California Legislature—2015–16 Regular Session

Assembly BillNo. 1668


Introduced by Assembly Member Calderon

(Coauthors: Assembly Members Bonta, Brown, Campos, Chu, Dababneh, Daly, Frazier, Gatto, Gipson, Gonzalez, Gray, Roger Hernández, Jones-Sawyer, Lackey, Low, McCarty, Medina, Obernolte, O'Donnell, Olsen, Rendon, Rodriguez, Salas, Mark Stone, Waldron, and Williams)

(Coauthors: Senators Allen and Stone)

January 15, 2016


An act to add Article 4.5 (commencing with Section 111548) to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, relating to drugs and devices.

LEGISLATIVE COUNSEL’S DIGEST

AB 1668, as introduced, Calderon. Investigational drugs, biological products, and devices.

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 United States 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department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the federal Food, Drug, and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 would permit a manufacturer of an investigational drug, biological product, or device to make the product available to eligible patients with an immediately life-threatening disease or condition, as specified. The bill would authorize, but not require, a health benefit plan, as defined, to provide coverage for any investigational drug, biological product, or device made available pursuant to these provisions. 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 if the recommendation or prescription is consistent with protocol approved by the physician’s institutional review board or an accredited institutional review board, and would require the institutional review board to biannually report specified information to the State Department of Public Health, among others. 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 a patient have access to an investigational drug, biological product, or device.

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

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

P3    1

SECTION 1.  

Article 4.5 (commencing with Section 111548)
2is added to Chapter 6 of Part 5 of Division 104 of the Health and
3Safety Code
, to read:

4 

5Article 4.5.  Right to Try Act
6

 

7

111548.  

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

9

111548.1.  

For purposes of this article, unless the context
10otherwise requires, the following definitions shall apply:

11(a) “Consulting physician” means a physician and surgeon
12licensed under the Medical Practice Act or an osteopathic physician
13and surgeon licensed under the Osteopathic Act who performs all
14of the following:

15(1) Examines the qualified individual and his or her relevant
16medical records.

17(2) Confirms, in writing, the primary physician’s diagnosis and
18prognosis.

19(3) Verifies, in the opinion of the consulting physician, that the
20 eligible patient is competent, acting voluntarily, and has made an
21informed decision.

22(b) “Eligible patient” means a person who meets all of the
23following conditions:

24(1) Has an immediately life-threatening disease or condition.

25(2) Has considered all other treatment options currently approved
26by the United States Food and Drug Administration.

27(3) Has not been accepted to participate in the nearest clinical
28trial to his or her home for the immediately life-threatening disease
29or condition identified in paragraph (1) within one week of
30completion of the clinical trial application process, or, in the
31treating physician’s medical judgment, it is unreasonable for the
32patient to participate in that clinical trial due to the patient’s current
33condition and stage of disease.

34(4) Has received a recommendation from his or her primary
35physician and a consulting physician for an investigational drug,
36biological product, or device.

37(5) Has given written informed consent for the use of the
38investigational drug, biological product, or device, or, if he or she
P4    1lacks the capacity to consent, his or her legally authorized
2representative has given written informed consent on his or her
3behalf.

4(6) Has documentation from his or her primary physician and
5a consulting physician attesting that the patient has met the
6requirements of this subdivision.

7(c) “Health benefit plan” means a plan or program that provides,
8arranges, pays for, or reimburses the cost of health benefits. “Health
9benefit plan” includes, but is not limited to, a health care service
10plan contract issued by a health care service plan, as defined in
11Section 1345, and a policy of health insurance, as defined in
12Section 106 of the Insurance Code, issued by a health insurer.

13(d) “Immediately life-threatening disease or condition” means
14a stage of disease in which there is a reasonable likelihood that
15death will occur within a matter of months.

16(e) “Investigational drug, biological product, or device” means
17a drug, biological product, or device that has successfully
18completed phase one of a clinical trial approved by the United
19States Food and Drug Administration, but has not been approved
20for general use by the United States Food and Drug Administration
21and remains under investigation in a clinical trial approved by the
22United States Food and Drug Administration.

23(f) “Primary physician” means a physician and surgeon licensed
24under the Medical Practice Act or an osteopathic physician and
25surgeon licensed under the Osteopathic Act.

26(g) “State regulatory board” means the Medical Board of
27California or the Osteopathic Medical Board of California.

28(h) (1) “Written, informed consent” means a written document
29that has been approved by the primary physician’s institutional
30review board or an accredited independent institutional review
31board, is signed by an eligible patient, or his or her legally
32authorized representative when the patient lacks the capacity to
33consent, and attested to by the patient’s primary physician and a
34witness that, at a minimum, does all of the following:

35(A) Explains the currently approved products and treatments
36for the immediately life-threatening disease or condition from
37which the patient suffers.

38(B) Attests to the fact that the patient, or when the patient lacks
39the capacity to consent his or her legally authorized representative,
40concurs with the patient’s primary physician in believing that all
P5    1currently approved and conventionally recognized treatments are
2unlikely to prolong the patient’s life.

3(C) Clearly identifies the specific proposed investigational drug,
4biological product, or device that the patient is seeking to use.

5(D) Describes the potentially best and worst outcomes of using
6the investigational drug, biological product, or device and describes
7the most likely outcome. This description shall include the
8possibility that new, unanticipated, different, or worse symptoms
9might result and that death could be hastened by the proposed
10treatment. The description shall be based on the primary
11physician’s knowledge of the proposed treatment in conjunction
12with an awareness of the patient’s condition.

13(E) Clearly states that the patient’s health benefit plan, if any,
14and health care provider are not obligated to pay for the
15investigational drug, biological product, or device or any care or
16treatments consequent to use of the investigational drug, biological
17product, or device.

18(F) Clearly states that the patient’s eligibility for hospice care
19may be withdrawn if the patient begins curative treatment and that
20care may be reinstated if the curative treatment ends and the patient
21meets hospice eligibility requirements.

22(G) Clearly states that in-home health care may be denied if
23treatment begins.

24(H) States that the patient understands that he or she is liable
25for all expenses consequent to the use of the investigational drug,
26biological product, or device, and that this liability extends to the
27patient’s estate, except as otherwise provided in the patient’s health
28benefit plan or a contract between the patient and the manufacturer
29of the drug, biological product, or device.

30(2) Written, informed consent for purposes of this article shall
31be consistent with the informed consent requirements of the
32Protection of Human Subjects in Medical Experimentation Act
33(Chapter 1.3 (commencing with Section 24170) of Division 20).

34

111548.2.  

(a) Notwithstanding Section 110280, 111520, or
35111550, a manufacturer of an investigational drug, biological
36product, or device may make available the manufacturer’s
37investigational drug, biological product, or device to an eligible
38patient pursuant to this article. This article does not require that a
39manufacturer make available an investigational drug, biological
40product, or device to an eligible patient.

P6    1(b) A manufacturer may do both of the following:

2(1) Provide an investigational drug, biological product, or device
3to an eligible patient without receiving compensation.

4(2) Require an eligible patient to pay the costs of, or associated
5with, the manufacture of the investigational drug, biological
6product, or device.

7(c) (1) This article does not expand the coverage provided under
8Sections 1370.4 and 1370.6 of this code, Sections 10145.3 and
910145.4 of the Insurance Code, or Sections 14087.11 and 14132.98
10of the Welfare and Institutions Code.

11(2) This article does not require a health benefit plan to provide
12coverage for the cost of any investigational drug, biological
13product, or device, or the costs of services related to the use of an
14investigational drug, biological product, or device under this article.
15A health benefit plan may provide coverage for an investigational
16drug, biological product, or device made available pursuant to this
17section.

18(d) If the clinical trial for an investigational drug, biological
19product, or device is closed due to the lack of efficacy or for
20toxicity, the investigational drug, biological product, or device
21shall not be offered. If notice of closure of a clinical trial is given
22for an investigational drug, biological product, or device taken by
23a patient outside of a clinical trial, the manufacturer and the
24patient’s primary physician shall notify the patient of the
25information from the safety committee of the clinical trial.

26(e) If an eligible patient dies while being treated by an
27investigational drug, biological product, or device made available
28pursuant to this article, the patient’s heirs are not liable for any
29outstanding debt related to the treatment or lack of insurance for
30the treatment.

31

111548.3.  

(a) Notwithstanding any other law, a state regulatory
32board shall not revoke, fail to renew, or take any other disciplinary
33action against a physician’s license based solely on the physician’s
34recommendation to an eligible patient regarding, or prescription
35for or treatment with, an investigational drug, biological product,
36or device if the recommendation or prescription is consistent with
37protocol approved by the physician’s institutional review board
38or an accredited independent institutional review board.

39(b) The physician’s institutional review board or an accredited
40institutional review board shall biannually report the following
P7    1information to the State Department of Public Health, the Medical
2 Board of California, and the Osteopathic Medical Board of
3California:

4(1) The number of requests made for an investigational drug,
5biological product, or device.

6(2) The status of the requests made.

7(3) The duration of the treatment.

8(4) The costs of the treatment paid by eligible patients.

9(5) The success or failure of the investigational drug, biological
10product, or device in treating the immediately life-threatening
11disease or condition from which the patient suffers.

12(6) Any adverse event for each investigational drug, biological
13product, or device.

14(c) A state agency shall not alter any recommendation made to
15the federal Centers for Medicare and Medicaid Services regarding
16a health care provider’s certification to participate in the Medicare
17or Medicaid program based solely on the recommendation from
18an individual health care provider that a patient have access to an
19investigational drug, biological product, or device.

20(d) A violation of this section shall not be subject to Chapter 8
21(commencing with Section 111825).

22

111548.5.  

This article does not create a private cause of action,
23and actions taken pursuant to this article shall not serve as a basis
24for a civil, criminal, or disciplinary claim or cause of action,
25including, but not limited to, product liability, medical negligence,
26or wrongful death, against a manufacturer of an investigational
27drug, biological product, or device, or against any other person or
28entity involved in the care of an eligible patient for harm done to
29the eligible patient or his or her heirs resulting from the
30investigational drug, biological product, or device, or the use or
31nonuse thereof, if the manufacturer or other person or entity has
32complied with the terms of this article in relation to the eligible
33patient, unless there was a failure to exercise reasonable care.



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