BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 671|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
UNFINISHED BUSINESS
Bill No: SB 671
Author: Hill (D)
Amended: 7/16/15
Vote: 21
SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 7-0, 4/13/15
AYES: Hill, Bates, Block, Galgiani, Hernandez, Jackson,
Wieckowski
NO VOTE RECORDED: Berryhill, Mendoza
SENATE HEALTH COMMITTEE: 9-0, 4/29/15
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
SENATE FLOOR: 31-5, 5/22/15
AYES: Allen, Anderson, Bates, Beall, Block, Cannella, De León,
Galgiani, Hall, Hancock, Hernandez, Hertzberg, Hill, Hueso,
Huff, Jackson, Lara, Leno, Leyva, Liu, McGuire, Mendoza,
Mitchell, Monning, Moorlach, Nguyen, Pan, Pavley, Roth,
Wieckowski, Wolk
NOES: Gaines, Morrell, Nielsen, Stone, Vidak
NO VOTE RECORDED: Berryhill, Fuller, Runner
ASSEMBLY FLOOR: 78-0, 8/27/15 (Consent) - See last page for
vote
SUBJECT: Pharmacy: biological product
SOURCE: Author
DIGEST: This bill authorizes a pharmacist to substitute an
alternative biological product when filling a prescription for a
SB 671
Page 2
prescribed biological product if the alternative biological
products is designated as interchangeable with the reference
product, among other conditions, and communication is provided
to the patient and physician that a substitution was made. It
also requires the Board of Pharmacy to maintain a link on its
Website to the list of biological products recognized as
interchangeable by the federal Food and Drug Administration.
Assembly Amendments clarify the types of electronic records
systems that a communication to the prescriber could be made
through and specify that entry into one of those systems is
presumed to provide notice to the prescriber.
ANALYSIS:
Existing federal law:
1)Creates an abbreviated pathway for biological products that
are similar to or interchangeable with licensed biological
products, known as the Biologics Price Competition and
Innovation Act of 2009 (BPCIA). (42 U.S.C. Sec. 262 (k))
2)Requires that, for a biological product to be considered
biosimilar to a reference product, data must be derived from
analytical, animal and clinical studies as specified. (42
U.S.C. Sec. 262 (k)(2))
3)Clarifies that a product is biosimilar to a reference product
under the BPCIA if the proposed biosimilar product is highly
similar to the reference product, notwithstanding minor
differences in clinically inactive components, and that no
clinically meaningful differences exist between the proposed
biosimilar product and the reference product in terms of
safety, purity and potency. (42 U.S.C. Sec. 262(i)(2)(A) and
(B))
4)Clarifies that state law governs how and when pharmacists may
make prescription drug substitutions. (1 Food and Drug Admin.
Sec. 13:197 (2011))
Existing state law:
SB 671
Page 3
1)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a
person from furnishing any dangerous drug or device except
upon the prescription of a physician, dentist, podiatrist,
optometrist, veterinarian or naturopathic doctor. (BPC §
4059)
2)Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to
substitute generic drugs for orders if the generic contains
the same active chemical ingredients of equivalent strength
and duration of therapy, subject to a patient notification and
bottle labeling requirement, unless the prescriber specifies
that a pharmacist may not substitute another drug product by
either indicating on the form submitted for the filling of the
prescription drug orders "Do not substitute" or words of
similar meaning or selecting a box on the form marked "Do not
substitute." (BPC § 4073)
3)Authorizes pharmacists filling prescription orders for drug
products prescribed by their trade or brand names to
substitute a drug product with a different form of medication
with the same active chemical ingredients of equivalent
strength and duration of therapy as the prescribed drug
product when the change will improve the ability of the
patient to comply with the prescribed drug therapy, subject to
a patient notification and bottle labeling requirement, unless
the prescriber specifies that a pharmacist may not substitute
another drug product by either indicating on the form
submitted for the filling of the prescription drug orders "Do
not substitute" or words of similar meaning or selecting a box
on the form marked "Do not substitute." (BPC § 4052.5)
This bill:
1)Authorizes a pharmacist to substitute an alternative
biological product for a prescribed biological product if the
alternative biological product is interchangeable or if the
prescriber has not personally indicated, either orally or in
his or her own handwriting "Do not substitute" or words of
similar meaning.
SB 671
Page 4
2)Requires a dispensing pharmacist or pharmacist's designee,
within five days following the dispensing of a biological
product, to make an entry of the specific biological product
provided to the patient, including the name of the biological
product and the manufacturer. Provides that the communication
shall be conveyed by making an entry that can be
electronically accessed by the prescriber through an
electronic records system, including an interoperable
electronic medical records system, an electronic prescribing
technology, a pharmacy benefit management system, or a
pharmacy record.
3)Specifies that communication is not required to be made to a
prescriber when either there is no federal Food and Drug
Administration (FDA)-approved interchangeable biological
product or a refill prescription is not changed from the
product dispensed on the prior filing of the prescription.
4)Applies these provisions to all prescriptions, including those
presented by or on behalf of persons receiving assistance from
the federal government or pursuant to the Medi-Cal Act.
5)Requires a communication be made to the patient when an
alternative biological product is substituted for a biological
product.
6)Requires the Board of Pharmacy to maintain a link to the
current list, if available, of biological products determined
by the FDA to be interchangeable, on its website.
Background
Biologics, often referred to as originator biological products
or reference biological products, when discussing
interchangeability and therapeutic equivalence, are large,
complex protein molecules used in the treatment, diagnosis or
prevention of disease. These are quite different from small
molecule drugs, pills, which are not as structurally complex and
are instead relatively simple, organic substances produced by
chemical methods. Biologic medicines, on the other hand, are
made in living organisms to produce proteins by genetically
modifying cell constructs or cell lines. Biologics are grown,
SB 671
Page 5
cultivated and purified and are typically administered as
injectables. Biologic medicines are sensitive medications that
typically treat very serious diseases and conditions, including
blood conditions, cancers, immune disorders like Rheumatoid
Arthritis, Psoriasis and Crohn's Disease and neurological
disorders like Multiple Sclerosis. According to the FDA,
biologics are regulated under the federal Public Health Service
Act while drugs, including insulin and other hormone therapies,
are regulated under the Food Drug and Cosmetics Act.
Alternative biological products, biosimilars, are similar but
not identical versions of the original biologic. The active
ingredient of a biosimilar is expected to closely resemble that
of the original biologic and unlike generic pills which require
the active ingredient to be identical, the exact manufacturing
process of an original biologic cannot be exactly duplicated.
Biosimilars are not clinically identical to their reference
products.
In response to increases in an aging population and larger
numbers of patients suffering from chronic disease, there has
been a rise in use of biologics, and accordingly a rise in the
production efforts of biosimilars. Biosimilars go through an
extensive review process and manufacturers are required to
submit immense studies and data demonstrating a products'
efficacy and ensuring it is safe for use by consumers.
A pathway for biosimilar regulation in the U.S. was established
as a provision of the 2008 Patient Protection and Affordable
Care Act (ACA) and in 2012 the FDA issued draft guidelines for
biosimilars. The guidance included which types of studies
manufacturers should undertake in order to ensure product
safety, potency and purity. In addition to the draft guidelines
for biosimilars the FDA has also compiled a list of biological
products, including any biosimilar and interchangeable
biological products licensed by the FDA under the PHSA. This
list, known as the "Purple Book", includes the date a biological
product was licensed under the PHSA and whether FDA evaluated
the biological product for reference product exclusivity under
section 351(k)(7) of the PHSA. The Purple Book will enable a
prescriber or dispenser of a biological product to see whether
a biological product licensed under the PHSA has been determined
SB 671
Page 6
by FDA to be biosimilar to or interchangeable with a reference
biological product (an already-licensed FDA biological product).
Currently, only one biosimilar product has been approved by the
FDA. On March 6, 2015, the FDA approved, Zarxio
(filgrastim-sndz). Zarxio is manufactured by Sandoz, Inc. and
is biosimilar to Amgen Inc.'s Neupogen (filgrastim). There are
currently no interchangeable biological products approved by the
FDA and the timeline for approval of an interchangeable
biological product is unknown. Biosimilars seen as playing an
important part in medication cost reductions by providing
cost-effective alternatives to very expensive originator
biological products and are anticipated to play a key role in
the treatment of illnesses and chronic conditions in the U.S.
The goal of this bill is to make clear the procedures for
substitution of biosimilars for a biologic which include
communication to the prescriber, intended to provide a record of
the substitution, in the event of an adverse reaction, or other
clinical responses to the medication.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
According to the Assembly Committee on Appropriations, this bill
will result in minor and absorbable additional costs to the
Board's Pharmacy Fund and, contingent on future FDA approval of
biosimilars, biosimilar substitution could result in significant
future savings in state health programs (primarily Medi-Cal,
CalPERS, and correctional health).
SUPPORT: (Verified8/27/15)
AIM at Melanoma
Alliance for Patient Access
Alliance of Specialty Medicine
SB 671
Page 7
American Academy of Facial Plastic & Reconstructive Surgery
American Association of Neurological Surgeons
American Cancer Society
American College of Mohs Surgery
American Gastroenterological Association
American Society of Cataract and Refractive Surgery
American Society of Echocardiography
American Society of Plastic Surgeons
Amgen
Arthritis Foundation
Association of Northern California Oncologists
Biotechnology Industry Organization
BIOCOM
California Healthcare Institute
California Rheumatology Alliance
Coalition of State Rheumatology Organizations
Congress of Neurological Surgeons
Crohn's & Colitis Foundation of America
Express Scripts
Genentech
Hospira
International Cancer Advocacy Network
Johnson & Johnson
Kidney Cancer Association
Lilly USA
Medical Oncology Association of Southern California
Merck
National Black Nurses Association
National Kidney Foundation
North American Spine Society
Novartis
Novo Nordisk
Pharmaceutical Research and Manufacturers of America
Sandoz
Sanofi
Society for Cardiovascular Angiography and Interventions
Society for Excellence in Eyecare
State Building and Construction Trades Council
UCB, Inc.
U.S. Pain Foundation
NEUTRAL: (Verified 8/27/15)
SB 671
Page 8
Board of Pharmacy
CalPERS
California Pharmacists Association
California Retailers Association
CVS
National Association of Chain Drug Stores
Walgreens
OPPOSITION: (Verified8/27/15)
America's Health Insurance Plans
Association of California Life and Health Insurance Companies
California Association of Health Plans
Kaiser Permanente
ARGUMENTS IN SUPPORT: Supporters state that this bill
updates Pharmacy Law to allow for substitution of a new class of
FDA-approved medicines and will do so in a manner than ensures
patient access to these important medications while providing
for a communication about the substitution to be shared with the
patient's health care provider. Supporters believe that this
bill addresses key policy issues to ensure patient safety is
preserved and ensures patients and their physicians remain in
control of their medical treatment options as the market for
complex biologics evolves.
ARGUMENTS IN OPPOSITION: Opponents believe that the
notification requirement in this bill create a false impression
about the safety of biologics, will hinder their use and creates
unnecessary burdens. Opponents state that legislation that
limits biosimilar or interchangeable biologic substitution is
unnecessary, will increase costs for consumers and employers and
limit access to crucial therapies and state that the price of a
biologic should not be a factor in their use. Opponents also
argue that before-the-fact administrative burdens like those
contained in this bill will do little if anything to ensure
public safety and will increase the cost and access to these
SB 671
Page 9
life savings drugs.
ASSEMBLY FLOOR: 78-0, 8/27/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,
Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang,
Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle,
Daly, Dodd, Eggman, Beth Gaines, Gallagher, Cristina Garcia,
Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray,
Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones,
Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low,
Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin,
Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea,
Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago,
Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber,
Wilk, Wood, Atkins
NO VOTE RECORDED: Frazier, Williams
Prepared by: Janelle Miyashiro / B., P. & E.D. / (916)
651-4104, Sarah Mason / B., P. & E.D. / (916) 651-4104
8/28/15 10:13:22
**** END ****