill is not limited only to patients with a life-
threatening condition. FDA has testified that the process under this
bill would be available much more broadly to patients with chronic
conditions such as diabetes.
That is a large population with a condition that is managed with
currently available treatments. Under this bill, bad actors could see
the dollar signs to market ineffective drugs to these patients.
The bill before us today does not require FDA or Institutional Review
Boards (or IRB's) to review any request for experimental therapy, and
rescinds any requirement to report adverse effects of a drug
immediately.
This means that if someone loses their eyesight or dies from taking
an unproven experimental treatment, then no one is required to report
it immediately. This puts other patients taking the same drug in
danger.
Additionally, if a patient does have a success with a drug, but it is
not reported or considered in a clinical trial, that success will not
translate to other patients that could be saved by the treatment.
I am also incredibly concerned that in 19 states, taking experimental
treatment will result in the loss of people's hospice care, and in 4
states it will result in the loss of their insurance, completely.
To rake matters worse, this legislation does not stipulate that
patients must be informed of this loss of coverage or hospice coverage
in advance.
This legislation, therefore, puts patients' care network, financial
stability, and safety at risk--without any legal recourse.
If we open this loophole, a surge of bad actors who may claim to have
experimental drug therapies could make money peddling dangerous
therapies to unsuspecting patients with no system of oversight, safety,
and accountability.
The unfortunate victims will be families and their loved ones. I
strongly urge my colleagues to vote no on this bill.
Mr. GENE GREEN of Texas. Mr. Speaker, I rise in opposition to S. 204,
the so-called ``Right to Try'' bill that offers false hope for patients
and families while circumventing FDA's role in overseeing drugs.
Two months ago, our chamber debated the House Republican version of
this legislation, H.R. 5247. I spoke out in opposition to that bill due
to my serious concerns over the lack of oversight and protections for
terminally ill patients and their families, particularly by excluding
the U.S. Food and Drug Administration from any role in ensuring the
safety and efficacy of experimental therapies.
Instead of addressing our concerns, the Majority has double-downed on
this unnecessary legislation with an even broader proposal that would
expose a great number of patients to unproven medical treatments and
unwanted side effects.
S. 204 eliminates critical patient protections, such as a review by a
third party of clinical protocols and informed consent, and eliminates
the requirement that treating physicians and manufacturers report
adverse events to the FDA in real time.
Under this legislation, insurers and pharmaceutical companies are not
required to cover the cost, or reduce the cost, of these often-
expensive treatments--meaning the full cost of these experimental drugs
would fall on patients and their families.
All the while, we already have a proven Right-to-Try system already
in place through the FDA. This program, popularly known as
Compassionate Use, has been helping seriously ill Americans have access
to experimental therapies still under clinical trials for 31 years.
FDA approves nearly all requests for investigational drugs. For the
past five years, FDA's approval rate for expanded access requests is
over 99 percent. In fact, FDA physicians are available 24 hours a day
to approve emergency requests.
My daughter, an infectious disease expert at the University of
Nebraska, used FDA's Compassionate Use pathway to provide an
experimental therapy for an American missionary who had contracted
ebola while in Africa in 2014. FDA approved the request for the
experimental treatment over the telephone in less than 24 hours.
The new pathway created in S. 204 is not necessary and, in fact, may
well endanger the health and safety of seriously ill patients by
bypassing FDA's oversight and expertise.
This is an unnecessary and dangerous bill that offers false hope to
seriously ill patients and families. I ask my colleague to oppose this
legislation and work with me to advance proven measures that will help
Americans facing life-threatening diseases.
The SPEAKER pro tempore (Mr. Kelly of Pennsylvania). All time for
debate has expired.
Pursuant to House Resolution 905, the previous question is ordered on
the bill.
The question is on the third reading of the bill.
The bill was ordered to be read a third time, and was read the third
time.
Motion to Recommit
Ms. SCHAKOWSKY. Mr. Speaker, I have a motion to recommit at the desk.
The SPEAKER pro tempore. Is the gentlewoman opposed to the bill?
Ms. SCHAKOWSKY. Mr. Speaker, I am opposed in its current form.
The SPEAKER pro tempore. The Clerk will report the motion to
recommit.
The Clerk read as follows:
Ms. Schakowsky moves to recommit the bill S. 204 to the
Committee on Energy and Commerce with instructions to report
the same back to the House forthwith, with the following
amendment:
Strike all after section 1 and insert the following:
SEC. 2. USE OF UNAPPROVED INVESTIGATIONAL DRUGS BY PATIENTS
DIAGNOSED WITH A TERMINAL ILLNESS.
(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act is amended by inserting after section 561A (21
U.S.C. 360bbb-0) the following:
``SEC. 561B. ELIGIBLE INVESTIGATIONAL DRUGS FOR USE BY
ELIGIBLE PATIENTS.
``(a) Use of Clinical Outcomes.--
``(1) In general.--The Secretary shall issue guidance
describing the Secretary's consideration and evaluation, for
purposes of the review of, and decision on whether to
approve, a marketing application under section 505 of this
Act or section 351 of the Public Health Service Act for an
eligible investigational drug, of clinical outcomes
associated with the provision by a sponsor or manufacturer of
such drug under subsection (b) or (c) of section 561. Such
guidance shall address--
``(A) specific instances in which the Secretary will
determine that the public health requires such consideration
and evaluation;
``(B) specific instances in which a sponsor may request
such consideration and evaluation; and
``(C) the context in which such consideration and
evaluation will occur, particularly with regard to
information and data relevant to the evaluation of a
marketing application under section 505 of this Act or
section 351 of the Public Health Service Act for the eligible
investigational drug.
``(2) Guidance.--
``(A) Draft guidance.--Not later than 1 year after the date
of enactment of this section, the Secretary shall issue draft
guidance with a public comment period regarding the use of
clinical outcomes associated with the use of an eligible
investigational drug that a sponsor or manufacturer has
provided under subsection (b) or (c) of section 561, as
described in paragraph (1).
``(B) Final guidance.--Not later than 1 year after the
public comment period on such draft guidance ends, the
Secretary shall issue final guidance.
``(b) Posting of Information.--Not later than 1 year after
the date of enactment of this section, the Secretary shall
post on the internet website of the Food and Drug
Administration and update annually, categorized by
therapeutic area--
``(1) the number of requests that were received by the Food
and Drug Administration for the provision by a sponsor or
manufacturer of an eligible investigational drug under
subsection (b) or (c) of section 561; and
``(2) the number of such requests that were granted.
``(c) Definition.--In this section, the term `eligible
investigational drug' means an investigational drug (as such
term is used in section 561)--
``(1) for which a Phase 1 clinical trial has been
completed;
``(2) 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;
``(3)(A) for which an application has been filed under
section 505(b) of this Act or section 351(a) of the Public
Health Service Act; or
``(B) 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
[[Page H4364]]
505(i) of this Act or section 351(a)(3) of the Public Health
Service Act, as applicable; and
``(4) the active development or production of which is
ongoing and has not been discontinued by the manufacturer or
placed on clinical hold under section 505(i); and''.
(b) Reporting.--Section 561A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-0) is amended adding at the
end the following:
``(g) Reporting.--
``(1) In general.--The manufacturer or sponsor of an
eligible investigational drug shall post on the same publicly
available internet website used by the manufacturer for
purposes of subsection (b) of this section an annual summary
of any provision by the manufacturer or sponsor of an
eligible investigational drug under subsection (b) or (c) of
section 561. 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.
Such annual summary shall be provided to the Secretary upon
request.
``(2) Definition.--In this subsection, the term `eligible
investigational drug' has the meaning given to such term in
section 561B(c).''.
(c) Liability.--Section 561 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb) is amended--
(1) by redesignating subsection (e) as subsection (f); and
(2) by inserting after subsection (d) the following:
``(e) Liability.--
``(1) Alleged acts or omissions.--
``(A) Manufacturer or sponsor.--No manufacturer or sponsor
(or their agent or representative) of an eligible
investigational drug provided to a single patient or small
group of patients for treatment use shall be liable for any
alleged act or omission related to the provision of such
drug, so long as such drug was provided in accordance with
subsection (b) or (c), including the reporting of safety
information, from clinical trials or any other source, as
required pursuant to 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 to a single patient or small group
of patients for treatment use of an eligible investigational
drug in accordance with the requirements described in clause
(ii), unless such act or omission constitutes on the part of
such physician, clinical investigator, or hospital with
respect to such 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 eligible 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), including--
``(I) the reporting of safety information, from clinical
trials or any other source, as required pursuant to under
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, nor the Secretary, shall be liable for determining
not to provide access to an eligible 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 or section 561B 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 or
section 561B shall be construed to modify or otherwise affect
the authority of the Federal Government to bring suit under
any Federal law.
``(2) Definition.--In this subsection, the term `eligible
investigational drug' has the meaning given to such term in
section 561B(c).''.
Ms. SCHAKOWSKY (during the reading). Mr. Speaker, I ask unanimous
consent to dispense with the reading.
The SPEAKER pro tempore. Is there objection to the request of the
gentlewoman from Illinois?
There was no objection.
The SPEAKER pro tempore. The gentlewoman from Illinois is recognized
for 5 minutes in support of her motion.
Ms. SCHAKOWSKY. Mr. Speaker, this that I am proposing today would be
the final amendment to the bill, which will not kill the bill or send
it back to committee.
If adopted, the bill will immediately proceed to final passage, as
amended, and this amendment would offer a more targeted approach to
improve FDA's expanded access program that allows patients access to
experimental drugs that can possibly save their lives, which is the
goal of all of us.
{time} 1645
The FDA ensures that expanded access requests are safe, and it
approves nearly 100 percent of all the requests that are made, and most
in a matter of hours, if necessary.
The right-to-try legislation we are considering today presents a huge
risk to patients and is much worse than the House bill we passed in
March, as our ranking member explained.
If this bill is so good, why are 104 patient groups--these are the
groups that represent the sick and dying people--opposed? And PhRMA,
the big pharmaceutical companies, are not supportive because this gives
open license to snake oil salesmen.
This bill exposes far more patients to serious risks through a
dangerous and unnecessary pathway for experimental treatment.
FDA Commissioner Gottlieb noted this legislation is not limited to
patients with terminal illness anymore: ``We are certainly going to be
exposing patients with potentially less severe conditions to a risk.''
It is troubling that, in some States, patients using an
investigational drug can lose their hospice coverage and, in other
States, that they can be denied home care. These are the very people
who need this care.
Why should we put more patients at risk when the current process does
work? FDA already approves, as I said, nearly 100 percent of the
requests for experimental therapies through the expanded access
program. If a person is denied treatment, it is because the
manufacturer will not provide it. It also isn't going about giving the
terminally ill hope.
If that were true, then why would these 104 patient groups, including
the American Cancer Society, the Cystic Fibrosis Foundation, and the
Vietnam Veterans of America also oppose this bill?
The main reason that this bill is being pushed is to remove FDA
oversight of the safety and effectiveness of our drugs. It allows
manufacturers to serve as the gatekeeper and protector of patients. It
opens the door for bad actors to prey on people desperate to save their
lives or the lives of their children.
Imagine if someone like Martin Shkreli, the infamous pharmaceutical
bad actor, promised a cure to save a child's life provided that the
parents pay whatever price he might charge, under this bill, FDA would
play no role in determining if that drug were safe and effective.
Bad actors do exist, and this Republican bill gives them the
opportunity to prey on desperate people who are looking for any
treatment that might help to save their lives.
Unlike S. 204, this motion to recommit is not based on the false
premise that the FDA approval is a barrier to investigational
treatments; rather, it provides clarification of the liability and how
FDA will utilize clinical outcomes.
With this motion to recommit, the FDA would provide manufacturers
guidance to clarify how FDA will consider clinical outcomes associated
with treatments under expanded access when making a decision about
whether or not the drug should be granted full approval. It also
provides transparency as to how many patients are making expanded
access requests and how often these requests are granted or denied by
the FDA and manufacturers. It also offers to provide manufacturers or
sponsors liability protection if they comply with the requirements of
the expanded access program.
I believe that these legislative fixes facilitate patient accessing
of experimental treatments while ensuring critical FDA oversight to
protect public health.
In conclusion, patients already have the right to try. Rather than
creating an unnecessary pathway that puts patients at risk by allowing
the sale of
[[Page H4365]]
snake oil, I would urge my colleagues to join the over 100 patient
groups, organizations that care about their neighbors and their friends
and people who have these diseases, in support of the expanded access
program.
These targeted improvements are one way to achieve that goal, so I
urge my colleagues to support my motion to recommit and oppose the
dangerous Republican proposal.
Mr. Speaker, I yield back the balance of my time.
Mr. BURGESS. Mr. Speaker, I claim the time in opposition to the
motion.
The SPEAKER pro tempore. The gentleman from Texas is recognized for 5
minutes.
Mr. BURGESS. Mr. Speaker, while the motion to recommit may be well
intentioned, it has a practical effect of killing this bill because the
Senate has rejected House attempts to refine the Senate bill that was
passed by unanimous consent last August. So if you want to provide that
right to try for patients, this is the vehicle.
Now, interestingly enough, the Food and Drug Administration
Administrator, this morning, Dr. Gottlieb, put out a statement. He said
that he is: ``. . . ready to implement it in a way that achieves
Congress' intent to promote access and protect patients; and build on
FDA's longstanding commitment to these important goals.''
Mr. Speaker, I urge people to vote against the motion to recommit and
vote for the underlying bill. Let's give patients that expanded access,
and I yield back the balance of my time.
The SPEAKER pro tempore. Without objection, the previous question is
ordered on the motion to recommit.
There was no objection.
The SPEAKER pro tempore. The question is on the motion to recommit.
The question was taken; and the Speaker pro tempore announced that
the noes appeared to have it.
Ms. SCHAKOWSKY. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 and clause 9 of rule
XX, this 15-minute vote on the motion to recommit will be followed by
5-minute votes on:
Passage of S. 204, if ordered;
The motion to suspend the rules on H.R. 5682; and
Passage of S. 2155.
The vote was taken by electronic device, and there were--yeas 187,
nays 231, not voting 9, as follows:
[Roll No. 213]
YEAS--187
Adams
Aguilar
Barragan
Bass
Beatty
Bera
Beyer
Bishop (GA)
Blumenauer
Blunt Rochester
Bonamici
Boyle, Brendan F.
Brady (PA)
Brown (MD)
Brownley (CA)
Bustos
Butterfield
Capuano
Carbajal
Cardenas
Carson (IN)
Cartwright
Castor (FL)
Castro (TX)
Chu, Judy
Cicilline
Clark (MA)
Clarke (NY)
Clay
Cleaver
Clyburn
Cohen
Connolly
Cooper
Correa
Costa
Courtney
Crist
Crowley
Cuellar
Cummings
Davis (CA)
Davis, Danny
DeFazio
DeGette
Delaney
DeLauro
DelBene
Demings
DeSaulnier
Deutch
Dingell
Doggett
Doyle, Michael F.
Ellison
Engel
Eshoo
Espaillat
Esty (CT)
Evans
Foster
Frankel (FL)
Fudge
Gabbard
Gallego
Garamendi
Gomez
Gottheimer
Green, Al
Green, Gene
Grijalva
Gutierrez
Hanabusa
Hastings
Heck
Higgins (NY)
Himes
Hoyer
Huffman
Jackson Lee
Jayapal
Jeffries
Johnson (GA)
Johnson, E. B.
Keating
Kelly (IL)
Kennedy
Khanna
Kihuen
Kildee
Kilmer
Kind
Krishnamoorthi
Kuster (NH)
Lamb
Langevin
Larsen (WA)
Larson (CT)
Lawrence
Lawson (FL)
Lee
Levin
Lewis (GA)
Lieu, Ted
Lipinski
Loebsack
Lofgren
Lowenthal
Lowey
Lujan Grisham, M.
Lujan, Ben Ray
Lynch
Maloney, Carolyn B.
Maloney, Sean
Matsui
McCollum
McEachin
McGovern
McNerney
Meeks
Meng
Moore
Moulton
Murphy (FL)
Nadler
Napolitano
Neal
Nolan
Norcross
O'Halleran
O'Rourke
Pallone
Panetta
Pascrell
Payne
Pelosi
Perlmutter
Peters
Peterson
Pingree
Pocan
Price (NC)
Quigley
Raskin
Rice (NY)
Richmond
Rosen
Roybal-Allard
Ruiz
Ruppersberger
Rush
Ryan (OH)
Sanchez
Sarbanes
Schakowsky
Schiff
Schneider
Schrader
Scott (VA)
Scott, David
Serrano
Sewell (AL)
Shea-Porter
Sherman
Sires
Smith (WA)
Soto
Suozzi
Swalwell (CA)
Takano
Thompson (CA)
Thompson (MS)
Titus
Tonko
Torres
Tsongas
Vargas
Veasey
Vela
Velazquez
Visclosky
Wasserman Schultz
Waters, Maxine
Watson Coleman
Welch
Wilson (FL)
Yarmuth
NAYS--231
Abraham
Aderholt
Allen
Amash
Amodei
Arrington
Babin
Bacon
Banks (IN)
Barletta
Barr
Barton
Bergman
Biggs
Bilirakis
Bishop (MI)
Bishop (UT)
Blackburn
Blum
Bost
Brady (TX)
Brat
Brooks (AL)
Brooks (IN)
Buchanan
Buck
Bucshon
Budd
Burgess
Byrne
Calvert
Carter (GA)
Carter (TX)
Chabot
Cheney
Coffman
Cole
Collins (GA)
Collins (NY)
Comer
Comstock
Conaway
Cook
Costello (PA)
Cramer
Crawford
Culberson
Curbelo (FL)
Curtis
Davidson
Davis, Rodney
Denham
DeSantis
DesJarlais
Diaz-Balart
Donovan
Duffy
Duncan (SC)
Duncan (TN)
Dunn
Emmer
Estes (KS)
Faso
Ferguson
Fitzpatrick
Fleischmann
Flores
Fortenberry
Foxx
Gaetz
Gallagher
Garrett
Gianforte
Gibbs
Gohmert
Gonzalez (TX)
Goodlatte
Gosar
Gowdy
Granger
Graves (GA)
Graves (LA)
Graves (MO)
Griffith
Grothman
Guthrie
Handel
Harper
Harris
Hartzler
Hensarling
Herrera Beutler
Hice, Jody B.
Hill
Holding
Hollingsworth
Hudson
Huizenga
Hultgren
Hunter
Hurd
Issa
Jenkins (KS)
Jenkins (WV)
Johnson (LA)
Johnson (OH)
Johnson, Sam
Jones
Jordan
Joyce (OH)
Kaptur
Katko
Kelly (MS)
Kelly (PA)
King (IA)
King (NY)
Kinzinger
Knight
Kustoff (TN)
Labrador
LaHood
LaMalfa
Lamborn
Lance
Latta
Lesko
Lewis (MN)
LoBiondo
Long
Loudermilk
Love
Lucas
Luetkemeyer
MacArthur
Marchant
Marino
Marshall
Massie
Mast
McCarthy
McCaul
McClintock
McHenry
McKinley
McMorris Rodgers
McSally
Meadows
Messer
Mitchell
Moolenaar
Mullin
Newhouse
Noem
Norman
Nunes
Olson
Palazzo
Palmer
Paulsen
Perry
Pittenger
Poe (TX)
Poliquin
Polis
Posey
Ratcliffe
Reed
Reichert
Renacci
Rice (SC)
Roby
Roe (TN)
Rogers (AL)
Rohrabacher
Rokita
Rooney, Francis
Rooney, Thomas J.
Ros-Lehtinen
Roskam
Ross
Rothfus
Rouzer
Royce (CA)
Russell
Rutherford
Sanford
Scalise
Schweikert
Scott, Austin
Sensenbrenner
Sessions
Shimkus
Shuster
Simpson
Sinema
Smith (MO)
Smith (NE)
Smith (NJ)
Smith (TX)
Smucker
Stefanik
Stewart
Taylor
Tenney
Thompson (PA)
Thornberry
Tipton
Trott
Turner
Upton
Valadao
Wagner
Walberg
Walden
Walker
Walorski
Walters, Mimi
Weber (TX)
Webster (FL)
Wenstrup
Westerman
Williams
Wilson (SC)
Wittman
Womack
Woodall
Yoder
Yoho
Young (AK)
Young (IA)
Zeldin
NOT VOTING--9
Black
Frelinghuysen
Higgins (LA)
Mooney (WV)
Pearce
Rogers (KY)
Speier
Stivers
Walz
{time} 1717
Ms. STEFANIK, Messrs. WALKER, McCAUL, BILIRAKIS, and AUSTIN SCOTT of
Georgia changed their vote from ``yea'' to ``nay.''
Ms. SANCHEZ, Mr. VISCLOSKY, and Ms. HANABUSA changed their vote from
``nay'' to ``yea.''
So the motion to recommit was rejected.
The result of the vote was announced as above recorded.
The SPEAKER pro tempore (Mr. Bergman). The question is on the passage
of the bill.
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Recorded Vote
Mr. PALLONE. Mr. Speaker, I demand a recorded vote.
A recorded vote was ordered.
The SPEAKER pro tempore. This is a 5-minute vote.
The vote was taken by electronic device, and there were--ayes 250,
noes 169, not voting 8, as follows:
[Roll No. 214]
AYES--250
Abraham
Aderholt
Allen
Amash
Amodei
Arrington
Babin
Bacon
Banks (IN)
Barletta
Barr
Barton
Bergman
Biggs
Bilirakis
Bishop (GA)
Bishop (MI)
Bishop (UT)
Blackburn
Blum
Bost
Brady (TX)
Brat
Brooks (AL)
Brooks (IN)
Buchanan
Buck
Bucshon
Budd
Burgess
Byrne
Calvert
Carson (IN)
Carter (GA)
Carter (TX)
Chabot
Cheney
Coffman
Cole
Collins (GA)
Collins (NY)
Comer
Comstock
Conaway
Cook
Cooper
Correa
Costa
Costello (PA)
Cramer
Crawford
Cuellar
Culberson
Curbelo (FL)
Curtis
Davidson
Davis, Rodney
Denham
DeSantis
DesJarlais
Diaz-Balart
Donovan
Duffy
[[Page H4366]]
Duncan (SC)
Duncan (TN)
Dunn
Emmer
Estes (KS)
Faso
Ferguson
Fitzpatrick
Fleischmann
Flores
Fortenberry
Foxx
Gabbard
Gaetz
Gallagher
Garrett
Gianforte
Gibbs
Gohmert
Goodlatte
Gosar
Gottheimer
Gowdy
Granger
Graves (GA)
Graves (LA)
Graves (MO)
Griffith
Grothman
Guthrie
Handel
Harper
Harris
Hartzler
Hensarling
Herrera Beutler
Hice, Jody B.
Hill
Holding
Hollingsworth
Hudson
Huizenga
Hultgren
Hunter
Hurd
Issa
Jenkins (KS)
Jenkins (WV)
Johnson (LA)
Johnson (OH)
Johnson, Sam
Jones
Jordan
Joyce (OH)
Katko
Kelly (MS)
Kelly (PA)
Kind
King (IA)
King (NY)
Kinzinger
Knight
Kuster (NH)
Kustoff (TN)
Labrador
LaHood
LaMalfa
Lamborn
Lance
Larson (CT)
Latta
Lawson (FL)
Lesko
Lewis (MN)
Lieu, Ted
LoBiondo
Long
Loudermilk
Love
Lucas
Luetkemeyer
Lynch
MacArthur
Maloney, Sean
Marchant
Marino
Marshall
Massie
Mast
McCarthy
McCaul
McClintock
McHenry
McKinley
McMorris Rodgers
McSally
Meadows
Messer
Mitchell
Moolenaar
Mooney (WV)
Mullin
Newhouse
Noem
Norman
Nunes
O'Halleran
O'Rourke
Olson
Palazzo
Palmer
Paulsen
Perlmutter
Perry
Peterson
Pittenger
Poe (TX)
Poliquin
Polis
Posey
Ratcliffe
Reed
Reichert
Renacci
Rice (SC)
Roby
Roe (TN)
Rogers (AL)
Rohrabacher
Rokita
Rooney, Francis
Rooney, Thomas J.
Ros-Lehtinen
Roskam
Ross
Rothfus
Rouzer
Royce (CA)
Russell
Rutherford
Sanford
Scalise
Schweikert
Scott, Austin
Sensenbrenner
Sessions
Shimkus
Shuster
Simpson
Sinema
Smith (MO)
Smith (NE)
Smith (NJ)
Smith (TX)
Smucker
Stefanik
Stewart
Taylor
Tenney
Thompson (PA)
Thornberry
Tipton
Trott
Turner
Upton
Valadao
Veasey
Wagner
Walberg
Walden
Walker
Walorski
Walters, Mimi
Weber (TX)
Webster (FL)
Wenstrup
Westerman
Williams
Wilson (SC)
Wittman
Womack
Woodall
Yoder
Yoho
Young (AK)
Young (IA)
Zeldin
NOES--169
Adams
Aguilar
Barragan
Bass
Beatty
Bera
Beyer
Blumenauer
Blunt Rochester
Bonamici
Boyle, Brendan F.
Brady (PA)
Brown (MD)
Brownley (CA)
Bustos
Butterfield
Capuano
Carbajal
Cardenas
Cartwright
Castor (FL)
Castro (TX)
Chu, Judy
Cicilline
Clark (MA)
Clarke (NY)
Clay
Cleaver
Clyburn
Cohen
Connolly
Courtney
Crist
Crowley
Cummings
Davis (CA)
Davis, Danny
DeFazio
DeGette
Delaney
DeLauro
DelBene
Demings
DeSaulnier
Deutch
Dingell
Doggett
Doyle, Michael F.
Ellison
Engel
Eshoo
Espaillat
Esty (CT)
Evans
Foster
Frankel (FL)
Fudge
Gallego
Garamendi
Gomez
Gonzalez (TX)
Green, Al
Green, Gene
Grijalva
Gutierrez
Hanabusa
Hastings
Heck
Higgins (NY)
Himes
Hoyer
Huffman
Jackson Lee
Jayapal
Jeffries
Johnson (GA)
Johnson, E. B.
Kaptur
Keating
Kelly (IL)
Kennedy
Khanna
Kihuen
Kildee
Kilmer
Krishnamoorthi
Lamb
Langevin
Larsen (WA)
Lawrence
Lee
Levin
Lewis (GA)
Lipinski
Loebsack
Lofgren
Lowenthal
Lowey
Lujan Grisham, M.
Lujan, Ben Ray
Maloney, Carolyn B.
Matsui
McCollum
McEachin
McGovern
McNerney
Meeks
Meng
Moore
Moulton
Murphy (FL)
Nadler
Napolitano
Neal
Nolan
Norcross
Pallone
Panetta
Pascrell
Payne
Pelosi
Peters
Pingree
Pocan
Price (NC)
Quigley
Raskin
Rice (NY)
Richmond
Rosen
Roybal-Allard
Ruiz
Ruppersberger
Rush
Ryan (OH)
Sanchez
Sarbanes
Schakowsky
Schiff
Schneider
Schrader
Scott (VA)
Scott, David
Serrano
Sewell (AL)
Shea-Porter
Sherman
Sires
Smith (WA)
Soto
Suozzi
Swalwell (CA)
Takano
Thompson (CA)
Thompson (MS)
Titus
Tonko
Torres
Tsongas
Vargas
Vela
Velazquez
Visclosky
Wasserman Schultz
Waters, Maxine
Watson Coleman
Welch
Wilson (FL)
Yarmuth
NOT VOTING--8
Black
Frelinghuysen
Higgins (LA)
Pearce
Rogers (KY)
Speier
Stivers
Walz
Announcement by the Speaker Pro Tempore
The SPEAKER pro tempore (during the vote). The Chair will remind all
persons in the gallery that they are here as guests of the House and
that any manifestation of approval or disapproval of proceedings is in
violation of the rules of the House.
{time} 1725
So the bill was passed.
The result of the vote was announced as above recorded.
A motion to reconsider was laid on the table.
____________________