Comprehensive Compliance Program Description
I. IntroductionSilvergate Pharmaceuticals, Inc. (Silvergate) is committed to conducting its business in compliance with all applicable laws, rules, and regulations and to the highest standards of ethical conduct. To this end, we have established and will maintain a Comprehensive Compliance Program (“Compliance Program”) in accordance with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers (the “OIG Guidance”), published by the Office of Inspector General, U.S. Department of Health and Human Services. Our Compliance Program is a key component of our commitment to adhering to the highest standards of corporate responsibility and fostering a culture of compliance that places a premium on doing business with integrity.
The purpose of our Compliance Program is to (1) prevent, detect, and remediate violations of laws, rules, regulations, as well as Silvergate policies and procedures and (2) promote a culture of the highest ethics within the organization. It is Silvergate’s expectation that employees will comply with our Code of Business Conduct and the policies and procedures established in support of such Code. As the OIG Guidance recognizes, however, the implementation of a Compliance Program cannot guarantee the elimination of improper employee conduct.
Silvergate has described below the fundamental elements of our Compliance Program. As recognized in the OIG Guidance, we have tailored our Compliance Program to fit the unique environment of our company. Moreover, our Compliance Program is dynamic and we regularly review and enhance our Compliance Program to meet our evolving compliance needs.
You may obtain a copy of the Compliance Program description by calling 1-855-245-2099.
II. Overview of Compliance Program
Leadership and StructureCompliance Officer. Silvergate has appointed a Compliance Officer who is charged with developing, implementing, and monitoring the Compliance Program. We will ensure that the Compliance Officer has the ability to exercise independent judgment and effectuate change within the organization as needed. The Compliance Officer reports to the President and Chief Executive Officer of Silvergate and has direct access to the Silvergate Board of Directors.
Compliance Committee. Silvergate has established a Compliance Committee made up of Silvergate senior management. The role of the Compliance Committee is to advise and assist the Compliance Officer in the development, implementation, and ongoing oversight of the Compliance Program. The Compliance Committee meets on a regular basis to identify and manage areas of risk and areas of critical focus for the Compliance Program.
Written StandardsSilvergate has established policies and procedures, including our Code of Business Conduct, which articulates our fundamental principles and values and provides a framework for ethical conduct within our organization. The Code of Business Conduct establishes our expectation that management, employees, and agents of Silvergate act in accordance with all applicable laws, rules, regulations, and Silvergate policies and procedures, as well as the highest standards of ethics.
Silvergate has established an annual spending limit for certain promotional activities directed toward healthcare professionals who prescribe or may influence prescribing in California. At the present time our annual spending limit is $1,000.00. Examples of items that fall within this spending limit are occasional modest meals in connection with informational presentations and educational items. This annual spending limit does not include payments to healthcare professionals for bona fide consulting or other services.
It is Silvergate’s policy to not provide any item of value to any healthcare professional with the intent of influencing that healthcare professional’s prescribing habits.