Paratek Pharmaceuticals (Paratek) is committed to conducting its business ethically and in compliance with applicable laws, regulations, guidelines, and policies. In keeping with that commitment, Paratek has implemented comprehensive compliance programs which govern its business operations.
Our Healthcare Compliance Program is designed following the framework laid out by the United States Department of Health and Human Services Office of Inspector General’s May 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” and the Pharmaceutical Research and Manufacturers of America “Code on Interactions with Healthcare Professionals.”
Leadership and Structure
The Chief Compliance Officer along with employees hired to support Paratek compliance activities (collectively, the “Compliance Department”) are responsible for overseeing the implementation and administration of the Company’s Healthcare Compliance Program. Paratek has also established a Healthcare Compliance Committee that meets as frequently as necessary to meet the Company’s compliance needs, but in any event, no less than quarterly each year.
Documented Policies and Procedures
Paratek has implemented healthcare compliance-related policies that are consistent with the evolving business and strict regulatory environment. The organization’s healthcare compliance policies and procedures are designed to ensure that interactions with healthcare professionals are appropriate, ethical, and consistent with applicable laws, regulations, guidelines, and policies.
In accordance with California Health and Safety Code §§ 119400-119402, Paratek has established an annual dollar limit of $2,500 on items of value that Paratek may provide to California medical or healthcare professionals, including meals associated with educational presentations, educational items, promotional materials and other items of value. The following are exempt from counting towards Paratek’s annual aggregate dollar limit: drug samples given to healthcare professionals for free distribution to patients; financial support for CME programs; financial support for health educational scholarships; and fair market value payments provided for a healthcare professional’s professional services (e.g., consulting activities).
The Paratek Healthcare Compliance Program includes training and educating employees regarding their general ethical obligations and their specific obligations to comply with our policies and procedures and with applicable laws and regulations. New employees receive healthcare compliance training as part of their initial training. Also, employees whose job functions involve interactions with healthcare professionals receive on-going healthcare compliance training on a routine and periodic basis.
Effective Lines of Communication
Paratek is committed to fostering an environment where open communication regarding our Healthcare Compliance Program’s policies and procedures is encouraged. This includes, in particular, the airing of concerns and reporting of suspected improper practices. Any employee who has concerns about a particular activity that the employee feels may violate policies or the law is required to report such concerns. Employees may either report their concerns to their supervisors, to senior leaders, or to any member of the Compliance Department. Paratek also maintains a global independent third-party compliance hotline where employees may anonymously report potential compliance concerns. Paratek expressly prohibits retaliation or retribution against any employee who reports or makes a good faith effort to report a suspected misconduct or improper behavior.
Auditing and Monitoring
The Healthcare Compliance Program at Paratek includes activities designed to monitor, audit and ensure compliance with the Company’s policies and procedures. The Compliance Department oversees periodic monitoring and auditing to ensure adherence to applicable policies. The Compliance Department will work with relevant internal and external experts and management as necessary to evaluate auditing and monitoring findings and ensure the implementation of any corrective action deemed necessary as a result of audits or routine monitoring activities.
In addition, the Compliance Department in conjunction with the General Counsel reviews and evaluates potential compliance concerns to determine whether further investigation is required. The Compliance Department may, as necessary, request assistance from the members of the Compliance Committee or outside experts to conduct an investigation, depending on the nature of the alleged misconduct.
Corrective and Disciplinary Action
If after investigation it is determined that noncompliant conduct occurred, the matter will be forwarded to the appropriate parties for corrective and/or disciplinary action. Such response and disciplinary action may include (but is not limited to): terminating or otherwise disciplining the employee(s) involved; disciplining supervisors in accordance with the facts for failure to supervise adequately and control the behavior of the employee(s); revising guidelines, policies, and procedures or any function of the Healthcare Compliance Program to prevent the recurrence of misconduct in the area; increasing auditing and monitoring procedures; or retraining.
Annual Declaration for Purposes of California Health and Safety Code §§ 119400-119402
Paratek declares that, to the best of its knowledge, and based on a good faith understanding of the legal requirements of California Health and Safety Code § 119400 and 119402, it has adopted a comprehensive compliance program consistent with the requirements of California law. Paratek has tailored its Healthcare Compliance Program to its current size and business operations and continues to develop and implement changes to the Healthcare Compliance Program as compliance and operational needs evolve. To the best of our knowledge and based on a good faith belief, Paratek is in material compliance with its Healthcare Compliance Program.
A description of our Healthcare Compliance Program and a copy of this annual declaration are publicly available on our website or by calling us at 617-275-0040.
Dated: June 30, 2023
INFORMATION FOR VERMONT PRESCRIBERS OF PRESCRIPTION DRUGS: