[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.

                          ____________________