Bill Text: IA HF320 | 2025-2026 | 91st General Assembly | Introduced

---

Bill Title: A bill for an act relating to the right to try Act.

Spectrum: Partisan Bill (Republican 1-0)

Status: (Introduced) 2025-02-19 - Subcommittee recommends passage. [HF320 Detail]

Download: Iowa-2025-HF320-Introduced.html

---

House File 320 - Introduced
HOUSE FILE 320
BY BRADLEY
A BILL FOR
An Act relating to the right to try Act.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
TLSB 1518YH (2) 91
lh/ko

H.F. 320
Section 1. Section 144E.2, Code 2025, is amended to read as
follows:
144E.2 Definitions.
As used in this chapter :
1. “Eligible facility” means an institution operating under
a federalwide assurance for the protection of human subjects
pursuant to 42 U.S.C. §289(a) and 45 C.F.R. pt. 46, and
subject to the federalwide assurance laws, rules, policies, and
guidelines including renewals and updates.
1. 2. “Eligible patient” means an individual who meets all
of the following conditions specified under paragraph “a” or
“b” :
a. (1) Has a terminal illness, attested to by the patient’s
treating physician.
b. (2) Has considered and rejected or has tried and failed
to respond to all other treatment options approved by the
United States food and drug administration.
c. (3) Has received a recommendation from the individual’s
physician for an investigational drug, biological product, or
device.
d. (4) Has given written informed consent for the use of
the investigational drug, biological product, or device.
e. (5) Has documentation from the individual’s physician
that the individual meets the requirements of this subsection
paragraph “a” .
b. (1) Has a life-threatening or severely debilitating
illness, attested to by the patient’s treating physician.
(2) Has considered all other treatment options currently
approved by the United States food and drug administration.
(3) Has received a recommendation from the individual’s
physician for an individualized investigational treatment,
based on an analysis of the patient’s genomic sequence, human
chromosomes, deoxyribonucleic acid, ribonucleic acid, genes,
gene products such as enzymes and other types of proteins, or
metabolites.
-1-
LSB 1518YH (2) 91
lh/ko 1/ 9

H.F. 320
(4) Has given written informed consent for the use of the
individualized investigational treatment.
(5) Has documentation from the individual’s physician that
the individual meets the requirements of this paragraph “b” .
3. “Individualized investigational treatment” means a drug,
biological product, or device that is unique to, and produced
exclusively for use by, an individual patient, based on the
individual patient’s own genetic profile. “Individualized
investigational treatment” includes but is not limited to
individualized gene therapy, antisense oligonucleotides, and
individualized neoantigen vaccines.
2. 4. “Investigational drug, biological product, or
device” means a drug, biological product, or device that has
successfully completed phase 1 of a United States food and drug
administration-approved clinical trial but has not yet been
approved for general use by the United States food and drug
administration and remains under investigation in a United
States food and drug administration-approved clinical trial.
3. 5. “Terminal illness” means a progressive disease
or medical or surgical condition that entails significant
functional impairment, that is not considered by a treating
physician to be reversible even with administration of
treatments approved by the United States food and drug
administration, and that, without life-sustaining procedures,
will result in death.
4. 6. “Written informed consent” means a written document
that is signed by the patient, a parent of a minor patient, or a
legal guardian or other legal representative of the patient and
attested to by the patient’s treating physician and a witness
and that includes , at a minimum, all of the following:
a. If the patient is an eligible patient as specified in
subsection 2, paragraph “a” :
(1) An explanation of the products and treatments approved
by the United States food and drug administration for the
disease or condition from which the patient suffers.
-2-
LSB 1518YH (2) 91
lh/ko 2/ 9

H.F. 320
b. (2) An attestation that the patient concurs with the
patient’s treating physician in believing that all products
and treatments approved by the United States food and drug
administration are unlikely to prolong the patient’s life.
c. (3) Clear identification of the specific proposed
investigational drug, biological product, or device that the
patient is seeking to use.
d. (4) A description of the best and worst potential
outcomes of using the investigational drug, biological product,
or device and a realistic description of the most likely
outcome. The description shall include the possibility that
new, unanticipated, different, or worse symptoms might result
and that death could be hastened by use of the proposed
investigational drug, biological product, or device. The
description shall be based on the treating physician’s
knowledge of the proposed investigational drug, biological
product, or device in conjunction with an awareness of the
patient’s condition.
e. (5) A statement that the patient’s health plan or
third-party administrator and provider are not obligated to
pay for any care or treatments consequent to the use of the
investigational drug, biological product, or device, unless
they are specifically required to do so by law or contract.
f. (6) A statement that the patient’s eligibility for
hospice care may be withdrawn if the patient begins curative
treatment with the investigational drug, biological product,
or device and that hospice care may be reinstated if this
treatment ends and the patient meets hospice eligibility
requirements.
g. (7) A statement that the patient understands that the
patient is liable for all expenses consequent to the use of
the investigational drug, biological product, or device and
that this liability extends to the patient’s estate unless
a contract between the patient and the manufacturer of the
investigational drug, biological product, or device states
-3-
LSB 1518YH (2) 91
lh/ko 3/ 9

H.F. 320
otherwise.
b. If the patient is an eligible patient as specified in
subsection 2, paragraph “b” :
(1) An explanation of the currently approved products and
treatments for the disease or condition from which the patient
suffers.
(2) An attestation that the patient concurs with the
patient’s treating physician in believing that all currently
approved and conventionally recognized products and treatments
are unlikely to prolong the patient’s life.
(3) Clear identification of the specific proposed
individualized investigational treatment that the patient is
seeking to use.
(4) A description of the best and worst potential outcomes
of using the individualized investigational treatment
and a realistic description of the most likely outcome.
The description shall include the possibility that new,
unanticipated, different, or worse symptoms might result
and that death could be hastened by use of the proposed
individualized investigational treatment. The description
shall be based on the treating physician’s knowledge of
the proposed individualized investigational treatment in
conjunction with an awareness of the patient’s condition.
(5) A statement that the patient’s health plan or
third-party administrator and provider are not obligated to
pay for any care or treatments consequent to the use of the
individualized investigational treatment, unless they are
specifically required to do so by law or contract.
(6) A statement that the patient’s eligibility for hospice
care may be withdrawn if the patient begins curative treatment
with the individualized investigational treatment and that
hospice care may be reinstated if this treatment ends and the
patient meets hospice eligibility requirements.
(7) A statement that the patient understands that the
patient is liable for all expenses consequent to the use of
-4-
LSB 1518YH (2) 91
lh/ko 4/ 9

H.F. 320
the individualized investigational treatment and that this
liability extends to the patient’s estate, unless a contract
between the patient and the manufacturer of the individualized
investigational treatment states otherwise.
Sec. 2. Section 144E.3, Code 2025, is amended to read as
follows:
144E.3 Manufacturer and eligible facility rights.
1. A manufacturer of an investigational drug, biological
product, or device or a manufacturer operating within, and in
compliance with all requirements applicable to, an eligible
facility may make available , and an eligible patient , as
applicable under section 144E.1, subsection 2, paragraph “a”
or “b” , may request from a manufacturer of an investigational
drug, biological product, or device, or a manufacturer
operating within, and in compliance with all requirements
applicable to, an eligible facility, the manufacturer’s
investigational drug, biological product, or device , or the
manufacturer’s individualized investigational treatment under
this chapter . This chapter does not require a manufacturer
of an investigational drug, biological product, or device , or
of an individualized investigational treatment to provide or
otherwise make available the investigational drug, biological
product, or device , or the individualized investigational
treatment to an eligible patient.
2. A An eligible facility, or a manufacturer described
in subsection 1 , that is in compliance with all applicable
requirements, may do any of the following:
a. Provide an investigational drug, biological product,
or device , or an individualized investigational treatment
to an eligible patient , as applicable under section 144E.1,
subsection 2, paragraph “a” or “b” , without receiving
compensation.
b. Require an eligible patient , as applicable under section
144E.1, subsection 2, paragraph “a” or “b” , to pay the costs
of, or the costs associated with, the manufacture of the
-5-
LSB 1518YH (2) 91
lh/ko 5/ 9

H.F. 320
investigational drug, biological product, or device , or the
individualized investigational treatment .
Sec. 3. Section 144E.4, Code 2025, is amended to read as
follows:
144E.4 Treatment coverage.
1. This chapter does not expand the coverage required of an
insurer under Title XIII, subtitle 1 .
2. A health plan, third-party administrator, or
governmental agency may , but is not required to, provide
coverage for the cost of an investigational drug, biological
product, or device, or the cost of an individualized
investigational treatment, the cost of services related to the
use of an investigational drug, biological product, or device ,
or the cost of services related to the use of an individualized
investigational treatment under this chapter .
3. This chapter does not require any governmental agency
to pay costs associated with the use, care, or treatment of a
patient with an investigational drug, biological product, or
device , or an individualized investigational treatment .
4. This chapter does not require a hospital licensed under
chapter 135B or other health care facility to provide new or
additional services , unless approved by the hospital or other
health care facility .
Sec. 4. Section 144E.5, Code 2025, is amended to read as
follows:
144E.5 Heirs not liable for treatment debts.
If a patient dies while being treated by with an
investigational drug, biological product, or device, or
an individualized investigational treatment, the patient’s
heirs are not liable for any outstanding debt related to the
treatment or lack of insurance due to the treatment , unless
otherwise required by law .
Sec. 5. Section 144E.6, Code 2025, is amended to read as
follows:
144E.6 Provider recourse.
-6-
LSB 1518YH (2) 91
lh/ko 6/ 9

H.F. 320
1. To the extent consistent with state law, the board of
medicine created under chapter 147 shall not revoke, fail
to renew, suspend, or take any action against a physician’s
license based solely on the physician’s recommendations to
an eligible patient regarding access to or treatment with an
investigational drug, biological product, or device , or an
individualized investigational treatment .
2. To the extent consistent with federal law, an entity
responsible for Medicare certification shall not take action
against a physician’s Medicare certification based solely on
the physician’s recommendation that a patient have access to
an investigational drug, biological product, or device , or an
individualized investigational treatment .
Sec. 6. Section 144E.7, Code 2025, is amended to read as
follows:
144E.7 State interference.
An official, employee, or agent of this state shall not
block or attempt to block an eligible patient’s access to an
investigational drug, biological product, or device , or to an
individualized investigational treatment . Counseling, advice,
or a recommendation consistent with medical standards of care
from a licensed physician is not a violation of this section .
Sec. 7. Section 144E.8, Code 2025, is amended to read as
follows:
144E.8 Private cause of action.
1. This chapter shall not create a private cause of action
against a manufacturer of an investigational drug, biological
product, or device , or an individualized investigational
treatment, against an eligible facility, or against any other
person or entity involved in the care of an eligible patient
using the investigational drug, biological product, or device ,
or the individualized investigational treatment for any harm
done to the eligible patient resulting from the investigational
drug, biological product, or device, or the individualized
investigational treatment, if the manufacturer , eligible
-7-
LSB 1518YH (2) 91
lh/ko 7/ 9

H.F. 320
facility, or other person or entity is complying in good faith
with the terms of this chapter and has exercised reasonable
care.
2. This chapter shall not affect any mandatory health care
coverage for participation in clinical trials under Title XIII,
subtitle 1 .
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
This bill relates to Code chapter 144E, the right to try Act.
Under current law, an “eligible patient” under the Code
chapter is, in part, a person who has a terminal illness.
Under the bill, an “eligible patient” also includes, in part,
a person who has a life-threatening or severely debilitating
illness.
Under current law, the Code chapter applies to an
“investigational drug, biological product, or device”,
meaning a drug, biological product, or device that has
successfully completed phase I of a United States food and
drug administration (FDA)-approved clinical trial but has not
yet been approved for general use by the FDA and that remains
under investigation in an FDA-approved clinical trial. Under
the bill, the Code chapter also applies to an “individualized
investigational treatment”, meaning a drug, biological product,
or device that is unique to and produced exclusively for use
by an individual patient based on the individual patient’s
own genetic profile and includes individualized gene therapy,
antisense oligonucleotides, and individualized neoantigen
vaccines.
The bill amends the definition for “written informed
consent” to reflect the changes made to “eligible patient”
and the application of the Code chapter to individualized
investigational treatments.
“Eligible facility” is defined as an institution that is
operating under a federalwide assurance for the protection
-8-
LSB 1518YH (2) 91
lh/ko 8/ 9

H.F. 320
of human subjects pursuant to federal law. The bill amends
provisions relating to a manufacturer’s rights under the
Code chapter to also apply to eligible facilities. The bill
provides that a manufacturer of an investigational drug,
biological product, or device or a manufacturer operating
within, and in compliance with all requirements applicable
to, an eligible facility may make available, and an eligible
patient may request from a manufacturer of an investigational
drug, biological product, or device, or a manufacturer
operating within, and in compliance with all requirements
applicable to, an eligible facility, the manufacturer’s
investigational drug, biological product, or device, or the
manufacturer’s individualized investigational treatment.
However, the Code chapter does not require a manufacturer of
an individualized investigational treatment to provide or
otherwise make available the individualized investigational
treatment to an eligible patient. The bill provides that an
eligible facility or a manufacturer that is in compliance with
all applicable requirements may provide an individualized
investigational treatment to an eligible patient without
receiving compensation, or require an eligible patient to pay
the costs of, or the costs associated with, the manufacture of
the individualized investigational treatment.
The bill makes conforming changes in the Code chapter.
-9-
LSB 1518YH (2) 91
lh/ko 9/ 9