LRB-3064/1
FFK:sac&cjs:rs
2011 - 2012 LEGISLATURE
March 15, 2012 - Introduced by Representative Krusick. Referred to Committee
on Health.
AB745,1,3 1An Act to amend 448.02 (3) (a); and to create 448.31, 448.32 and 448.40 (2) (h)
2of the statutes; relating to: obtaining informed consent for the prescription
3and use of drugs and devices and granting rule-making authority.
Analysis by the Legislative Reference Bureau
Under current law, a physician who treats a patient must inform the patient
about the availability of all alternate, viable medical modes of treatment and about
the benefits and risks of these treatments. A physician who violates this
requirement is subject to discipline by the Medical Examining Board (board) for
unprofessional conduct and may be fined up to $25,000 and imprisoned for up to 9
months. If the board finds that the physician has engaged in unprofessional conduct,
the board may warn or reprimand the physician, or limit, suspend, or revoke any
license, certificate, or limited permit granted to the physician.
Under this bill, a physician may not prescribe or use a drug or device in a
manner that constitutes an off-label use without obtaining the patient's informed
consent unless the board has determined that the off-label use is safe and effective.
The bill defines an off-label use as a use that has not been approved by the U.S.
Federal Drug Administration (FDA) to be included on the product's label. The bill
specifies that a patient's consent is informed only if the physician informs the patient
that the drug or device is being prescribed or used in a manner that is an off-label
use and of the uses for which the drug or device has been approved by the FDA.
The bill also provides that, beginning on January 1, 2014, a physician may not
prescribe or use any drug or device in which the physician has a financial interest

unless the physician obtains the patient's informed consent. Under the bill, a
physician has a financial interest in a drug or device if the physician has received
gifts or payments of more than $10 from the manufacturer and information about
those gifts or payments is available to the public on an Internet Web site. Under
federal law, information on gifts or payments of more than $10 from manufacturers
to physicians must be available to the public on an Internet Web site no later than
September 30, 2013. The bill specifies that a patient's consent is informed only if the
physician provides the patient with any information related to gifts or payments the
physician received from the manufacturer of a drug or device that is publicly
available on the Internet Web site established by the federal government.
Under the bill, a physician who fails to obtain a patient's informed consent
related to the off-label use of a drug or device or for the prescription or use of a drug
or device in which the physician has a financial interest is subject to the same
penalties as a physician who fails to inform a patient about the availability of all
alternate, viable medical modes of treatment.
Because this bill creates a new crime or revises a penalty for an existing crime,
the Joint Review Committee on Criminal Penalties may be requested to prepare a
report concerning the proposed penalty and the costs or savings that are likely to
result if the bill is enacted.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
AB745, s. 1 1Section 1. 448.02 (3) (a) of the statutes is amended to read:
AB745,3,82 448.02 (3) (a) The board shall investigate allegations of unprofessional conduct
3and negligence in treatment by persons holding a license, certificate or limited
4permit granted by the board. An allegation that a physician has violated s. 253.10
5(3), 448.30, 448.31, 448.32, or 450.13 (2); or has failed to mail or present a medical
6certification required under s. 69.18 (2) within 21 days after the pronouncement of
7death of the person who is the subject of the required certificate ; or that a physician
8has failed at least 6 times within a 6-month period to mail or present a medical
9certificate required under s. 69.18 (2) within 6 days after the pronouncement of death
10of the person who is the subject of the required certificate, is an allegation of
11unprofessional conduct. Information contained in reports filed with the board under
12s. 49.45 (2) (a) 12r., 50.36 (3) (b), 609.17, or 632.715, or under 42 CFR 1001.2005, shall

1be investigated by the board. Information contained in a report filed with the board
2under s. 655.045 (1), as created by 1985 Wisconsin Act 29, which is not a finding of
3negligence or in a report filed with the board under s. 50.36 (3) (c) may, within the
4discretion of the board, be used as the basis of an investigation of a person named in
5the report. The board may require a person holding a license, certificate, or limited
6permit to undergo, and may consider the results of, one or more physical, mental, or
7professional competency examinations if the board believes that the results of any
8such examinations may be useful to the board in conducting its investigation.
AB745, s. 2 9Section 2. 448.31 of the statutes is created to read:
AB745,3,11 10448.31 Informed consent; off-label uses of drugs and devices. (1) In this
11section:
AB745,3,1212 (a) "Device" has the meaning given in 21 USC 321 (h).
AB745,3,1313 (b) "Drug" has the meaning given in 21 USC 321 (g).
AB745,3,1614 (c) "Off-label use" means a use that is not an intended use for which a drug or
15device is legally marketed under the federal Food, Drug, and Cosmetic Act, 21 USC
16301
to 399d.
AB745,3,21 17(2) (a) Except as provided in par. (b), a physician may not prescribe a drug or
18device or use a drug or device in the course of treating a patient in a manner that
19constitutes an off-label use unless the physician first obtains the patient's informed
20consent. A patient's consent is informed for purposes of this subsection only if all of
21the following occur:
AB745,3,2322 1. The physician informs the patient that the manner in which the drug or
23device is being prescribed or used is an off-label use.
AB745,4,3
12. The physician informs the patient of uses for which the drug or device may
2be legally marketed under the federal Food, Drug, and Cosmetic Act, 21 USC
3301-399a
.
AB745,4,54 (b) Paragraph (a) does not apply to an off-label use that the board determines,
5by rule, is safe and effective.
AB745, s. 3 6Section 3. 448.32 of the statutes is created to read:
AB745,4,11 7448.32 Informed consent; financial disclosures. (1) In this section,
8"financial interest" means that the manufacturer of a drug or device provided a
9payment or other transfer of value to a physician, as described under 42 USC
101320a-7h
(a) (1) (A), and information about the payment or transfer of value is
11available to the public on an Internet Web site under 42 USC 1320a-7h (c) (1) (C).
AB745,4,19 12(2) Beginning on January 1, 2014, no physician may prescribe a drug or device
13to a patient or use a drug or device in the course of treating a patient if the physician
14has a financial interest in the drug or device unless the physician first obtains the
15patient's informed consent. For purposes of this subsection, a patient's consent is
16informed only if the physician provides the patient with information that is available
17to the public on an Internet Web site under 42 USC 1320a-7h (c) (1) (C) that is related
18to any payment or other transfer of value that the manufacturer of the drug or device
19provided to the physician.
AB745, s. 4 20Section 4. 448.40 (2) (h) of the statutes is created to read:
AB745,4,2221 448.40 (2) (h) Establishing off-label uses, as defined in s. 448.31 (1) (c), that
22are medically safe and effective.
AB745,4,2323 (End)
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