Our mission to make novel antibiotics accessible to all patients in need cannot be achieved without total commitment to compliance in all areas of our business. Tetraphase proactively implements a compliance program to ensure our employees and contractors adhere to our standards of conduct. We have established a compliance program designed to meet all applicable laws, rules, and regulations and strive to foster a culture dedicated to ethics.
The Tetraphase compliance program is based on the "Commercial Compliance Program Guidance for Pharmaceutical Manufacturers," published by the Office of Inspector General (OIG), U.S. Department of Health and Human Services (DHHS), and the "Code on Interactions with Healthcare Professionals," published by Pharmaceutical Research and Manufacturers of America (PhRMA).
Tetraphase has identified an individual who is responsible for developing, operating and monitoring the commercial compliance program. This person reports to the President and CEO of Tetraphase and has direct access to the Board of Directors regarding all compliance concerns.
Documented Policies and Procedures
Tetraphase has documented policies and procedures that address the Company's expectations regarding adherence to all applicable laws and regulations. These pertain to the risk areas identified in the OIG guidance as well as other areas specific to Tetraphase activities.
Tetraphase is dedicated to an ongoing training and education program for its employees with regard to their legal and ethical obligations. Tetraphase trains its employees on its Code of Conduct and specific risk areas related to each employee's responsibilities. The training program is subject to review and modification as deemed appropriate by the Company.
Tetraphase encourages an open dialogue of concerns from employees with regard to its business activities. All employees have access to report potential instances of fraud and abuse or other instances of potential violation of law, regulations, or company policy. These reports may be submitted through their management, compliance, HR, or Legal. In addition, Tetraphase has established a hotline to report potential violations of laws and policies. If desired, the individual may submit reports anonymously.
To report any potential compliance concerns, please contact Compliance at the number and email address below.
Auditing and Monitoring
The Tetraphase compliance program includes ongoing internal efforts to assess, evaluate, monitor, and audit compliance with the Company's policies and procedures. The results of these activities are reported to local and corporate management.
Tetraphase has an established disciplinary process for those employees who violate the law, regulations, or company policy. The Company will investigate the matter based on the nature of the violation and consider discipline to address the violation and prevent or correct where necessary.
ANNUAL DECLARATION (August 29, 2018)
Tetraphase reviewed the OIG Guidance and the PhRMA Code and believes that its Commercial Compliance Program is in compliance with these documents and other applicable laws and regulations, including California Health and Safety Code sections 119400-119402, as of the date of this declaration.
In accordance with California Health and Safety Code section 119402(d)(1), Tetraphase has established an annual limit of $2,500 per provider for spend on promotional items and activities. This stated limit is not a goal, but a maximum that the company sets for itself as a limitation. In most cases, the amounts actually spent are significantly less than the maximum amount set by this limitation. Tetraphase may change this spending limit upon review at the discretion of the Company.