BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Deborah V. Ortiz, Chair
BILL NO: SB 1683
S
AUTHOR: Scott
B
AMENDED: As introduced
HEARING DATE: April 19, 2006
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FISCAL: Appropriations
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CONSULTANT:
3
Park / ak
SUBJECT
Pharmaceutical information: clinical trial data
SUMMARY
Requires pharmaceutical manufacturers to register all
clinical trials and publish all clinical trials results on
the federal clinical trials database for every medicine
they sell in California, regardless of when the clinical
trials were initiated or completed, or where they were
conducted.
ABSTRACT
Existing federal law:
1.Requires the Secretary of Health and Human Services (HHS)
to develop a publicly-accessible registry of clinical
trials for serious or life-threatening diseases and
conditions.
2.Requires the sponsors of investigational new drug
applications to submit to the registry created by the
Secretary of HHS a description of the purpose of each
experimental drug, eligibility criteria for participation
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in the trial, the location of clinical trial sites and a
point of contact for people interested in enrolling in
the trial.
3.Prohibits any new drug from being introduced or delivered
for introduction into interstate commerce, unless
application has been approved by the Food and Drug
Administration (FDA).
4.Prohibits an approved drug from being marketed or
promoted for uses not specified in an application and
approved by the FDA.
5.Exempts trade secrets and confidential commercial or
financial information, among other information, from
disclosure by federal agencies under the Freedom of
Information Act.
Existing federal regulation:
1.Requires clinical trial sponsors to submit an
Investigational New Drug (IND) application to the FDA for
clinical investigation of a new drug or new indication of
an approved drug, with certain exceptions.
2.Requires review and approval from an Institutional Review
Board (IRB) before a clinical study can be initiated
under an IND.
3.Defines an IRB as an appropriately constituted group that
has been designated to review and monitor biomedical
research involving human subjects, to ensure that a
clinical trial is ethical and that the rights of study
participants are protected.
4.Authorizes an IRB to approve, require modifications in
(to secure approval), or disapprove research, or to
suspend or terminate approval of research that is not
being conducted in accordance with the IRB's requirements
or that has been associated with unexpected serious harm
to subjects.
5.Requires annual reports, safety reports (including
adverse event information) and protocol changes, among
other things, to be reported to the FDA and IRB for all
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clinical trials conducted under an IND.
6.Requires drug sponsors to submit a new drug application,
including clinical data or information relevant to an
evaluation of the safety and effectiveness of the drug
from any source, prior to approval for marketing a drug
for a specific purpose.
Existing state law:
1.Regulates the packaging, labeling and advertising of
drugs under state department of health services.
2.Requires drugs sold, delivered, or given away in the
state to be approved through a new drug application or
through the State Department of Health Services (DHS).
This bill:
1.Makes findings and declarations regarding the need for
the state to better protect California consumers who take
pharmaceutical products and the lack of publicly
available clinical trial data.
2.Requires a pharmaceutical company, as defined, to make
publicly available information, as specified, for every
new and ongoing clinical trial, for every completed
clinical trial, as well as an explanation of any
uncompleted clinical trial that the company conducts or
sponsors for every pharmaceutical drug that the company
sells, delivers, offers for sale, or gives away in the
state.
3.Requires a pharmaceutical company to make the required
information publicly available by posting on to
www.clinicaltrials.gov or its successor Web site by
certain dates, as specified.
4.Authorizes the Director of DHS to adopt additional
reporting requirements and rules for implementation.
5.Requires each pharmaceutical company to submit an annual
report to the Attorney General certifying that the
company is in compliance with the provisions of the bill.
6.Makes violation of provisions subject to a civil penalty
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of an undetermined amount.
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
Need for the bill
The author writes that too often, pharmaceutical companies
have only publicized clinical trials that are favorable to
their products, and that doctors and patients do not have
enough access to information regarding pharmaceutical drugs
and their testing history. The author cites the Vioxx
trial as an example of the need for increased consumer
information. The author believes this bill is the least
costly and most direct way to provide information to
consumers.
The author further states that, in addition to tackling
safety concerns, the bill also addresses the problem of
overpriced and underperforming medicines. With this bill,
researchers, doctors and the general public will have
access to all of the health and effectiveness studies
conducted by manufacturers. The author contends that once
accurate comparisons can be made on issues of safety and
effectiveness, drug companies may have a harder time
convincing doctors and patients that expensive brand-name
drugs are worth two or three times the price of generic
medicines.
Drug approval and public safety
Drug approval is a rigorous process, which on average takes
about 8 years. However, recent congressional hearings on
the FDA's role in protecting public health in the cases of
Vioxx and Paxil call into question whether the current
regulatory process adequately protects consumer health. In
the case of Vioxx, nearly two years passed before a label
change was made by the FDA in response to a study Merck
submitted finding that heart attacks were more common in
Vioxx patients than patients on another drug. Merck
voluntarily withdrew Vioxx from the market in September
2004. In the case of Paxil, in 2004 the FDA required
manufacturers to place a warning in bold print alerting
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consumers that the drug could cause suicidal tendencies in
children and teenagers. News stories reported that the
manufacturer had such evidence as far back as 1997. These
cases raise the question whether more direct and fuller
disclosure of clinical trials can provide added protection,
where the FDA regulations or enforcement fall short.
FDA drug approval process
Before any investigational new drug is approved for
marketing, drug companies must conduct different types of
clinical trials:
Phase I are initial studies to determine the metabolism
and pharmacologic actions of drugs in humans, the side
effects associated with increasing doses, and to gain
early evidence of effectiveness. May include healthy
participants and/or patients.
Phase II are controlled clinical studies conducted to
evaluate the effectiveness of the drug for a particular
indication in patients with the disease or condition
under study and to determine the common short-term side
effects and risks.
Phase III are expanded controlled and uncontrolled trials
after preliminary evidence suggesting effectiveness of
the drug has been obtained, and are intended to gather
additional information to evaluate the overall
benefit-risk relationship of the drug and provide an
adequate basis for physician labeling.
Phase I and Phase II trials are performed on a small number
of subjects (generally 20-80 people in Phase I; 100-300 in
Phase II), while phase III trials, often noted as pivotal
trials, typically involve several hundred to thousands of
subjects. Phase III trials are used to extrapolate what
effects of a drug would be on a population at large.
Additionally, companies sometimes conduct Phase IV studies.
Phase IV are post-marketing studies (i.e., after the FDA
has approved a drug) to delineate additional information
including the drug's risks, benefits, and optimal use.
According to the FDA, a drug company generally submits at
least two pivotal trials (phase III trials) in support of a
New Drug Application (NDA). While the NDA does not require
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submission of details of all clinical trials in full, the
NDA does require descriptions and analyses of each clinical
pharmacology study, each controlled clinical study
pertinent to a proposed use of the drug, each uncontrolled
clinical study, any other clinical data or information
relevant to an evaluation of the safety and effectiveness
of the drug from any source (foreign or domestic, including
controlled and uncontrolled studies of uses of the drug
other than those proposed in the application, commercial
marketing experience, reports in the scientific literature,
and unpublished papers). Additionally, the NDA requires an
integrated summary of the data demonstrating substantial
evidence of effectiveness for the claimed indications as
well as a summary and updates of safety information. NDAs
can often run in excess of 100,000 pages.
Role of Institutional Review Boards
While the FDA ultimately approves or disapproves a drug for
a specific use, each clinical study is overseen by an
Institutional Review Board (IRB). IRBs ensure that
clinical studies are conducted according to the guidelines
set in regulation, and that the rights of the human
subjects are protected. When an IRB approves a study, the
IRB must provide continuing review at least annually and
keep detailed records set forth in regulation. In
addition, clinical investigators must provide written
progress reports for all studies and report adverse events
directly to the responsible IRB.
Adverse Events
All adverse events must be reported through safety reports
and annual reports to the IRB and the FDA. The FDA must
receive reports of serious or life-threatening adverse
events within 15 days. According to the FDA, the agency
trends and tracks adverse events as they come in. For
serious adverse events, the agency may send out an
investigator to the trial site. Action taken depends on the
seriousness of the event, as well as any trends that
emerge.
While clinical trials have many reporting requirements,
levels of oversight, and requirements for investigators,
sponsors, IRBs, monitors and reviewers, gaps remain.
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Lack of transparency. Although the Freedom of
Information Act requires federal agencies to disclose
requested information, one notable exception is
confidential commercial information. The FDA considers
all clinical trial data confidential commercial
information. The FDA will not acknowledge the
existence of an IND, unless it has already been made
public. Once a drug is approved, however, the FDA will
disclose its review of the new drug application (with
certain exceptions), which will contain summary
information on clinical trials. The actual trial
results, however, are still not disclosed.
Lack of data. Certain clinical studies are exempt
from the FDA's IND process, and, as such, are not
required to be reported to the FDA. Clinical
investigations that are exempt must pertain to a drug
that is legally marketed and must meet certain other
criteria: i) the investigation is not intended to be
reported to FDA as a well-controlled study in support
of a new indication for use nor intended to be used to
support any other significant change in the labeling
for the drug; (ii) the investigation is not intended
to support a significant change in the advertising for
the product; (iii) the investigation does not involve
a route of administration or dosage level or use in a
patient population or other factor that significantly
increases the risks (or decreases the acceptability of
the risks) associated with the use of the drug
product; among certain other criteria.
Federal Clinical Trials Data Bank: www.clinicaltrials.gov
To provide the public with better information and easier
access to clinical trials, the Food and Drug Administration
Modernization Act (FDAMA) of 1997 required HHS to establish
a publicly accessible data bank of information about
clinical trials for serious or life threatening diseases
and conditions. FDAMA requires the sponsors of
investigational new drug applications to submit to the data
bank a description of the purpose of each experimental
drug, eligibility criteria for participation in the trial,
the location of clinical trial sites and a point of contact
for people interested in enrolling in the trial. The Web
site currently contains more than 28,000 listings, from
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trials not yet registering to completed trials.
According to FDA evaluations, compliance with the
legislation has been mixed: "While progress has been made,
participation by the pharmaceutical industry is less than
expected despite a federal law, a final guidance document,
a targeted education program, and an easy-to-use web-based
data entry tool. Some pharmaceutical companies do not
provide required clinical trials, some provide only limited
information, while others voluntarily list trials that go
beyond the criteria specified in the guidance." The FDA's
2002 evaluation revealed that industry sponsor compliance
was at 30%. In 2004, the FDA investigated compliance
specifically with regard to cancer trials and it found that
compliance by nonfederal clinical trial sponsors jumped
from 48% in 2002 to nearly 70%. It did not investigate
compliance increase overall between those two years. A New
York Times editorial published June 1st noted compliance
varied widely by company.
With regard to the posting of clinical trial results,
listing results on ClinicalTrials.gov is voluntary.
ClinicalTrials.gov contains a general "More Information"
data field, where sponsors can provide links to
publications, or other links that reveal results. All
submitted links are subject to review by
ClinicalTrials.gov. The 2004 evaluation suggests that
somewhere between 5-10% of records contain links or
references under "More Information."
Pharmaceutical Research and Manufacturers of America's(
PhRMA) www.clinicalstudyresults.org
In response to a growing call for transparency, the
pharmaceutical industry has developed an online
clearinghouse to provide greater access to the results of
its clinical studies. According to PhRMA, the new
database, found at www.clinicalstudyresults.org , will
contain the results from all "hypothesis-testing" clinical
studies (mainly phase III and IV studies) completed since
October 1, 2002, for drug products that are approved in the
United States. This will include both published articles
and unpublished study summaries. This information will be
presented in a standard format that includes the sponsoring
company's name, the proprietary and generic names of the
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drug, a link or reference to the FDA-approved drug label,
the studied indication(s), a bibliography of published
studies together with a link (where available) to the
printed articles, and a summary of the results of clinical
studies that have not been published. This summary
presentation will include information on the drug such as
the design of the trial, the number of patients studied,
the dose and mode of administration, and a summary of
conclusions and outcomes on the safety and efficacy of the
drug.
According to a PhRMA representative, the group does not
keep track of the total clinical trials currently listed on
this Web site. With regard to the clinical trial results
listed, approximately 41 companies are listed with 262
drugs with studies listed on the site. For each study,
numerous results are identified.
FDA and other policies on registering clinical trials and
posting results
Food and Drug Administration (FDA). The FDA states that
the collection and dissemination of information about
clinical trials and their outcomes is an important consumer
and health practitioner issue. The FDA will continue to
encourage sponsors to put required and voluntary
information into ClinicalTrials.gov. The FDA believes a
comprehensive clinical trials database can lead to more
efficient and timely discovery of the answers to scientific
questions that will result in more quickly learning about
the safety and efficacy of treatments for patients.
American Medical Association (AMA). Since 2004, the AMA
has supported a national clinical trials registry that is
centralized, includes identifying information, trial
details and links to results or the reason a trial was
terminated. The AMA has stated publicly that clinical
trial results should be made publicly available, and has
also suggested that registration should be a condition of
trial approval by IRBs.
International Committee of Medical Journal Editors (ICMJE).
In 2004, the editors of ICMJE stated that selective
reporting of trials distorts the evidence available for
clinical decision-making, and that trial results that place
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financial interests at risk are particularly likely to
remain unpublished and hidden from public view. In
addition the editors stated: "When research sponsors or
investigators conceal the presence of selected trials,
these studies cannot influence the thinking of patients,
clinicians, other researchers and experts who write
practice guidelines or decide on insurance-coverage policy.
If all trials are registered in a public repository at
their inception, every trial's existence is part of the
public record and the many stakeholders in clinical
research can explore the full range of clinical evidence"
The ICMJE announced its position that trials must be
registered in order to be considered for publication. New
trials will be required to be registered starting July 1,
2005, and ongoing trials must be registered by September
13, 2005.
PhRMA . Under a new voluntary disclosure policy announced
in January 2005, PhRMA members have agreed to register
ongoing hypothesis-testing clinical trials for all diseases
to ClinicalTrials.gov by September 13, 2005. This excludes
what PhRMA calls exploratory trials, which serve to "set
direction (i.e., to generate hypotheses) for possible
future studies, whereas, 'hypothesis-testing trials' serve
to examine pre-stated questions (i.e., to test hypotheses)
using statistically valid plans for data analysis and
provide firm evidence of safety and/or efficacy to support
product claims." New trials should be registered on a
free, publicly accessible registry within 21 days of
patient enrollment initiation.
Under the voluntary disclosure policy, PhRMA members have
agreed to disclose the results (published and unpublished)
of all clinical trials, other than exploratory trials,
conducted on a drug that is approved for marketing on a
free, publicly accessible, clinical trial results database,
regardless of outcome. Additionally, PhRMA recommends
disclosing trial results from exploratory trials if they
are deemed to have significant medical importance and may
have an impact on a marketed product's labeling. PhRMA
recommends posting of results within one year after the
drug is first approved and commercially available, or for
trials completed after this initial approval, within one
year of trial completion, unless such posting would
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compromise publication in a peer-reviewed medical journal
or contravene national laws or regulations.
Maine and other states
According to the author, more than 10 states have
introduced legislation attempting to make more clinical
trials information accessible to the public. They range
from requiring registration of clinical trials and
disclosure of results for all trials conducted in the state
to requiring disclosure of trial results by state hospitals
and universities to requiring a fee to be paid by drug
manufacturers for public education on clinical trials, as
well as other variations on these approaches.
Only one state, Maine, has passed a law regarding
disclosure of clinical trial information. The Maine law,
passed in 2005, requires drug manufacturers to disclose
clinical trial information and results for prescription
drugs advertised in the state. The law directs the Maine
Department of Health and Human Services to maintain this
information on a Web site, and collect fees from the
manufacturers to support a clinical trials database. The
law also makes violation of these requirements subject to a
fine of up to $10,000, under the Maine Unfair Trade
Practices Act.
Federal legislation
The following bills are pending in Congress:
S.470 (Dodd, Grassley, 2005) and H.R. 3196 (Waxman,
Markey, 2005). Both would expand the scope of
ClinicalTrials.gov and establish a database of clinical
trial results. While these bills are similar, they are
not identical. Both exclude early trials (with
exceptions), apply only to future trials, require trial
results to be submitted within one year of completion
(with exceptions), and allow for imposition of fines. In
the case of Dodd-Grassley, a fine of $10,000 per day.
Both bills have been referred to committee; neither has
been heard.
S. 930 (Grassley, 2005) and H.R. 4429 (Tierney, 2005)
establish the Center for Postmarket Drug Evaluation and
Research within the Food and Drug Administration (FDA).
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Requires the Director of the Center to conduct activities
to ensure the safety and effectiveness of FDA-approved
drugs and licensed biological products. Allows the
Director to withdraw or suspend approval of a drug or
license for a biological product using expedited
procedures under certain circumstances. Transfers to the
Center the functions and duties of the Office of Drug
Safety. Both bills have been referred to committee;
neither has been heard.
Arguments in support
The California Public Interest Research Group (CalPIRG),
sponsor of SB 1683, writes that consumers and doctors are
not getting the full story about the safety and
effectiveness of pharmaceutical products. CalPIRG cites
both Vioxx and Paxil as expensive and tragic examples.
CalPIRG states that as companies bury test results that
prove newer and more expensive medicines are no more
effective than older, more affordable ones, consumers are
left to pay the price. The sponsor argues that requiring
companies to publish all health studies they have sponsored
for drugs they sell in California evens the playing field
for companies, medical professionals and patients.
Consumers Union (CU) writes that drug companies now sponsor
more clinical trials than the federal government, but tend
to publicize only the positive findings in medical
journals. CU states that although drug companies have said
they will voluntarily disclose clinical trial results, the
industry has been slow to live up to that promise. CU
cites examples (Zoloft, Paxil, Vioxx) where pharmaceutical
companies did not disclose or publish clinical trial data
that showed negative results, and the FDA also did not
disclose their conclusions or act because it considered
these data proprietary. CU contends that the public is
losing confidence in drug companies with these examples,
and there is widespread support in the health care
community, including the AMA, and the American Pharmacists
Association, for public access to clinical trial results.
Supporters state that SB 1683 would substantially improve
the information that health care professionals and patients
have so they can make better informed decisions about the
drugs they take, weighing the benefits with the risks of
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prescription drugs.
Arguments in opposition
PhRMA writes that the bill imposes significant additional
requirements that are not consistent with the intent and
operation of the federally-sponsored Data Bank
( www.clinicaltrials.gov ). PhRMA also writes it is
concerned that competing state and federal requirements for
clinical trials will create a patchwork of regulations that
may have a chilling effect on the initiation of clinical
trials in California and creation of new medicines. PhRMA
states that the bill will duplicate what PhRMA signatories
have agreed to post on www.clinicalstudyresults.org , which
posts the results of all signatories' clinical trials
(i.e., mid to late stages), both positive and negative,
completed since October 2002 for drug products that are on
the market.
The California Healthcare Institute (CHI) writes that the
measure is overly broad, inconsistent with other state and
federal requirements, does not allow for publication in
peer-reviewed journals, and could cause undue delays in the
submittal of this information to the federal Health and
Human Services Agency. Additionally, CHI writes that Phase
I trials contain proprietary information and no possible
public benefit could result from the publication of Phase I
trial results. CHI states it is concerned about state
legislation in an area that federal law should control.
CHI believes that the Clinical Trials Data Bank, managed by
the FDA, is the appropriate vehicle for synthesizing,
coordinating and publishing clinical studies.
AstraZeneca opposes this measure because it has created its
own Web site where results and other information about
AstraZeneca sponsored trials are posted. AstraZeneca cites
three Web sites, including its own, where clinical trial
results can be found. AstraZeneca believes the bill is
unnecessary given the wealth of information already
accessible.
Prior legislation
AB 72 (Frommer, 2005) would have required sponsors of
clinical trials to certify that they have registered the
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clinical trials and that they will publish the results of
the trial, whether positive or negative, as specified.
Died on inactive file on the Assembly Floor.
SB 380 (Alquist, 2005) requires health care providers to
report suspicious serious adverse drug events to the FDA.
Inactive on the Assembly Floor.
AB 71 (Chan, 2005) establishes the Office of California
Drug Safety Watch (Office) within DHS to create a central
repository of information about the safety and
effectiveness of prescription drugs that are frequently
advertised on television. In Senate Health Committee.
AB 1674 (Richman, 2005) would have required the
Department of Managed Health Care (DMHC) to contract with
an academic institution or public policy research
institution for the establishment of a Center for Quality
Medicine to conduct periodic research on various issues
related to medical treatment data. Vetoed by Governor.
AB 2326 (Corbett, 2004) would have required the Office of
Patient Advocate at DMHC to publish a report card before
January 1, 2006, and update it annually thereafter, on
the safety, effectiveness, and cost of prescription
drugs, to be posted on DMHC's Internet Web site. Failed
in the Senate Appropriations Committee.
QUESTIONS AND COMMENTS
1.Would disclosure of later stage clinical trial data
(Phase III and IV) suffice to cover the objectives stated
in the bill? Given the relatively small number of
subjects in the earlier stage clinical trials, it is
unclear if results of these trials would be as meaningful
for public safety as the later trials.
2.Certain clinical studies are exempt from the FDA's IND
process, and, as such, are not required to be reported to
the FDA. Clinical investigations that are exempt must
pertain to a drug that is legally marketed and must meet
certain other criteria: i) the investigation is not
intended to be reported to FDA as a well-controlled study
in support of a new indication for use nor intended to be
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used to support any other significant change in the
labeling for the drug; (ii) the investigation is not
intended to support a significant change in the
advertising for the product; (iii) the investigation does
not involve a route of administration or dosage level or
use in a patient population or other factor that
significantly increases the risks (or decreases the
acceptability of the risks) associated with the use of
the drug product; among certain other criteria. The bill
would require reporting of trials that are currently
exempt for reporting to the FDA to
www.clinicaltrials.gov .
3.This bill takes a more rigorous approach than the Maine
bill or proposed federal legislation in that it requires
more data to be disclosed and applies to all clinical
trials for all drugs sold, rather than applying only to
future trials or only to trials that are intended to be
submitted to the FDA as part of an NDA. Currently , the
standard for the amount of data that should be reported
as part of a public ly accessible clinical trials results
database is unclear. Should the bill require DHS to
determine the scope of data that is needed to protect
public safety ? If further federal legislation or
regulation is forthcoming, would conformance with a
federal standard be warranted?
4.The author's office notes an error in drafting regarding
the reporting dates of clinical trial results.
On page 8, strike lines 4 through 8 inclusive, and
delete the phrase "given away in the state" in line 9.
Insert "For clinical trials with a trial completion
date on or after January 1, 2007, the sponsor of the
trial shall submit the information required pursuant
to Section 130653 to www.clinicaltrials.gov or its
successor Web site no later than 90 days after the
trial's completion. For clinical trials with a trial
completion date before January 1, 2007, the sponsor of
the trial shall submit the information required
pursuant to Section 130653 to www.clinicaltrials.gov
or its successor Web site on or before April 1, 2007."
Continued---
5.Format for reporting results. ClinicalTrials.gov
currently accepts results data in the form of a
publication citation, or a link to another Web site
containing results data. Is this format for reporting
results of clinical trials acceptable to the author, or
does the author intend for the Web site to be an actual
repository of clinical trial results? In the latter
case, if ClinicalTrials.gov does not agree to be the
repository, will pharmaceutical companies be subject to
the civil penalty?
6.Technical Amendments
a) Page 5, line 1 - insert "in the trial" after
enrolled.
b) Page 6, line 16 - add "a complete citation and, if
available, a hyperlink" at the end of the sentence.
c) Page 6, line 18 - clarify that employer refers to
employer during the conduct of the trial and the
preparation and publication of the results.
d) Page 6, line 21 - clarify that financial interest
refers to financial interest during the testing or at
the time of results posting.
e) Page 6, line 37 - add, "if any" after the second
"drugs"
f) Page 7, line 17 - insert hyphen for "e-mail"
g) Page 7, line 19 - Does the author wish to add
"including participants that dropped out of the trial
for whatever reason, prior to the termination date"
after "participants"?
h) Page 7, line 18 - insert "prior to the termination
date" before the comma.
i) Page 7, line 34 - insert a comma after "site" and
remove the comma after "subject".
j) Page 8, line 11 - shall "promptly" be better
defined?
POSITIONS
Support: California Public Interest Research Group
(sponsor)
AARP California
American Federation of State, County and
Municipal Employees
California Alliance for Retired Americans
California Labor Federation/AFL-CIO
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California Nurses Association
Congress of California Seniors
Greenlining Institute
HealthAccess
Senior Action Network
42 individuals
Oppose: AstraZeneca
California Healthcare Institute
GlaxoSmithKline
Pharmaceutical Research and Manufacturers of
America
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