BILL ANALYSIS Ó
AB 1277
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 1277 (Hill and Perea)
As Amended August 9, 2012
Majority vote
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|ASSEMBLY: |78-0 |(May 19, 2011) |SENATE: |37-0 |(August 23, |
| | | | | |2012) |
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Original Committee Reference: HEALTH
SUMMARY : Eliminates licensing inspections by the Department of
Public Health (DPH) for drug or medical device manufacturers
that provide documentation of ownership and other information to
DPH, and limits the ability of DPH to investigate or inspect
licensed drug or device manufacturers to certain specified
circumstances.
The Senate amendments :
1)Repeal the requirement that DPH conduct an inspection of the
place of business prior to issuing a new license to a drug or
device manufacturer, and, instead, require DPH to receive
documentation from the manufacturer that evidences ownership
and any of the following:
a) The business is operating pursuant to a valid biologics
license issued by the United States Food and Drug
Administration (FDA), as specified;
b) The business is operating with a valid federal
establishment registration that includes an attestation
that a federal inspection was completed within the two
years prior to the date of the attestation, as specified;
c) The business is operating in compliance with audits
conducted pursuant to quality management standards issued
by the International Standards Organization or pursuant to
federal regulations, as specified; or,
d) The business is operating pursuant to an approved
investigational new drug or an approved investigational
device exemption issued by the FDA, as specified.
AB 1277
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2)Prohibit DPH from inspecting the business prior to issuing a
license if DPH receives documentation that satisfies the
requirements in 1) above, and require DPH to inspect the
business prior to issuing a license if this documentation is
not received.
3)Delete current law requiring DPH to conduct renewal
inspections of licensed drug or device manufacturers once
every two years.
4)Specify that DPH shall investigate or inspect licensed drug or
device manufacturers only when any of the following occur:
a) DPH becomes aware of an issue and determines that the
health and safety of the public is at serious risk;
b) A complaint has been registered with DPH and DPH
determines that the public health and safety is at serious
risk;
c) A notification has been sent by the FDA to DPH
requesting assistance with certain recall actions; or,
d) The FDA has requested assistance for enforcement
activities, including, but not limited to, embargoes,
seizures, or injunctions.
5)Make other minor technical and conforming changes.
AS PASSED BY THE ASSEMBLY , this bill revised the frequency of
licensing inspections by DPH for drug and medical device
manufacturers from once every two years to once every four
years.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS : 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 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
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facilitation. The author contends that duplicative and
occasionally unnecessary inspections place an increased
financial burden on these companies when they must expend
substantial financial resources already in order to prepare for
them.
Supporters of this bill, including California Healthcare
Institute, Advanced Medical Technology Association,
Pharmaceutical Research and Manufacturers of America, BIOCOM,
and BayBio, state that this bill will relieve companies of the
added financial burden from redundant inspections, as well as
relieve state staff resources. They add that all aspects of
their manufacturing operations, ranging from the sterility of
facilities to the quality of final product to the font size used
on packaging, is scrutinized and approved by the FDA, and this
bill will ensure that California is doing all it can to remove
barriers for its industry.
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097
FN: 0005555