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Untitled Document
Introduction
In 2004 the California Legislature passed SB-1765, the “fair drug marketing bill”. It was
signed into law by the Governor and became effective on July 1, 2005.
The bill amended the Health and Safety Code by adding sections 119400 to 119402. The
focus of the bill is to ensure that healthcare products companies that do business in
California maintain the highest ethical standards in their interactions with healthcare
professionals.
Policy
It is the policy of Aerogen that we will comply with the provisions of California Health &
Safety Code §§119400 – 119402. As part of this policy, we will maintain the highest
ethical standards in all our interactions with healthcare professionals.
Ethical relationships with healthcare professionals are critical to our mission of helping
patients by developing and marketing new medicines and delivery systems. An
important part of achieving this mission is ensuring that healthcare professionals have the
latest, most accurate information available regarding prescription medicines and delivery
systems, which play an ever-increasing role in patient healthcare. This document focuses
on our interactions with healthcare professionals that relate to the marketing of our
products.
Effective marking of medicines and delivery systems ensures that patients have access to
the products they need and that the products are used correctly for maximum patient
benefit. Our relationships with healthcare professionals are critical to achieving these
goals because they enable us to:
- Inform healthcare professionals about the benefits and risks of our products
- Provide scientific and educational information
- Support medical research and education
- Obtain feedback and advice about our products through consultation with medical experts
In interacting with the medical community, we are committed to following the highest
ethical standards as well as all legal requirements. We are also concerned that our
interactions with healthcare professionals not be perceived as inappropriate by patients or
the public at large. This code of conduct and its accompanying policy is to reinforce our
intention that our interactions with healthcare professionals are to benefit patients and to
enhance the practice of medicine. The code of conduct is based on the principal that a
healthcare professional’s care of patients should be based, and should be perceived as
being based, solely on each patient’s medical needs and the healthcare professional’s
medical knowledge and experience. It is modeled on the industry code of conduct
promulgated by the Pharmaceutical Research and Manufacturers of America (PhRMA)
and adopted by PhRMA on July 1, 2002.
Therefore, effective July 1st, 2005, Aerogen, Inc. hereby adopts this Code of Conduct and
policy on relationships with healthcare professionals as part of our Comprehensive
Compliance Program. This code and policy addresses interactions with respect to
marketed products and related pre-launch activities. It does not address relationships
with clinical investigators relating to pre-approval studies.
Core Documents:
We hereby adopt the following core documents as the foundation of the Comprehensive
Compliance Program:
- OIG: Office of the Inspector General, United States Department of Health and
Human Services, “Compliance Program Guidance for Pharmaceutical
Manufacturers,” April 2003. (OIG Compliance Program)
- PhRMA: Pharmaceutical Research and Manufacturers of America, “Code on
Interactions with Health Care Professionals,” July 1, 2002. (PhRMA Code)
http://www.phrma.org/publications/policy//2004-01-19.391.pdf
Company Code of Conduct – Interactions with Healthcare Professionals
A key part of the Comprehensive Compliance Program is the Company Code of Conduct
– Interactions with Healthcare Professionals (“Code”). The Code is based on the PhRMA
Code on Interactions with Healthcare Professionals referenced above.
The Code shall serve as a guide for interactions with healthcare professionals and is not
meant to be all-inclusive. Individuals with questions on specific practices should seek the
guidance of the Compliance Officer.
- Basis of Interactions
Our relationships with healthcare professionals are intended to benefit patients
and to enhance the practice of medicine. Interactions should be focused on
informing healthcare professionals about our products, providing scientific
and educational information, and supporting medical research and education.
- Informational Presentations
Informational presentations and discussions by industry representatives and
others speaking on behalf of a company provide valuable scientific and educational
benefits. In connection with such presentations or discussions,
occasional meals (but no entertainment/recreational events) may be offered so
long as they: (a) are modest as judged by local standards; and (b) occur in a
venue and manner conducive to informational communication and provide
scientific or educational value. Inclusion of a healthcare professional’s spouse
or other guests is not appropriate. Offering “take-out” meals or meals to be
eaten without a company representative being present (such as “dine & dash”
programs) is not appropriate.
- Third-party Educational or Professional Meetings
Continuing medical education (CME) or other third-party scientific and
educational conferences or professional meetings can contribute to the
improvement of patient care and therefore, financial support from companies
is permissible. Since the giving of any subsidy directly to a healthcare
professional by a company may be viewed as an inappropriate cash gift, any
financial support should be given to the conference’s sponsor which, in turn,
can use the money to reduce the overall conference registration fee for all
attendees. In addition, when companies underwrite medical conferences or
meetings other than their own, responsibility for and control over the selection
of content, faculty, educational methods, materials, and venue belongs to the
organizers of the conferences or meetings in accordance with their guidelines.
Financial support should not be offered for the costs of travel, lodging, or
other personal expenses of non-faculty healthcare professionals attending
CME or other third-party scientific or educational conferences or professional
meetings, either directly to the individuals at tending the conference or
indirectly to the conference’s sponsor (except as set out in section 6 below).
Similarly, funding should not be offered to compensate for the time spent by
healthcare professionals attending the conference or meeting.
Financial support for meals or receptions may be provided to the CME
sponsors who in turn can provide meals or receptions for all attendees. A
company also may provide meals or receptions directly at such events if it
complies with the sponsoring organization’s guidelines. In either of the above
situations, the meals or receptions should be modest and be conducive to
discussion among faculty and attendees, and the amount of time at the meals
or receptions should be clearly subordinate to the amount of time spent at the
educational activities of the meeting.
A conference or meeting shall mean any activity, held at an appropriate
location, where (a) the gathering is primarily dedicated, in both time and
effort, to promoting objective scientific and educational activities and
discourse (one or more educational presentations(s) should be the highlight of
the gathering), and (b) the main incentive for bringing attendees together is to
further their knowledge on the topic(s) being presented.
- Consultants
It is appropriate for consultants who provide services to be offered reasonable
compensation for those services and to be offered reimbursement for reasonable
travel, lodging, and meal expenses incurred as part of providing those
services. Compensation and reimbursement that would be inappropriate in
other contexts can be acceptable for bona fide consultants in connection with
their consulting arrangements. Token consulting or advisory arrangements
should not be used to justify compensating healthcare professionals for their
time or their travel, lodging, and other out-of-pocket expenses. The following
factors support the existence of a bona fide consulting arrangement (not all
factors may be relevant to any particular arrangement):
A written contract specifies the nature of the services to be provided and the
basis for payment of those services;
A legitimate need for the services has been clearly identified in advance of
requesting the services and entering into arrangements with the prospective
consultants;
The criteria for selecting consultants are directly related to the identified
purpose and the persons responsible for selecting the consultants have the
expertise necessary to evaluate whether the particular healthcare professionals
meet those criteria;
The number of healthcare professionals retained is not greater than the
number reasonably necessary to achieve the identified purpose;
The retaining company maintains records concerning and makes appropriate
use of the ser vices provided by consultants;
The venue and circumstances of any meeting with consultants are conducive
to the consulting services and activities related to the services are the primary
focus of the meeting, and any social or entertainment events are clearly
subordinate in terms of time and emphasis. It is not appropriate to pay honoraria or travel or lodging expenses to nonfaculty
and non-consultant attendees at company-sponsored meetings
including attendees who participate in interactive sessions.
- Speaker Training Meetings
It is appropriate for healthcare professionals who participate in programs
intended to recruit and train speakers for company sponsored speaker bureaus
to be offered reasonable compensation for their time, considering the value of
the type of services provided, and to be offered reimbursement for reasonable
travel, lodging, and meal expenses, when (1) the participants receive extensive
training on the company’s drug products and on compliance with FDA
regulatory requirements for communications about such products, (2) this
training will result in the participants providing a valuable service to the
company, and (3) the participants meet the criteria for consultants (as
discussed above).
- Scholarships and Educational Funds
Financial assistance for scholarships or other educational funds to permit
medical students, residents, fellows, and other healthcare professionals in
training to attend carefully selected educational conferences may be offered so
long as the selection of individuals who will receive the funds is made by the
academic or training institution. “Carefully selected educational conferences”
are generally defined as the major educational, scientific, or policy-making
meetings of national, regional, or specialty medical associations.
- Educational and Practice-Related Items
Items primarily for the benefit of patients may be offered to healthcare
professionals if they are not of substantial value ($100 or less). Items should
not be offered on more than an occasional basis, even if each individual item
is appropriate. Providing product samples for patient use is acceptable.
Items of minimal value may be offered if they are primarily associated with a
healthcare professionals practice (such as pens, notepads, and similar
“reminder” items with company or product logos).
Items intended for the personal benefit of healthcare professionals (such as
floral arrangements, artwork, music CDs or tickets to a sporting event) should
not be offered.
Payments in cash or cash equivalents (such as gift certificates) should not be
offered to healthcare professionals either directly or indirectly, except as
compensation for bona fide services (as described in parts 4 and 5). Cash or
equivalent payments of any kind create a potential appearance of impropriety
or conflict of interest.
- Independence and Decision Making
No grants, scholarships, subsidies, support, consulting contracts, or
educational or practice related items should be provided or offered to a
healthcare professional in exchange for prescribing products or for a
commitment to continue prescribing products. Nothing should be offered or
provided in a manner or on conditions that would interfere with the
independence of a healthcare professional’s prescribing practices.
- Adherence to Code
It is the Policy of Aerogen, Inc. to require adherence to this Code by its
employees, Consultants and Agents.
Compliance Officer and Task Force
Aerogen, Inc. hereby appoints Ms. Nancy Isaac as the Compliance Officer. Ms. Isaac
shall have responsibility for updating this policy and for informing the public in response
to inquiries. Ms. Isaac may be reached at 650.864.7493 during normal business hours.
Compliance Committee: The Company plans on convening a task-force to advise and
assist the Compliance Officer in addressing specific problem areas or issues.
The Compliance Officer will report directly to the CEO on all matters concerning this
program. Furthermore, the Compliance Officer will brief the CEO and Board regarding
the implementation of this Policy.
The Compliance Officer shall report on the compliance with this policy to the CEO on at
least a semi annual basis. The Compliance Officer will establish additional procedures to
accomplish the stated goal of the Company, as necessary.
Employee Training and Education
The Compliance Officer will ensure that all employees who have interactions with
healthcare professionals are given copies of this document.
The Compliance Officer will also hold training sessions that will be mandatory for
employees during which the program will be explained and questions answered.
Communication
The Compliance Officer has the authority to establish communication programs as they
deem necessary to implement this policy. These programs, at a minimum, will include:
Employee suggestion box for questions or to report violations
Email – set up a separate address for reporting violations
The Compliance Officer shall take steps to ensure the confidentiality of the reporting
individuals.
Auditing
The Company recognizes that effective auditing is of paramount importance in ensuring
compliance with this policy. Therefore, the Compliance Officer will initiate a program of
regular audits to ensure compliance with the policy. These audits shall be conducted both
internally and by outside consultants. Sufficient resources will be allocated to support the
audit effort. The Compliance Officer will establish a schedule of audits and coordinate as
necessary.
Enforcement and Corrective Action
The Company will support the Compliance Officer in enforcement of this policy.
If internal or external audits uncover an issue or a confidential communication to the
Compliance Officer reports a potential problem area, the Compliance Officer shall
promptly conduct an investigation of the problem. It is anticipated that the Compliance
Officer shall complete the investigation in a reasonable time and present the results to the
CEO of the Company. If the CEO and Compliance Officer decide that the problem
warrants further investigation and to recommend corrective action, a Task Force will be
formed of senior management to address the problem.
The Task Force shall recommend appropriate corrective action and policy revisions to
prevent the issue from occurring in the future. The Task Force will report directly to the
CEO and shall conduct its investigation and present recommendations in a reasonable
time frame.
Public Access:
Copies of this policy and the annual declaration are available on the company website
www.aerogen.com. Copies are also available by calling 1-866-423-7643.
Annual Monetary Limits:
As part of this Comprehensive Compliance Program, Aerogen, Inc. has established an
annual limit on the amount of legitimate monetary and other incentives provided to
healthcare professionals. The company hereby establishes a limit on gifts or incentives
provided to healthcare professionals of $25 per year.
Updates to the Policy:
This policy will be updated within 6 months of changes made to either of the two core
documents listed above.
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