Introduction
Xellia Pharmaceuticals (“Xellia”) is committed to conducting its business consistently with all applicable laws and the highest standards of business integrity. As required by California Health and Safety Code § 119402, Xellia has established a Compliance Program to ensure adherence with all applicable laws and guidance, including those that govern the sale and marketing of pharmaceutical products. The Compliance Program has been designed to be consistent with the “Compliance Program Guidance for Pharmaceutical Manufacturers” issued by the U.S. Department of Health and Human Services, Office of Inspector General (“OIG Guidance”), and the Pharmaceutical Research and Manufacturers of America’s “Code on Interactions with Healthcare Professionals” (“PhRMA Code”).
The following is an overview of the Compliance Program and its key elements:
Leadership and Structure
The Xellia Compliance Officer has responsibility for development and execution of the Compliance Program. Specific oversight responsibilities include: ensuring appropriate and ongoing training and education; investigating reports of violations of the Compliance Program or applicable laws, and taking disciplinary when appropriate; and regularly reviewing the Compliance Program and its elements, and refining them when necessary, to support continuous improvement with the organization and compliance with the Compliance Program and applicable laws.
The Xellia Compliance Committee consists of members of the Xellia leadership team, and includes the Xellia Compliance Officer. The Compliance Committee advises and provides active support to the Xellia Compliance Officer. It has responsibilities including meeting quarterly, or as often as necessary, to review any updates or other relevant information related to the Compliance Program, and recommending any updates to the Compliance Program and related Xellia policies and procedures, as appropriate.
Written Policies and Procedures
Xellia has written policies and procedures in place to address all aspects of the Compliance Program. These procedures cover topics including: interactions with healthcare professionals; use of consultants; support to external organizations; use of product samples; and compliance with applicable state laws governing the marketing and sale of prescription drugs and devices.
To support its objectives under the Compliance Program, Xellia also follows the Xellia Code of Conduct, which summarizes additional compliance and ethics standards.
Education and Training
Xellia is committed to providing ongoing and effective education and training to all Xellia employees on the Compliance Program as well as relevant company policies and procedures. This training is implemented in a manner to promote: (1) awareness and understanding of applicable laws and internal policies and procedures and (2) compliant and ethical behaviors within the organization. It includes general Compliance Program training for all new Xellia employees, including specific training for any employees whose activities implicate any applicable state laws, as well as annual refresher training and other training programs as appropriate.
Internal Lines of Communication.
Xellia is committed to fostering dialogue between management and employees so that all employees, whether seeking answers to questions or reporting potential instances of fraud and abuse, know who to turn to for a meaningful response and are able to do so without fear of retribution. Xellia has adopted open-door, confidentiality, and non-retaliation policies. As part of its commitment to ethical and legal behavior, Xellia requires its employees to report any actual or suspected violations of law or ethical standards so that they can be appropriately investigated and addressed. Employees can raise their concerns in a number of way including with an appropriate member of management, through our Human Resources, Legal, or Compliance Departments, or through an online Whistleblower System.
Monitoring and Auditing
Xellia’s Compliance Program includes activities to monitor, audit, and evaluate compliance with the Company’s policies and procedures. Xellia’s approach includes targeted monitoring and auditing based on identified and prioritized risk areas. In accordance with the OIG Guidance, the nature of Xellia’s reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
Responding to Potential Violations, Discipline, and Corrective Action
Adherence to the Compliance Program and Code of Conduct is a condition of employment at Xellia. Any violation of an employee’s obligations can subject an employee to serious disciplinary measures, including possible termination of employment. Although each situation is considered on a case-by-case basis, Xellia undertakes significant efforts to ensure consistent and appropriate disciplinary action is taken in response to violations.
A Xellia employee who has knowledge or a good faith suspicion of any violation of the Compliance Program or applicable laws has an affirmative duty to report such information, and a failure to report a suspected or actual violation may be subject to disciplinary action. All reported violations of the Compliance Program or applicable laws are documented and appropriately investigated to determine their veracity and the scope and cause of any underlying problem.
Violations of the Compliance Program or applicable laws shall be dealt with accordingly. Depending on the results of an appropriate investigation, sanctions could range from oral or written warning, to suspension or termination. Violations of the Compliance Program or applicable laws trigger an appropriate review by the Compliance Officer of the violated component of the Compliance Program to determine appropriate corrective measures or changes either in the Compliance Program or in Xellia’s other existing policies and procedures.
Annual Aggregate Limit
Xellia has established an annual dollar limit of $1,000.00 on spending for gifts, promotional materials, and items or activities provided to a healthcare professional in California, as required by California law. This limit represents a spending cap, not a goal or average, and in many cases, the amount spent per healthcare professional may be significantly less than the cap amount.
Declaration of Compliance
Based on a good faith understanding of applicable California requirements, as of the date of this Declaration, Xellia declares that, to the best of its knowledge, its Compliance Program is in compliance with the requirements of California Health and Safety Code § 119402.
A copy of this California Comprehensive Compliance Program Summary and Declaration may be obtained by calling 1-833-295-6953.
Updated August 15, 2023