Senate BillNo. 715


Introduced by Senator Anderson

February 27, 2015


An act to add Article 4.3 (commencing with Section 111547) to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, relating to drugs and devices.

LEGISLATIVE COUNSEL’S DIGEST

SB 715, as introduced, Anderson. Investigational drugs, biological products, or devices: right to try.

Existing law, the federal Food, Drug, and Cosmetic Act, prohibits a person from introducing into interstate commerce any new drug unless the drug has been approved by the federal Food and Drug Administration (FDA). Existing law requires the sponsor of a new drug to submit to the FDA an investigational new drug application and to then conduct a series of clinical trials to establish the safety and efficacy of the drug in human populations and submit the results to the FDA in a new drug application.

Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates the packaging, labeling, and advertising of drugs and devices and is administered by the State Department of Public Health. A violation of that law is a crime. The Sherman Food, Drug, and Cosmetic Law prohibits, among other things, the sale, delivery, or giving away of a new drug or new device unless either the department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the federal Food, Drug, and Cosmetic Act.

The Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and requires the board to take action against a licensee who is charged with unprofessional conduct. The Osteopathic Act provides for the licensure and regulation of osteopathic physicians and surgeons by the Osteopathic Medical Board of California and requires the board to enforce the Medical Practice Act with respect to its licensees.

This bill, among other things, would permit a manufacturer of an investigational drug, biological product, or device to make the product available to eligible patients with terminal illnesses, as specified. The bill would authorize, but not require, a health benefit plan, as defined, or governmental agency to provide coverage for any investigational drug, biological product, or device made available pursuant to these provisions or the associated costs. The bill would prohibit the Medical Board of California and the Osteopathic Medical Board of California from taking any disciplinary action against the license of a physician based solely on the physician’s recommendation to an eligible patient regarding, or prescription for or treatment with, an investigational drug, biological product, or device, provided that the recommendation or prescription is consistent with medical standards of care. The bill would prohibit a state agency from altering any recommendation made to the federal Centers for Medicare and Medicaid Services regarding a health care provider’s certification to participate in the Medicare or Medicaid program based solely on the recommendation from an individual health care provider that an eligible patient have access to an investigational drug, biological product, or device. The bill would prohibit an official, employee, or agent of the state from blocking an eligible patient’s access to the investigational drug, biological product, or device pursuant to the bill’s provisions.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

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SECTION 1.  

Article 4.3 (commencing with Section 111547)
2is added to Chapter 6 of Part 5 of Division 104 of the Health and
3Safety Code
, to read:

4 

5Article 4.3.  Right to Try Act
6

 

7

111547.  

This article shall be known and may be cited as the
8Right to Try Act.

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111547.1.  

In this article, unless the context otherwise requires,
2the following definitions shall apply:

3(a) “Eligible patient” means a person who meets all of the
4following conditions:

5(1) Has a terminal illness, attested to by the eligible patient’s
6treating physician.

7(2) Has considered all other treatment options currently approved
8by the United States Food and Drug Administration.

9(3) Has received a recommendation from his or her physician
10for an investigational drug, biological product, or device.

11(4) Has given written, informed consent for the use of the
12investigational drug, biological product, or device, or if he or she
13lacks the capacity to consent, his or her legally authorized
14representative has given written informed consent on his or her
15behalf.

16(5) Has documentation from his or her treating physician
17attesting that the eligible patient has met the requirements of this
18subdivision.

19(b) “Health benefit plan” means any plan or program that
20provides, arranges, pays for, or reimburses the cost of health
21benefits. “Health benefit plan” includes, but is not limited to, a
22health care service plan contract issued by a health care service
23plan, as defined in Section 1345 of this code, and a policy of health
24insurance, as defined in Section 106 of the Insurance Code, issued
25by a health insurer.

26(c) “Investigational drug, biological product, or device” means
27a drug, biological product, or device that has successfully
28completed phase one of a clinical trial approved by the United
29States Food and Drug Administration, but has not been approved
30for general use by the United States Food and Drug Administration
31and remains under investigation in a clinical trial approved by the
32United States Food and Drug Administration.

33(d) “Physician” means a physician and surgeon licensed under
34the Medical Practice Act or an osteopathic physician and surgeon
35licensed under the Osteopathic Act.

36(e) “State regulatory board” means the California Medical Board
37or the Osteopathic Medical Board of California.

38(f) “Terminal illness” means progressive disease or medical or
39surgical condition that entails significant functional impairment,
40that is not considered by a treating physician to be reversible even
P4    1with theadministration of current United States Food and Drug
2Administration approved and available treatments, and that, without
3life-sustaining procedures, will soon result in death.

4(g) “Written, informed consent” means a written document that
5is signed by an eligible patient, parent or legal guardian if the
6eligible patient is a minor, or his or her legally authorized
7representative if the eligible patient lacks the capacity to consent,
8and attested to by the eligible patient’s physician and a witness
9that, at a minimum, does all of the following:

10(1) Explains the currently approved products and treatments for
11the terminal illness from which the eligible patient suffers.

12(2) Attests to the fact that the eligible patient, or if the eligible
13patient lacks the capacity to consent, his or her legally authorized
14representative, concurs with the eligible patient’s physician in
15believing that all currently approved and conventionally recognized
16treatments are unlikely to prolong the eligible patient’s life.

17(3) Clearly identifies the specific proposed investigational drug,
18biological product, or device that the eligible patient is seeking to
19use.

20(4) Describes the potentially best and worst outcomes of using
21the investigational drug, biological product, or device and provides
22a realistic description of the most likely outcome. This description
23shall include the possibility that new, unanticipated, different, or
24worse symptoms may result and that death could be hastened by
25the proposed treatment. The description shall be based on the
26physician’s knowledge of the proposed treatment in conjunction
27with an awareness of the eligible patient’s condition.

28(5) States that the eligible patient’s health benefit plan or
29third-party administrator, if any, and health care provider are not
30obligated to pay for the investigational drug, biological product,
31or device or any care or treatments consequent to use of the
32investigational drug, biological product, or device, unless otherwise
33specifically required to do so by law or contract.

34(6) States that the eligible patient’s eligibility for hospice care
35may be withdrawn if the eligible patient begins curative treatment
36with the investigational drug, biological product, or device and
37that care may be reinstated if the curative treatment ends and the
38eligible patient meets hospice eligibility requirements.

39(7) States that the eligible patient understands that he or she is
40liable for all expenses consequent to the use of the investigational
P5    1drug, biological product, or device, and that this liability extends
2to the eligible patient’s estate, except as otherwise provided in the
3eligible patient’s health benefit plan or a contract between the
4eligible patient and the manufacturer of the drug, biological
5product, or device.

6

111547.2.  

(a) Notwithstanding Section 110280, 111520, or
7111550, a manufacturer of an investigational drug, biological
8product, or device may make available the manufacturer’s
9investigational drug, biological product, or device to an eligible
10patient pursuant to this article. This article does not require that a
11manufacturer make available an investigational drug, biological
12product, or device to an eligible patient.

13(b) A manufacturer may do both of the following:

14(1) Provide an investigational drug, biological product, or device
15to an eligible patient without receiving compensation.

16(2) Require an eligible patient to pay the costs of, or associated
17with, the manufacture of the investigational drug, biological
18product, or device.

19(c) (1) This article does not expand or otherwise affect the
20health care coverage required to be provided by a health benefit
21plan or governmental agency pursuant to the laws of this state.

22(2) This article does not expand or otherwise affect the coverage
23provided under Sections 1370.4 and 1370.6 of this code, Sections
2410145.3 and 10145.4 of the Insurance Code, or Sections 14087.11
25and 14132.98 of the Welfare and Institutions Code.

26(3) A health benefit plan, third-party administrator, if any, or
27governmental agency may, but is not required to, provide coverage
28for the cost of an investigational drug, biological product, or device,
29or the cost of services related to the use of an investigational drug,
30biological product, or device under this article.

31(4) This article does not require any governmental agency to
32pay costs associated with the use, care, or treatment of an eligible
33patient with an investigational drug, biological product, or device.

34(5) This article does not require a health facility, as described
35in Section 1250, to provide new or additional services, unless
36approved by the health facility.

37(d) If an eligible patient dies while being treated by an
38investigational drug, biological product, or device made available
39pursuant to this article, the eligible patient’s heirs are not liable
P6    1for any outstanding debt related to the treatment or lack of
2insurance for the treatment.

3

111547.3.  

(a) Notwithstanding any other law, a state regulatory
4board shall not revoke, fail to renew, suspend, or take any other
5disciplinary action against a physician’s license based solely on
6the physician’s recommendation to an eligible patient regarding,
7prescription for, or treatment with, an investigational drug,
8biological product, or device, provided that the recommendation
9or prescription is consistent with medical standards of care.

10(b) A state agency shall not alter any recommendation made to
11the federal Centers for Medicare and Medicaid Services regarding
12a health care provider’s certification to participate in the Medicare
13or Medicaid program based solely on the recommendation from
14an individual health care provider that an eligible patient have
15access to an investigational drug, biological product, or device.

16(c) An official, employee, or agent of this state shall not block
17or attempt to block an eligible patient’s access to an investigational
18drug, biological product, or device pursuant to this article.
19Counseling, advice, or a recommendation consistent with medical
20standards of care from an individual licensed under Division 2
21(commencing with Section 500) of the Business and Professions
22Code shall not be considered a violation of this section.

23(d) A violation of this article shall not be subject to Chapter 8
24(commencing with Section 111825).

25

111547.4.  

This article does not create a private cause of action
26against a manufacturer of an investigational drug, biological
27product, or device, or against any other person or entity involved
28in the care of an eligible patient using the investigational drug,
29biological product, or device, for any harm done to the eligible
30patient resulting from the investigational drug, biological product,
31or device, so long as the manufacturer or other person or entity is
32complying in good faith with the terms of this article, unless there
33was a failure to exercise reasonable care.



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