State of California
Declaration of Compliance
Vyera Pharmaceuticals, LLC, formerly known as Turing Pharmaceuticals LLC, (Vyera) has developed a Comprehensive Compliance Program (CCP) and declares, in good faith, that it is in substantial compliance with the CCP and the requirements of California Health and Safety Code §§ 119400-119402. This declaration is based upon information available during the twelve month period from January 1, 2016 through December 31, 2016. The next declaration will be based upon information captured beginning January 1, 2017.
As appropriate and consistent with applicable law, Vyera will amend and make conforming changes to its CCP. Vyera's CCP is tailored to the size, organizational structure, and resources of the company and is reasonably designed to prevent and detect compliance violations in accordance with the HHS OIG Compliance Program Guidance for Pharmaceutical Manufacturers. A copy of the Comprehensive Compliance Program and this written declaration can be requested by calling 646-565-4341.
Compliance Program Summary
It is the policy of Vyera to comply with applicable laws and regulations and industry standards, including the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG Guidance”). Our Comprehensive Compliance Program incorporates the following elements from the OIG Guidance:
- Written Policies and Procedures
- Compliance Committee
- Effective Training and Education
- Effective Lines of Communication
- Internal Monitoring and Auditing
- Enforcement Through Discipline Pursuant to Established Guidelines; and
- Prompt Response and Corrective Action for Detected Problems
Vyera sales and marketing personnel interact with healthcare professionals to provide them with information about Vyera products and other relevant educational or scientific topics. Vyera believes that these interactions provide educational value to healthcare professionals and help benefit patients. In connection with certain of these interactions, Vyera may provide promotional materials, or educational items intended to benefit a patient or related to a healthcare professionals’ practice. Vyera may also on occasion offer modest meals to healthcare professionals in connection with educational presentations, which meals are secondary to an educational discussion. On occasion Vyera may approve the distribution of an educational item to a healthcare professional, which educational item is designed primarily for the education of patients or healthcare professionals and is not of substantial value, and does not have a value to the healthcare professional outside of his or her professional responsibilities. Vyera's Comprehensive Compliance Program is designed to ensure that these activities are conducted in lawful manner.
Annual Spend Limit
Subject to the California law, Vyera has determined that the annual aggregate limit on covered promotional expenditures in California is set at $700.00 per covered healthcare professional for each calendar year. This limit may be revised by Vyera from time to time. It is important to note that this annual dollar limit is an upper limit and is not meant to be a representation of the average value of gifts, promotional materials, items or activities that Vyera may provide generally to a healthcare professional. The average could be a lower amount. In accordance with the law, certain items and payments are excluded in determining whether the annual limit has been met. The annual limit does not include the value of:
- Drug samples provided to healthcare professionals intended for free distribution to patients;
- Financial support for continuing medical education forums;
- Financial support for health educational scholarships; and
- Payments for legitimate professional services, including professional speaking, advising, consulting, training or market research services, that are based on the fair market value of the services provided.
Dated: September 1, 2017