[Congressional Record Volume 164, Number 49 (Wednesday, March 21, 2018)]
[House]
[Pages H1738-H1748]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




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

  Mr. BURGESS. Mr. Speaker, pursuant to House Resolution 787, I call up 
the bill (H.R. 5247) to authorize the use of eligible investigational 
drugs by eligible patients who have been diagnosed with a stage of a 
disease or condition in which there is reasonable likelihood that death 
will occur within a matter of months, or with another eligible illness, 
and for other purposes, 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 787, the bill 
is considered read.
  The text of the bill is as follows:

                               H.R. 5247

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

     SECTION 1. SHORT TITLE.

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

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

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

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

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

[[Page H1739]]

     as correspondence to the investigational new drug application 
     described in subsection (a)(2).
       ``(4) Adverse event reporting.--The condition specified in 
     this paragraph, with respect to an eligible investigational 
     drug referred to in paragraph (1), is that the sponsor or 
     manufacturer of such eligible investigational drug has 
     required, as a condition of providing the drug to a physician 
     for use by an eligible patient pursuant to this section, that 
     such physician will immediately report to such sponsor or 
     manufacturer any serious adverse events, as such term is 
     defined in section 312.32 of title 21, Code of Federal 
     Regulations (or any successor regulations), associated with 
     the use of the eligible investigational drug by the eligible 
     patient.
       ``(5) Application.--For purposes of this section, the 
     requirements set forth in sections 312.7 and 312.8(d)(1) of 
     title 21 of the Code of Federal Regulations (or any successor 
     regulations) are deemed to apply to any person who 
     manufactures, distributes, prescribes, dispenses, introduces 
     or delivers for introduction into interstate commerce, or 
     provides to an eligible patient an eligible investigational 
     drug pursuant to this section.
       ``(c) Use of Clinical Outcomes.--
       ``(1) In general.--Notwithstanding any other provision of 
     this Act, the Public Health Service Act, or any other 
     provision of Federal law, the Secretary may not use a 
     clinical outcome associated with the use of an eligible 
     investigational drug pursuant to this section to delay or 
     adversely affect the review or approval of such drug under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act unless--
       ``(A) the Secretary makes a determination, in accordance 
     with paragraph (2), that use of such clinical outcome is 
     critical to determining the safety of the eligible 
     investigational drug; or
       ``(B) the sponsor requests use of such outcomes.
       ``(2) Limitation.--If the Secretary makes a determination 
     under paragraph (1)(A), the Secretary shall provide written 
     notice of such determination to the sponsor, including a 
     public health justification for such determination, and such 
     notice shall be made part of the administrative record. Such 
     determination shall not be delegated below the director of 
     the agency center that is charged with the premarket review 
     of the eligible investigational drug.
       ``(d) Reporting.--The manufacturer or sponsor of an 
     eligible investigational drug that provides an eligible 
     investigational drug pursuant to this section shall post on 
     the same publicly available internet website used by the 
     manufacturer for purposes of section 561A(b) an annual 
     summary of any provision by the manufacturer or sponsor of an 
     eligible investigational drug under this section. The summary 
     shall include the number of requests received, the number of 
     requests granted, the number of patients treated, the 
     therapeutic area of the drug made available, and any known or 
     suspected serious adverse events, as such term is defined in 
     section 312.32 of title 21, Code of Federal Regulations (or 
     any successor regulations), associated with the use of the 
     eligible investigational drug.
       ``(e) Rule of Construction.--Nothing in this section shall 
     be construed as limiting the authority of the Secretary to 
     require manufacturers or sponsors of investigational drugs to 
     review and report information relevant to the safety of such 
     investigational drug obtained or otherwise received by the 
     sponsor pursuant to part 312 of title 21, Code of Federal 
     Regulations (or successor regulations).''.
       (b) No Liability.--Section 561B of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), is amended by 
     adding at the end the following:
       ``(f) Liability.--
       ``(1) Alleged acts or omissions.--
       ``(A) Manufacturer or sponsor.--No manufacturer or sponsor 
     (or their agent or representative) of an investigational drug 
     shall be liable for any alleged act or omission related to 
     the provision of such drug to a single patient or small group 
     of patients for treatment use in accordance with subsection 
     (b) or (c) of section 561 or the provision of an eligible 
     investigational drug to an eligible patient in accordance 
     with this section, including, with respect to the provision 
     of an investigational drug under section 561 or an eligible 
     investigational drug under this section, the reporting of 
     safety information, from clinical trials or any other source, 
     as required by section 312.32 of title 21, Code of Federal 
     Regulations (or any successor regulations).
       ``(B) Physician, clinical investigator, or hospital.--
       ``(i) No licensed physician, clinical investigator, or 
     hospital shall be liable for any alleged act or omission 
     related to the provision of an investigational drug to a 
     single patient or small group of patients for treatment use 
     in accordance with subsection (b) or (c) of section 561, as 
     described in clause (ii), or the provision of an eligible 
     investigational drug to an eligible patient in accordance 
     with this section, unless such act or omission constitutes on 
     the part of such physician, clinical investigator, or 
     hospital with respect to such investigational drug or 
     eligible investigational drug--

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

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

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

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

  The SPEAKER pro tempore. 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 
may have 5 legislative days in which to revise and extend their remarks 
and to insert extraneous material on H.R. 5247.
  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, earlier this year, Members of Congress heard the 
President during his State of the Union Address make a specific promise 
to the American people that the passage of right-to-try legislation 
would occur. This afternoon, I am proud to stand with the President and 
the thousands of Americans with terminal illnesses, their families, and 
their friends, in passing this important bill in the House.
  Since 2014, nearly three out of four States, including my home State 
of Texas, have passed a version of right-to-try laws. I am pleased that 
the House is again considering H.R. 5247, the Trickett Wendler, Frank 
Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, 
so that terminally ill patients have a chance, or 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.
  Over the course of the past decade, our Nation has achieved an 
unprecedented number of innovations and scientific breakthroughs. 
Through the contributions of researchers in academia and the private 
sector, Americans have more innovative treatments at their fingertips.
  Despite these achievements, I still hear from patients with serious, 
life-threatening conditions, including my own constituents in north 
Texas, who are frustrated with what they see as regulatory barriers 
from trying new therapies when everything else has failed.
  Mr. Speaker, 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, life-
threatening conditions.
  To my friends on the other side of the aisle, I have a simple 
question: Why do you not want to allow these patients to exercise their 
right to fight for their future?
  It is worth mentioning that the bill before us today is a revised, 
more narrowly crafted version of the one that passed the Senate last 
August. Since that time, the Energy and Commerce Subcommittee on Health 
held a hearing in early October to consider the Senate bill, where 
Members heard from

[[Page H1740]]

the Commissioner of the Food and Drug Administration, Dr. Scott 
Gottlieb, about the agency's concerns. We also heard testimony from 
patients and groups that support and oppose right to try.
  From then to just recently, our committee engaged in multistakeholder 
efforts to improve the original right-to-try bill, as passed by the 
Senate. It entailed numerous conversations with patients, advocates, 
the Administration, authors of the bill, and stakeholders on all sides 
of this complex topic.
  The Food and Drug Administration was never left out of the 
discussion. In fact, the agency provided valuable input throughout the 
process and up until the introduction of H.R. 5247. The aim was to open 
the door to innovative, experimental drugs for terminally ill patients 
without necessarily compromising the vital work and the mission of the 
Food and Drug Administration.
  The current compassionate use program at the Food and Drug 
Administration does make a good faith effort to help patients who do 
not qualify for clinical trials. But right to try would actually offer 
patients an alternative pathway to access eligible investigational 
drugs, so long as they are certified by a physician who is in good 
standing and abides by the rules laid out in the bill.
  Again, we have worked closely with the Food and Drug Administration 
to ensure that this new, alternative pathway does not hinder or 
conflict with the critically important oversight that the agency 
conducts.
  Additionally, this bill protects patients from manufacturers 
mislabeling or misbranding drugs, requires sponsors and manufacturers 
to report adverse events to the Food and Drug Administration, and 
provides certain liability protections for parties participating in the 
new pathway.
  Mr. Speaker, this alternative pathway would also be limited to 
individuals who are suffering from a disease or a condition where there 
is a reasonable likelihood of death within a matter of months or 
significant, reversible morbidity, and who have exhausted all FDA-
approved treatment options.
  Lastly, it is essential that we do not create additional hurdles in 
this process so that manufacturers in the drug approval process have 
the certainty that they need.
  The revised right-to-try bill clearly states that the Secretary of 
the Department of Health and Human Services ``may not use a clinical 
outcome associated with the use of an eligible investigational drug . . 
. to delay or adversely affect the review or approval of such drug. . . 
. `'
  After months of work and thoughtful discussions, this legislation is 
a positive step forward in our shared goal of improving care for 
America's patients. It strikes the proper balance between ensuring 
patient safety and granting access to new treatments.
  The President outlined in his State of the Union Address that this 
was an important priority for the administration. In the words of our 
Vice President and former colleague, Mike Pence: ``It's about restoring 
hope and giving patients with life-threatening diseases a fighting 
chance.''
  Mr. Speaker, for these reasons, I urge my colleagues in the House to 
vote in support of H.R. 5247, and 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 to voice my strong opposition to H.R. 5247, 
the Right to Try Act of 2018.
  This legislation, introduced only last week, is an egregious attempt, 
in my opinion, by the Goldwater Institute to undermine the gold 
standard drug approval process at the Food and Drug Administration.
  The supporters of this bill claim to be helping desperate patients 
who are looking for hope.
  If this is such a patient-centered bill, then why does every major 
patient organization overwhelmingly oppose it?
  More than 100 patient organizations, including the National 
Organization for Rare Disorders, the Friends of Cancer Research, and 
the American Cancer Society have all written in opposition to this 
legislation.
  In a letter to congressional leadership, these 103 patient 
organizations noted ``that the alternative pathway in the latest 
version of this legislation is still less safe for our patients than 
the current expanded access process under the FDA.''
  It is not only the patient organizations that are voicing concerns. 
Four former FDA Commissioners--Drs. Hamburg and Califf, who served 
under the Obama administration; and Drs. McClellan and Andrew von 
Eschenbach, who served under the Bush administration--also oppose this 
legislation. That is two former Republican Commissioners and two former 
Democratic Commissioners who are opposed to both the House bill and the 
Senate bill on this same issue.
  These four Commissioners explained their opposition by saying: 
``There is no evidence that either bill 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, I think most importantly, I would stress that this 
legislation is simply not needed. There is already a successful program 
in place today at the FDA in which seriously ill patients and their 
doctors can request access to an experimental treatment from a 
manufacturer. This application process, which takes as little as 45 
minutes for a physician to complete, has been overwhelmingly 
successful.
  Last summer, a review by the Government Accountability Office found 
that the FDA approves 99 percent of the requests submitted to the 
agency. In fact, of the nearly 1,700 requests the FDA received last 
year, only 9 were not approved.
  Physicians and patients also receive approval quickly. Emergency 
requests are often granted immediately over the phone and, on average, 
receive a response within 4 days.
  While the FDA approves 99 percent of the treatments it reviews 
through this expanded access process, as it is called, it also adjusts 
applications for 11 percent of the patients to improve patient safety 
protections.
  In order to protect patients, this review, in my opinion, should 
continue. We must protect patients from bad actors or from dangerous 
treatments that might make their lives worse. Just imagine the health 
consequences to patients if these 11 percent of applicants had not been 
adjusted.
  This is the very reason that the FDA must be involved in the process. 
If you eliminate FDA review, as this bill does, you are putting 
patients at risk.
  I want to talk a little bit about the fact that many States now have 
right-to-try statutes. I fear that some Members--and I heard this last 
week when the bill was on the suspension list--might support this 
legislation under the false belief that the State right-to-try laws in 
their States have provided help to patients. But nothing could be 
further from the truth.
  One example supporters of this legislation like to bring up is Dr. 
Delpassand from Texas, who claims to have treated patients under the 
State right to try.
  Mr. Speaker, I include in the Record a letter from Mr. Andrew 
McFadyen of The Isaac Foundation, who dispels this myth.

                                         The Isaac Foundation,

                                                   March 20, 2018.
     Rep. Greg Walden, Chair,
     Rep. Frank Pallone, Ranking Member,
     Energy & Commerce Committee.
       Dear Mr. Pallone and Mr. Walden: I am writing to you 
     regarding your upcoming debate on HR 5247, the Right to Try 
     initiative fronted by the Goldwater Institute. I am the 
     Executive Director of The Isaac Foundation, an organization 
     that is dedicated to providing advocacy and support to 
     patients dealing with a wide range of disorders and needing 
     access to rare disease treatments. Our work pushes 
     international boundaries, with the bulk of our efforts taking 
     place in Canada and the United States. I am also a member of 
     the NYU Working Group on Compassionate Use and Pre-Approval 
     Access where we are making a concerted effort to improve and 
     address the issues around access to experimental medications, 
     and I'm involved with a non-profit called GE2P2.
       I'm proud to say at The Isaac Foundation that we've never 
     been unsuccessful gaining access to life-saving medications 
     and treatments for patients in Canada, and our work directly 
     with pharmaceutical companies is helping countless patients 
     see similar results in the United States. We have had success 
     by being collaborative partners with industry, regulatory 
     authorities, and patients in need.
       I watched the discussion last week with growing 
     consternation that many of our elected officials have not 
     taken the opportunity to fact-check claims being made by RTT 
     proponents. Most notably, continued mention of Right to Try 
     being used by Dr.

[[Page H1741]]

     Delpassand out of Texas is both egregiously wrong and, 
     indeed, is the perfect example of why RTT should not be 
     passed by lawmakers.
       In October 2016, I testified during Senator Ron Johnson's 
     hearing on Right to Try, at which Johnson introduced and 
     played a video created by the Goldwater Institute of Dr. 
     Delpassand. During that 3-minute video, Dr. Delpassand 
     explained that he was using the state RTT law to treat his 
     patients because the FDA would not allow him to do it through 
     an Expanded Access Program. Senator Johnson asked me what I 
     thought about this video--which included few facts, no 
     context, and was edited by the people fronting the RTT push 
     themselves. I explained that there must be a reason why Dr. 
     Delpassand was in the 1% of cases not allowed by the FDA and 
     vowed I would investigate.
       In March of 2017, I received a set of documents from the 
     FDA under a FOIA request. They show that Dr. Delpassand's 
     clinic failed inspections during the clinical trial of 
     Lutathera (lutetium Lu 177 dotatate). Specifically, he failed 
     inspection due to 3 key and very important reasons:
       1. Enrolling subjects into the study during a partial 
     clinical hold, issued by the Agency.
       2. Underreporting of Adverse Events.
       3. 1572-protocol noncompliance.
       The failed inspections were discovered after complaint from 
     the CDER Good Clinical Practice Compliance Oversight Branch, 
     Division of Good Clinical Practice Compliance Evaluation, 
     Office of Scientific Investigations (OSI). A ``Clinical 
     Hold'' was placed on the lab and Dr. Delpassand. During a 
     clinical hold, subjects may not be given an investigational 
     drug. Dr. Delpassand and his clinic disregarded this clinical 
     hold and enrolled 6 patients.
       Additionally, and just as concerning in terms of patient 
     safety, Dr. Delpassand's clinic failed to promptly report 
     significant new adverse events or risks to the FDA. This 
     failure to report was noted numerous times during the 
     inspection. The inspection also found numerous other areas of 
     concern. I have attached the full report for your 
     consideration.
       After these inspections, the FDA would not allow Dr. 
     Delpassand to open an EAP at his clinic for patients in need, 
     and rightly so. They FDA did, however, allow 42 different 
     locations the ability to provide this drug for patients 
     requiring access, including two sites in Texas. A quick 
     search on ClinicialTrials.gov shows this information, further 
     proving that the FDA has been able to provide patients the 
     required access they need, ensuring the environment that they 
     are receiving the drug they need is safe.
       My understanding of the situation is that the company 
     running the clinical trial distanced themselves from Dr. 
     Delpassand after these failed inspections. Without company 
     support, and without the FDA's permission to open an EAP, Dr. 
     Delpassand had to use the state legislation to provide drug 
     to his patients. Questions remain, however, such as how Dr. 
     Delpassand paid for the product he was giving his patients, 
     did patients themselves have to pay for that drug supply 
     (which isn't allowed under the Texas RTT law) and who, if 
     anyone, was overseeing the program to ensure safety of the 
     patients, especially after multiple infractions were seen 
     during the failed FDA inspection.
       Most important, it should be noted that the FDA process 
     here worked exactly how it is supposed to. A lab was 
     inspected for safety to ensure patients are looked after in 
     the appropriate fashion. That inspection placed a hold on 
     further treating of patients due to numerous infractions. The 
     FDA worked with the company to ensure access for patients 
     across the USA in 42 different sites, helping to monitor 
     adverse events while also allowing the product to advance to 
     approval. That product was approved by the FDA in January 
     2018.
       Also importantly, RTT was used because it was the only way 
     for Dr. Delpassand to treat patients in his clinic after it 
     failed inspection. RTT is a loophole designed to allow people 
     who cannot otherwise follow safety rules set forth by the FDA 
     that are meant to protect vulnerable patients. It's not being 
     used--anywhere--to provide patients with hope or access to 
     life-saving drugs.
       One final note, and one that I've not see mentioned 
     anywhere. HR 5247 includes the name of a young child--a brave 
     child battling Duchenne Muscular Dystrophy--named Jordan 
     McLinn. Jordan has been photographed numerous times with Vice 
     President Pence, and is often used as an example of why Right 
     to Try is needed. The problem with these optics is that 
     Jordan has never received any treatment under Right to Try, 
     even though Right to Try has been available in his state of 
     Indiana for 3 years. He already has access to the life-saving 
     treatment he needs--through an FDA approved clinical trial. 
     He's doing well on that trial drug, as I understand it, and 
     receives all the benefits of FDA oversite to ensure his 
     safety on that trial. In essence, the child used to promote 
     RTT is the perfect example of why the FDA process works and 
     is needed.
       The true reality is that the landscape for access to 
     medications for dying patients does not change tomorrow if a 
     Federal Right to Try law is passed today. Very clearly, those 
     patients in dire need of help today will wake up tomorrow 
     needing access to the same life-saving treatments, and feel 
     the same despair because they will not be getting the access 
     they need through Right to Try.
       The barrier to that access here isn't the FDA, and no Right 
     to Try law enacted by lawmakers in this country is going to 
     remove the true barrier--pharmaceutical companies. The 
     gatekeepers to these medications are the pharmaceutical 
     companies themselves, and we need to be working 
     collaboratively as a team--Industry, Government, physicians, 
     and Patients--to craft solutions that will work for everyone, 
     keeping in mind that we are all on the same side, that we all 
     want the same thing--broad and expeditious access to life-
     saving medications for patients in need.
       I understand how difficult this is for patients--I see it 
     every day, and I feel it every night as I check in on my son 
     (who is battling his own devastating and very rare disease) 
     to make sure he is still breathing, to make sure he is still 
     with us. But I also understand that the change we all need 
     will not come with Right to Try. It will come through 
     collaboration with all stakeholders and by providing 
     companies the safety and assurances they need to make their 
     medications available to our dying patients.
       Lawmakers should be spending their time helping make that 
     collaboration happen because that is how we are going to save 
     our dying patients. They should not spin their wheels passing 
     legislation like Right to Try that looks good, and feels 
     good, but will do nothing for those in need. If they do, they 
     are doing a disservice to a large and very vulnerable group 
     of patients now and in the future, my own son, my own hero 
     Isaac, included.
       Thank you for your time on this matter.
           Sincerely,
                                                  Andrew McFadyen,
                         Executive Director, The Isaac Foundation.

  Mr. PALLONE. Andrew McFadyen said:

       Dr. Delpassand claims to have used right to try because FDA 
     would not allow him to do expanded access. And this was for a 
     very good reason. FDA placed a clinical hold on a study, due 
     to the fact that his clinic was not reporting serious, 
     adverse events, as required; and he continued to enroll 
     patients, despite the clinic hold.
       The work of Dr. Delpassand's study was associated with 40 
     deaths and 2 hospitalizations. FDA's clinical hold on Dr. 
     Delpassand's work is a sign to me that FDA's expanded access 
     pathway was working to prevent bad actors from continuing to 
     expose vulnerable patients to experimental treatments.

  Mr. Speaker, H.R. 5247 is dangerous for our patients. It is an 
unprecedented attempt to roll back the FDA's oversight of 
investigational treatments. 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 3 minutes to the gentleman from 
Pennsylvania (Mr. Fitzpatrick), one of the authors of the bill.
  Mr. FITZPATRICK. Mr. Speaker, I want to thank Chairman Walden, Mr. 
Burgess, Mr. Griffith, and my friends  Andy Biggs and Senator Johnson 
for their unflinching commitment to see right to try debated, passed, 
and signed into law.
  Moreover, I thank the overwhelming bipartisan majority of the House, 
who, just last week, 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.
  Each year, thousands of Americans receive a life-altering diagnosis 
of a terminal illness. Even with the amazing work done in American 
medical research and development, for too many families, access to 
these potentially lifesaving treatments will come too late or not at 
all.

                              {time}  1315

  As their Representatives, we should each endeavor to support these 
individuals in their time of need, as well as support new pathways to 
potentially lifesaving treatment. That is what right to try is all 
about.
  For those patients caught between traditional drug approval delays, a 
clinical trial process for which they do not qualify and limited time, 
right to try simply establishes the freedom for patients and their 
doctors to try therapies where the benefits far outweigh the risks. It 
gives them the option of trying to save their life.
  Although the FDA has a program that allows terminal patients to apply 
for early access to a promising treatment, right to try is needed 
because the FDA compassionate use process doesn't help enough people. 
Moreover, the application process is complicated, time consuming, and 
expensive. Only about 1,200 people each year can make it through the 
application process.
  In 2014, more than 12,000 people in France were using investigational

[[Page H1742]]

treatments through that government's equivalent program. If a country 
with one-fifth the population of the United States can help 900 percent 
more people then the FDA's plan, clearly, is not working.
  In Australia, doctors are allowed to work directly with drug and 
device manufacturers to provide investigational treatments to terminal 
patients without the government's approval. They simply must report to 
the government at some point that the patient received the drug. No 
permission slip is required.
  This bill requires robust informed consent between the patient, 
doctor, and manufacturer, while requiring notification be given to the 
FDA after an unapproved drug becomes available to an eligible patient 
and requires doctors and manufacturers to report adverse events to the 
FDA.
  Mr. Speaker, when a life hangs in the balance, the Federal Government 
should not stand in the way of access to these potential treatments. I 
have traveled our district in all corners and have met so many 
different people--L.J. Kidon and Claire Concilio, most recently. Mr. 
Speaker, these people are an inspiration for this bill. They want to 
see this bill passed. Let's get this done for them.
  Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the 
gentlewoman from Illinois (Ms. Schakowsky), who is the ranking member 
for the Digital Commerce and Consumer Protection Subcommittee.
  Ms. SCHAKOWSKY. Mr. Speaker, I thank the gentleman for his generosity 
and time.
  I want to say, Mr. Speaker, that I rise in opposition to H.R. 5247 
because it creates a dangerous back door for modern-day snake oil 
salesmen, a back door around the FDA approval process for people who 
may or may not be preying on desperate people, and it ignores that 
there actually is a safe pathway for terminally ill patients to get 
treatment.
  This bill failed to pass last week and it should fail again. It is a 
harmful policy that both Republican-and Democratic-appointed former FDA 
Commissioners concluded there is ``no evidence'' that this bill ``would 
meaningfully improve access for patients, but would just remove the FDA 
from the approval process and create a dangerous precedent that would 
erode protections for vulnerable patients,'' the most vulnerable 
patients. People whose lives are in danger feel that they will try 
anything, and there are people out there who will prey on that.
  This bill denies patients what they really need, which is safe and 
effective treatments. This bill strips away important safeguards in the 
name of helping patients, but it does not, and that is why 78 patient 
groups and doctors, groups like the American Cancer Society, the Cystic 
Fibrosis Foundation, and the Leukemia & Lymphoma Society, oppose this 
bill. In total, there are now 110 groups opposing this bill.
  Mr. Speaker, I include in the Congressional Record a multipage list 
of opponents to this bill.

               Groups Opposed to Right To Try Legislation

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

  Ms. SCHAKOWSKY. Mr. Speaker, it opens the door for bad actors to take 
advantage of terminally ill patients. It is the FDA's job to ensure 
that drugs are safe and effective, and we can't trust manufacturers to 
act as this gatekeeper.
  There is already a safe process for terminally ill patients to access 
experimental treatments. Under what is called the expanded access 
program, 99 percent of applications are approved. The expanded access 
program plays a vital safety role.
  I am very troubled by what can happen to patients in some States who 
undergo treatment from right-to-try companies. In 19 States, patients 
using an investigational drug could actually lose their hospice 
coverage; in 6 States, they could be denied home care coverage. These 
are the very people who are dependent on hospice and home healthcare, 
and this bill would cause them to lose that coverage.
  This is not a humane, patient-centered bill for people who are facing 
death; it is just a dangerous pathway for bad actors to exploit those 
very people.
  Mr. Speaker, I urge my colleagues to oppose H.R. 5247, and, again, I 
thank the gentleman for the opportunity to speak against this piece of 
legislation.
  Mr. BURGESS. Mr. Speaker, at this time, I am pleased to yield such 
time as he may consume to the gentleman from Oregon (Mr. Walden), the 
chairman of the full committee.
  Mr. WALDEN. Mr. Speaker, I rise today on behalf of the patients, the 
patients who face terminal diagnoses but have exhausted all available 
known treatment options.
  Before us today we have legislation that received 260 bipartisan 
votes last week; that was nearly 260 votes to increase patient access 
to investigational drugs through a new pathway.
  I want to thank Dr. Burgess for his incredible work on our Energy and 
Commerce Committee to do our due diligence, to take an issue that is 
important to our citizens and our colleagues and make sure that it has 
been properly vetted, reviewed, and improved upon from what we got from 
the Senate.
  Mr. Speaker, 38 States have right-to-try laws, including my own State 
of Oregon. This is something that people want and deserve. Wisconsin 
will make it number 39 once the bill they have passed gets across 
Governor Scott Walker's desk.
  While the State policies vary, they have a common goal, and that is 
helping vulnerable patients. President Trump praised the movement 
during

[[Page H1743]]

the State of the Union, saying: ``People who are terminally ill should 
not have to go from country to country to seek a cure--I want them to 
have a chance right here at home.''
  I have spoken to the President directly about what we are doing here, 
and he gave me a shout-out when he was up in New Hampshire the other 
day about moving this bill forward. We worked closely with the Vice 
President and his team and with Scott Gottlieb, who is the doctor who 
heads the FDA, the Food and Drug Administration, to get a really good, 
thoughtful product before this House, and they support what we are 
doing here. President Trump also highlighted this bill, as I said, when 
he was in New Hampshire.
  It is important to note that this isn't the first time we have 
considered this bill. As you may know, last week, we tried to move this 
on the suspension calendar, never imaging that the Democrats would 
actually whip against giving dying patients the right to try one of 
these drugs. We had 32 Democrats support this legislation, and that is 
why we brought it back under regular order in a rule today.
  Now, today, there is an existing process, and you have heard about 
it--and we looked at this in the committee--for patients to access 
unapproved drugs. The FDA oversees expanded access, commonly known as 
compassionate use. This program has been critical in helping patients 
access experimental drugs. It does work.
  Commissioner Gottlieb and the agency should be commended for their 
continued work to improve the expanded access program for patients. As 
you have heard from my colleagues on both sides of the aisle, this 
program works, and works effectively, but it doesn't do it all, and 
that is why this legislation is before us.
  To improve upon this successful program, the bill before us today 
provides liability protections for manufacturers, sponsors, physicians, 
clinical investigators, and hospitals that participate in the existing 
expanded access program and the new alternative pathway that we create 
under this legislation.
  This was a very big issue for those who needed to be brought into 
participation who otherwise might have sat on the sidelines and never 
made these drugs available. This provision removes one of the biggest 
hurdles that patients face and that was identified by the Government 
Accountability Office; it is the biggest hurdle they face in getting 
access to experimental therapies: manufacturers' hesitancy to 
participate. That is the hurdle we are trying to overcome today in a 
safe way.
  The bill also creates a new alternative pathway for patients who do 
not qualify for a clinical trial. This legislation strengthens patient 
protections with clearer informed consent and adverse event reporting. 
The bill also ensures the FDA is notified when a patient receives an 
unapproved drug through the new alternative pathway to ensure proper 
oversight.
  Mr. Speaker, I want to thank my colleagues in the House, and 
especially Dr. Burgess on the Health Subcommittee, but also 
Representative Brian Fitzpatrick;  Andy Biggs, who is behind me; Morgan 
Griffith; and our Vice President, Mike Pence. I am grateful for their 
work and for their understanding that our job here in the House is to 
do our work: to hear from people who are affected or might be affected, 
to improve upon products, to go through regular order, and to bring 
this bill to you today.
  Mr. Speaker, I urge all of my colleagues in the House to support this 
legislation.
  Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the 
gentlewoman from California (Ms. Matsui).
  Ms. MATSUI. Mr. Speaker, I thank the gentleman for yielding to me.
  Mr. Speaker, I rise in opposition to H.R. 5247, the so-called right-
to-try legislation. This bill does not give patients the right to try; 
rather, it gives patients the right to request, which fails to address 
real barriers to accessing experimental drugs such as drug costs or 
company restrictions.
  I will reiterate that patients already have the right to try through 
an expedited process that approves 99 percent of requests it receives. 
This legislation, however, fails to recognize that, if a patient is 
denied access, it is usually because a drug manufacturer says no due to 
manufacturer concerns about safety or side effects, not because the FDA 
denied a request.
  I know, like everyone else, I have heard from many constituents 
suffering from terminal illnesses such as ALS who are desperate for 
cures; and I believe that every single one of us in this Chamber has 
confronted, in some way, a family member--mother, father, spouse--who 
had, heartbreakingly, an illness that had no cure. We have gone through 
the process many times, and I think we all have felt desperate from 
time to time.
  However, having said that, just because a person at the end has no 
hope, to try something that might make things worse so you cannot go on 
to a more peaceful resolution would be hurtful not only to the patient, 
but to the family.
  Opening up unregulated pathways to drugs after only a phase 1 
clinical trial may expose patients to severe and unpredictable side 
effects. This bill would prevent FDA from documenting these side 
effects and, worse, would prevent FDA from protecting other patients 
from a similar fate.
  When a loved one is in pain, the last thing a family wants is to 
cause further suffering. We need clinical trials to ensure drugs are 
safe and effective and to find real cures for patients, and we need the 
FDA to be a part of the process as a matter of patient protection for 
all.
  Rescinding any FDA oversight on unproven therapies that have not 
undergone multiple clinical trials is a slippery slope. The expedited 
process we have now is working, and I cannot support a bill that offers 
a ``right to ask'' alongside proposals that could be dangerous for all.
  Mr. Speaker, I urge my colleagues to oppose this bill.
  Mr. BURGESS. Mr. Speaker, I am pleased to yield 3 minutes to the 
gentleman from Virginia (Mr. Griffith), a valuable member of the Energy 
and Commerce Committee, the vice chairman of the Oversight and 
Investigations Subcommittee.
  Mr. GRIFFITH. Mr. Speaker, I have heard people say that they don't 
want to support a bill that makes things worse. We have people who are 
terminal, whose life expectancy is measured in months, not in decades, 
and how do you make things worse?
  I said last week, and I repeat it today, that if I--if, and I am not, 
thank God--but if I were faced with one of these heart-rendering 
situations, I would take any risk, including injecting monkey urine, if 
that meant I could spend a few more days, months, or years with my 
children.

                              {time}  1330

  I think many people are in that same boat, and the American people 
deserve a right to try. When we were doing our hearings on this, we had 
an Energy and Commerce Subcommittee on Health hearing where Lieutenant 
Commander Matthew Bellina, who graduated from Virginia Tech in my 
district and served in the United States Navy, testified before us. He 
said, in the conclusion of his comments: ``I know that it is probably 
too late for me, and I have made my peace with that. I need to know 
before I die that, if my children find themselves in this unenviable 
position, this Nation that I proudly served will respect their 
liberties and their right to make their own decisions about their 
medical treatments.''
  He suffered from ALS, as I said. I have had three friends during my 
lifetime die of that: Ray Robrecht, my predecessor a couple terms back 
in the Virginia House of Delegates; Julie Mullins, whose family I have 
known for decades; and Mike Ahern, who was connected with the United 
States Senate through his sister. All of these folks were people who 
lived in Salem County or Roanoke County, and they all died from ALS. 
They were all brave people. They should have had the right to try to 
see if they could make an improvement for others.
  Even more poignant are my family friends who lost both a grandparent 
and their mother to Huntington's chorea. I was their family lawyer. I 
did their will. I would like to believe, and I know they would have 
liked the option, that their mother would have chosen the right to try, 
knowing that, even if it failed, it might help another generation 
because, as you know, Huntington's chorea is a genetically transmitted 
disease.

[[Page H1744]]

  So I do not understand why people are afraid of letting people try 
who have no other hope, whose life is going to be cut short, without 
taking that Hail Mary pass. And so I hope that everyone will support 
this reasonable, measured effort to let people have a choice and a 
right to try.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I want to explain some other reasons why I am very 
opposed to this bill. I am concerned that H.R. 5247 essentially does 
nothing to address what may be the true barrier to expanded access, and 
that is the determination by the manufacturer as to whether or not they 
will provide access to their product that is under development. And I 
want to stress, there is nothing in this legislation before us today 
that would compel a manufacturer to grant access upon request.
  Further, I believe that trusted manufacturers like J&J, or Johnson & 
Johnson, which is headquartered in my district, have already said that 
any compassionate use request must be subject to FDA review. Now, I 
have heard my colleagues refer to this as a Hail Mary pass for the 
terminally ill. I think, in reality, it is offering false hope of a 
cure to patients and their families when there is no guarantee that any 
patient will receive access to treatment from a manufacturer.
  In fact, H.R. 5247 sets an extremely low threshold for the types of 
experimental treatments that may be available through this alternative 
pathway by allowing patients access to investigational treatments that 
have only completed a phase 1 clinical trial. Patients will be exposed 
to treatments with no or relatively little data that they are actually 
effective. These extremely small trials only examine the safety and 
toxicity of a drug and do not determine the effectiveness or potential 
side effects. Access at this phase 1 stage in the development could 
expose patients to untested products and further harm and result in 
delaying access to a treatment that may be more appropriate and more 
beneficial for their underlying disease or condition.
  Only 1 in 10 products move on from phase 1 clinical trials to FDA 
approval. Mr. Speaker, the bill does not make any adverse-event 
reporting to the FDA immediate. It also limits FDA's ability to use 
clinical outcomes associated with the use of an investigational product 
when reviewing a product for approval if it could adversely impact its 
review. It also prevents any entity from being held liable for use of 
the treatment.
  Again, these are some of the many reasons that more than 100 
organizations oppose this dangerous bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield 4 minutes to the gentlewoman from 
Indiana (Mrs. Brooks), another valuable member of the Committee On 
Energy and Commerce and the Subcommittee on Health.
  Mrs. BROOKS of Indiana. Mr. Speaker, the right-to-try legislation 
will be considered on the House floor today. This is about giving 
people hope to try. It is about hope to try investigational drugs which 
have passed the first of three phases of the FDA clinical trial 
process, the safety testing phase. And these investigational drugs 
could possibly prolong or save the lives of terminally ill patients.
  I like to remind my colleagues that a little boy was in Washington, 
D.C., on the House floor just last week when we first voted on this 
legislation. Prior to that vote, I had met Jordan during an Energy and 
Commerce Committee hearing focusing on the implementation of the 21st 
Century Cures Act.
  Jordan McLinn is a second grader from Indianapolis who may look like 
any other healthy child, but he has Duchenne muscular dystrophy, or 
DMD, a fatal, degenerative condition which causes muscle weakness. DMD 
is caused by an absence of dystrophin, a protein that helps keep muscle 
cells intact. Oftentimes, kids born with DMD are wheelchair-bound by 
age 12, and they have a life expectancy of just 25 years old.
  DMD is a genetic disease that is typically passed on to boys through 
their mother's X chromosome. But sometimes the mother is not a carrier, 
there is no family history of the disease, but a child is born with the 
disease anyway. This is what happened to Jordan McLinn. His mother, 
Laura, is not a carrier. This disease does not run in their family.
  Jordan was born with DMD, but it was not diagnosed until he was 4 
years old. So can you imagine what this family has been through? After 
Jordan was diagnosed, his family hit the ground running, trying to find 
the best possible treatment options and therapies for people with DMD. 
His mother, Laura, was quoted in The Indianapolis Star today in an 
article focused on the right-to-try bill saying: ``The reason we have 
remained on this journey and fighting so hard for it is not necessarily 
for Jordan immediately. It's for all the patients that we've met along 
the way.''

  Jordan and his family have been on this journey advocating this fair 
and compassionate bill in Indiana and beyond for Jordan but also for so 
many others. In 2015, then-Governor Mike Pence signed Indiana's right-
to-try law with Jordan McLinn by his side. Now a total of 38 States 
have already passed laws that take a variety of approaches to helping 
vulnerable patients. By passing this legislation in the House today, we 
will increase access--nationwide--to unapproved, investigational drugs 
for patients with a terminal illness.
  In that same IndyStar article I mentioned earlier, Laura shared that 
Jordan has always wanted to be a firefighter, but now, after coming to 
the Nation's Capital many times, he has aspirations to be something 
else. He now wants to be President of the United States. This bill 
allows Jordan to have those big dreams, and it will be providing 
patients across this country with hope.
  Yes, it is hope, hope for patients that they may find the cure 
someday that they have been searching and fighting for, hope for 
patients and their families that there will be more time to make more 
memories that can last a lifetime.
  In closing, I would just like to emphasize how critically important 
it is that Congress join together to support the bill for the millions 
of Americans who fight for their lives because of a terminal illness. I 
urge my colleagues to support this bill.
  Mr. PALLONE. Mr. Speaker, may I inquire how much time I have 
remaining?
  The SPEAKER pro tempore. The gentleman from New Jersey has 15\1/2\ 
minutes remaining.
  Mr. PALLONE. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Texas (Mr. Gene Green), the ranking member of the Health 
Subcommittee.
  Mr. GENE GREEN of Texas. Mr. Speaker, I thank my ranking member for 
yielding to me. I rise in opposition to the right-to-try legislation 
that would bypass the Food and Drug Administration's longstanding 
review and oversight of drug treatments and endanger patients with 
life-threatening diseases.
  Many States have passed this right-to-try piece of legislation, 
including my home State of Texas, but the States don't have the FDA. 
The Federal Government has the right to be able to make sure we can 
protect both constituents and consumers. My heart goes out to the loved 
ones who are terminally ill and desperate for a breakthrough treatment. 
I cannot support legislation that offers false hope to the terminally 
ill and their families.
  The FDA has a pathway whereby those in need of investigational 
medications may seek to obtain them. This program is known as the 
expanded access pathway, or compassionate use, and has been in the law 
since 1987. Over the last decade, the FDA has a clinical hold on only 
two commercial drug development programs due to adverse events 
associated with compassionate use.
  There are many patient advocacy groups that are opposing this 
legislation. Groups such as the Alliance for Aging Research, the 
American Cancer Society Cancer Action Network, American Lung 
Association, the American Society of Clinical Oncology, the Cystic 
Fibrosis Foundation, Defeat MSA, the Disability Rights Legal Center, 
and dozens more that are committed to seeking effective treatment cures 
to many diseases which are terminal, are against this bill. These 
patients' rights groups seek to ensure that the medication that is 
offered to individuals is safe, has been tested, and has gone

[[Page H1745]]

through the proper approval process before it is given to a patient.
  The most vulnerable and terminally ill individuals deserve to have 
access to safe therapies that have undergone the necessary approval 
process before being given to those who can least afford to receive 
unproven treatment that may do them more harm than good. In addition to 
the physical harm which unproven treatments may cause, there is also 
the risk of financial exploitation of terminally ill patients given 
that such treatments are not covered by insurance. Manufacturers are 
not required to cover the cost of investigational treatment.
  The majority's decision to go around our committee's consideration 
and effort to pass the bill on suspension last week exemplifies what 
this legislation is trying to do, circumvent existing rules and 
processes that have been created to protect Americans from hasty 
decisions.
  I ask my colleagues on both sides of the aisle to stand up for 
Americans facing serious and life-threatening diseases by opposing this 
unnecessary and potentially dangerous legislation.

  Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from 
Arizona (Mr. Biggs), one of the primary drivers on this legislation.
  Mr. BIGGS. Mr. Speaker, I thank the gentleman from Texas for 
yielding. I also pay my respects and give honor to Ron Johnson, the 
Senator from Wisconsin who championed the bill in the Senate and gave 
us a superb bill; also, Chairman Walden and his committee, who have 
worked hard to give us this bill today; and my original cosponsor on 
the bill that I introduced, Mr. Fitzpatrick from Pennsylvania.
  Mr. Speaker, I want to address just a couple of things that I think 
are really intriguing to me because it certainly seems a bit 
condescending to me when I hear people say: I am not going to support 
this because it gives false hope that people might be taken advantage 
of by bad actors. They cannot identify the bad actors, but they might 
be taking advantage of them. That is a fallacious and specious argument 
to make when you are denying people who have a terminal illness, who 
have been diagnosed with a terminal illness, who have gone through the 
already approved FDA processes in order to get and petition a 
pharmaceutical company for an experimental drug that might prolong 
their life and might heal them.
  False hope, that argument, is the argument that I am hearing. But the 
reality is these people are individuals. They have a higher sense of 
reality than virtually anybody else I know because their mortality is 
there. They want the opportunity. It is not false hope. It is hope. 
Support of this bill is compassionate. Support of this bill is fair.
  I have also heard that there may be some liability issues on the part 
of pharmaceutical companies which might impede them from providing 
drugs. Yet, in order to satisfy them, the bill itself says that they 
are exculpated unless their conduct is willful or criminal. That means 
that they have protection.
  What I am asking here today, and what everyone with whom I have met 
over the years who want a right to try is asking, is simply a chance to 
have some determination and control over their own lives.

                              {time}  1345

  One of the intriguing arguments I hear today and I heard last week 
is, well, you know what, the pharmaceutical companies aren't compelled 
to provide these drugs. So my immediate question is: Oh, so you would 
be more comfortable, then, if we would have included a compulsory means 
in the bill? Did you want the pharmaceutical companies to be compelled 
to provide these?
  The answer would be no. It is simply they don't like this bill. They 
don't want the bill.
  When you have 38, soon to be 39, States that want to give their 
citizens, Americans all, the right to try to preserve their lives and 
to be healed and have a chance, they need to get that; they need that 
opportunity. We need to give it to them today.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, there has been a lot of misinformation spread by 
supporters of this legislation that FDA is a barrier to patients 
receiving access to these investigational treatments, and I want to be 
very clear that that is simply not the case.
  FDA's expanded access program approves nearly all requests for 
investigational drugs or biologics it receives. For the past 5 years, 
FDA's approval rate for expanded access requests has been over 99 
percent. In fiscal year 2017, as I previously mentioned, only nine 
individual requests were denied.
  FDA also conducts its review quickly. FDA physicians are available 24 
hours a day to approve any emergency expanded access requests the 
agency receives, typically granting 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 the expanded access request 
process for physicians to make it less burdensome. I think that was 
mentioned by Mr. Walden, the chairman.
  Pharmaceutical companies can choose to deny a patient access to an 
experimental treatment because, for example, there is not enough of the 
drug available or they are concerned about dangerous side effects. The 
fact is, when a patient is denied access to an experimental treatment, 
it is because the company has said no, not the FDA.
  So let's be clear as to what this legislation is. It is an attempt to 
undermine the authority of the expert public health agency charged with 
reviewing drugs to ensure their safety and efficacy.
  I would urge my colleagues to oppose this grab at FDA's authority. 
That is really what this legislation is all about.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from 
Georgia (Mr. Allen).
  Mr. ALLEN. Mr. Speaker, I rise today to encourage my colleagues to 
join me in supporting H.R. 5247, the Right to Try Act, and I thank Dr. 
Burgess and the Energy and Commerce Committee for bringing this 
important legislation to the floor of this House.
  In certain States across our Nation, patients who are diagnosed as 
terminally ill are being told by doctors that all of the treatment 
options have been exhausted because they do not have access to 
experimental drugs. This type of overregulation by the Federal 
Government is creating hopeless situations for thousands of Americans 
whom we hold dearest to our hearts.
  This right-to-try legislation allows terminal patients to have a 
choice on whether or not an experimental approach is the path for them, 
as sometimes, and many times, this is their only option.
  Should this bill become Federal law, our terminally ill patients will 
have increased access, nationwide, to unapproved drugs, leading to more 
scientific breakthroughs that will benefit all Americans and, in lots 
of cases, will save a life.
  Now is the time for Congress to take action and give terminally ill 
patients a fighting chance for their God-given right to life. How in 
God's name can this Congress deny an American the right to life?
  Mr. Speaker, I urge all my colleagues to join me today in supporting 
this bill on this floor.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I said before that I have found that some Members were 
looking to vote for this bill because they said: Well, we have the 
right to try in our State by State statute, so what is the difference 
if we do it on the Federal level?
  I just want to stress again that the State right-to-try laws do not 
give patients a right to try effectively and have done little to expand 
access to investigational treatments.
  There are 37 States and the District of Columbia that have enacted 
right-to-try laws, and there is no evidence that anyone has obtained an 
investigational treatment via these laws that couldn't have been 
obtained through FDA's expanded access program.
  Right-to-try laws do not compel companies to provide patients access 
to investigational treatments; therefore, under these State laws, 
patients still do not have a right to try, only the

[[Page H1746]]

right to request the treatment from the company.
  State right-to-try laws do not address the fundamental barriers of 
cost and company restrictions. Neither the FDA nor States require 
insurers or pharmaceutical companies to cover the cost or reduce the 
costs of these often expensive treatments. Instead, these laws put 
patients at higher risk by prohibiting or weakening FDA's oversight of 
investigational treatments.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from 
Tennessee (Mr. Roe), the chairman of the Committee on Veterans' 
Affairs.
  Mr. ROE of Tennessee. Mr. Speaker, I rise today in strong support of 
H.R. 5247, the Right to Try Act.
  I am a physician and scientist with over 40 years experience treating 
patients, some of whom had the dreaded diagnosis of cancer.

  Six months ago, I was operated on for cancer, and I, to this day, am 
a cancer survivor. If needed, I would like to have the right to try.
  A little over 3 years ago, my beloved wife, Pam Roe, a nurse and 
friend, died of stage IV colon cancer. She would have liked to have had 
the right to try.
  Less than 2 months after that, one of the best friends I will ever 
have in my life, Phil Street, a Vietnam veteran, Air Force veteran, 
died of a cancer related to Agent Orange. Phil would have liked to have 
had the right to try.
  My senior partner in medical practice, a year later, good friend, was 
diagnosed with brain cancer. Dr. Cone would have liked the right to 
try.
  Shortly after that, Linda Baines, a scrub nurse that I have operated 
with hundreds of times in my medical practice, was diagnosed with 
cancer. Linda would have liked the right to try.
  I have two dear friends at this moment who are both being treated for 
stage IV cancer. If those treatments don't work--and I have had to look 
patients in the eye and say, Mr. Speaker: ``Your life is not in my 
hands anymore. It is in God's hands''--they would like to have the 
right to try.
  I tell you this: all these patients want and deserve is a right to 
try. Please, I am asking you to support this legislation.
  Mr. PALLONE. Mr. Speaker, may I inquire how much time remains and 
whether the gentleman has additional speakers on his side.
  Mr. BURGESS. Mr. Speaker, I will be closing.
  The SPEAKER pro tempore. The gentleman from New Jersey has 9 minutes 
remaining. The gentleman from Texas has 3\1/2\ minutes remaining.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I just want to stress that, as I said before, we have 
the four previous FDA Commissioners, two Democrats and two Republicans 
appointed by President Bush, who have raised serious concerns about 
this legislation because it excludes FDA review and they think could 
pose serious risks to vulnerable patients.
  I just wanted to read, once again, a statement that they made jointly 
to The Washington Post, where they said: ``There is no evidence that 
either bill 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, I just want to stress to my colleagues on both sides of 
the aisle that my concern is that no one is actually going to be able 
to get an experimental drug by this bill. In other words, if you are a 
manufacturer that actually has done something and come up with an 
experimental drug that you believe will make a difference to someone 
who is terminally ill, you are likely going to want to go through the 
FDA expanded access process because then there is a seal of approval 
that the FDA has actually looked at this and said that it is relatively 
safe to use.
  So my real fear is that the only thing this is going to do is open up 
to the possibility of some charlatan, fly-by-night snake oil drug 
company or manufacturer who is going to make all kinds of claims that 
have not been reviewed by the FDA for any kind of safety, and that then 
people may say: Okay. Well, I will take that because I am terminally 
ill and I might as well try something.
  But that isn't really what we should be doing here. We should be 
providing a process, as the FDA does right now, where, if someone is 
terminally ill and they want to try something, they at least have some 
certification of approval by the FDA that this is something that may 
help them, that may make a difference, and that, in the case of about 
11 percent of the cases where the application is made to the FDA, some 
changes are made to make sure that even though there is a certain level 
of risk, that that level of risk is reduced by the FDA putting on 
additional safety precautions.
  So my real concern here is I don't want people to vote for this 
legislation thinking that somehow it is going to make a difference. I 
really don't believe that is true. Otherwise, I wouldn't urge the 
opposition that I am. But for all these reasons, I do urge strong 
opposition to this bill and ask that my colleagues vote ``no.''
  Mr. Speaker, I yield back the balance of my time.
  Mr. BURGESS. Mr. Speaker, I yield myself the balance of my time.
  Mr. Speaker, yesterday, during the rule debate on this bill, I 
outlined a case where the previous Speaker, Nancy Pelosi, provided the 
right to try for a patient, a Democratic donor, back in my home State 
of Texas. So, really, all we are asking today is that we give regular 
Americans, the forgotten men and women of this country, the same rights 
that the Speaker of the House provided to a Democratic donor back in 
October of 2008.

  Yesterday I quoted from an article from the Dallas Morning News. I 
have a different but similar article today talking about the same case, 
talking about the individual who had a diagnosis of multiple myeloma.
  There was a drug that perhaps would provide some hope. The individual 
was clearly terminal. This monoclonal antibody that was primarily used 
to treat multiple sclerosis might show some efficacy in treating the 
advanced form of multiple myeloma that this patient had. The drug had 
been through phase 1 clinical trials. The patient did not have time for 
the drug to go through phase 2 and phase 3 clinical trials.
  The article says:

       Enter Nancy Pelosi. Through means to which we have never 
     been privy, Ms. Pelosi got the FDA to give the manufacturer 
     the all-clear to give the drug to the patient. The patient 
     got the drug, the patient took the drug, but, unfortunately, 
     the patient died anyway, but his family remains grateful to 
     the Speaker for interceding on his behalf.

  I don't doubt that they are.
  Yesterday, I quoted the Dallas Morning News article where the 
patient's spouse said, somehow, Nancy Pelosi got it done.
  Well, do you know what, Mr. Speaker? You shouldn't have to depend on 
the Speaker of the House to intercede on your behalf to get the FDA to 
get the manufacturer to make a drug available. If you are really up 
against a bad situation, wouldn't it be better if we provided everyone 
that same pathway?
  That is what this bill does today. That is why the right-to-try 
legislation was advocated by the President of the United States. In 
fact, I think it was the only legislative priority that the President 
laid out during his State of the Union Address where he wanted to see 
Congress act.
  So today, we are going to do that. Today, we are going to act. It is 
an important bill. I encourage my colleagues to vote in favor of it.
  Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. All time for debate has expired.
  Pursuant to House Resolution 787, the previous question is ordered on 
the bill.
  The question is on the engrossment and third reading of the bill.
  The bill was ordered to be engrossed and read a third time, and was 
read the third time.

                              {time}  1400


                           Motion to Recommit

  Mr. PALLONE. Mr. Speaker, I have a motion to recommit at the desk.
  The SPEAKER pro tempore. Is the gentleman opposed to the bill?
  Mr. PALLONE. I am opposed to the bill in its current form.
  The SPEAKER pro tempore. The Clerk will report the motion to 
recommit.

[[Page H1747]]

  The Clerk read as follows:

       Mr. Pallone moves to recommit the bill H.R. 5247 to the 
     Committee on Energy and Commerce with instructions to report 
     the same back to the House forthwith, with the following 
     amendment:

       Strike section 2 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. 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 
     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 
     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 
     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 investigational drug under subsection (b) 
     or (c) of section 561; and
       ``(2) the number of such requests that were granted.''.
       (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.--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 
     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.''.
       (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 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 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 investigational drug--

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

       ``(ii) The requirements described in this clause are the 
     requirements under subsection (b) or (c), 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 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.''.

  Mr. PALLONE (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 
gentleman from New Jersey?
  There was no objection.
  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey is recognized for 5 minutes in support of his motion.
  Mr. PALLONE. Mr. Speaker, this is an amendment to the bill, or 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 improving the FDA's current expanded access 
program.
  In October, the Energy and Commerce Committee held a hearing on the 
widely opposed Senate right-to-try legislation. At that hearing, we 
heard concerns from FDA Commissioner Gottlieb and also from 
manufacturers, academic experts, and patient groups that S. 204 was 
legislation that would expose broad numbers of patients to harm, and 
sought to hamstrung the FDA's ability to oversee or engage in any 
meaningful way on the use of investigational treatments.
  Since that time, my colleagues on the other side of the aisle have 
drafted new legislation that maintains, in my opinion, the same harmful 
approach prohibiting FDA review of experimental treatments. The FDA is 
part of the process for a reason. It protects patients from potentially 
bad actors or from experimental treatments that might do more harm than 
good.
  So my motion to recommit, Mr. Speaker, abandons this harmful attempt 
to undermine the FDA's expanded access pathway and, instead, seeks to 
make two improvements that have been identified as meaningful by both 
manufacturers and patient groups.
  This proposal will also not be any surprise to Chairman Walden or 
Chairman Burgess because it was the bipartisan proposal our staffs were 
negotiating prior to the introduction of the current Republican bill.
  So I want to stress that, unlike the current bill, H.R. 5247, this 
proposal is not based on the false premise that FDA approval is a 
barrier to accessing investigational treatments. Rather, it addresses 
the two key problems identified by expert witnesses at our hearing: how 
the FDA will utilize clinical outcomes of investigational treatments 
and liability protection.
  To that end, under this motion to recommit, the FDA is directed to 
issue guidance to manufacturers specifically on how and when the FDA 
will consider clinical outcomes, and when a sponsor may request the 
consideration of such outcomes when it comes time to submit an 
application for approval for the investigational treatment.
  This will provide manufacturers with the clarity they are seeking 
regarding

[[Page H1748]]

how allowing patients access to drugs that are still under development 
may impact their ability to gain full FDA approval. It will also ensure 
that there is a public process for such guidance, ensuring that 
stakeholders will have the opportunity to offer their views on this 
issue.
  Mr. Speaker, the motion to recommit also provides liability 
protection to manufacturers, physicians, clinical investigators, and 
hospitals, if they are in compliance with the current law and 
regulations for expanded access. If you are a manufacturer, a 
physician, or a hospital that is in compliance with current rules and 
requirements related to expanded access, you will receive protection 
for allowing access to the investigational treatment.
  Finally, it also provides transparency around the number of expanded 
access requests the FDA receives and grants, how many requests a 
manufacturer receives and grants, and if there are any serious adverse 
events. This transparency, I believe, will provide clear data as to how 
many patients are making expanded access requests and how often these 
requests are granted or denied by the FDA and manufacturers.
  Mr. Speaker, I believe that these legislative fixes will go a long 
way to bolstering the existing successful expanded access pathway, 
while maintaining the critical review and oversight of the agency 
charged with protecting our public health, that being the FDA.
  I just want to say that, last fall, FDA Commissioner Gottlieb 
testified on right-to-try efforts and told our committee: ``There is a 
perception that certain products that aren't being offered under FDA 
expanded access will be offered under right-to-try, and I don't see 
that.''
  That is our current Commissioner Gottlieb, who I respect a great 
deal.
  Rather than creating an unnecessary alternative pathway that 
threatens our drug approval process and our clinical trial program, I 
would urge my colleagues to join with Democrats and 103 patient 
organizations in supporting the current expanded access program.
  These targeted improvements under the motion to recommit to the 
existing program are, I think, a way to achieve a better goal. So I 
urge my colleagues to support my motion to recommit and oppose this, 
what I consider, dangerous Republican proposal in the bill before us.
  Mr. Speaker, I yield back the balance of my time.
  Mr. BURGESS. Mr. Speaker, I claim the time in opposition to the 
motion to recommit.
  The SPEAKER pro tempore. The gentleman from Texas is recognized for 5 
minutes.
  Mr. BURGESS. Mr. Speaker, while well-intentioned, this motion to 
recommit falls short of providing vulnerable patients full access to 
experimental treatments.
  Providing clarity on how negative side effects will be accounted for 
during drug approvals is helpful. Giving manufacturers, sponsors, 
physicians, hospitals, and clinical investigators certainty on 
liability protections is meaningful. Taken together, these improvements 
to the existing expanded access program could lead to enhanced 
manufacturer and sponsor participation and increased patient access.
  But this would not provide an alternative pathway for patients who 
cannot get into a clinical trial and have been rejected from 
participation in the existing compassionate use program.

  This bill before us today does provide an alternative pathway, one 
that strengthens patient protections with clearer informed consent and 
real-time adverse event reporting. This bill--the underlying bill--also 
makes certain that the FDA is notified when a patient receives an 
unapproved drug through the new alternative pathway to ensure proper 
oversight. These are significant patient protections.
  With this motion to recommit, we have a choice. The underlying bill 
is the only choice that gives those patients in the greatest need of 
help access to investigational drugs, with their consent, even after 
they were rejected from participating in a clinical trial or expanded 
access.
  Mr. Speaker, the choice is clear. We need to vote to expand patient 
access. We need to vote down the motion to recommit. We need to vote 
for the underlying bill.
  Mr. Speaker, 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.
  Mr. PALLONE. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this question will be postponed.

                          ____________________