California Compliance Declaration
SUPERNUS COMPLIANCE PROGRAM
Supernus is committed to maintaining an effective compliance program in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of Inspector General of the United States Department of Health and Human Services (the “OIG Guidance”). A compliance program is one of the key components of our commitment to the highest standards of corporate conduct. The compliance program adopted by Supernus is intended to adhere to the OIG Guidance, as well as the current Pharmaceutical Research and Manufacturers of America (PhRMA) "Code on Interactions with Healthcare Professionals” (the “PhRMA Code”). Supernus is committed to complying with the OIG Guidance and the PhRMA Code.
Effective July 1, 2005, California law [Cal. Health & Safety Code §119402 (SB 1765)], requires certain pharmaceutical companies doing business in California to make available their program for compliance with applicable federal and state laws regulating the marketing and promotion of their products. In addition, California law requires pharmaceutical companies to establish annual dollar limits on items and promotional materials given to healthcare professionals.
Our current policies support adherence to the voluntary guidelines that California law will now enforce. Supernus will enhance its existing policies and programs to cover the formal annual dollar limits required by the law and begin monitoring performance against those limits.
Annual Spending Limit per California Healthcare Professional
Supernus sales professionals may occasionally provide items to health care professionals designed for the education of patients or healthcare professionals. These items will be of reasonable value and provided in accordance with the provisions of the PhRMA Code and other applicable Company policies. In addition, Supernus sales professionals may occasionally offer modest meals as part of an educational presentation or in connection with Supernus' efforts to advance the professionals’ understanding of the efficacy, safety, and benefits of Supernus' approved products. Supernus has currently established an annual limit of $2,500 per individual health care professional for these types of items.
Consistent with Supernus' understanding of the California law, Supernus excludes certain items and payments in determining whether the annual limit has been met. Supernus' annual dollar limit, as of the date of this declaration, does not include the value of:
- Drug samples provided to individual healthcare professionals intended for free distribution to patients.
- Financial support of independent education, including continuing medical education forums.
- Financial support for health education scholarships.
- 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.
- Items, including but not limited to patient educational brochures, anatomical instruction sheets, diaries or other materials to track medical information, provided to patients by their physician with the purpose of enhancing patients’ understanding or management of a disease state or disorder.
Annual Declaration for Purposes of California Health & Safety Code, §§ 119400-119402
As part of its ongoing efforts in the area of compliance, Supernus maintains a compliance program that is designed to comply with applicable federal and state laws related to the marketing and promotion of our products. To our knowledge as of the date of this declaration, Supernus is, in all material respects, in compliance with California Health & Safety Code, §§ 119400-119402.
Copies of this summary and declaration and Supernus Compliance Program may be obtained by contacting Supernus Compliance Office at the following toll-free number: 855-836-3925.