Neos Therapeutics, Inc. (“Neos” or the “Company”) is committed to compliance with all applicable laws, regulations, and policies governing its operations and the marketing and promotion of its commercial products. Accordingly, the Company has established a comprehensive compliance program, as more fully described below.
Elements of an Effective Compliance Program
In 2003, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services developed the OIG Compliance Program Guidance for Pharmaceutical Manufacturers. According to the OIG, it is essential for pharmaceutical manufacturers to establish and maintain effective compliance programs. The program should foster a culture of compliance that begins at the executive level and filters throughout the organization. The OIG’s guidance includes seven fundamental elements for an effective compliance program:
- Designated compliance officer and compliance committee
- Written policies and procedures
- Effective training and education
- Open lines of communication
- Internal monitoring and auditing
- Enforcement of standards through disciplinary guidelines
- Prompt response to detected problems through corrective actions
The Neos Compliance department has established a mission and strategy to create and maintain a culture of compliance through the establishment of a robust corporate compliance program that reflects these seven elements.
To ensure all Neos stakeholders (e.g., patients, healthcare professionals, payers, regulators, stockholders and employees) understand and see the Company’s commitment to integrity in the development, research, manufacturing, marketing and sales of Neos products.
- Foster a culture based on trust, integrity, open and honest communications, accountability and an uncompromising focus on the well-being of patients.
- Provide effective training on our Code of Conduct, company policies and procedures and industry standards and regulations.
- Partner with business leadership to drive annual compliance goals.
- Collaborate with business partners to create policies and procedures that enable the business to operate in an efficient and compliant manner.
- Promote continuous improvement of our compliance program through monitoring and auditing.
- Provide open lines of communication to allow concerns to be raised in a safe environment. Oversee a fair and objective investigation and corrective action process.
Neos leadership fosters a culture of compliance by setting the appropriate “tone at the top” and by demonstrating a commitment to integrity in business practices every day. Through the Neos Corporate Compliance Program, Neos leadership supports managers and employees to conduct business ethically by providing resources such as the Code of Business Conduct and Ethics, policies, procedures, and training and education. Neos leadership is encouraged to foster an “open door” policy, and the Company offers a variety of channels through which individuals may raise concerns, including through the Compliance Helpline.
Additionally, Neos leadership holds all personnel accountable for ethical business conduct by:
- Enforcing established policies and standards;
- Routinely monitoring or auditing business processes;
- Promptly responding to detected concerns and conducting investigations, as appropriate; and
- Taking corrective action and following disciplinary procedures.
Compliance Program Stature
- The Neos Chief Compliance Officer reports directly to the Chief Executive Officer and has dotted-line reporting to the Audit Committee of the Board of Directors.
- The Board of Directors receives an annual Compliance update and the Audit Committee receives regular updates from the Neos Chief Compliance Officer.
- The Chief Compliance Officer chairs the Company’s Compliance Committee, which oversees the Company’s efforts and includes representatives of the Company’s Senior Leadership team.
Reporting a Concern
- Neos has established various ways for individuals to raise concerns regarding individual employee and/or business conduct. One avenue for raising such issues, the Compliance Helpline, is described below. Neos takes all reports to the Compliance Helpline seriously and has a process in place to handle all reports on a case-by-case basis.
Contacting the Compliance Helpline
- Phone Number: 1-844-375-8324
- Website: www.whistleblowerservices.com/neos/
- The Compliance Helpline is managed by a third-party vendor and allows employees to make a report or ask a question 24-hours a day, 7 days a week. Reports to the Compliance Helpline can be made anonymously (see further information on Anonymity and Confidentiality below). The reporter will be asked for details about the issue or question and given a unique case number for follow up. Though not required, individuals are encouraged to leave a name and number in case additional information is needed.
- Neos maintains a Policy on Investigations for triaging and investigating reports and has provisions protecting employees against retaliation in its Code of Business Conduct and Ethics. Investigations are undertaken promptly so the company may determine whether misconduct has occurred and what remediation actions are appropriate. Neos attempts to handle investigations in a manner that keeps them as confidential as possible under the circumstances.
- Reporters can contact the Compliance Helpline at any time during the process to request follow-up information or final feedback using the case number originally given when the concern was reported. Please be aware that we may be limited in the information that can be shared.
Anonymity and Confidentiality
- While reports to the Compliance Helpline may be made anonymously, some issues such as requests for guidance, are more efficiently handled if contact information is provided. Without sufficient details, the Company may not be able to investigate the matter fully or take appropriate action.
Annual Declaration Pursuant to
California Health and Safety Codes §§ 119400-119402
Neos Therapeutics has established a Compliance Program in accordance with California Health and Safety Codes §§ 119400-119402. To the best of its knowledge and based on its good faith understanding of the statutory requirements, the Company has established a Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402.
Neos has tailored its Compliance Program to meet the specific needs of the Company and continuously assesses the effectiveness of the Compliance Program. The Company has established an internal monitoring system designed to help ensure compliance with its respective annual spending limits in California and established routine corporate tracking and monitoring processes to evaluate other business activities. Based on the above efforts, Neos declares that the Company is in compliance with the Compliance Program and annual aggregate dollar limit provisions outlined in the California statutory requirements.
As recognized in the April 2003 Compliance Program Guidance for Pharmaceutical Manufacturers, published by the United States Department of Health and Human Services, Office of Inspector General (OIG Guidance), even an effective Compliance Program cannot completely eliminate the possibility that individual employees are engaging in conduct that would be considered improper. The Compliance Program at Neos Therapeutics, however, is reasonably designed, implemented and enforced with the goal of preventing, detecting and/or remediating such improper conduct.
August 1, 2019