Stiefel Laboratories,
Inc.
Corporate Compliance Program Description
Description
I.
Introduction
Who
we are
Stiefel
Laboratories, Inc. is a specialized pharmaceutical company with a
singular, steadfast focus on the advancement of dermatology and skin care
therapy around the globe.
A.
General
Stiefel has
established an effective Corporate Compliance Program in accordance with
"Compliance Program Guidance for Pharmaceutical Manufacturers," published
by the Office of Inspector General, U.S. Department of Health and Human
Services (the "HHS-OIG Guidance).
The Corporate Compliance Program is a component of Stiefel's Peak
Performance Behaviors, which encourages integrity, honest, and fair
actions by Stiefel employees.
B.
Purpose
The purpose of the Stiefel
Corporate Compliance program is to prevent and to detect violations of law or
company policies. As the HHS-OIG
Guidance recognizes, however, the implementation of such a program cannot
guarantee that improper employee conduct will be entirely eliminated. In
the event that we become aware of violations of law or company policy, we will
investigate the matter and where appropriate, take disciplinary action and
implement corrective measures to prevent future violations.
To view our Compliance
Declaration please click on the link; (2007 Compliance Declaration)
Described below are
the fundamental elements the Corporate Compliance program that governs the
business activities of Stiefel Laboratories, Inc. and its U.S.-based
subsidiaries. As HHS-OIG
calls for in its Guidance, we regularly review our program to meet our
compliance needs.
II.
Overview
of the Corporate Compliance Program
A.
Leadership
and Structure
Jeff Klimaski is the
designated senior-level official serving as Stiefel's Global Compliance
Officer with daily responsibility for overseeing the development,
implementation and monitoring the Stiefel Corporate Compliance
program. Jeff can be reached at
compliance@stiefel.com.
B.
Compliance
Organization
Stiefel has
implemented a Corporate Compliance program that develops and implements
policies and procedures for employees and contractors to follow while
complying with all federal healthcare programs and relevant state
laws. The Corporate
Compliance Office oversees all activities of the compliance program,
including analyzing risk areas, monitoring internal audits, and conducting
investigations.
C.
Written
Standards
Stiefel has
established written procedures to maintain support of applicable laws and
regulations, and reinforces organizational policies and procedures including,
but not limited to, those identified in the HHS-OIG Guidance such as data
integrity pertaining to government reimbursement practices, kickbacks, and
other illegal remuneration.
D.
Gifts
Stiefel has
implemented a procedure governing meals and gifts to healthcare
professionals and has set a cumulative annual spend limit of $2,750 per
healthcare professional.
These
activities and items consist of (1) occasional modest meals given in
conjunction with informational educational presentations and discussions
that provide educational and scientific value related to Stiefel products
or disease states, (2) modest meals and receptions provided to all
attendees of CME forums and meetings, (3) gifts that provide a clinical
benefit to the patient and are medically relevant, (4) items of minimal
value associated with a healthcare professional's
practice.
E.
Education
and Training
Stiefel is committed
to providing a comprehensive Corporate Compliance education and training
program to our employees on their legal and ethical obligations under
applicable health care program requirements. Stiefel is committed to
communicate steps to effectively endorse our policies and procedures to
all appropriate personnel and stakeholders. We review and update our training
programs regularly and identify additional areas of training on an "as
needed" basis.
F.
Internal
Lines of Communication
Stiefel is committed
to encouraging dialogues between management and employees. Stiefel's goal is that employees
should be able to report any potential instances of fraud and abuse. Employees should know whom to turn
to for a meaningful response and should be able to do so without fear of
retaliation. To that end, we
have adopted principles regarding confidentiality and policies prohibiting
retaliation as well as a hotline number to report any issues
anonymously. Employees can
report suspected violations of company policy by telling their supervisor,
calling the Stiefel hotline at 1-888-280-1847, or by contacting Jeff
Klimaski by email at compliance@stiefel.com
G.
Auditing
and Monitoring
The Stiefel Corporate
Compliance program includes efforts to monitor, audit and evaluate
adherence to Stiefel compliance policies, procedures and applicable
federal and state laws. Results of these auditing and evaluation
activities are shared with senior management to improve our business
practices and maintain ties between compliance efforts and business
decisions.
H.
Responding
to Potential Violations and Corrective Actions
The Stiefel Corporate
Compliance program strives to ensure that the consequences of violating
the law and or Stiefel policy are clearly understood and that appropriate,
consistent disciplinary action is taken. Stiefel's Compliance program
requires 1) evaluation and prompt response to all reported incidents, 2) clear
appropriate disciplinary action, 3) conducting a post-reporting assessment
to identify whether the violations were a result of gaps in our policies,
practices or internal controls, and 4) appropriate action taken to prevent future
violations.
III.
Contact
Information
For questions or comments regarding the Stiefel
Corporate Compliance program, or to request a printed copy of the program,
please email compliance@stiefel.com.
/s/ Charles W.
Stiefel
Charles W. Stiefel
Chairman of the Board,
President and Chief Executive Officer
June 30, 2007