LRB-1695/2
MED:emw
2017 - 2018 LEGISLATURE
March 2, 2017 - Introduced by Senators Moulton, Risser, Carpenter, Johnson, L.
Taylor
, Cowles, Feyen, Lasee, Craig, Kapenga, Darling, Marklein, Miller,
Petrowski, LeMahieu, Harsdorf and Vinehout, cosponsored by
Representatives Snyder, Kleefisch, Hesselbein, Krug, Skowronski,
Steffen, Milroy, Kremer, Brandtjen, Pope, Kooyenga, Edming, Mursau,
Tittl, Sargent, Horlacher, Kulp, Mason, E. Brooks, Spiros, Bernier, C.
Taylor
, Vruwink, Novak, R. Brooks, VanderMeer, Jagler, Knodl, Quinn,
Anderson, Ballweg, Tauchen, Berceau, Murphy, Subeck, Gannon, Sinicki,
Ripp, Katsma, Allen, Doyle, Zamarripa, Tusler, Hutton and Loudenbeck.
Referred to Committee on Health and Human Services.
SB84,1,3 1An Act to create 450.135 of the statutes; relating to: access to investigational
2drugs, devices, and biological products and limitations on liability related to
3their use.
Analysis by the Legislative Reference Bureau
Under this bill, a manufacturer of an investigational drug, device, or biological
product may make the investigational drug, device, or biological product available
to an eligible patient. Under the bill, an investigational drug, device, or biological
product is one that has not yet been approved for use by the federal Food and Drug
Administration, but, among other requirements, has successfully completed a phase
one clinical trial and remains under investigation or is pending approval by the FDA.
A patient is eligible under the bill if, among other things, the patient has considered
all other available treatment options, has received a treating physician's
recommendation or prescription order for an investigational drug, device, or
biological product, and has given written informed consent for use of the
investigational drug, device, or biological product.
The bill provides a limitation of liability under state law for a manufacturer,
distributor, pharmacist, physician or other practitioner, or other person who makes
available, delivers, distributes, prescribes, dispenses, or administers an
investigational drug, device, or biological product to an eligible patient consistent
with the bill's provisions, and who in doing so exercises reasonable care.

Finally, the bill prohibits an official, employee, or agent of the state from
blocking or attempting to block an eligible patient's access to an investigational drug,
device, or biological product.
The people of the state of Wisconsin, represented in senate and assembly, do
enact as follows:
SB84,1 1Section 1. 450.135 of the statutes is created to read:
SB84,2,3 2450.135 Access to investigational drugs, devices, and biological
3products for terminally ill patients.
(1) Definitions. In this section:
SB84,2,44 (a) “Eligible patient" means a patient who is eligible under sub. (2).
SB84,2,75 (b) “Investigational drug, device, or biological product" means a drug, device,
6or biological product that has not been approved for use by the federal food and drug
7administration and meets all of the following conditions:
SB84,2,98 1. Has successfully completed a phase one clinical trial approved by the federal
9food and drug administration.
SB84,2,1210 2. Remains under investigation in a phase 2 or 3 clinical trial approved by the
11federal food and drug administration or has completed a phase 3 clinical trial and
12is pending approval by the federal food and drug administration.
SB84,2,1413 3. Is not the subject of a clinical trial that was closed due to the toxicity or lack
14of efficacy of the drug, device, or biological product.
SB84,2,1715 (c) “Terminal illness" means a disease that, without life-sustaining procedures,
16will soon result in death or a state of permanent unconsciousness from which
17recovery is unlikely.
SB84,2,19 18(2) Eligibility. An individual is an eligible patient for purposes of this section
19if the individual meets all of the following conditions:
SB84,2,2020 (a) Has a terminal illness.
SB84,3,1
1(b) Has considered all other available treatment options.
SB84,3,32 (c) Has received a recommendation or prescription order from the individual's
3treating physician for an investigational drug, device, or biological product.
SB84,3,74 (d) Has given written informed consent to use the investigational drug, device,
5or biological product. The content of the written informed consent provided by the
6patient shall be consistent with and at least as comprehensive as the consent used
7in clinical trials for the investigational drug, device, or biological product.
SB84,3,98 (e) Possesses a written verification executed by the individual's treating
9physician attesting that the individual meets the conditions under pars. (a) to (d).
SB84,3,16 10(3) Manufacturers. A manufacturer of an investigational drug, device, or
11biological product may, but is not required to, make that investigational drug, device,
12or biological product available to an eligible patient. If the manufacturer charges an
13eligible patient for an investigational drug, device, or biological product, the
14manufacturer may not charge more than an amount that is equal to the
15manufacturer's actual cost to manufacture the investigational drug, device, or
16biological product provided to the eligible patient.
SB84,3,21 17(4) Limitations of liability. (a) A physician is immune from civil or criminal
18liability or from professional discipline under s. 448.02 based solely on the
19physician's recommendation to an eligible patient for the use of an investigational
20drug, device, or biological product to treat the patient's terminal illness if the eligible
21patient gives written informed consent that satisfies sub. (2) (d) and s. 448.30.
SB84,4,222 (b) Any manufacturer, distributor, pharmacist, practitioner, or other person
23who lawfully makes available, delivers, distributes, prescribes, dispenses, or
24administers an investigational drug, device, or biological product to an eligible
25patient consistent with this section, and who in doing so exercises reasonable care,

1may not be held liable in any action under state law for any loss, damage, or injury
2arising out of, relating to, or resulting from any of the following:
SB84,4,53 1. The design, development, clinical testing, investigation, manufacture,
4labeling, distribution, sale, purchase, donation, dispensing, prescribing,
5administration, or use of the investigational drug, device, or biological product.
SB84,4,76 2. The lack of safety or effectiveness of the investigational drug, device, or
7biological product.
SB84,4,12 8(5) State officials. No official, employee, or agent of this state may block or
9attempt to block an eligible patient's access to an investigational drug, device, or
10biological product. Any counseling, advice, or recommendation of a practitioner that
11is consistent with the applicable standard of care for the practitioner is not a
12violation of this subsection.
SB84,4,14 13(6) Insurance. Nothing in this section alters the obligations of an eligible
14patient's insurer under the contract of insurance and applicable law.
SB84,4,1515 (End)
Loading...
Loading...