BILL NUMBER: SB 606 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JULY 16, 2007
AMENDED IN ASSEMBLY JUNE 27, 2007
AMENDED IN SENATE JUNE 4, 2007
AMENDED IN SENATE MAY 15, 2007
INTRODUCED BY Senator Scott
(Coauthor: Senator Kuehl)
(Coauthors: Assembly Members Brownley and Ruskin)
FEBRUARY 22, 2007
An act to add Division 112.6 (commencing with Section 130650) to
the Health and Safety Code, relating to pharmaceutical information.
LEGISLATIVE COUNSEL'S DIGEST
SB 606, as amended, Scott. Pharmaceutical information: clinical
trial data.
Existing law, the Sherman Food, Drug, and Cosmetic Law, regulates
the packaging, labeling, and advertising of food, drugs, and
cosmetics, under the administration of the State Department of Public
Health.
This bill would require a pharmaceutical company
manufacturer that sells, delivers, offers for
sale, or gives away pharmaceutical drugs within the state to make
publicly available the results of every completed clinical trial,
except a phase I trial or bioequivalence study
study used to establish bioequivalence , for that drug and
an explanation of noncompletion for any clinical trial, except a
phase I trial, that the company manufacturer
initiates or sponsors the initiation of, but does not complete.
Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Division 112.6 (commencing with Section 130650) is
added to the Health and Safety Code, to read:
DIVISION 112.6. Pharmaceutical Drug Information and Safety Act
130650. This division shall be known, and may be cited as the
"Pharmaceutical Drug Information and Safety Act."
130651. For purposes of this division, the following definitions
shall apply:
(a) "Clinical trial" means a hypothesis testing clinical
investigation that involves any experiment to test a specific
clinical hypothesis as well as the safety or efficacy of a drug or
biological product with one or more human subjects.
(b) (1) "Pharmaceutical manufacturer" means any entity that is
engaged in either any of the following:
(A) The production, preparation, propagation, compounding,
conversion, or processing of prescription drug products, either
directly or indirectly by extraction from substances of natural
origin, or independently by means of chemical synthesis, or by a
combination of extraction and chemical synthesis.
(B) The packaging, repackaging, labeling, relabeling, or
distribution of prescription drug products.(2) "Pharmaceutical
manufacturer" does not include a any of the
following:
(A) A corporation that meets the
definition in paragraph (1) solely because it is in the business of
repackaging or compounding prescriptions, if that corporation is not
in the business of developing FDA-approved drug products for sale to
the general public.
(B) A wholesale distributor of drugs, mail order pharmacy, or
retail pharmacy licensed under state law.
(c) "Pharmaceutical drug" means any drug which is approved by the
federal Food and Drug Administration and commercially available in
the state.
(d) "Phase I trial" means the initial studies designed exclusively
to determine the metabolic and pharmacologic actions of drugs in
humans, and the side effects associated with increasing doses, and to
gain early evidence of effectiveness.
(e) "Serious adverse events" means any untoward medical
occurrence, in a patient or clinical investigation subject who has
been administered a pharmaceutical product, which does not
necessarily have to have a causal relationship with this treatment.
(e) (1) "Serious adverse events" means any adverse drug experience
occurring at any dose that results in any of the following outcomes:
(A) Death.
(B) A life-threatening adverse drug experience.
(C) Inpatient hospitalization or prolongation of existing
hospitalization.
(D) A persistent or significant disability or incapacity.
(E) A congenital anomaly or birth defect.
(2) "Serious adverse events," as used in this subdivision, may
include important medical events that may not result in death, be
life-threatening, or require hospitalization when, based upon
appropriate medical judgment, these events may jeopardize the patient
or subject and may require medical or surgical intervention to
prevent one of the outcomes listed in paragraph (1).
(f) "Scientific work product" means a writing that reflects a
scientist, clinician, or researcher's impressions, conclusions,
opinions, research, statistical calculations, or theories.
(g) "Sponsor" means an individual or pharmaceutical manufacturer,
governmental agency, academic institution, private organization, or
other organization that takes responsibility for or initiates a
clinical investigation.
130652. Any pharmaceutical company
manufacturer that sells, delivers, offers for sale, or gives
away any pharmaceutical drug within this state shall make publicly
available, in accordance with Section 130654, the results of every
completed clinical trial, except for a phase I trial or
bioequivalence study study used to establish
bioequivalence , that the company
manufacturer conducts or sponsors on and after October 15,
2002, for every pharmaceutical drug that the company
manufacturer sells, delivers, offers for sale,
or gives away in this state. The information required to be provided
with the results shall include, but not be limited to, all of the
following:
(a) The name of the trial.
(b) Commercial and chemical name of all pharmaceutical drugs
tested, including comparator drugs, if any.
(c) Initiation and completion dates of the trial.
(d) Purposes of the trial, including the medical condition or
conditions studied.
(e) Outcomes of the trial including any time points at which
outcome data were measured and used either subsequently for marketing
purposes or other actions taken to publicly promote the outcomes of
a trial, including, but not limited to, a news release.
(f) Trial funding sources.
(g) Number of patients initially enrolled in the trial.
(h) Number of patients completing the trial.
(i) A list of all specific characteristics used to include and
exclude people as trial participants, such as gender, race, age,
preexisting health conditions, and an explanation of the suitability
of the trial participant population for the purposes of the study.
(j) Names and contact information for principal sponsors of the
trial. Contact information shall include at least a telephone number
and mailing address for public inquiry.
(k) Names and contact information for principal researchers of the
trial.
(l) Frequency, severity, and nature of all serious adverse events
experienced by trial participants, including participants that did
not complete the trial, for each drug.
(m) If the study involved a comparison of two or more
pharmaceutical drugs, all information regarding the relative efficacy
of each drug and the relative frequency, severity, and nature of all
serious adverse events experienced by trial participants, including
participants that did not complete the trial.
(n) If any of the data from the study were published by a clinical
trial investigator in a peer-reviewed medical journal that
summarizes the safety or efficacy results of the clinical trial, a
complete citation and, if available, a hyperlink for each of these
publications.
(o) A hyperlink to the package insert approved by the federal Food
and Drug Administration for the drug.
130653. Any pharmaceutical company
manufacturer that sells, delivers, offers for sale, or gives
away any pharmaceutical drug within this state shall make publicly
available, in accordance with Section 130654, an explanation of
noncompletion for any clinical trial, except a phase I trial, that
the pharmaceutical company manufacturer
initiates, or sponsors the initiation of, on and after October 15,
2002, but does not complete for every pharmaceutical drug that the
company manufacturer sells, delivers,
offers for sale, or gives away in this state. The explanation shall
state why the clinical trial was terminated and shall include all
available information described in Section 130652.
130654. (a) The information required pursuant to Sections 130652
and 130653 shall be submitted for inclusion on the Web site
administered by the National Institutes of Health or on another
publicly accessible Web site, or shall be posted on a publicly
accessible Web site directly linked to the pharmaceutical
company's manufacturer's primary corporate Web
site. For purposes of this section, a Web site is publicly accessible
only if it provides free, nonsubscription access to its contents and
clearly indicates the location and instructions for downloading the
files or information submitted pursuant to this division.
(b) If a drug is sold, delivered, offered for sale, or given away
within the state prior to January 1, 2008, and has a trial completion
or termination date on or before January 2008, the pharmaceutical
company manufacturer shall submit or
post the information pursuant to subdivision (a) by January 1, 2009.
If a drug is sold, delivered, offered for sale, or given away within
the state prior to January 1, 2008, and has a trial completion or
termination date after January 2008, the pharmaceutical
company manufacturer shall submit or post the
information pursuant to subdivision (a) within one year of the
completion or termination date of the trial.
(c) If a drug is sold, delivered, offered for sale, or given away
within the state on or after January 1, 2008, the pharmaceutical
company manufacturer shall submit or
post the information pursuant to subdivision (a) within one year of
the date that the drug is first sold, delivered, offered for sale, or
given away within the state or within one year of the completion or
termination date of the trial, whichever is later.
(d) Notwithstanding subdivisions (b) and (c), a pharmaceutical
company manufacturer may extend the
deadline requirements of these subdivisions by not more than six
months if both of the following occur:
(1) The compilation and analysis of the data in the clinical trial
have not been substantially completed by the appropriate deadline
described in subdivision (b) or (c).
(2) The pharmaceutical company
manufacturer submits for inclusion on the Web site administered
by the National Institutes of Health or on another publicly
accessible Web site, or posts on a publicly accessible Web site
directly linked to the pharmaceutical company's
manufacturer's primary corporate Web site, a statement
that the availability of the information required by this section has
been delayed, a statement that provides the reasons for the delay,
and a statement that provides a date when the information is
anticipated to be made available.
(e) Notwithstanding subdivisions (b), (c), and (d), a
pharmaceutical company manufacturer may
extend the deadline requirements of these subdivisions if the
company manufacturer submits the
results of the clinical trial in a peer-reviewed journal for
publication. However, the extension of these deadline requirements
may not extend beyond one year from the applicable deadline described
in those subdivisions or 30 days from the date of publication,
whichever is earlier.
130655. (a) A pharmaceutical company
manufacturer subject to the requirements of this division that
complies with a federal law or regulation that requires public
disclosure on a Web site of information that is substantially similar
to the information required pursuant to this division shall be
deemed to be in compliance with this division.
(b) No provision of this division shall be construed to require
the public disclosure of a trade secret, as defined in Section 3426.1
of the Civil Code, or scientific work product.
(c) If some factors, conclusions, results, or points of data from
a clinical trial are deemed a trade secret, as defined in Section
3426.1 of the Civil Code, or scientific work product, only those
sections shall be withheld from disclosure.
(d) If parts or all of a clinical trial are withheld from
disclosure because this information constitutes a trade secret, as
defined in Section 3426.1 of the Civil Code, or scientific work
product, a pharmaceutical company
manufacturer shall disclose the fact that information
was is being withheld because it constitutes a
trade secret or scientific work product .
(e) Nothing in this division shall be construed to permit public
disclosure of information currently protected from public disclosure
under the federal Health Insurance Portability and Accountability Act
(HIPAA) (Public Law 104-191).
(f) This division shall apply only to the regulatory
sponsors of clinical trials.
(g) Nothing in this division shall either hinder or enhance the
disclosure of any scientific work product during the discovery period
of litigation.
130658. Nothing in this division shall constitute a duty by the
State Department of Public Health to enforce the implementation of
this division.