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, honesty, 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; (2009 Compliance Declaration)
Described below are the fundamental elements 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 the program to meet compliance.
II. Overview of the Corporate Compliance Program
A. Leadership and Structure
Jeff Klimaski is the designated senior-level official serving as Stiefel's Global Ethics & 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 maintain compliance with all federal healthcare program requirements 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 standards 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. Business Meals and Educational Items
Stiefel has implemented a procedure governing business meals and educational items to healthcare professionals and has set a cumulative annual spending limit of $1000.00 per California healthcare professional. These activities and items consist of 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 and educational items that provide a clinical benefit to the patient and are medically relevant.
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. 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 midconduct, fraud or 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 helpline number to report any issues. Employees can report suspected violations of company policy by telling their supervisor, calling the Stiefel helpline at 1-888-280-1847, or by contacting Global Ethics & Compliance by email at compliance@stiefel.com.
G. Auditing and Monitoring
Stiefel's 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) where applicable clear and 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.