BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1727
AUTHOR: Rodriguez
AMENDED: May 15, 2014
HEARING DATE: June 11, 2014
CONSULTANT: Bain
SUBJECT : Prescription drugs: collection and distribution
program.
SUMMARY : Prohibits a medication that is the subject of a United
States Food and Drug Administration managed risk evaluation and
mitigation strategy (REMS) from being donated to a prescription
drug repository and distribution program if this inventory
transfer is restricted by that strategy. Requires the medication
that is the subject of the REMS to be managed and dispensed
according to the requirements of that strategy.
Existing law:
1.Authorizes counties, by ordinance, to establish a program,
subject to specified requirements, for medically indigent
patients to receive donated prescription drugs free of charge.
2.Allows the following entities to donate medication to a
program: a hospital; an acute psychiatric hospital; a skilled
nursing facility (SNF); a SNF designated as an institution for
mental disease (IMD); an intermediate care facility; a
licensed correctional treatment center; a licensed psychiatric
health facility; a chemical dependency recovery hospital; a
residential care facility for the elderly, an approved mental
health rehabilitation center; a pharmacy whose primary or sole
purpose is limited to SNF; home health care or mail order; a
drug wholesaler; and, a drug manufacturer.
3.Limits the types of pharmacies that can dispense medication
through a program to county-owned pharmacies and pharmacies
that contract with the county; licensed pharmacies owned and
operated by primary care clinics; and, primary care clinics
licensed to administer and dispense drugs.
4.Requires a county that elects to establish a program to
establish procedures for program eligibility for medically
indigent patients, and to ensure proper safety and management
of medications, among other requirements.
Continued---
AB 1727 | Page 2
5.Prohibits the donation to a program of the following:
controlled substance; medication that has been adulterated,
misbranded, or stored under conditions contrary to standards
set by the United States Pharmacopoeia or the product
manufacturer; and, medication that has been in the possession
of a patient or any individual member of the public.
This bill:
1.Prohibits a medication that is the subject of a United States
Food and Drug Administration (FDA) managed risk evaluation and
mitigation strategy (REMS) from being donated to a
prescription drug repository and distribution program if this
inventory transfer is restricted by that strategy.
2.Requires the medication that is the subject of the REMS to be
managed and dispensed according to the requirements of that
strategy.
FISCAL EFFECT : This bill has been keyed non-fiscal.
PRIOR VOTES :
Assembly Health:19- 0
Assembly Floor:76- 0
COMMENTS :
1.Author's statement. According to the author, this bill seeks
to prevent medications that are strictly regulated by the FDA
from being donated to county drug repository and distribution
programs. There are some medications that may have very
serious side effects such as birth defects and vision loss. To
ensure the benefits of these drugs outweigh the risks, the FDA
requires doctors, pharmacies and drug manufactures to follow
strict safety guidelines. For certain drugs, the FDA requires
manufacturers to track each prescription from the doctor,
through the pharmacy, to the patient. If these highly
regulated drugs are sent to repository programs, it would
become difficult if not impossible to track each prescription
from the doctor, through the pharmacy, to the patient. This
bill would ensure that the safety precautions required by the
FDA are followed and that patients are safe from unsafe
medications.
2.Background. SB 798 (Simitian), Chapter 444, Statutes of 2005,
authorized the establishment of a program. Under the program,
counties can adopt an ordinance to establish such a program,
under which specified entities can donate unused medications
AB 1727 | Page
3
for dispensing to medically indigent patients free of charge.
Prior to the enactment of SB 798, SNFs were required to either
destroy the drugs in the presence of a pharmacist or nurse, or
return the drugs to the issuing pharmacy (if unopened and in a
sealed container) for disposition. To date, one county (Santa
Clara) has established such a program, and Santa Clara
indicates it has saved approximately $5,000 through the
program as of February 2012. According to an issue brief from
the National Conference of State Legislatures, 38 states have
enacted laws as of 2010 regarding prescription recycling
programs for unused medications. Counties establishing a
program have to meet certain requirements, including
establishing eligibility for medically indigent patients,
developing a formulary of medications appropriate for the
program, ensuring the privacy of patients donating medication
to the program, and ensuring proper safety and medication
management.
3.Federal Risk Evaluation and Mitigation Strategy. The Food and
Drug Administration Amendments Act of 2007 gave the FDA the
authority to require a REMS from manufacturers to ensure that
the benefits of a drug or biological product outweigh its
risks. In determining whether to require a REMS, the FDA is
required to consider the following:
a. The estimated size of the population likely to
use the drug involved;
b. The seriousness of the disease or condition
that is to be treated with the drug;
c. The expected benefit of the drug with respect
to such disease or condition;
d. The expected or actual duration of treatment
with the drug;
e. The seriousness of any known or potential
adverse events that may be related to the drug and the
background incidence of such events in the population
likely to use the drug; and,
f. Whether the drug is a new molecular entity.
According to the FDA's web site, approximately 65 drugs have a
REMS although not all REMS prohibit inventory transfer. A REMS
may be required by the FDA as part of the approval of a new
product, or for an approved product when new safety
AB 1727 | Page 4
information arises. REMS are a safety strategy to manage a
known or potential serious risk associated with a medicine,
and to enable patients to have continued access to such
medicines by managing their safe use. Since medicines are very
different from each other, REMS for each medicine is also
different. REMS can be required for a particular drug, or for
an entire drug in a class.
REMS can require additional information to be provided to
patients (such as an information guide), a communication plan
to support implementation of the REMS (such as providing
information to health care providers and professional medical
societies about the risks involved in using the drug drug) and
a timetable for determining the effectiveness of the safety
measures in the REMS. A REMS can also include "Elements to
Assure Safe Use," which requires specific actions by health
care providers prior to ordering or dispensing a drug (such as
requiring certification by health care providers or
pharmacists in order to prescribe or dispense the drug),
limiting the drug to only certain settings, requiring patient
monitoring when on the drug, or requiring the patient be
enrolled in a registry.
4.Double referral. This bill is double referred. Should it pass
out of this committee, it will be referred to the Senate
Committee on Business, Professions and Economic Development.
5.Prior legislation. SB 1329 (Simitian), Chapter 709, Statutes
of 2012 expanded the types of entities that can donate and
dispense medication in the prescription drug depository and
distribution program that provides donated medication to
medically indigent patients, and allows counties to establish
a program through an action by the county board or through an
action of the public health officer of the county, instead of
only through county ordinance under existing law.
6.Support. Celgene Corporation (Celgene), a biotech company
based in California, writes in support of this bill to ensure
medications with strict FDA restrictions are not distributed
in county surplus drug collection and distribution programs.
Celgene states this bill works to provide safety to both
patients and their families as the federal FDA has imposed
strict restricted distribution programs for specified drugs
that require drug manufacturers to track each prescription
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5
from the doctor, through the pharmacy, to the patient in order
to minimize the risk of fetal exposure. Only physicians,
pharmacies, and patients registered with these restricted
distribution programs are authorized to write, fill, or
receive a prescription for these products. This allows
manufacturers to reconcile the medication shipped to
pharmacies with what is ultimately dispensed to patients. In
addition, it ensures that patients receive initial and ongoing
education about the risks and necessary precautions associated
with these drugs. Celgene argues allowing pharmacies that
participate in a repository program to receive and
redistribute these types of drugs undermines the safety
precautions established by its product REMS programs. Celgene
states that other states, including Arizona, Colorado,
Montana, Washington and Wisconsin, have incorporated language
similar to that in AB 1727 in their drug repository programs
either through statute or regulation. Celgene states that,
since 2007, all bills to either create such a program or
expand an existing program have contained this type of
protective language.
The March of Dimes writes in support that this bill would
establish safeguards in the state's program to ensure that
certain prescription drugs with strict FDA restrictions on
their use and distribution, such as those that can cause birth
defects, are not distributed in county surplus drug programs.
One of the medications this would apply to is thalidomide,
which is a highly teratogenic drug with a broad spectrum of
pharmacological activities and causes severe birth defects
when taken during early pregnancy. March of Dimes supports
these safeguards and has a deeply vested interest on behalf of
the public in ensuring that thalidomide is managed safely in
this country, including how, and by whom, the medication is
dispensed.
7.Policy and drafting issue. This bill only allows the donation
of medication that is the subject of a REMS if this inventory
transfer is not restricted by that REMS, and to require this
medication to be managed and dispensed according to the
requirements of that REMS. However, of the thirteen drugs that
are currently subject to a REMS under this bill, inventory
transfers are prohibited for some, while others do not
prohibit inventory transfers but require the prior approval of
the manufacturer. By using the term "restricted," this bill
AB 1727 | Page 6
would be prohibiting transfers that may otherwise be allowed
under the REMS.
SUPPORT AND OPPOSITION :
Support: BayBio
Biocom
California State Board of Pharmacy
Celgene Corporation
March of Dimes
Pharmaceutical Research and Manufacturers of America
Oppose:None received.
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