Florida Senate - 2015 SB 1052
By Senator Brandes
22-00658A-15 20151052__
1 A bill to be entitled
2 An act relating to the Florida Right to Try Act;
3 providing a short title; creating s. 385.213, F.S.;
4 defining terms; authorizing a manufacturer of an
5 investigational drug, biological product, or device to
6 make such drug, product, or device available to
7 certain eligible patients with a terminal illness
8 without charge or for a specified cost; authorizing
9 the manufacturer to require eligible patients to
10 participate in certain data collection; specifying
11 that an insurer, a health plan, or a government health
12 care program is not required to provide coverage for
13 the cost of such drug, product, or device; authorizing
14 such entities to provide coverage under specified
15 circumstances; specifying that such entities are not
16 required to cover care or treatment needed as the
17 result of the use of such drug, product, or device
18 except under certain circumstances; specifying that
19 the Department of Corrections and the Department of
20 Juvenile Justice are not required to provide coverage
21 for such drugs, products, or devices for individuals
22 in the departments’ custody; prohibiting a state
23 regulatory board or agency from taking action against
24 the licenses of certain health care providers or
25 against the licenses or Medicare certifications of
26 certain health care institutions for specified actions
27 with respect to an eligible patient’s access to,
28 treatment with, or use of investigational drugs,
29 biological products, or devices; specifying when an
30 investigational drug, biological product, or device
31 may continue to be offered by the manufacturer if the
32 drug, product, or device is found to be ineffective
33 under certain circumstances; requiring certain
34 information relating to clinical trials to be provided
35 to a patient taking an investigational drug,
36 biological product, or device outside of the clinical
37 trial; providing that the section does not create a
38 private cause of action against certain manufacturers,
39 entities, and individuals for any harm to an eligible
40 patient which results from the use of an
41 investigational drug, biological product, or device
42 under certain circumstances; providing a criminal
43 penalty for an official, employee, or agent of the
44 state who blocks or attempts to block the access of an
45 eligible patient to certain investigational drugs,
46 biological products, or devices; creating s. 408.064,
47 F.S.; requiring the Agency for Health Care
48 Administration to establish and maintain a database
49 that allows a state resident to electronically submit
50 a plan that indicates his or her directives for
51 compassionate and palliative care; requiring the
52 database to serve as a clearinghouse of plan
53 information that is accessible by certain health care
54 providers; authorizing the agency to subscribe to or
55 participate in a national or private clearinghouse in
56 lieu of establishing and maintaining an independent
57 clearinghouse; requiring the agency to publish and
58 disseminate certain information and provide certain
59 training relating to the clearinghouse; providing an
60 effective date.
61
62 Be It Enacted by the Legislature of the State of Florida:
63
64 Section 1. This act may be cited as the “Florida Right to
65 Try Act.”
66 Section 2. Section 385.213, Florida Statutes, is created to
67 read:
68 385.213 Compassionate treatment; access to experimental
69 treatments.—
70 (1) DEFINITIONS.—As used in this section, the term:
71 (a) “Eligible patient” means an individual who:
72 1. Has a terminal illness, as determined by the
73 individual’s physician and consulting physician;
74 2. As determined by the individual’s physician, does not
75 have any comparable or satisfactory United States Food and Drug
76 Administration-approved option available to be diagnosed,
77 monitored, or treated for the individual’s disease or condition,
78 and the probable risk to the individual from the investigational
79 drug, biological product, or device is not greater than the risk
80 from the disease or condition;
81 3. Has received a prescription or recommendation from the
82 individual’s physician for an investigational drug, biological
83 product, or device;
84 4. Has provided written, informed consent in accordance
85 with s. 766.103 for the use of an investigational drug,
86 biological product, or device or, if the individual is a minor
87 or lacks the mental capacity to provide informed consent, a
88 parent’s or legal guardian’s written, informed consent on the
89 individual’s behalf; and
90 5. Has documentation from the individual’s physician
91 indicating that the individual has met all the requirements of
92 this section.
93 (b) “Investigational drug, biological product, or device”
94 means a drug, biological product, or device that has
95 successfully completed phase one of a clinical trial but has not
96 yet been approved for general use by the United States Food and
97 Drug Administration.
98 (c) “Physician” means the physician licensed under chapter
99 458 or chapter 459 who provides medical care or treatment to the
100 eligible patient for the terminal illness.
101 (d) “Terminal illness” means a disease or condition that
102 without life-sustaining procedures will result in the patient’s
103 death in the near future or a state of permanent unconsciousness
104 from which recovery is unlikely.
105 (2) AVAILABILITY OF INVESTIGATIONAL DRUGS, BIOLOGICAL
106 PRODUCTS, OR DEVICES.—
107 (a) A manufacturer of an investigational drug, biological
108 product, or device may make the investigational drug, biological
109 product, or device, available to an eligible patient. A
110 manufacturer may:
111 1. Provide the investigational drug, biological product, or
112 device to an eligible patient without charge or require the
113 eligible patient to pay the cost of, or the cost associated
114 with, the manufacture of the investigational drug, biological
115 product, or device.
116 2. Require an eligible patient to participate in data
117 collection relating to the eligible patient’s use of the
118 investigational drug, biological product, or device.
119 (b) This section does not require:
120 1. An insurer, a health plan, or a government health care
121 program to provide coverage for:
122 a. The cost of an investigational drug, biological product,
123 or device provided to an eligible patient. An insurer, a health
124 plan, or a government health care program may elect to provide
125 coverage for an investigational drug, biological product, or
126 device that is not part of a clinical trial.
127 b. Care or treatment needed as a result of an eligible
128 patient’s use of an investigational drug, biological product, or
129 device unless the use is part of an approved clinical trial.
130 2. The Department of Corrections or the Department of
131 Juvenile Justice to provide coverage for an investigational
132 drug, biological product, or device for individuals in the
133 custody of the Department of Corrections or the Department of
134 Juvenile Justice.
135 (3) ACTION AGAINST PROVIDER LICENSURE PROHIBITED.
136 Notwithstanding any other law, a state regulatory board or
137 agency:
138 (a) May not take any action against a health care
139 provider’s license issued under chapter 458 or chapter 459 based
140 solely on the health care provider’s recommendation to an
141 eligible patient regarding access to or treatment with an
142 investigational drug, biological product, or device.
143 (b) May not, with respect to a health care institution
144 licensed in this state, take any action against the
145 institution’s:
146 1. License based solely on the institution’s participation
147 in the treatment with, or in any other use of, an
148 investigational drug, biological product, or device.
149 2. Medicare certification based solely on a health care
150 provider’s recommendation to an eligible patient regarding
151 access to an investigational drug, biological product, or
152 device.
153 (4) CLINICAL TRIALS.—
154 (a) If a clinical trial of an investigational drug,
155 biological product, or device is not effective for a certain
156 patient or condition and the trial is closed due to lack of
157 efficacy, the manufacturer or health care provider may continue
158 to offer the investigational drug, biological product, or device
159 for a different condition to the patient or to new patients.
160 (b) If the United States Food and Drug Administration or
161 the safety committee for a clinical trial provides notice of
162 information for an investigational drug, biological product, or
163 device that is being taken by a patient outside of the clinical
164 trial, the manufacturer of such drug, product, or device or the
165 patient’s physician shall notify the patient of the information.
166 (5) NO CAUSE OF ACTION.—This section does not create a
167 private cause of action against a manufacturer of an
168 investigational drug, biological product, or device or against
169 an entity or individual involved in the care of an eligible
170 patient for any harm to the eligible patient which results from
171 the use of the investigational drug, biological product, or
172 device if the manufacturer, entity, or individual is complying
173 in good faith with this section, unless the manufacturer,
174 entity, or individual failed to exercise reasonable care.
175 (6) PENALTY.—An official, employee, or agent of the state
176 who blocks or attempts to block the access of an eligible
177 patient to an investigational drug, biological product, or
178 device that has been recommended to the eligible patient by his
179 or her physician and that has not been banned or removed from a
180 clinical trial as unsafe by the United States Food and Drug
181 Administration commits a misdemeanor of the second degree,
182 punishable as provided in s. 775.082 or s. 775.083.
183 Section 3. Section 408.064, Florida Statutes, is created to
184 read:
185 408.064 Clearinghouse for compassionate and palliative care
186 plans.—
187 (1) The agency shall establish and maintain a reliable and
188 secure database that allows a resident of this state to
189 electronically submit a plan that indicates his or her
190 directives for compassionate and palliative care. The database
191 shall serve as a clearinghouse of plan information that may be
192 accessed by a health care provider who is treating the resident.
193 The agency shall seek advice from residents, compassionate and
194 palliative care providers, and health care facilities for the
195 development and implementation of the clearinghouse.
196 (2) The agency may subscribe to or otherwise participate in
197 a national or private clearinghouse that will accomplish the
198 requirements under subsection (1) in lieu of establishing and
199 maintaining an independent clearinghouse for this state’s
200 residents.
201 (3) The agency shall publish and disseminate information to
202 the residents of this state regarding the availability of the
203 clearinghouse. The agency must also provide training to health
204 care providers and health care facilities in this state on how
205 to access plans through the clearinghouse.
206 Section 4. This act shall take effect July 1, 2015.