BILL ANALYSIS Ó AB 1668 Page 1 ASSEMBLY THIRD READING AB 1668 (Calderon) As Amended March 7, 2016 Majority vote ------------------------------------------------------------------ |Committee |Votes|Ayes |Noes | | | | | | | | | | | | | | | | |----------------+-----+----------------------+--------------------| |Health |18-0 |Wood, Maienschein, | | | | |Bonilla, Burke, | | | | |Campos, Dababneh, | | | | |Cooley, Roger | | | | |Hernández, Lackey, | | | | |Nazarian, Olsen, | | | | |Patterson, | | | | |Ridley-Thomas, | | | | |Rodriguez, Santiago, | | | | |Steinorth, Thurmond, | | | | |Waldron | | | | | | | |----------------+-----+----------------------+--------------------| |Business & |14-0 |Salas, Brough, Baker, | | |Professions | |Bloom, Campos, | | | | |Chávez, Dahle, Dodd, | | | | |Burke, Gatto, Jones, | | | | |Mullin, Ting, Wood | | | | | | | |----------------+-----+----------------------+--------------------| AB 1668 Page 2 |Appropriations |20-0 |Gonzalez, Bigelow, | | | | |Bloom, Bonilla, | | | | |Bonta, Calderon, | | | | |Chang, Daly, Eggman, | | | | |Gallagher, Eduardo | | | | |Garcia, Roger | | | | |Hernández, Holden, | | | | |Jones, Obernolte, | | | | |Quirk, Santiago, | | | | |Wagner, Weber, Wood | | | | | | | | | | | | ------------------------------------------------------------------ SUMMARY: Authorizes the manufacturer of an investigational drug, biological product, or device (investigational drug) that is not yet approved by the United States Food and Drug Administration (FDA) to make the investigational drug available to a patient with a serious or immediately life-threatening disease, when that patient has considered all other treatment options currently approved by the FDA, has been unable to participate in a relevant clinical trial, and for whom the investigational drug has been recommended by the patient's primary physician and a consulting physician. Specifies other criteria and parameters for the use of such investigational drugs in this way. FISCAL EFFECT: According to the Assembly Appropriations Committee: 1)Minor and absorbable costs to the California Department of Health Services (DPH), the Medical Board of California, and Osteopathic Medical Board of California to receive and review biannually reports from institutional review boards on the requests for treatment with an investigational product (various funds). AB 1668 Page 3 2)Costs of $380,000 in the first year of implementation, and $200,000 ongoing to Department of Managed Health Care (DMHC) (Managed Care Fund). First year costs are higher because of probable additional legal analysis and processing Public Records Act (PRA) requests for experimental procedures previously authorized or rejected by health plans. Ongoing costs are related to patient and provider inquiries to the DMHC's Help Center. DMHC indicates any of the investigational and/or experimental Independent Medical Review (IMR) requests require thorough analysis to determine if literature and studies on the treatments are available, and to review clinical trials, if completed or available. 3)The California Department of Insurance may, similarly to DMHC, experience unknown costs related to IMR requests, PRA requests, or other requests for other assistance to the extent these requests increase. (Insurance Fund). COMMENTS: 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 could be their last hope for survival. The author further states that those patients that have exhausted all other treatment options, and are not eligible for clinical trials, often seek access to investigational new drugs but face a variety of hurdles. These patients may seek compassionate use exemptions from the FDA, but the process is cumbersome and approval comes too late for many. The author explains this bill removes barriers for patients who need to immediately obtain investigational treatments, while also protecting physicians, hospitals, and manufacturers from retribution. Patient requests for access to drugs and biologics prior to their approval have long created a dilemma for regulators, who must balance the needs of patients and their families who believe that an experimental product could save their life, with AB 1668 Page 4 ensuring the safety of the greater population through tightly controlled clinical trials and drug approval. This issue has become increasingly visible and difficult in recent times, as views about the inherent right of patients in certain situations to unapproved products have been expressed by patients and their advocates, state legislators, members of Congress, and some court cases. In 2014 four states adopted legislation similar to this bill (Colorado, Louisiana, Michigan, and Missouri) and one state (Arizona) adopted a resolution to place the issue on the November 2014 ballot, where it was approved by voters. According to the National Conference on State Legislatures, at least 41 other states considered similar right-to-try legislation in 2015. Supporters argue that patients with no other treatment options should be able to take on more risk than healthy patients would otherwise choose. The Los Angeles County Board of Supervisors supports this bill, stating that terminally ill patients, who have exhausted their options to find a cure and who have identified a physician and pharmaceutical company willing to assist them, deserve the right to experimental treatments that could prolong their lives. The Medical Oncology Association of Southern California (MOASC) opposes, stating that "while we appreciate the interest in supporting patients, there are substantive dangers in a "right to try" outside the context of a clinical trial, including the damage to adult clinical trial enrollment, which hold the promise of the future of medicine." MOASC additionally raises concerns about the difficulty identifying an "immediately life-threatening condition", the lack of sufficient informed consent process to protect patients seeking these drugs, and the lack of appropriate physician supervision of the use of these drugs. The California Nurses Association (CNA) states that this bill erroneously suggests that consumers do not have access to these drugs because physicians fear their liability to practice medicine would be compromised and their liability increased if AB 1668 Page 5 they were to recommend such treatment. CNA points out that nothing in this legislation impacts the availability of drugs to terminally ill patients unless the manufacturer of a drug allows it to be used in advance of FDA approval. Analysis Prepared by: John Gilman / HEALTH / (916) 319-2097 FN: 0003206