California Senate Bill SB149 Amended / Bill

 BILL NUMBER: SB 149AMENDED BILL TEXT AMENDED IN SENATE APRIL 14, 2015 INTRODUCED BY Senator Stone  (   Coauthor:   Senator   Anderson   )  JANUARY 29, 2015 An act to add Article 4.1 (commencing with Section 111546) 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 149, as amended, Stone. 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   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department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended or the drug or device has been approved pursuant to specified provisions of federal law, including the federal Food, Drug, and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, 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 provide that the act does not require a health benefit plan, as defined, or governmental agency to provide coverage for the cost of any investigational drug, biological product, or device made available pursuant to these provisions. The bill would authorize a health benefit plan to provide coverage for an investigational drug, biological product, or device. The bill would also 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. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Article 4.1 (commencing with Section 111546) is added to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, to read: Article 4.1. Right to Try Act 111546. This article shall be known and may be cited as the Right to Try Act. 111546.1. In this article, unless the context otherwise requires, the following definitions shall apply: (a) "Eligible patient" means a person to whom all of the following conditions apply: (1) He or she has a terminal illness as determined by that person' s physician and a consulting physician. (2) His or her physician has determined that the person has no comparable or satisfactory United States Food and Drug Administration approved treatment options available to diagnose, monitor, or treat the disease or condition involved, and that the probable risk to the person from the investigational drug, biological product, or device is not greater than the probable risk from the disease or condition. (3) He or she has received a prescription or recommendation from his or her physician for an investigational drug, biological product, or device. (4) He or she has given written informed consent for the use of the investigational drug, biological product, or device, or if he or she is a minor or lacks the capacity to provide informed consent, his or her parent, legal guardian, or legally authorized representative has given written informed consent on his or her behalf. (5) He or she has documentation from his or her physician that the patient has met the requirements of this subdivision. (b) "Health benefit plan" means any plan or program that provides, arranges, pays for, or reimburses the cost of health benefits. "Health benefit plan" includes, but is not limited to, a health care service plan contract issued by a health care service plan, as defined in Section 1345 of this code, and a policy of health insurance, as defined in Section 106 of the Insurance Code, issued by a health insurer. (c) "Health facility" has the same meaning as in Section 1250. (d) "Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed phase one of a clinical trial approved by the United States Food and Drug Administration, but has not been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial approved by the United States Food and Drug Administration. (e) "Physician" means a physician and surgeon licensed under the Medical Practice Act or an osteopathic physician and surgeon licensed under the Osteopathic Act, and who is providing medical care or treatment to the eligible patient for the terminal illness, but does not include a primary care physician. (f) "State regulatory board" means the  California  Medical Board  of California  or the Osteopathic Medical Board of California. (g) "Terminal illness" means a disease that, without life-sustaining procedures, will result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely. 111546.2. (a) Notwithstanding Section 110280, 111520, or 111550, a manufacturer of an investigational drug, biological product, or device may make available the manufacturer's investigational drug, biological product, or device to an eligible patient pursuant to this article. This article does not require that a manufacturer make available an investigational drug, biological product, or device to an eligible patient. (b) A manufacturer may do any of the following: (1) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation. (2) Require an eligible patient to pay the costs of or associated with the manufacture of the investigational drug, biological product, or device. (3) Require an eligible patient to participate in data collection relating to the use of the investigational drug, biological product, or device. (c) (1) Except as otherwise required by law, this article does not require a health benefit plan or any state agency to provide coverage for the cost of any investigational drug, biological product, or device. (2) A health benefit plan may provide coverage for an investigational drug, biological product, or device. 111546.3. (a) Notwithstanding any other law, a state regulatory board shall not revoke, fail to renew, or take any other disciplinary action against a physician's license 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 pursuant to this article. (b) Notwithstanding any other law, a state agency shall not take any action against a health facility's license based solely on the facility's participation in the treatment by or use of an investigational drug, biological product, or device pursuant to this article. (c) A violation of this article shall not be subject to Chapter 8 (commencing with Section 111825).  (d) This article does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device, or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device, for any harm to the eligible patient resulting from the investigational drug, biological product, or device so long as the manufacturer or other person or entity complies in good faith with the terms of this article and exercises reasonable care.