Statement regarding compliance with California Health & Safety Code § 119402
NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make available their annual written declaration of compliance with the compliance program.
California Health & Safety Code, Sections 119400 – 119402, (“California Compliance Law”) requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”) developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”) and policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”) within six months of any update or revision of the PhRMA Code. Revisions to the July 1, 2002 PhRMA Code were effective January 2009.
Galena Biopharma, Inc. has established a comprehensive compliance program in accordance with the OIG Compliance Guidance and has policies and procedures in place to foster compliance with the PhRMA Code for their pharmaceutical business. For purposes of compliance with the requirements of the California Compliance Law and as part of the Company’s comprehensive compliance program, Galena Biopharma, Inc. established a specific annual aggregate dollar limit on gifts, promotional materials, or items or activities that the Company may give or otherwise provide to an individual medical or healthcare professional in California. This limit may be revised from time to time. The Company has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California.
Annual Declaration (August 28, 2014)
The Company is committed to conducting its business ethically and in compliance with all applicable laws. To the best of its knowledge and based on a good faith understanding of the statutory requirements, the Company has established a comprehensive compliance program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. The Company has tailored its program to meet the specific needs of the Company and continuously assesses the effectiveness of its program. The Company has established an internal monitoring system designed to help ensure compliance with its respective annual spending limits in California. Thus, subject to the limitations described herein, the Company declares that, based upon current tracking and monitoring systems, the Company is, in all material respects, in compliance with its established program and with the respective annual spending limits.
As recognized by the OIG Compliance Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that the Company has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program. In such situations, the Company takes reasonable and appropriate remedial or corrective action in a manner consistent with its compliance program.
For a written copy of the compliance program description or this declaration, call 1-855-855-GALE.