Corporate Compliance and Ethical Responsibilities
Analog Pharma is dedicated to ensuring that all business operations and activities that Analog Pharma is involved with are conducted in accordance with the highest of ethical standards. Analog Pharma considers its reputation within the medical community a valuable asset and as such, is committed to promoting the honest and ethical behavior of all individuals employed by or associated with Analog Pharma.
Compliance with all laws, regulations, company policies and other best practices applicable to the organization by all Analog Pharma employees is critical to Analog Pharma’s professional standards and corporate success. Analog Pharma’s Compliance Program incorporates the fundamental elements addressed within the Office of the Inspector General’s (OIG) “Compliance Program Guidance for Pharmaceutical Manufacturers,” and includes the following:
Written Policies and Procedures
Analog Pharma has developed a Code of Conduct to guide our business practices in an ethical and compliant manner. Analog Pharma expects all employees, executives, contractors and agents of Analog Pharma to abide by this Code of Conduct.
In addition, Analog Pharma has implemented policies and procedures to address risk areas identified in the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers, as well as to ensure adherence to the Pharmaceutical Research and Manufacturers of America Code “Code on Interactions with Health Care Professionals” (PhRMA Code).
Corporate Compliance Officer (CCO) and Compliance Committee
The CCO oversees the Compliance Program and is responsible for ensuring that all employees, directors and officers act in the utmost ethical, compliant and professional manner.
Analog Pharma has established a Compliance Committee consisting of key stakeholders from each departmental function within Analog Pharma. The purpose of the Compliance Committee is to assist the CCO in overseeing and providing guidance over Analog Pharma’s Compliance Program with regard to: (1) adherence to laws and regulations applicable to Analog Pharma’s business operations and activities; (2) compliance with Analog Pharma’s Code of Conduct and related policies and procedures by all employees, officers, and other agents and associates of Analog Pharma; and (3) assist the CCO in ensuring the effectiveness of the Corporate Compliance Program.
Training and Education
Training and education are essential to reinforcing Analog Pharma’s compliance and ethical standards, as well as providing personnel with the resources they need to understand and effectively abide by all legal, regulatory and Analog Pharma compliance requirements. As such, Analog Pharma trains our personnel on the Analog Pharma Code of Conduct and all job-related policies, procedures and other guidelines as well as updates training on an as-needed basis.
Effective Lines of Communication
Analog Pharma encourages an atmosphere of open communication that fosters dialog between management and employees regarding compliance or ethical concerns, or reporting potential instances of fraud and abuse. Analog Pharma employees are encouraged to report their concerns to their manager and/or the compliance hotline. Analog Pharma has policies and procedures in place to ensure employees making such reports will not be subject to retaliation or retribution.
Monitoring and Auditing
Analog Pharma is committed to conducting ongoing internal monitoring and auditing, as these activities serve as essential components of a Corporate Compliance Program. It is the duty of Analog Pharma to ensure that business processes and operations are as efficient and effective as possible. Analog Pharma’s CCO is responsible for ensuring that the elements of the Compliance Program are audited and monitored on an on-going basis.
Enforcement and Discipline
Analog Pharma develops and maintains documentation that informs all employees of Analog Pharma’s dedication to, and enforcement of, ethics and compliance policies regarding each employee’s day to day responsibilities, and the consequences of violations of these policies. Any employee who fails to abide by Analog Pharma’s ethics and compliance standards may be subject to appropriate disciplinary action following an investigation.
Response and Corrective Action for Detected Problems
Analog Pharma requires a prompt response and corrective action for identified potential compliance violations when necessary and appropriate. Personnel are expected to report any compliance issues or concerns they may have through Analog Pharma’s Compliance Hotline or other lines of reporting as necessary. All reported compliance issues will be reviewed, investigated and remediated as deemed appropriate on a case-by-case basis.
As a company dedicated to improving the lives of its patient and quality of life within the medical community, Analog Pharma is committed to further enhancing its culture of compliance on an on-going basis to continue to prevent, detect, and resolve any activities or interactions that may not align with Analog Pharma’s standards of compliance and business conduct.
ANALOG PHARMA’S DECLARATION OF COMPLIANCE WITH CALIFORNIA’S REQUIREMENTS
Analog Pharma, based upon a good faith belief and understanding of legal requirements, hereby declares Analog Pharma has adopted a Comprehensive Compliance Program compliant with the requirements of California Health and Safety Code §§119400-119402. Analog Pharma has tailored its Comprehensive Compliance Program to its current size and business operations and continues to develop and implement changes to the Comprehensive Compliance Program as compliance and operational needs evolve. To the best of our knowledge and based on a good faith belief, Analog Pharma is in compliance with its Comprehensive Compliance Program.
As required by California Health & Safety Code §§ 119400-119402, Analog Pharma has established an annual dollar limit on educational items, promotional material, meals associated with educational presentations, or other items of value which Field Based Employees are permitted to provide to medical or health professionals in California. The annual limit of $2500 applies to educational or practice-related items, items of minimal value, and meals associated with informational presentations or discussions provided to medical or health professionals located or licensed in California.