Pharmaceutical manufacturers-promotion of off label use.

2018
STATE OF WYOMING
18LSO-0300
Numbered
1.2

HOUSE BILL

NO.
HB0145

Pharmaceutical manufacturers-promotion of off label use.

Sponsored by:
Representative(s) Clem, Barlow, Hallinan, Halverson, Jennings and Lone and Senator(s) Bouchard

A BILL

for

AN ACT relating to food and drugs; allowing pharmaceutical manufacturers to engage in truthful promotion of an off label use of a drug, biological product or device; specifying that truthful promotion of an off label use is not misbranding; disallowing action by a licensing board against a licensee solely for engaging in truthful promotion or prescribing of an off label use of a drug, biological product or device; specifying that this act does not require a health care insurer to cover the cost of off label use; specifying that the off label promotion or prescribing of a drug does not create a cause of action; providing definitions; and providing for an effective date.

Be It Enacted by the Legislature of the State of Wyoming:

Section 1
.

W.S.
33
‑
24
‑
101(b) by creating a new paragraph (v),
35
‑
7
‑
110(a)
by
creating new paragraphs (xxxi
i
)
through
(xxxi
v)
and by renumbering (xxxii) as
(xxx
v)
, 35
‑
7
‑
111 by creating a new subsection (d), 35
‑
7
‑
116 and 35
‑
7
‑
118 by creating a new subsection (c) are amended to read:

33
‑
24
‑
101
.

Short title; definitions.

(b)

As used in this act:

(v)

"
Misbranding
"
does not
include
the
truthful promotion of an off label use of a drug, biological product or device
as defined in W.S. 35
‑
7
‑
110(a)
(xxxii) through
(xxxiv)
.

35
‑
7
‑
110
.

Definitions.

(a)

As used in this act:

(xxxii)

"
Misbranding
"
does not
include
the
truthful promotion of an off label use of a drug, biological product or device;

(xxxiii)

"
Off label use
"
means
the use of a United States food and drug administration
approved drug, biological product or device in a manner other than the use the United States food and drug administration approved;

(xxxiv)

"
Truthful promotion
"
means
the sharing
between a pharmaceutical manufacturer and a licensed professional who can prescribe medication within the professional
'
s scope of practice
of information that is not misleading, not contrary to fact and consistent with generally
accepted scientific principles
;

(xxxii)
(xxx
v
)

"
This act
"
means W.S. 35
‑
7
‑
109 through 35
‑
7
‑
127.

35
‑
7
‑
111
.

Prohibited acts.

(d)

The truthful promotion of
an off label use of a drug, biological product or device
shall not be considered

a violation of this act
.

35
‑
7
‑
116
.

Food, drugs and cosmetics; adulteration and misbranding.

A food, cosmetic or a drug or device is adulterated if it is adulterated under the federal act. A food, cosmetic or a drug or device is misbranded if it is misbranded under the federal act
, except that the
truthful promotion of an off label use of a drug, biological product or device
shall not constitute misbranding
.

35
‑
7
‑
118
.

New drugs
; off label use
of approved drugs
.

(
c
)

The
truthful
promot
ion of
an off label
use
of an existing approved drug

shall
not
be
considered a new d
rug. The following shall apply:

(
i
)

A health care insurer may, but is not required to,
cover the cost of off label use
of a drug, biological product or device
;

(ii)

No board
or commission shall revoke, fail to renew, suspend or take any other action against a licensee, certificate holder or registrant based solely on the person
'
s truthful promotion or prescribing of an off label use of a drug, biological product or device;

(iii)

The off label truthful promotion or prescribing of a drug
, biological product or device
shall
not create a cause of action against a
pharmaceutical
manufacturer or against any
licensed professional who can prescribe or dispense medication within the professional
'
s scope of practice
, so long as the manufacturer or other person
'
s actions are not misleading, not contrary to fact and consistent with generally accepted scientific principles
.

Section 2
.

This act is effective July 1, 201
8
.

(END)

1
HB0145