California Declaration of Compliance
Statement regarding compliance with California Health & Safety Code § 119402
California Health & Safety Code Section 119402 (“California Compliance Law”) requires pharmaceutical companies to adopt a compliance program in accordance with U.S. Department of Health and Human Services Office of Inspector General (“OIG”) Compliance Program Guidance for Pharmaceutical Manufacturers dated May 5, 2003 (the “OIG Compliance Guidance”), as well as other relevant industry guidance. Glenmark Pharmaceuticals Inc., USA (“Glenmark”) shall make conforming changes to its Comprehensive Compliance Program (“Compliance Program”) within six (6) months of any update or revision of the OIG Compliance Guidance and relevant industry guidance.
Glenmark has established a Compliance Program in accordance with the OIG Compliance Guidance and relevant industry guidance and has policies in place to address a variety of risk areas.. For purposes of compliance with the requirements of the California Compliance Law and as part of its Compliance Program, Glenmark has established a specific annual aggregate dollar limit of $1,500 per medical or healthcare professional in California on educational items and promotional activities in order to disseminate or communicate medical and scientific information and to assist medical and healthcare professionals in making clinical or other medical judgments. This limit represents a spending cap, not a goal or average; in many cases, the amount spent per physician may be substantially less than the cap amount. The current spend limit will be in effect for the period of January 1, 2020 through December 31, 2020 and will be evaluated annually. Glenmark will make any necessary adjustments to this spending limit consistent with any operational or practical issues related to complying with California Compliance Law. Glenmark 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 limits do not include the following:
- Drug samples given to physicians and healthcare professionals
- Financial support for continuing medical education forums
- Financial support for health educational scholarships
- Payments for legitimate professionals services, and any meals or expenses associated with the provision of such services
- Items of nominal value with a retail value of less than $10 (e.g., visual aids, reprints of medical journal articles)
- 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 their medical condition
Declaration of Compliance
To the best of its knowledge and based on a good faith understanding of the requirements set forth in California Health & Safety Code, Sections 119400-119402, Glenmark declares that, as of January 1, 2020, it is in material compliance with its Compliance Program and the California Health & Safety Code, Sections 119400-119402.
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, nor should it be construed to imply, that Glenmark 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, Glenmark takes reasonable and appropriate remedial or corrective action in a manner consistent with its Compliance Program.
Copies of Glenmark’s Compliance Program and its annual declaration documents are available on its website and a written copy may also be obtained by calling (855) 409-0973.