BILL ANALYSIS Ó AB 159 Page 1 Date of Hearing: May 13, 2015 ASSEMBLY COMMITTEE ON APPROPRIATIONS Jimmy Gomez, Chair AB 159 (Calderon) - As Amended April 28, 2015 ----------------------------------------------------------------- |Policy |Health |Vote:|17 - 0 | |Committee: | | | | | | | | | | | | | | |-------------+-------------------------------+-----+-------------| | |Business and Professions | |14 - 0 | | | | | | | | | | | |-------------+-------------------------------+-----+-------------| | | | | | | | | | | | | | | | ----------------------------------------------------------------- Urgency: No State Mandated Local Program: NoReimbursable: No SUMMARY: This bill sets up a legal structure whereby individuals with serious or immediately life-threatening conditions can gain access to investigational drugs, biological product, or medical devices (investigational products). Specifically, this bill: AB 159 Page 2 1) Defines investigational drug, biological product, or device as 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 (FDA), but has not been approved for general use and remains under investigation in an approved clinical trial. 2) Allows, but does not require, the manufacturer of an investigational product to make the product available to an eligible patient, as defined. Specifies that the manufacturer require a patient to pay for the costs of the investigational product. 3) Defines an eligible patient as one who has met a number of specified criteria, including having a serious or life-threatening condition, as defined, and having considered all FDA-approved treatment options. 4) Allows, but does not require, a health plan or insurer to provide coverage for the investigational product, or the costs of services related to the use of the investigational product. 5) Prohibits a state regulatory board from taking disciplinary action against a physician's license, and prohibits a state agency from altering a 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 on the recommendation, prescription, or treatment of the investigational product, provided the recommendation or AB 159 Page 3 prescription is consistent with protocol approved by an institutional review board. 6) Prohibits an official, employee, or agent of the state from blocking or attempting to block an eligible patient's access to an investigational product pursuant to this article. 7) Specifies it does not create a private cause of action against a manufacturer of an investigational product, or against any other person or entity involved in the care of an eligible patient using the investigational product, for any harm done to the patient resulting from it, so long as the manufacturer or other person or entity is complying in good faith with the terms of this article, unless there was a failure to exercise reasonable care. 8) Requires institutional review boards to report information about requests for investigational products to the California Department of Public Health (CDPH), the Medical Board of California (MBC), and the Osteopathic Medical Board of California (OBMC). FISCAL EFFECT: Minor and absorbable costs to CDPH, MBC, and OMBC to receive and review biannually reports from institutional review boards on the requests for treatment with an investigational product. COMMENTS: AB 159 Page 4 1)Purpose. According to the author, this bill removes barriers to accessing potentially life-saving drugs for terminally-ill patients and doctors who believe an investigational drug or device could be their last hope for survival. These patients may seek compassionate use exemptions from the FDA, but the process is cumbersome and approval comes too late for many. This bill removes barriers for patients who need to immediately obtain investigational treatments, while also protecting physicians, hospitals, and manufacturers from retribution. 2)Background. Drugs and devices go through clinical trials, stage one of which establishes safety and assesses toxicity. Once a drug or devices passes stage one, there are two more phases before being approved for sale. This bill would allow manufacturers to make available investigational products, that have passed phase one trials, to patients meeting specified criteria, and would protect from liability doctors who recommend or prescribe the investigational products, as well as manufacturers who make them available. Experimental treatments are often available by participating in a clinical trial. If a patient is unable to enroll in a clinical trial, the FDA expanded access exemption, also called "compassionate use," provides a pathway for patients to gain access to investigational drugs or devices for serious diseases or conditions. A licensed physician is able to apply for expanded access on behalf of the patient. The physician must be willing to commit to oversee the treatment, work with the manufacturing company and FDA, obtain the drugs, monitor the patient during the course of treatment, and file necessary paperwork. The FDA states that they receive approximately 1,000 expanded use applications per year, and has approved AB 159 Page 5 more than 99% of those applications. 3)Support. The Los Angeles County Board of Supervisors supports this bill. 4)Opposition. The California Medical Association, California Nurse Association/National Nurses United, Association of Northern California Oncologists oppose this bill, citing patient safety and other concerns. The Association of Northern California Oncologists believe this bill threatens the viability of adult clinical trial enrollment and would result in slowing the development of cancer care in the future. 5)Related Legislation. a) SB 149 (Stone), pending in Senate Appropriations Committee, is largely similar to this bill, with differences primarily in definitions and liability exemptions. b) SB 715 (Anderson) is largely the same as this bill with some differences in definitions. SB 715 was referred to Senate Health Committee and not heard. AB 159 Page 6 c) SB 128 (Wolk), pending in the Senate Appropriations Committee, permits a competent, qualified individual who is a terminally ill adult to receive a prescription for aid in dying medication if certain conditions are met. Analysis Prepared by:Lisa Murawski / APPR. / (916) 319-2081