Annual Declaration of Compliance for Purposes of California Health and Safety Code Sections 119400-119402
Section 119402 of the California Health & Safety Code requires a pharmaceutical company to adopt a Comprehensive Compliance Program that is in accordance with the U.S. Department of Health and Human Services, Office of Inspector General’s (“OIG) “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”), and include policies for complying with the Pharmaceutical Research and Manufacturers of America Code (“PhRMA Code”). The law further requires that the company adopt an annual spending limit for certain items and activities given to healthcare professionals, as defined by this California law. Finally, the law requires that each manufacturer make its comprehensive compliance program and an annual declaration of compliance publicly available. Enzon Pharmaceuticals adapted the objectives and principles underlying these guidelines to its own unique circumstances and adopted its Global Business Management Healthcare Compliance Program (Healthcare Compliance Program). Enzon Pharmaceuticals believes that its Healthcare Compliance Program is consistent with a reasonable interpretation of the OIG Compliance Guidance and the PhRMA Code. Accordingly, Enzon Pharmaceuticals declares that to the best of its knowledge, and based on a good faith understanding of the statutory requirements, that its comprehensive Healthcare Compliance Program encompasses the compliance program requirements stated in California Health and Safety Code, Sections 119400-119402 and that it is, in all material respects, in compliance with its Healthcare Compliance Program. By making this declaration, Enzon Pharmaceuticals is representing that its program is reasonably designed to prevent, detect, and address any misconduct. This declaration is not intended to and should not be construed to imply that Enzon Pharmaceuticals has not identified individual instances in which an employee or agent of the Company has or may have violated a policy or expectation of the Company’s Healthcare Compliance Program. In the event Enzon Pharmaceuticals becomes aware of such situations, it will take reasonable and appropriate corrective. You can see a copy of Enzon Pharmaceuticals’ Global Business Management Healthcare Compliance Program by clicking here Updated 1/1/08 |