Beruflich Dokumente
Kultur Dokumente
Bill
481
2016
Freedom
Index
Score
(+2)
Analyst:
Matthew
Keenan
Date:
March
1,
2016
ANALYSTS
NOTE:
House
Bill
481,
known
as
the
Right-To-Try
Act,
would
establish
a
new
chapter
in
Idaho
State
Code
concerning
terminally
ill
patients
and
their
access
to
investigational
treatments.
This
bill
would
only
affect
patients
who
seek
to
use
investigational
drugs
or
treatments
still
in
clinical
trials
under
the
supervision
of
the
FDA.
As
of
now,
the
FDA
must
approve
any
investigational
treatments,
drugs,
and
devices
before
they
are
sold
or
used
in
the
United
States.
HB
481
would
provide
a
potential
means
for
terminal
patients,
under
the
supervision
of
a
physician
or
doctor,
to
voluntarily
access
investigational
treatments,
drugs
or
devices
from
a
manufacturer.
The
legislation
does
not
obligate
a
manufacturer
to
provide
investigational
treatments,
drugs
or
devices
to
a
terminal
patient.
The
Right-To-Try
Act
would
not
require
a
health
plan,
third-party
administrator
or
government
agencyto
provide
coverage
for
the
cost
of
an
investigational
treatment,
biological
product
or
device.
Point
No.
1:
Does
it
create,
expand,
or
enlarge
any
agency,
board,
program,
function,
or
activity
of
government?
Conversely,
does
it
eliminate
or
curtail
the
size
or
scope
of
government?
ANALYSIS:
As
written,
House
Bill
481
prohibits
any
licensing
board
or
disciplinary
body
from
revoking
or
suspending
a
providers
license
when
(and
if)
they
were
to
provide
an
investigational
drug,
treatment
or
device
to
a
terminal
patient.
HB
481
also
places
limits
on
state
officials
ability
to
restrict
an
eligible
patients
access
to
investigational
drugs,
treatments
or
devices.
(+1)
Point
No.
12:
Does
it
violate
the
principles
of
federalism
by
increasing
federal
authority,
yielding
to
federal
blandishments,
or
incorporating
changeable
federal
laws
into
Idaho
statutes
or
rules?
ANALYSIS:
In
practice,
House
Bill
481
would
provide
an
alternative
path
to
investigational
treatments
(currently
in
FDA
clinical
trials)
for
Idaho
residents.
Investigational
drugs,
treatments
and
devices
would
still
be
required
to
go
through
the
FDA
clinical
trial
process;
however,
patients
deemed
terminal
would
have
the
option
to
seek
potentially
life-saving
treatments
directly
through
a
provider
or
manufacturer.
The
legislation
does
not
override
the
FDAs
process
for
ensuring
the
safety
of
investigational
treatments,
rather
it
expands
the
ability
of
Idaho
residents
to
exercise
their
treatment
options,
locally,
with
their
doctor.
This
bill,
in
practice,
would
cede
some
control
back
to
terminal
patients
within
the
state
by
allowing
them
to
seek
investigational
treatments
that
have
passed
phase
one
of
clinical
trials
and
are
ongoing
in
the
clinical
trials
process.
(+1)