BILL ANALYSIS �
AB 1277
Page 1
Date of Hearing: April 26, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 1277 (Hill and Perea) - As Amended: April 13, 2011
SUBJECT : Sherman Food, Drug, and Cosmetic Law.
SUMMARY : Revises the frequency of licensing inspections by the
Department of Public Health (DPH) for drug and medical device
manufacturers from once every two years to once every four
years, as specified. Specifically, this bill :
1)Clarifies that manufacturers of biologic products are included
in existing law allowing manufacturers of drugs and medical
devices to sell, deliver, or give away their products in
California if they meet existing licensing and approval
requirements prescribed by the federal Food and Drug
Administration (FDA).
2)States legislative intent to preclude DPH from requiring drug
and medical device manufacturers to also obtain separate state
approval from DPH, except to the extent that DPH requires
documentation that the federal requirements are met.
3)Changes the frequency of state licensing inspections for these
manufacturers from once every two years to once every four
years and permits DPH to, if necessary, perform follow up
inspections, as specified, to protect the health and safety of
the public.
EXISTING LAW establishes the Sherman Food, Drug, and Cosmetic
Law, administered by DPH, to regulate drug and medical device
manufacturers in California.
FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, biotechnology
and medical device companies are subject to inspections from
both the FDA and DPH every two years, in addition to
inspections performed by DPH prior to initial clinical trials
of products and the potential follow-up inspections the state
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performs within weeks after FDA inspections. The author
argues that, aside from the licensing and inspection fees,
these inspections can cost these companies thousands of
dollars in preparation, manpower, and facilitation. The
author points out that a recent survey of biomedical companies
demonstrated the widespread perception that often times the
state licensing and inspection process is duplicative of FDA
inspection requirements in that there is little difference
between what is inspected and a frequent lack of coordination
in the state and federal inspection timelines. The author
contends that duplicative and occasionally unnecessary
inspections place an increased financial burden on these
companies when they must already expend substantial financial
resources to prepare for them. This bill is intended to
reduce redundant inspections between the state and federal
government by changing the state inspection frequency from
once every two years to once every four years to better
complement the federal inspection schedule.
2)BACKGROUND . DPH's Food and Drug Branch (FDB) is responsible
for licensing and inspecting all manufacturers of
pharmaceutical drug products, including biologics, and medical
devices in California unless the manufacturer is specifically
exempted. DPH currently licenses and inspects 1,673 drug and
medical device manufacturing firms in California. FDB is
required to inspect the place of manufacture prior to issuing
a new drug or medical device manufacturing license; firms
cannot legally manufacture in California without a valid
license. Current law requires FDB to conduct license renewal
inspections of these companies once every two years and
permits additional follow up inspections to be conducted "for
cause" (e.g., to investigate injuries and deaths or to
investigate product recalls). DPH reports that its
inspections aim to prevent the sale and distribution of drugs
and medical devices that have been improperly manufactured;
are adulterated, misbranded or falsely advertised; have not
been shown to be safe or effective; or, in the case of medical
devices, fail to meet design verification requirements.
The FDA also plays a role in regulating drugs and medical
devices in California. According to DPH, the FDA and state
FDB have partnered to provide more oversight of these
industries. The FDA has taken the lead in regulating imported
drug and medical devices at the point of entry and has primary
responsibility for approving new drugs and devices. The FDA
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also inspects approximately 10% of manufacturers in California
each year. Since 2004, the FDA has adopted a risk-based
approach to selecting which drug and medical device
manufacturing facilities to inspect in an effort to more
effectively allocate its inspectional resources. Generally,
the FDA determines its frequency of a facility's inspections
based on such risk factors as the facility's compliance
history and the type of products that it manufactures. The
FDA reports that this model is designed to assist the agency
in predicting where its inspections are most likely to achieve
the greatest public health impact.
DPH indicates that, through partnership agreements, these
inspections are not duplicated by FDB and the results of both
FDA and FDB inspections are shared. In addition, DPH notes
that the FDA generally does not inspect new manufacturers
until two to three years after they have initiated
manufacturing. DPH states that, because these products are
used to treat life-threatening diseases or are necessary for
life-support, early regulation by FDB avoids product
contamination, misbranding, and a variety of formulation,
fabrication, and labeling problems.
3)INSPECTIONS . FDB conducts four types of inspections: new
drug, renewal drug, new medical device, and renewal medical
device. New license inspections of drug manufacturers require
an extensive examination of the facility, quality control,
employee qualifications, validation of processes, packaging,
labeling, and documentation. These inspections require an
average 60 hours to complete because of their complexity.
Inspection time for renewals is generally less than a new
license inspection because less explanation of requirements
and inspection activities are needed since the facility should
already be familiar with the process. The renewal inspection
consists of updating FDB's database and reviewing new elements
such as, examining corrective actions from the previous
inspection, following up on product problems, auditing
newly-established production process and result records, and
evaluating changes and new products. On average, drug
manufacturing renewal inspections require 40 hours for
completion.
New license inspections of medical device manufacturers are
similar to new license inspections of drug manufacturers
because they also require a comprehensive review of their
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manufacturing facilities, procedures, personnel, product
labeling, and advertising before a license is issued. On
average, these inspections take approximately 40 hours to
complete while renewal inspections, on average, take 35 hours
to complete. Similar to drug manufacturer renewal
inspections, the firm subject to the inspection is already
familiar with the requirements; therefore, the inspection
focuses on updating FDB files and reviewing new elements since
the last inspection.
DPH acknowledges that there is a current backlog for conducting
new and renewal drug and medical device manufacturer license
inspections due to an unanticipated increase in the number of
new medical device manufacturer license applications received
in 2010. According to DPH, the change in this bill to extend
the license renewal inspection frequency from two years to
four years will assist in reducing this backlog.
4)SUPPORT . BayBio and BIOCOM state that this bill seeks to
eliminate any overlap between state and federal inspections of
the life sciences industry while still allowing FDB to perform
follow up inspections in instances where the public's health
and safety may be at risk. The California Healthcare
Institute writes in support that this bill provides an
opportunity for manufacturers to demonstrate compliance with
federal and state laws through a more streamlined process that
clearly identifies an appropriate timeframe for when state and
federal inspections should occur.
5)DOUBLE REFERRAL . This bill is double referred. Should it
pass out of this committee, it will be referred to the
Assembly Committee on Business, Professions & Consumer
Protection.
6)POLICY COMMENT . It is unclear whether or not duplication
exists between the inspections of these facilities conducted
by DPH and those done by the FDA. Consequently, the extent to
which this bill is needed is unclear given that DPH indicates
that each agency executes its inspection responsibilities over
manufacturers with distinctly different operational and
inspectional strategies.
REGISTERED SUPPORT / OPPOSITION :
Support
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BayBio
BIOCOM
California Healthcare Institute
Opposition
None on file.
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097