Primus Pharmaceuticals, Inc. (Company) has established a compliance program based on the Compliance Program Guidance for Pharmaceutical Manufacturers, published by the Office of Inspector General of the United States Department of Health and Human Services. This guide describes seven elements which are the foundation of the Company’s Commercial Compliance Program.
1. Written Policies and Procedures
The Company has implemented written policies and procedures which govern interactions with health care professionals. These policies and procedures are based on the industry code standards including the PhRMA Code on Interactions with Healthcare Professionals and the AdvaMed Code of Ethics on Interactions with Healthcare Professionals.
2. Compliance Leadership
The Company has assigned an individual responsible for overseeing the administration and implementation of the Compliance Program. This person has been empowered to exercise independent judgement and reports to the President of the Company.
3. Training and Education
The Company has assigned an individual responsible for overseeing the administration and implementation of the Compliance Program. This person has been empowered to exercise independent judgement and reports to the President of the Company.
4. Communication
The Company is committed to fostering an open communication environment to encourage the reporting of concerns about suspected improper business practices. This includes reporting of potential violation of law, regulations or company policies and procedures.
5. Auditing and Monitoring
The Commercial Compliance Program includes activities designed to monitor and audit compliance with the Company’s policies and procedures. At least once every two years, the Commercial Compliance Officer develops an audit plan. The Company implements corrective actions deemed necessary as the result of audit and monitoring findings.
6. Enforcement and Discipline Guidelines
If the Company determines, after investigation, that noncompliant conduct occurred after completing an investigation, appropriate corrective and/or disciplinary action will occur. Responses and disciplinary action may include, but is not limited to, termination.
7. Corrective Actions
If it is determined that noncompliant conduct occurred after completing an investigation, appropriate corrective and/or disciplinary action will occur. Responses and disciplinary action may include, but is not limited to, termination. The Company is committed to implementing corrective and preventive measures to enhance its controls to prevent further violations.
Updating the Commercial Compliance Program
The Company will periodically assess the effectiveness of the Commercial Compliance Program and may modify to enhance as deemed necessary.
California Regulations
The Company’s Ethics and Compliance Program reflects our commitment to the laws, rules, and regulations applicable to our business including the California Health and Safety Code §119400-119402. For a copy of this declaration of compliance call: 480-483-1410
Annual Declaration of Compliance for Purposes of California Health and Safety Code Sections 119400-119402
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. The latest PhRMA Code revision was September, 2019.
The Company has developed a Commercial Compliance Program (CCP) in accordance with the requirements of California Health & Safety Code sections 119400-119402. The Company hereby declares in good faith that it is, in all material respects, in compliance with its CCP and the requirements of California Health & Safety Code §§ 119400-119402. The Company has developed and implemented elements of its CCP to address certain issues uniquely raised by the California law.
In accordance with California Health and Safety Code section 119402(d)(1), the Company has established an annual limit of $2,500 for spending on promotional items and activities provided to health care professionals licensed in California. Such items are generally provided to health care professionals in order to facilitate an educational or scientific discussion about the Company’s products, research and development efforts, and other healthcare related issues. The Company limit also includes educational items provided to a physician (such as medical textbook) that are intended to benefit patient care. Pursuant to California Health & Safety Code §119402(d)(2) and (3), drug samples given to healthcare professionals intended for free distribution to patients, financial support for continuing medical education forums, financial support for health educational scholarships, and fair market value payments made for legitimate services provided by a health care professional to the Company, including but not limited to consulting, have been excluded from the spending limit. This stated limit is not a goal, but a maximum that the company sets for itself as a limitation. In most cases, the amounts actually spent are significantly less than the maximum amount set by this limitation. The Company may change this spending limit upon review at the discretion of the Company.