COMPREHENSIVE COMPLIANCE PROGRAM
Neos Therapeutics (the “Neos”) is committed to compliance with the full range of laws, regulations and policies governing the marketing and promotion of its products. Accordingly, Neos has established this Comprehensive Compliance Program (the “CCP”). The CCP incorporates the elements described in the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the Office of the Inspector General (“OIG”) of the Department of Health and Human Services, as well as the PhRMA Code on Interactions with Healthcare Professionals (“PhRMA Code”). All Neos employees involved in sales, marketing and pricing are expected to be familiar with and adhere to the CCP. Appropriate disciplinary action, up to and including termination, may be taken against any employee whose conduct violates the CCP or applicable laws and regulations. This CCP complies with Cal. Health & Safety Code § 119400 et seq., as it may be amended or supplemented from time to time.
I. Overview of CCP
The fundamental elements of the Neos’ CCP are described below.
- Written Policies and Procedures.
Neos has developed a written Code of Business Conduct and Ethics (the “Code”) that articulates the core ethical and compliance principles that guide the Neos’ operations. The Code establishes our expectation that management, employees, and agents of Neos act in accordance with all applicable laws, rules, regulations, and Neos policies and procedures, as well as the highest standards of ethics.
Neos has also developed a Sales & Marketing Code of Conduct (the “Sales & Marketing Code”) addressing the specific risk areas identified in the OIG Compliance Program Guidance and implementing the PhRMA Code. The Sales & Marketing Code is designed to help ensure appropriate interactions between Neos personnel and healthcare professionals and organizations.
- Compliance Governance.
Compliance Officer. The Neos Board of Directors has appointed a compliance officer (the “Compliance Officer”) who is charged with developing, implementing, and monitoring the CCP. The Board and the company are committed to ensuring 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 and has direct access to the Neos Board of Directors.
Compliance Committee. Neos has established a Compliance Committee made up of Neos 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 CCP. The Compliance Committee meets on a regular basis to identify and manage areas of risk and areas of critical focus for the CCP.
- Training and Education.
A crucial element of the Neos CCP is the education and training of our employees and contractors on their legal and ethical obligations under applicable laws, rules, regulations, and company policies and procedures. Neos conducts compliance training for its employees and contractors, including sales, marketing, medical affairs, and pricing personnel, to ensure a thorough understanding of the company’s expectations. The training covers, at a minimum, a summary of the federal health care fraud and abuse laws, the requirements of the CCP, and the requirements of the company’s policies and procedures. Participation in training programs is mandatory. Neos’ training programs are regularly reviewed and updated.
- Lines of Communication.
Neos has developed effective lines of communication for Neos personnel to report concerns and ask questions regarding the CCP, company policies and procedures, or other compliance issues. Neos employees and contractors are required to report any suspected violation of law, the CCP, or Neos policies to his or her supervisor or the Compliance Officer. Supervisors are expected to report suspected violations to the Compliance Officer. Alternatively, employees and contractors may anonymously report violations by contacting the Neos Compliance HelpLine. No one who in good faith reports suspected wrongdoing will be subject to retaliation for having done so. Retaliation by a manager, supervisor, or any other company personnel will be grounds for disciplinary action, up to and including termination. Failure to report wrongdoing of which an employee has knowledge may, in itself, be a basis for disciplinary action.
- Monitoring and Auditing.
Neos conducts periodic auditing and monitoring to ensure that, among other things, the CCP is properly functioning, the Code and Sales & Marketing Code have been adequately disseminated, required training has taken place, and company policies and procedures are being implemented and followed. Such reviews are conducted under the direction of the Compliance Officer. We note that, in accordance with the OIG Guidance, the focus, extent, and frequency of these auditing and monitoring activities varies depending on a variety of factors including new regulatory requirements, changes in business practices, compliance history, and Neos’ assessment of identified risk areas. If a review indicates that there are gaps in Neos’ policies or controls, corrective action is taken.
- Disciplinary Action.
All Neos employees and contractors are expected to be familiar with and adhere to the CCP, company policies and procedures, and applicable laws, rules, and regulations. While each substantiated violation will be considered on a case-by-case basis, where appropriate we will utilize disciplinary action consistent with company policy, up to and including termination, to address violative conduct and to deter future violations.
- Investigative and Corrective Action.
All reported violations of laws, rules, and regulations, company policies and procedures, and other reported misconduct are investigated by the Compliance Officer to determine whether a violation has occurred. If corrective action or disciplinary action is required, it is undertaken promptly.
II. Annual Spending Limits
In addition to the above elements of the CCP, Neos has established an annual spending limit on certain promotional activities directed at health care professionals who may prescribe or influence prescribing in California. The annual limit is $1500 per health care professional. This annual spending limit includes occasional modest meals in connection with informational presentations and educational items but does not include payments to healthcare professionals for bona fide consulting or other services.
III. Declaration of Compliance
Neos’ declaration of compliance with Cal. Health & Safety Code § 119400 et seq. and with the CCP can be found at www.neostx.com. A copy of this CCP and the declaration of compliance may also be obtained by contacting infoHQ@neostx.com.