BILL ANALYSIS �
AB 1277
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Date of Hearing: May 11, 2011
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Felipe Fuentes, Chair
AB 1277 (Hill) - As Amended: April 13, 2011
Policy Committee: Business and
Professions Vote: 9-0
Health Vote: 17-0
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
This bill reduces state oversight of drug and device
manufacturers in California. 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)Changes the frequency of state licensing inspections for these
manufacturers from once every two years to once every four
years.
3)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.
4)States legislative intent to preclude DPH from requiring drug
and medical device manufacturers who meet federal requirements
to also obtain separate state approval from DPH, except to the
extent that DPH requires documentation that the federal
requirements are met.
FISCAL EFFECT
1)Reduced cost pressure to the Drug and Device Safety special
fund within DPH, associated with reduced frequency of
AB 1277
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inspections.
2)It is unclear whether the reduction in inspection frequency
will result in decreased expenditures for drug and device
regulation, as there is an existing and ongoing backlog in
initial licensure inspections. DPH indicates initial
licensure of manufacturers requires significantly more time
than renewal inspections, and the number of new manufacturers
continues to exceed DPH projections.
COMMENTS
1)Rationale . According to the author, inspections by DPH are
duplicative of inspections by the federal Food and Drug
Administration, and place a financial burden on companies that
must pay licensing fees and expend substantial financial
resources to facilitate these inspections. This bill intends
to limit ease the regulatory burden of having two regulatory
entities.
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, and every
two years thereafter. Firms cannot legally manufacture in
California without a valid license.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081