BILL ANALYSIS �
AB 1277
Page 1
Date of Hearing: May 3, 2011
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
AB 1277 (Hill) - As Amended: April 13, 2011
SUBJECT : Sherman Food, Drug, and Cosmetic Law.
SUMMARY : Changes the schedule 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 new 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 who meet federal requirements
as described in 1), above, 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.
4)Permits DPH to perform follow up inspections, as specified, to
protect the health and safety of the public, rather than to
determine ownership, adequacy of facilities, personnel
qualifications, and compliance with current law.
EXISTING LAW
1)Establishes the federal Food, Drug, and Cosmetic Act, granting
authority to the FDA to oversee the safety of food, drugs, and
cosmetics.
2)Establishes the California Sherman Food, Drug, and Cosmetic
Law, administered by DPH, to regulate drug and medical device
manufacturers in California.
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FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office, "Under
existing law, biotechnology and medical device companies undergo
inspections from the federal Food and Drug Administration every
two years and the state Food and Drug Branch every two years.
This is in addition to inspections performed by the state Food &
Drug Branch prior to clinical trials and potential follow-up
inspections the state performs within weeks following federal
Food and Drug Administration inspections.
"On top of the licensing and inspection fees, these inspections
can cost companies thousands of dollars in preparation, manpower
and facilitation. A recent survey of biomedical companies
demonstrated the widespread perception that oftentimes the
California Food and Drug Branch's inspection and licensing
process is duplicative of the federal Food and Drug
Administration in that there is little differentiation in what
is inspected and frequent lack of coordination in the state and
federal inspection timelines. For example, two companies
reported that they were inspected by the state within six months
of essentially identical inspections by the federal government.
"Duplicative and occasionally unnecessary inspections place an
increased financial burden on companies that must expend
substantial financial resources to facilitate these
inspections."
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
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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
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 the 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.
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
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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 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 take an average of 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.
Support . BayBio states, "?the life sciences industry is a very
tightly regulated industry. Everything from the sterility of
our facilities to the quality of final product to the font size
used on packaging is scrutinized and approved by the federal
Food and Drug Administration (FDA). Although the California
Department of Public Health's Food and Drug Branch (FDB) serves
a valuable and necessary role in the drug and device safety
chain, there is also some unnecessary and duplicative overlap.
AB 1277 seeks to address that overlap regarding state
inspections which may largely mirror recent federal inspections,
while maintaining the integrity of the FDB's core mission."
The California Healthcare Institute writes, "Given the
significant cost involved in duplicative state inspections and
approvals, and the federal oversight and regulation of
manufacturers, CHI believes that state and federal drug and
medical device laws should be harmonized."
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REGISTERED SUPPORT / OPPOSITION :
Support
BayBio
BIOCOM
California Healthcare Institute
Opposition
None on file.
Analysis Prepared by : Angela Mapp / B.,P. & C.P. / (916)
319-3301