BILL ANALYSIS �
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, Ch�vez, Chesbro, |
| |Gomez, Gonzalez, |
| |Roger Hern�ndez, |
| |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