BILL NUMBER: AB 2821	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Feuer

                        FEBRUARY 22, 2008

   An act to amend, repeal, and add Section 119402 of the Health and
Safety Code, relating to drug marketing.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 2821, as introduced, Feuer. Drug marketing: gifts.
   Existing law requires a pharmaceutical company to adopt and update
a Comprehensive Compliance Program that is in accordance with a
related federal government publication. The Comprehensive Compliance
Program is required to include, among other provisions, policies on
interactions with health care professionals and limits on gifts and
incentives to medical or health professionals. Each pharmaceutical
company is required to establish explicitly in its Comprehensive
Compliance Program a specific annual dollar limit on gifts,
promotional materials, or items, or activities that the
pharmaceutical company may give or otherwise provide to an individual
medical or health care professional, with certain exemptions.
   Existing law also requires a pharmaceutical company to annually
declare, in writing, compliance with the Comprehensive Compliance
Program. Existing law requires that the pharmaceutical company place
its Comprehensive Compliance Program and written acknowledgment of
compliance available to the public on its Web site, and provide a
toll-free telephone number where a copy or copies of the
Comprehensive Compliance Program and written declaration of
compliance may be obtained.
   This bill would, effective July 1, 2009, repeal the
above-described requirement regarding the establishment of a specific
annual dollar limit on gifts, promotional materials, or items, or
activities that may be given or provided. It would, instead, prohibit
any pharmaceutical company, or agent thereof, from offering or
giving a gift, as defined, or combination of gifts that have a total
value of more than $250 to a medical or health professional, except
as specified.
   The bill would, effective July 1, 2009, require each
pharmaceutical company to annually file a report with, and pay a
prescribed fee to, the State Department of Public Health that
identifies all permitted gifts, financial support, payments,
honoraria, or other compensation paid to medical or health
professionals during the proceeding year. The department would be
required to make the information contained in the reports available
to the public, as prescribed.
   The bill would establish the Pharmaceutical Gift Disclosure Fund
within the State Treasury, into which the fee would be deposited, the
moneys of which would be available upon appropriation by the
Legislature, to the department.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.


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

  SECTION 1.  Section 119402 of the Health and Safety Code is amended
to read:
   119402.  (a) Every pharmaceutical company shall adopt a
Comprehensive Compliance Program that is in accordance with the April
2003 publication "Compliance Program Guidance for Pharmaceutical
Manufacturers," which was developed by the United States Department
of Health and Human Services Office of Inspector General (OIG). A
pharmaceutical company shall make conforming changes to its
Comprehensive Compliance Program within six months of any update or
revision to the "Compliance Program Guidance for Pharmaceutical
Manufacturers."
   (b) Every pharmaceutical company shall include in its
Comprehensive Compliance Program policies for compliance with the
Pharmaceutical Research and Manufacturers of America (PhRMA) "Code on
Interactions with Health Care Professionals," dated July 1, 2002.
The pharmaceutical company shall make conforming changes to its
Comprehensive Compliance Program within six months of any update or
revision of the "Code on Interactions with Health Care Professionals."

   (c) Each pharmaceutical company shall include in its Comprehensive
Compliance Program limits on gifts or incentives provided to medical
or health professionals, in accordance with this chapter.
   (d) (1) Each pharmaceutical company shall establish explicitly in
its Comprehensive Compliance Program a specific annual dollar limit
on gifts, promotional materials, or items or activities that the
pharmaceutical company may give or otherwise provide to an individual
medical or health care professional in accordance with the
"Compliance Program Guidance for Pharmaceutical Manufacturers" and
with the "Code on Interactions with Health Care Professionals."
   (2) Notwithstanding paragraph (1), drug samples given to
physicians and healthcare professionals intended for free
distribution to patients, financial support for continuing medical
education forums, and financial support for health educational
scholarships are exempt from any limits if that support is provided
in a manner that conforms to the "Compliance Program Guidance for
Pharmaceutical Manufacturers" and the "Code on Interactions with
Health Care Professionals."
   (3) Payments made for legitimate professional services provided by
a health care or medical professional, including, but not limited
to, consulting, are exempt from any limits, provided that the payment
does not exceed the fair market value of the services rendered, and
those payments are provided in a manner that conforms to the
"Compliance Program Guidance for Pharmaceutical Manufacturers" and
with the "Code on Interactions with Health Care Professionals."
   (e) The pharmaceutical company shall annually declare, in writing,
that it is in compliance with both its Comprehensive Compliance
Program and this chapter. The pharmaceutical company shall make its
Comprehensive Compliance Program and its annual written declaration
of compliance with the program available to the public on the
pharmaceutical company's Web site and shall also provide a toll-free
telephone number where a copy or copies of the Comprehensive
Compliance Program and written declaration of compliance may be
obtained.
   (f) This section shall become  operative on July 1, 2005
  inoperative on July 1, 2009, and, as of January 1,
  2010, is repealed, unless a later enacted statute that is
enacted before January 1, 2010, deletes or extends the date on which
it becomes inoperative and is repealed  .
  SEC. 2.  Section 119402 is added to the Health and Safety Code, to
read:
   119402.  (a) Every pharmaceutical company shall adopt a
Comprehensive Compliance Program that is in accordance with the April
2003 publication "Compliance Program Guidance for Pharmaceutical
Manufacturers," which was developed by the United States Department
of Health and Human Services Office of Inspector General (OIG). A
pharmaceutical company shall make conforming changes to its
Comprehensive Compliance Program within six months of any update or
revision to the "Compliance Program Guidance for Pharmaceutical
Manufacturers."
   (b) Every pharmaceutical company shall include in its
Comprehensive Compliance Program policies for compliance with the
Pharmaceutical Research and Manufacturers of America (PhRMA) "Code on
Interactions with Health Care Professionals," dated July 1, 2002.
The pharmaceutical company shall make conforming changes to its
Comprehensive Compliance Program within six months of any update or
revision of the "Code on Interactions with Health Care Professionals."

   (c) The pharmaceutical company shall annually declare, in writing,
that it is in compliance with both its Comprehensive Compliance
Program and this chapter. The pharmaceutical company shall make its
Comprehensive Compliance Program and its annual written declaration
of compliance with the program available to the public on the
pharmaceutical company's Web site and shall also provide a toll-free
telephone number where a copy or copies of the Comprehensive
Compliance Program and written declaration of compliance may be
obtained.
   (d) (1) No pharmaceutical company, or any agent thereof, may offer
or give within a calendar year any gift or combination of gifts that
have a total value of more than two hundred fifty dollars ($250) to
a medical or health professional. Except as provided in paragraph
(2), a gift shall include a payment, food, entertainment, travel,
subscription, or any other item of value, under consideration of
equal or greater value is provided by the recipient to the donor. The
amount of any difference between the market value of a gift and any
consideration provided by the recipient shall be used to determine
the value of the gift for purposes of this section.
   (2) As used in this section, "gift" does not include any of the
following:
   (A) Drug samples provided to a prescriber for free distribution to
patients.
   (B) Financial support for continuing medical education forums, and
financial support for health educational scholarships, if that
support is provided in a manner that conforms to the "Compliance
Program Guidance for Pharmaceutical Manufacturers" and the "Code on
Interactions with Health Care Professionals."
   (C) Reasonable honoraria and payment of the reasonable expenses of
a medical or health professional who serves on the faculty at a
professional or educational conference or meeting.
   (D) Payments made for legitimate professional services provided by
a health care or medical professional, including, but not limited
to, consulting, provided that the payment does not exceed the fair
market value of the services rendered, and those payments are
provided in a manner that conforms to the "Compliance Program
Guidance for Pharmaceutical Manufacturers" and with the "Code on
Interactions with Health Care Professionals."
   (E) Publications and educational materials.
   (F) Salaries or other benefits paid to employees.
   (e) (1) Each pharmaceutical company shall annually file with the
State Department of Health Care Services a report, in a form and on
the date prescribed by the department, that identifies the nature and
value of all gifts, as well as all financial support, payments,
honoraria, or other compensation described in subparagraphs (B) to
(D), inclusive, of paragraph (2) of subdivision (d), with a value of
at least fifty dollars ($50) paid to a medical or health professional
in the state during the preceding calendar year. The report shall
also identify the first and last name of the recipient and his or her
business address.
   (2) The reports described in this subdivision shall be public
records available and open to the public for inspection. The State
Department of Health Care Services, not later than December 31, 2010,
shall provide access to all information contained in the reports by
means of an online database.
   (3) The State Department of Health Care Services shall not be
liable for any damages arising from the inaccuracy of information
provided in the reports filed pursuant to this subdivision.
   (f) Each pharmaceutical company shall, along with the report filed
pursuant to subdivision (c), pay a disclosure fee to the department
in an amount determined by the department to not exceed the costs of
administering this section. All fees collected pursuant to this
section shall be deposited in the Pharmaceutical Gift Disclosure
Fund, which is hereby established in the State Treasury, and shall
become available to the department, upon appropriation by the
Legislature, for the purposes of this section, including the
development and maintenance of the online database. Notwithstanding
Section 16305.7 of the Government Code, interest and dividends earned
on money in the fund shall accrue to the fund.
   (g) This section shall become operative on July 1, 2009.