LRB-5283/1
JPC:cjs
2021 - 2022 LEGISLATURE
February 15, 2022 - Introduced by Representatives Ramthun and Wichgers,
cosponsored by Senator Jacque. Referred to Committee on Health.
AB979,1,4 1An Act to amend 450.137 (title), 450.137 (2) (b), 450.137 (2) (c), 450.137 (2) (d),
2450.137 (2) (e), 450.137 (2) (f), 450.137 (3), 450.137 (4) (a), 450.137 (4) (b),
3450.137 (5) and 450.137 (6); and to create 450.137 (1) (d) of the statutes;
4relating to: right to try off-label therapies.
Analysis by the Legislative Reference Bureau
Under current law, a manufacturer of an investigational drug, device, or
biological product may make the investigational drug, device, or biological product
available to an eligible patient. “Investigational drug, device, or biological product”
is defined to mean a drug, device, or biological product that has not been approved
or licensed for use by the federal Food and Drug Administration and that meets
certain conditions relating to its status in clinical trials approved by the FDA. A
patient is eligible to receive an investigational drug, device, or biological product if
the patient meets several conditions, including that he or she has been diagnosed
with a life-threatening disease or condition, he or she has exhausted approved
treatment options and is unable to participate in a clinical trial involving the
investigational drug, device, or biological product, and he or she has received a
recommendation or prescription order from his or her treating physician for the
investigational drug, device, or biological product. If a manufacturer decides to make
an investigational drug, device, or biological product available to an eligible patient,
the manufacturer may charge an amount for the investigational drug, device, or
biological product that is not more than the cost to manufacture the investigational
drug, device, or biological product provided to the eligible patient. Current law also

protects certain individuals and entities from liability resulting from the design,
development, clinical testing, investigation, manufacture, labeling, distribution,
sale, purchase, donation, dispensing, prescribing, administration, or use of the
investigational drug, device, or biological product in certain circumstances.
This bill adds off-label therapies to those drugs, devices, or biological products
that an eligible patient may receive. Under the bill, “off-label therapy” is defined to
mean a use of a drug, device, or biological product approved by the FDA other than
a use approved by the FDA. The same requirements and protections that exist under
current law for investigational drugs, devices, and biological products also apply to
off-label therapies.
For further information see the state fiscal estimate, which will be printed as
an appendix to this bill.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
AB979,1 1Section 1. 450.137 (title) of the statutes is amended to read:
AB979,2,3 2450.137 (title) Access to off-label therapies, investigational drugs,
3devices, and biological products for terminally ill patients.
AB979,2 4Section 2. 450.137 (1) (d) of the statutes is created to read:
AB979,2,75 450.137 (1) (d) “Off-label therapy” means a use of a drug, device, or biological
6product approved by the federal food and drug administration other than a use
7approved by the federal food and drug administration.
AB979,3 8Section 3. 450.137 (2) (b) of the statutes is amended to read:
AB979,2,119 450.137 (2) (b) Has exhausted approved treatment options and is unable to
10participate in a clinical trial involving the off-label therapy or the investigational
11drug, device, or biological product.
AB979,4 12Section 4. 450.137 (2) (c) of the statutes is amended to read:
AB979,2,1513 450.137 (2) (c) Has received a recommendation or prescription order from the
14individual's treating physician for an off-label therapy or an investigational drug,
15device, or biological product.
AB979,5
1Section 5. 450.137 (2) (d) of the statutes is amended to read:
AB979,3,62 450.137 (2) (d) Has given written informed consent to use the off-label therapy
3or the
investigational drug, device, or biological product. The content of the written
4informed consent provided by the patient shall be consistent with and at least as
5comprehensive as the consent used in clinical trials for the off-label therapy or the
6investigational drug, device, or biological product.
AB979,6 7Section 6. 450.137 (2) (e) of the statutes is amended to read:
AB979,3,108 450.137 (2) (e) Is aware of the potential costs that may be associated with or
9otherwise result from the use of the off-label therapy or the investigational drug,
10device, or biological product under this section.
AB979,7 11Section 7. 450.137 (2) (f) of the statutes is amended to read:
AB979,3,1612 450.137 (2) (f) Possesses a written verification executed by the individual's
13treating physician attesting that the individual meets the conditions under pars. (a)
14to (e), and that the physician is not compensated directly by the manufacturer of the
15off-label therapy or the investigational drug, device, or biological product for making
16that attestation.
AB979,8 17Section 8. 450.137 (3) of the statutes is amended to read:
AB979,3,2518 450.137 (3) Manufacturers. A manufacturer of an off-label therapy or an
19investigational drug, device, or biological product may, but is not required to, make
20that off-label therapy or that investigational drug, device, or biological product
21available to an eligible patient. If the manufacturer charges an eligible patient for
22an off-label therapy or an investigational drug, device, or biological product, the
23manufacturer may not charge more than an amount that is equal to the
24manufacturer's actual cost to manufacture the off-label therapy or the
25investigational drug, device, or biological product provided to the eligible patient.
AB979,9
1Section 9. 450.137 (4) (a) of the statutes is amended to read:
AB979,4,72 450.137 (4) (a) A physician is immune from civil or criminal liability or from
3professional discipline under s. 448.02 based solely on the physician's
4recommendation to an eligible patient for the use of an off-label therapy or an
5investigational drug, device, or biological product to treat the patient's
6life-threatening disease or condition if the eligible patient gives written informed
7consent that satisfies sub. (2) (d) and s. 448.30.
AB979,10 8Section 10. 450.137 (4) (b) of the statutes is amended to read:
AB979,4,159 450.137 (4) (b) Any manufacturer, distributor, pharmacist, practitioner, health
10care facility, or other person who lawfully makes available, delivers, distributes,
11prescribes, dispenses, or administers an off-label therapy or an investigational drug,
12device, or biological product to an eligible patient consistent with this section, and
13who in doing so exercises reasonable care, may not be held liable in any action under
14state law for any loss, damage, or injury arising out of, relating to, or resulting from
15any of the following:
AB979,4,1916 1. The design, development, clinical testing, investigation, manufacture,
17labeling, distribution, sale, purchase, donation, dispensing, prescribing,
18administration, or use of the off-label therapy or the investigational drug, device, or
19biological product.
AB979,4,2120 2. The lack of safety or effectiveness of the off-label therapy or the
21investigational drug, device, or biological product.
AB979,11 22Section 11. 450.137 (5) of the statutes is amended to read:
AB979,5,523 450.137 (5) Reporting. The manufacturer or sponsor of an off-label therapy
24or an
investigational drug, device, or biological product that makes the off-label
25therapy or the
investigational drug, device, or biological product available to a

1patient in this state shall submit to the federal food and drug administration an
2annual summary of the use of the off-label therapy or the investigational drug,
3device, or biological product. The summary shall include the number of doses
4supplied, the number of patients treated, the uses for which it was made available,
5and any known serious adverse events.
AB979,12 6Section 12. 450.137 (6) of the statutes is amended to read:
AB979,5,117 450.137 (6) State officials. No official, employee, or agent of this state may
8block or attempt to block an eligible patient's access to an off-label therapy or an
9investigational drug, device, or biological product. Any counseling, advice, or
10recommendation of a practitioner that is consistent with the applicable standard of
11care for the practitioner is not a violation of this subsection.
AB979,5,1212 (End)
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