BILL ANALYSIS
AB 995
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 995 (Block)
As Amended July 23, 2009
Majority vote
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|ASSEMBLY: | |(May 28, 2009) |SENATE: |38-0 |(August 27, |
| | | | | |2009) |
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(vote not relevant)
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|COMMITTEE VOTE: |17-0 |(September 2, 2009) |RECOMMENDATION: |Concur |
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Original Committee Reference: HEALTH
SUMMARY : Exempts from tissue bank licensing requirements a
licensed physician or podiatrist storing a human cell, tissue, or
cellular- or tissue-based medical device or biologic product, as
specified.
The Senate amendments delete the Assembly version of this bill, and
instead:
1)Exempt from state "tissue bank" licensing requirements the
storage of a human cell, tissue, or cellular- or tissue-based
medical device or biologic product that is approved by the
federal government, as specified, by a licensed physician or
podiatrist acting within his or her scope of practice, and in a
lawful setting, if the product was obtained from a California
licensed tissue bank and stored as directed by the manufacturer,
for use by the physician or podiatrist on his or her own patient.
2)Require the entity or organization where the physician or
podiatrist practices to notify the Department of Public Health
(DPH) of the following: the practitioner is licensed and working
within the scope and authority of his or her license and practice
for the purpose of direct patient care; a list of practitioners
to whom the notification applies; agreement of each listed
practitioner to strictly abide by the manufacturer's directions
for storage and other instructions and guidelines; and,
AB 995
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acknowledgement that the product will not be resold or
distributed.
EXISTING LAW defines a tissue bank as any place, establishment, or
institution that collects, processes, stores, or distributes tissue
for transplantation into human beings, and requires tissue banks to
be licensed by DPH, unless specifically exempted. Current
exemptions include storage of freeze-dried dermis by a dentist and
storage of freeze-dried bone by a dentist or general acute care
hospital.
AS PASSED BY THE ASSEMBLY , this bill deleted requirements that DPH
establish regulations governing tissue banks, and instead required
tissue banks to comply with the current standards of the American
Association of Tissue Banks, required DPH to evaluate and consider
for adoption future amendments to the AATB standards pursuant to a
prescribed process, and changed the civil administrative penalties
DPH may impose for noncompliance with the standards.
FISCAL EFFECT : According to the Senate Appropriations Committee,
pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS : DPH recently began interpreting tissue bank laws to
require podiatrists and physicians to register as tissue banks if
they store tissue products for more than 24 hours, even if the
tissue product is intended solely for the practitioner's own
patient. According to the author, requiring licensed health care
practitioners who lawfully obtain products from a California
licensed tissue bank to also be licensed as tissue banks could
jeopardize access to bioactive devices and products. The author
states the purpose of this bill is to continue to allow licensed
physicians and podiatrists to use and store tissue products to
treat patients without being licensed as tissue banks.
The author states that newly developed bioactive devices and
products deliver living, cell-based products to stimulate the
body's own healing process, and are approved by the federal Food
and Drug Administration (FDA) to treat painful diabetic foot ulcers
and venous leg ulcers, which are the most frequently occurring
chronic wounds. According to the author, physicians and
podiatrists must obtain bioactive devices and products from
licensed tissue banks and store and use them according to
manufacturer directions, which are regulated by FDA.
The California Podiatric Medical Association (CPMA), co-sponsor of
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this bill, writes that diabetic ulcers and other chronic wounds can
lead to significant pain, diminished quality of life, impaired
mobility, reduced productivity, and even amputations and death.
CPMA asserts that when conventional wound care fails, bioengineered
tissue products can sometimes be used to assist the body's natural
healing process. Such bioactive devices are often administered in
small clinical settings, such as a physician's or podiatrist's
office. Advanced BioHealing, Inc., also a co-sponsor of this bill,
state that under current practice, there have been no significant
negative events. Another co-sponsor, Organogenesis, Inc., states
advanced biologic products are subject to strict premarket approval
and post-approval requirements over the manufacturing process,
shipping method and container, storage requirements, expiration
dates, and instructions for use and storage.
This bill was substantially amended in the Senate and the
Assembly-approved provisions of this bill were deleted. This bill,
as amended in the Senate, is inconsistent with Assembly actions.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097
FN: 0002837