[Congressional Record (Bound Edition), Volume 163 (2017), Part 9]
[Senate]
[Pages 12577-12578]
[From the U.S. Government Publishing Office, www.gpo.gov]




               TRICKETT WENDLER RIGHT TO TRY ACT OF 2017

  Mr. JOHNSON. Mr. President, in about 5 minutes, I am going to be 
asking for consent to pass the Trickett Wendler, Frank Mongiello, 
Jordan McLinn, and Matthew Belina Right to Try Act of 2017.
  I wish to take a few moments, though, to tell the story of how that 
right-to-try bill, which has been passed by 37 States, obtained that 
name. I believe it was probably March of 2014 that I met Trickett 
Wendler, a young mom with three children, who came to Washington, DC, 
with a group of other individuals advocating for those patients and 
their families with people suffering from ALS, or Lou Gehrig's 
disease--an incurable and devastating disease.
  A week before meeting Trickett, I met with the Goldwater Institute, 
which was talking about its right-to-try legislation. They were 
beginning to pass through State legislatures. Just mentioning the fact 
that I supported the right to try brought tears streaming down Trickett 
Wendler's face. Unfortunately, Trickett Wendler lost her battle to ALS 
on March 18, 2015. She has inspired something that I think is going to 
give so many thousands--maybe tens of thousands, maybe millions--of 
Americans hope when they face a similar type of disease, where there is 
no hope, where there are no further options, other than potentially an 
experimental drug that has been proven safe, according to the FDA.
  In our press conference announcing the introduction of this bill, we 
had met Matthew Belina, a naval aviator and lieutenant commander--one 
of the finest among us--also stricken with ALS. We had little Jordan 
McLinn, a little boy with Duchenne muscular dystrophy, and his mother 
Laura was speaking at that press conference. Remarkably, a man also 
stricken with ALS, Frank Mongiello, his wife Marilyn, and their 
children asked to speak. He made such an impression on our gathering, 
which encapsulated that press conference, particularly his speech in a 
video that I showed to my colleagues, which resulted in so many 
cosponsorships of this bill.
  These are real people facing their mortality with no hope. This 
right-to-try piece of legislation will give those individuals and their 
families hope.
  I want to truly thank my lead cosponsor from across the aisle, 
Senator Joe Donnelly, who is in the Chamber here today, and also 
Senator King and Senator Manchin, who decided not to play any politics 
whatsoever and also were willing to cosponsor a bill offered by 
somebody who was in a tough reelection fight. I want to thank my 43 
Republican cosponsors, particularly Senator McConnell. As leader, he 
was one of the first cosponsors who helped me to get those other 42 
cosponsors. I want to particularly thank Chairman Alexander and Ranking 
Member Murray, who have worked so cooperatively with me and my staff to 
make this moment possible. I would like to thank Vice President Pence, 
who also met Frank Mongiello and became a real advocate for this, and 
President Trump, who after meeting these types of victims--these 
individuals--also supported this piece of legislation.
  I wish to thank the Goldwater Institute and Darcy Olson for their 
tireless efforts at promoting the right to try and the 37 States and 
the 97.7 percent of the legislators who, when given a chance to vote to 
give people the right to try and the right to hope, voted yes.
  I would also like to thank a very special person, Dr. Delpassand, who 
really demonstrated why this is such an important piece of legislation. 
Dr. Delpassand is an oncologist from Houston, TX. He was engaged in an 
FDA trial on an aggressive form of endocrine cancer with 150 patients. 
It was working. The drug was working. He petitioned the FDA to allow 
another 78 patients to participate in the trial. The FDA said no, but 
Dr. Delpassand said yes, putting his career at risk.
  It is that kind of courage that we want to reward today by passing 
this right-to-try bill.
  In conclusion, I want to thank the thousands of patients and their 
families who have taken their wheelchairs and gone to their State 
capitals and have come here to Washington, DC, to advocate for their 
personal freedom, their personal liberty, for their right to try, for 
their right to hope, and for the right to hope of millions of other 
Americans faced with these incurable diseases.
  Mr. President, I ask unanimous consent that the Committee on Health, 
Education, Labor, and Pensions be discharged from further consideration 
of S. 204 and the Senate proceed to its immediate consideration.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will report the bill by title.
  The legislative clerk read as follows:

       A bill (S. 204) to authorize the use of unapproved medical 
     products by patients diagnosed with a terminal illness in 
     accordance with State law, and for other purposes.

  There being no objection, the Senate proceeded to consider the bill.
  Mr. JOHNSON. Mr. President, I ask unanimous consent that the Johnson-
Donnelly amendment at the desk be considered and agreed to, and the 
bill, as amended, be considered read a third time and passed, and the 
motion to reconsider be considered made and laid upon the table.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 753) in the nature of a substitute was agreed to, 
as follows:

                (Purpose: In the nature of a substitute)

       Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Trickett Wendler, Frank 
     Mongiello, Jordan McLinn, and Matthew Bellina Right to Try 
     Act of 2017''.

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

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

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

       ``(a) Definitions.--For purposes of this section--
       ``(1) the term `eligible patient' means a patient--
       ``(A) who has been diagnosed with a life-threatening 
     disease or condition (as defined in section 312.81 of title 
     21, Code of Federal Regulations (or any successor 
     regulations));
       ``(B) who has exhausted approved treatment options and is 
     unable to participate in a clinical trial involving the 
     eligible investigational drug, as certified by a physician, 
     who--
       ``(i) is in good standing with the physician's licensing 
     organization or board; and
       ``(ii) will not be compensated directly by the manufacturer 
     for so certifying; and
       ``(C) who has provided to the treating physician written 
     informed consent regarding the eligible investigational drug, 
     or, as applicable, on whose behalf a legally authorized 
     representative of the patient has provided such consent;
       ``(2) the term `eligible investigational drug' means an 
     investigational drug (as such term is used in section 561)--
       ``(A) for which a Phase 1 clinical trial has been 
     completed;
       ``(B) that has not been approved or licensed for any use 
     under section 505 of this Act or section 351 of the Public 
     Health Service Act;
       ``(C)(i) for which an application has been filed under 
     section 505(b) of this Act or section 351(a) of the Public 
     Health Service Act; or
       ``(ii) that is under investigation in a clinical trial 
     that--
       ``(I) is intended to form the primary basis of a claim of 
     effectiveness in support of approval or licensure under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act; and
       ``(II) is the subject of an active investigational new drug 
     application under section 505(i) of this Act or section 
     351(a)(3) of the Public Health Service Act, as applicable; 
     and
       ``(D) the active development or production of which is 
     ongoing and has not been discontinued by the manufacturer or 
     placed on clinical hold under section 505(i); and
       ``(3) the term `phase 1 trial' means a phase 1 clinical 
     investigation of a drug as described

[[Page 12578]]

     in section 312.21 of title 21, Code of Federal Regulations 
     (or any successor regulations).
       ``(b) Exemptions.--Eligible investigational drugs provided 
     to eligible patients in compliance with this section are 
     exempt from sections 502(f), 503(b)(4), 505(a), and 505(i) of 
     this Act, section 351(a) of the Public Health Service Act, 
     and parts 50, 56, and 312 of title 21, Code of Federal 
     Regulations (or any successor regulations), provided that the 
     sponsor of such eligible investigational drug or any person 
     who manufactures, distributes, prescribes, dispenses, 
     introduces or delivers for introduction into interstate 
     commerce, or provides to an eligible patient an eligible 
     investigational drug pursuant to this section is in 
     compliance with the applicable requirements set forth in 
     sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code of 
     Federal Regulations (or any successor regulations) that apply 
     to investigational drugs.
       ``(c) Use of Clinical Outcomes.--
       ``(1) In general.--Notwithstanding any other provision of 
     this Act, the Public Health Service Act, or any other 
     provision of Federal law, the Secretary may not use a 
     clinical outcome associated with the use of an eligible 
     investigational drug pursuant to this section to delay or 
     adversely affect the review or approval of such drug under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act unless--
       ``(A) the Secretary makes a determination, in accordance 
     with paragraph (2), that use of such clinical outcome is 
     critical to determining the safety of the eligible 
     investigational drug; or
       ``(B) the sponsor requests use of such outcomes.
       ``(2) Limitation.--If the Secretary makes a determination 
     under paragraph (1)(A), the Secretary shall provide written 
     notice of such determination to the sponsor, including a 
     public health justification for such determination, and such 
     notice shall be made part of the administrative record. Such 
     determination shall not be delegated below the director of 
     the agency center that is charged with the premarket review 
     of the eligible investigational drug.
       ``(d) Reporting.--
       ``(1) In general.--The manufacturer or sponsor of an 
     eligible investigational drug shall submit to the Secretary 
     an annual summary of any use of such drug under this section. 
     The summary shall include the number of doses supplied, the 
     number of patients treated, the uses for which the drug was 
     made available, and any known serious adverse events. The 
     Secretary shall specify by regulation the deadline of 
     submission of such annual summary and may amend section 
     312.33 of title 21, Code of Federal Regulations (or any 
     successor regulations) to require the submission of such 
     annual summary in conjunction with the annual report for an 
     applicable investigational new drug application for such 
     drug.
       ``(2) Posting of information.--The Secretary shall post an 
     annual summary report of the use of this section on the 
     internet website of the Food and Drug Administration, 
     including the number of drugs for which clinical outcomes 
     associated with the use of an eligible investigational drug 
     pursuant to this section was--
       ``(A) used in accordance with subsection (c)(1)(A);
       ``(B) used in accordance with subsection (c)(1)(B); and
       ``(C) not used in the review of an application under 
     section 505 of this Act or section 351 of the Public Health 
     Service Act.''.
       (b) No Liability.--
       (1) Alleged acts or omissions.--With respect to any alleged 
     act or omission with respect to an eligible investigational 
     drug provided to an eligible patient pursuant to section 561B 
     of the Federal Food, Drug, and Cosmetic Act and in compliance 
     with such section, no liability in a cause of action shall 
     lie against--
       (A) a sponsor or manufacturer; or
       (B) a prescriber, dispenser, or other individual entity 
     (other than a sponsor or manufacturer), unless the relevant 
     conduct constitutes reckless or willful misconduct, gross 
     negligence, or an intentional tort under any applicable State 
     law.
       (2) Determination not to provide drug.--No liability shall 
     lie against a sponsor manufacturer, prescriber, dispenser or 
     other individual entity for its determination not to provide 
     access to an eligible investigational drug under section 561B 
     of the Federal Food, Drug, and Cosmetic Act.
       (3) Limitation.--Except as set forth in paragraphs (1) and 
     (2), nothing in this section shall be construed to modify or 
     otherwise affect the right of any person to bring a private 
     action under any State or Federal product liability, tort, 
     consumer protection, or warranty law.

     SEC. 3. SENSE OF THE SENATE.

       It is the sense of the Senate that section 561B of the 
     Federal Food, Drug, and Cosmetic Act, as added by section 2--
       (1) does not establish a new entitlement or modify an 
     existing entitlement, or otherwise establish a positive right 
     to any party or individual;
       (2) does not establish any new mandates, directives, or 
     additional regulations;
       (3) only expands the scope of individual liberty and agency 
     among patients, in limited circumstances;
       (4) is consistent with, and will act as an alternative 
     pathway alongside, existing expanded access policies of the 
     Food and Drug Administration;
       (5) will not, and cannot, create a cure or effective 
     therapy where none exists;
       (6) recognizes that the eligible terminally ill patient 
     population often consists of those patients with the highest 
     risk of mortality, and use of experimental treatments under 
     the criteria and procedure described in such section 561A 
     involves an informed assumption of risk; and
       (7) establishes national standards and rules by which 
     investigational drugs may be provided to terminally ill 
     patients.

  The bill (S. 204), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed.
  The PRESIDING OFFICER. The Senator from Indiana.
  Mr. DONNELLY. Mr. President, I want to talk about what a great moment 
this is. I want to thank Chairman Alexander for all his help, Ranking 
Member Patty Murray for all of her help, and to my colleague the 
Senator from Wisconsin, Mr. Johnson, for all he has done to spearhead 
this effort.
  This gives folks a shot. It doesn't provide any guarantees, but it 
allows folks to be able to take their care into their own hands, to 
make judgments, and to decide: I want to take a shot at this.
  For me, it was a wonderful family from Indiana who, by the way, this 
morning they are at Legoland down in Florida because their young boy is 
in good health, is getting along, but time is ticking. Young Jordan 
McLinn has Duchenne muscular dystrophy. His mom Laura and Jordan met 
with me and said: All we want is a shot. We don't want a guarantee. We 
want a chance to try to make Jordan better. That is what this Right to 
Try Act does. That is why I am so proud of all our colleagues coming 
together to support this, and to all the families Senator Johnson 
mentioned, we are so proud of you. We are so grateful to you for your 
advocacy because it was your words, your examples that have helped to 
get this done.
  I want to say to everyone in Indiana and everyone in America how 
grateful we are that this Right to Try Act has passed, and to Chairman 
Alexander and Ranking Member Murray, thank you for working together to 
make this happen.
  I yield back.

                          ____________________