AB 1277 Assembly Bill

BILL NUMBER: AB 1277	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  MARCH 31, 2011

INTRODUCED BY   Assembly Members Hill and Perea

                        FEBRUARY 18, 2011

    An act relating to business.   An act to
amend Sect   ions 111550 and 111630 of the Health and Safety
Code, relating to public health. 


	LEGISLATIVE COUNSEL'S DIGEST


   AB 1277, as amended, Hill.  Biotechnology industry:
regulation.   Sherman Food, Drug, and Cosmetic Law 

   (1) The Sherman Food, Drug, and Cosmetic Law regulates the
packaging, labeling, and advertising of drugs and devices, and is
administered by the State Department of Public Health. The law
prohibits the sale, delivery, or giving away of any new drug or new
device unless either the department has approved a new drug or device
application for that new drug or new device and that approval has
not been withdrawn, terminated, or suspended or a new drug
application has been approved for it and that approval has not been
withdrawn, terminated, or suspended under specified provisions of the
federal Food, Drug, and Cosmetic Act, or it is a new device for
which a premarket approval application has been approved, and that
approval has not been withdrawn, terminated, or suspended under the
federal act.  
   (2) The Sherman Food, Drug, and Cosmetic Law requires the
department to adopt regulations to establish the application form and
set the fee for licensure and renewal of a drug or device license.
 
   This bill would revise the above described prohibition, as
specified, and require the department to waive the fee for the
issuance and renew of a license for a person who has paid the most
recent annual fees required pursuant to the federal act. 

   Existing law creates various state agencies and authorizes certain
of those agencies to regulate the operations of businesses.
 
   This bill would make findings and declarations of the Legislature
and state the intent of the Legislature to adopt legislation that
would reduce regulatory redundancies impacting the biotechnology
industry. 
   Vote: majority. Appropriation: no. Fiscal committee:  no
  yes  . State-mandated local program: no.



THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

   SECTION 1.    Section 111550 of the   Health
and Safety Code   is amended to read: 
   111550.  No person shall sell, deliver, or give away any new drug
or new device unless it satisfies either of the following:
   (a) It is a new drug, and a new drug application has been approved
for it and that approval has not been withdrawn, terminated, or
suspended under Section 505 of the federal act (21 U.S.C. Sec. 355);
 it is a new biologic product for which a license has been issued
as required by the federal Public Health Service Act (42 U.S.C. Sec.
262),  or it is a new device  that is reported under
Section 510(k) of the federal act (21 U.S.C. Sec. 360) and  for
which a premarket approval application has been approved, and that
approval has not been withdrawn, terminated, or suspended under
Section 515 of the federal act (21 U.S.C. Sec. 360e).
   (b) The department has approved a new drug or device application
for that new drug or new device and that approval has not been
withdrawn, terminated, or suspended. Any person who files a new drug
or device application with the department shall submit, as part of
the application, all of the following information:
   (1) Full reports of investigations that have been made to show
whether or not the new drug or device is safe for use and whether the
new drug or device is effective in use under the conditions
prescribed, recommended, or suggested in the labeling or advertising
of the new drug or device.
   (2) A full list of the articles used as components of the new drug
or device.
   (3) A full statement of the composition of the new drug or device.

   (4) A full description of the methods used in, and the facilities
and controls used for, the manufacture, processing, and packing of
the new drug or in the case of a new device, a full statement of its
composition, properties, and construction and the principles of its
operation.
   (5) Samples of the new drug or device and of the articles used as
components of the drug or device as the department may require.
   (6) Specimens of the labeling and advertisements proposed to be
used for the new drug or device.
   SEC. 2.    Section 111630 of the  Health and
Safety Code   is amended to read: 
   111630.   (a)    The department shall by
regulation establish the application form and set the fee for
licensure and renewal of a license. The penalty for failure to apply
for renewal of a license within 30 days after its expiration is ten
dollars ($10) and shall be added to the renewal fee and be paid by
the applicant before the renewal license may be issued. All moneys
collected as fees shall be expended when appropriated by the
Legislature in the carrying out  of the provisions 
of this part and the regulations adopted pursuant to this part. 
   (b) Notwithstanding subdivision (a), the department shall waive
the fee for the issuance and renew of a license for a person licensed
pursuant to this section who has paid the most recent annual fees
required pursuant to the federal act.  
   Any 
    (c)     A  person licensed pursuant to
this section shall immediately notify the department of any change
in the information reported in the license application. 
  SECTION 1.    (a) The Legislature finds and
declares both of the following:
   (1) There are over 2,200 companies and more than 267,000 employees
statewide in the biotechnology industry. It is imperative that
government agencies do not unnecessarily hinder this unique
California industry, which added 12,000 jobs between 2005 and 2009.
   (2) According to the 2011 California Biomedical Industry Report,
68 percent of chief executive officers said they expected to expand
the overall size of their workforce within California. For the first
time in the report's 17-year history, nearly twice as many biomedical
chief executive officers said they intend to increase manufacturing
within California, 41 percent, compared to out-of-state, 21 percent,
over the next two years. In addition, 62 percent of chief executive
officers surveyed said they expect to expand research and development
within California.
   (b) It is the intent of the Legislature to enact legislation that
would reduce regulatory redundancies impacting the biotechnology
industry in California.