TESARO (the “Company”) has implemented a comprehensive compliance program (“Compliance Program”) based on the key elements outlined in the Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG Guidance”). Our program includes internal controls, policies and procedures that foster compliance with federal and state laws and regulations, training and other requirements applicable to our business. The Compliance Program has been designed to fit the specific needs of the Company, and we regularly review the Compliance Program to ensure that it remains aligned with our evolving business needs and associated compliance risks, as well as any changes in legal requirements or industry standards.
TESARO has a Compliance Officer who coordinates and oversees the Compliance Program. The Compliance Officer interacts frequently with the Company’s Executive Leadership and has the authority to report potential concerns directly to the President of the Company and to TESARO’s parent company, GlaxoSmithKline (GSK). The Compliance Committee, which is comprised of leaders from key areas throughout the Company, meets regularly to identify areas of potential risk, discuss best practices, and monitor compliance activities. As TESARO integrates with GSK, some roles of the Compliance Committee will transfer to leaders at GSK.
As part of the Compliance Program, TESARO has established a Code of Business Conduct and Ethics (“Code”), which provides an overview of the principles to which all TESARO directors, officers, associates, and independent contractors must adhere. This Code seeks to foster a culture of compliance across the Company.
In addition to the Code, TESARO has established a number of compliance policies that govern day-to-day operations. The compliance policies cover the key issues identified by the OIG as being potential areas for fraud and abuse, including promotional activities, consulting and advisory arrangements with healthcare professionals, grants and charitable donations, clinical trials, and meals and travel that may be provided to healthcare professionals. The compliance policies are supplemented by procedures and guidance documents for specific activities or business functions where appropriate. TESARO reviews its policies and procedures on a routine basis and revises them as necessary.
Training and education are critical components of TESARO’s Compliance Program. All associates receive annual training on the Code. Additionally, TESARO requires those associates whose job responsibilities involve interactions with healthcare professionals and/or healthcare organizations to receive additional training on relevant compliance policies. The Company may require additional training based on specific job functions as it deems necessary. Additional training programs may also be implemented in response to needs identified through ongoing monitoring or auditing.
TESARO actively fosters dialogue between management and associates. Our goal is that all associates ask questions and know where to turn when seeking answers. TESARO maintains an open-door policy to encourage open dialogue about compliance questions and concerns. Associates are required to report any suspected violation of the Code or the Compliance Program, and TESARO provides several avenues for these types of communications. An associate may report concerns to his or her supervisor, Human Resources, the Legal Department or Compliance. TESARO has also established an external hotline, which allows associates to report concerns by phone or web, and to do so by name or anonymously. TESARO policies are designed to protect associates from retaliation for raising concerns in good faith.
TESARO monitors and audits its activities for compliance with applicable laws and regulations, and the company’s own policies and procedures. Effective monitoring can provide TESARO with the ability to detect and prevent deviations that can potentially affect Company compliance goals.
TESARO’s Compliance Program supports prompt response and appropriate corrective action for any detected compliance violations. It is expected that any compliance concerns will be reviewed carefully, investigated in a timely manner, and, if substantiated, result in appropriate corrective action and preventive measures to ensure the integrity of the Compliance Program. Corrective action may include disciplinary action, training, revisions to or development of new policies and procedures, and/or additional monitoring and auditing. Disciplinary action may include oral or written warnings, suspension, termination or other sanctions, as determined on a case-by-case basis.
Per the requirements of California Health & Safety Code §§ 119400-119402, TESARO has established an annual dollar limit of $2000 for certain spending on individual medical or healthcare professionals licensed in California. TESARO includes in this dollar limit the value of educational items and meals provided to healthcare professionals in connection with business and educational discussions with those individuals. This dollar limit does not include prescription product samples intended for free distribution to patients, medical education or sponsorship grants, research grants, or fair market value payments for legitimate professional services. This dollar limit represents a spending maximum and not an average or goal. TESARO reserves the right to change this limit at any time.
To the best of its knowledge and based on its good faith understanding of the statutory requirements, TESARO declares that it is in compliance with this Compliance Program and the requirements of California Health & Safety Code §§ 119400-119402 in all material respects. Hard copies of TESARO’s Comprehensive Compliance Program and Declaration of Compliance with California Law may be obtained by calling (339) 970-0900.