BILL ANALYSIS Ó AB 1727 Page 1 ASSEMBLY THIRD READING AB 1727 (Rodriguez) As Amended May 15, 2014 Majority vote HEALTH 19-0 -------------------------------- |Ayes:|Pan, Maienschein, | | |Ammiano, Gordon, Bonilla, | | |Bonta, Chávez, Chesbro, | | |Gomez, Gonzalez, | | |Roger Hernández, | | |Lowenthal, Waldron, | | |Nazarian, Nestande, | | |Patterson, Ridley-Thomas, | | |Wagner, Wieckowski | | | | -------------------------------- SUMMARY : Prohibits the redistribution of any prescription drug that the federal Food and Drug Administration (FDA) through Risk Evaluation and Mitigation Strategies (REMS) requires be dispensed only to patients registered with the drug's manufacturer. FISCAL EFFECT : None COMMENTS : According to the author, this bill is needed to strengthen patient protections and ensure patients that are using drugs with serious side effects have access to the required monitoring procedures. The author notes existing law governing county surplus drug collection and distribution programs does not prohibit medications which are mandated by the FDA to have a REMS from being donated to and dispensed from drug repository programs. REMS programs imposed by the FDA require pharmaceutical manufactures to track prescriptions from the doctor, through the pharmacy, and to the patient in order to minimize serious side effects. The author argues allowing pharmacies that participate in a repository program to receive and re-distribute these types of drugs undermines the safety precautions established by REMS programs. Counties that adopt an ordinance to establish a voluntary drug repository and distribution program in California must also establish eligibility for medically indigent patients who may AB 1727 Page 2 participate in the program free of charge; develop a formulary of appropriate medications for the program; provide for the proper safety and management of any medications collected by and maintained under the authority of a participating licensed pharmacy; and, protect the privacy of individuals for whom the medication was originally prescribed. Controlled substances, i.e., prescription drugs with the potential for abuse, and medication in the possession of a patient or any individual member of the public are not eligible for donation. Drugs that are dispensed under the program are required to be in a new and properly labeled container that is specific to the eligible patient. In addition, donated drugs are required to be physically separated from the participating pharmacy's other drug stock for purposes of inventory, accounting, and inspections. Pharmacies must also keep complete records of the acquisition and disposition of medication donated to and dispensed under the program. Lastly, a participating pharmacy is required to follow the same procedural drug pedigree instructions for donated drugs as it would follow for drugs purchased from a wholesaler or directly from a manufacturer. Only Santa Clara County has established a voluntary drug repository and distribution program. The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require a REMS from pharmaceutical manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. Many different drugs are on this list, including some that are quite commonly prescribed. The elements of REMS can vary dramatically. For AndroGel, a commonly prescribed drug used in testosterone replacement therapy, the very brief REMS requires dispensing a consumer information packet with each prescription. There is no registration of the patients. For thalidomide, a drug that once resulted in the death or mutation of 10,000 children worldwide, the requirements are much different. The FDA approved a 179-page REMS with very strict controls, including limiting prescription and dispensing rights only to authorized prescribers and pharmacies, keeping a registry of all patients prescribed thalidomide, providing extensive patient education about the risks associated with the drug, and providing periodic pregnancy tests for women who take the drug. The program includes physician-patient agreements governing use of contraceptives and contingencies if the patient needs to be AB 1727 Page 3 tested for pregnancy. The FDA approved the use of the drug because it has therapeutic value for a number of very serious illnesses and conditions, including many cancers. This bill would allow donations to a county voluntary drug repository and distribution program of some of the drugs that are subject to the REMS. This bill would allow drugs to be donated if not prohibited by the REMS and if the drug is dispensed in accordance with the REMS. Celgene Corporation (Celgene) supports this bill because it will help provide safety to both patients and their families and comply with the strict controlled distribution guidelines for various drugs that require the manufacturers to track each prescription from the doctor, through the pharmacy, to the patient to minimize the risk of fetal exposure. Celgene notes these risk management programs are an integral part of the FDA approval and are designed to minimize the risk of fetal exposure. Celgene argues that allowing pharmacies to participate in a repository program to receive and redistribute these types of drugs undermines the safety precautions established by the FDA program. The Pharmaceutical Research and Manufacturers of America (PhARMA) support this bill because it will protect consumers. According to PhARMA, concerns about possible fetal exposure renders these medications unsuitable for redistribution. They note that other states have enacted similar controls over products which must adhere to strict FDA guidelines on distribution. There is no opposition on file. Analysis Prepared by : Roger Dunstan / HEALTH / (916) 319-2097 FN: 0003477