[Congressional Record Volume 163, Number 132 (Thursday, August 3, 2017)]
[Senate]
[Pages S4788-S4789]
From the Congressional Record Online through the 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;
[[Page S4789]]
``(C)(i) for which an application has been filed under
section 505(b) of this Act or section 351(a) of the Public
Health Service Act; or
``(ii) that is under investigation in a clinical trial
that--
``(I) is intended to form the primary basis of a claim of
effectiveness in support of approval or licensure under
section 505 of this Act or section 351 of the Public Health
Service Act; and
``(II) is the subject of an active investigational new drug
application under section 505(i) of this Act or section
351(a)(3) of the Public Health Service Act, as applicable;
and
``(D) the active development or production of which is
ongoing and has not been discontinued by the manufacturer or
placed on clinical hold under section 505(i); and
``(3) the term `phase 1 trial' means a phase 1 clinical
investigation of a drug as described in section 312.21 of
title 21, Code of Federal Regulations (or any successor
regulations).
``(b) Exemptions.--Eligible investigational drugs provided
to eligible patients in compliance with this section are
exempt from sections 502(f), 503(b)(4), 505(a), and 505(i) of
this Act, section 351(a) of the Public Health Service Act,
and parts 50, 56, and 312 of title 21, Code of Federal
Regulations (or any successor regulations), provided that the
sponsor of such eligible investigational drug or any person
who manufactures, distributes, prescribes, dispenses,
introduces or delivers for introduction into interstate
commerce, or provides to an eligible patient an eligible
investigational drug pursuant to this section is in
compliance with the applicable requirements set forth in
sections 312.6, 312.7, and 312.8(d)(1) of title 21, Code of
Federal Regulations (or any successor regulations) that apply
to investigational drugs.
``(c) Use of Clinical Outcomes.--
``(1) In general.--Notwithstanding any other provision of
this Act, the Public Health Service Act, or any other
provision of Federal law, the Secretary may not use a
clinical outcome associated with the use of an eligible
investigational drug pursuant to this section to delay or
adversely affect the review or approval of such drug under
section 505 of this Act or section 351 of the Public Health
Service Act unless--
``(A) the Secretary makes a determination, in accordance
with paragraph (2), that use of such clinical outcome is
critical to determining the safety of the eligible
investigational drug; or
``(B) the sponsor requests use of such outcomes.
``(2) Limitation.--If the Secretary makes a determination
under paragraph (1)(A), the Secretary shall provide written
notice of such determination to the sponsor, including a
public health justification for such determination, and such
notice shall be made part of the administrative record. Such
determination shall not be delegated below the director of
the agency center that is charged with the premarket review
of the eligible investigational drug.
``(d) Reporting.--
``(1) In general.--The manufacturer or sponsor of an
eligible investigational drug shall submit to the Secretary
an annual summary of any use of such drug under this section.
The summary shall include the number of doses supplied, the
number of patients treated, the uses for which the drug was
made available, and any known serious adverse events. The
Secretary shall specify by regulation the deadline of
submission of such annual summary and may amend section
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.
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