OSI Comprehensive Compliance Program and Declaration of Compliance
CA Health and Safety Code Sec. 119402
Reposted June 30, 2007
OSI Pharmaceuticals, Inc. (“OSI” or the “Company”) is committed to maintaining a quality organization made up of talented individuals with the highest standards of integrity. Our commitment to doing the right things for the right reasons remains an imperative because it is the cornerstone of our success, as individuals and as a company. Ethical behavior and appropriate business conduct are essential to everything we do, every day.
OSI has adopted this Comprehensive Compliance Program (“CCP”) in accordance with the 2003 U.S. Department of Health and Human Services Office of the Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers. This CCP is a companion to the OSI Code of Conduct, and other Company SOPs and guidelines related to compliance.
The CCP and the Code of Conduct are intended to provide a clear understanding of the principles of business conduct and ethics that are expected of OSI. These standards apply to every director and full-time and part-time employee of OSI and its subsidiaries. Employees should bring any questions regarding clarification or interpretation of OSI compliance requirements to the General Counsel.
Training and Education
The Company has made this CCP and the Code of Conduct available on the OSI website. All employees are obligated to sign an acknowledgement that they have read and will abide by the provisions of the Code of Conduct. Upon being initially hired, every OSI Sales Specialist receives training on the relevant OSI SOPs and guidelines. Refresher training on the relevant SOPs and guidelines is held annually.
Compliance with Laws, Rules and Regulations
As a member of the health care industry, OSI is subject to significant rules and restrictions. All OSI employees are expected to comply with this CCP and all applicable federal, state and local laws and regulations. Under the federal Antikickback Statute, kickbacks and illegal remuneration between OSI and any person or entity in a position to generate federal healthcare business for the Company are strictly prohibited. As described in more detail below, OSI has SOPs, guidelines and requirements to prohibit employees from providing items or benefits in order to induce or reward a health care professional to purchase or prescribe OSI products or refer for purchase or prescribing of OSI products. OSI product sampling programs are also subject to detailed laws and regulations. [1] Employees must comply with these requirements and all other applicable legal obligations in order to preserve the moral fiber, integrity and mission of our Company.
Fair Dealing with Customers
OSI does not seek to gain any advantage through the improper use of favors or other inducements. Our dealings with customers and potential customers must be in compliance with all applicable laws and ethical standards. When dealing with health care professionals, we must take particular care to exercise good judgment and moderation to avoid misinterpretation and adverse effect on our reputation. To that end, OSI has adopted the 2002 PhRMA Code on Interactions with Healthcare Professionals. A copy of the PhRMA Code is available to all employees on the OSI intranet. In addition, to comply with CA Health and Safety Code Sec. 119402, OSI has established an annual dollar limit of $900 on gifts, promotional materials, items and activities that OSI may provide to an individual health care professional in California between July 1 and June 30 of each year.
OSI has SOPs, guidelines and requirements regarding many of the compliance areas identified in the PhRMA Code. The OSI SOP on sales and promotional activities requires that all marketing, sales and promotional activities be conducted in full compliance with all relevant federal, state and local laws, rules, regulations and ordinances as well as the PhRMA Code. This SOP also imposes specific limits on the items and meals that may be supplied to health care professionals. OSI guidelines on grants and sponsorships set forth policies and procedures for supporting programs with bona fide educational, scientific, and/or charitable purposes. In addition, OSI requires that the compensation OSI provides to health care professionals for consulting services be determined solely on the basis of the fair market value of the consulting services, as determined in an arms-length transaction. [2] All dealings with customers and potential customers must be consistent with these SOPs, guidelines and requirements.
Accurate Records and Record Keeping
OSI is required to keep books, records and accounts that fairly and accurately reflect all transactions, dispositions of assets and other events that are the subject of specific regulatory record keeping requirements. OSI has developed and maintains a system of internal controls including written policies and procedures, supervisory review, and monitoring to provide reasonable assurance that the information OSI provides is full, fair, accurate, timely and understandable.
Administering the OSI Compliance Program
OSI has established a Compliance Committee responsible for overseeing OSI’s compliance activities. Among other responsibilities, they serve as point persons for reporting violations and suspected violations, conduct internal investigations of suspected compliance violations, and evaluate and improve the effectiveness of the CCP. They provide a summary of any violations or suspected violations they consider and any internal investigations they conduct to the Company’s Audit Committee. Any member of the OSI Compliance Committee can assist employees in reporting violations or suspected violations.
Process for Reporting Violations
As set forth in OSI’s Code of Conduct, OSI has a detailed process for reporting violations. OSI has established an ethics line for reporting violations. Each OSI employee who has any information or knowledge regarding the existence of any violation or suspected violation has a moral obligation and, in certain circumstances, a legal obligation to report the violation or suspected violation via the ethics line, to any member of the Compliance Committee or to his/her own or any other OSI supervisor. If any employee so chooses, he/she may make any reports anonymously via the ethics line. OSI endeavors to keep reports confidential to the fullest extent practicable under the circumstances.
Non Retaliation
Any employee who reports a violation or suspected violation either via the ethics line or to the Compliance Committee, an OSI supervisor or a federal regulatory or law enforcement agency may not be reprimanded, discharged, demoted, suspended, threatened, harassed or in any manner discriminated against in the terms or conditions of employment for, or because of reporting the suspected violation, regardless of whether the suspected violation involves the employee, the employee’s supervisor or senior management.
Investigations
Once a suspected violation is reported, an investigation of the reported violation is promptly commenced. All complaints are fully investigated and appropriate action taken. Information about the allegation is gathered to determine if a factual basis for the allegation exists.
Disciplinary Actions
- If an allegation involving an employee is substantiated, the Compliance Committee makes a judgment as to the degree of severity of the violation and then makes a recommendation to the CEO with respect to an appropriate disciplinary response. Failure to comply with the CCP may result in disciplinary action, up to and including termination. Individuals who violate OSI policies may simultaneously violate federal, state, local or foreign laws, regulations or policies. Such employees may be subject to prosecution, imprisonment and fines and may be required to make reimbursement to OSI, the government or any other person for losses resulting from the violation.
Declaration of Compliance
To the best of its knowledge, as of June 30, 2007, OSI is in compliance with its CCP and CA Health and Safety Code Sec. 119402, in all substantial respects.
Copies
To obtain a copy or copies of this document, please call 1-866-797-4744 toll free.
- To the extent that OSI institutes a prescription drug sampling program, any samples of OSI-promoted drug products shall be provided only in compliance with the Prescription Drug Marketing Act.
- To the extent that OSI institutes a speaker training program, we will develop speaker training guidelines that comply with the PhRMA Code.