Celgene Corporation is committed to complying with all applicable laws, regulations and industry standards. Celgene has developed a Comprehensive Compliance Program in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the U.S. Department of Health and Human Services Office of Inspector General in April 2003 (OIG Guidance) and which includes policies consistent with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code).
The Celgene Compliance Program includes numerous policies and procedures and is continually assessed and evaluated to ensure consistency with additional laws and guidance. It is designed to prevent, detect and remediate violations of law, regulations and company policies, as well as to promote an ethical culture that will, among other things, guide our interactions with healthcare professionals and healthcare entities. In the event that Celgene becomes aware of any potential or actual violations of policy or law, an investigation will be triggered and, if necessary, followed by appropriate remedial or corrective actions in accordance with the Celgene Compliance Program.
As part of the Compliance Program, Celgene has established a specific annual aggregate dollar limit of $1,500 on gifts, items or activities Celgene may give or otherwise provide to an individual medical or healthcare professional in California on an annual basis. This limit may be revised from time to time by Celgene in its sole discretion, in which case the revised limit will be published in this section of the Celgene website within a reasonable period of time following revision. This limit represents an expenditure cap and not a goal or an average expenditure amount. Historically, expenditures for such items have been substantially less than this limit for most healthcare professionals with whom Celgene interacts. The Company has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California and is working to establish additional monitoring processes.
The annual limit does not include expenditures the following:
- Drug samples given to physicians and healthcare professionals;
- Financial support for continuing medical education programs;
- Financial support for health educational scholarships;
- Payments for legitimate professional services, and any meals or expenses associated with the provision of such services; and
- Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition
Based on a good faith understanding of the requirements of Section 119402 of the California Health & Safety Code, Celgene hereby declares that, to the best of its knowledge, its Comprehensive Compliance Program addresses the California statutory requirements for inclusion of policies addressing the OIG Guidance and PhMRA Code and limits on gifts and incentives to health professionals. Subject to the above, Celgene also hereby declares that it is, in all material respects, in compliance with its Comprehensive Compliance Program as of June 30, 2019.
Celgene makes this declaration available on this website and copies may also be obtained by dialing 1-844-335-8902.