ARBOR PHARMACEUTICALS COMPLIANCE PROGRAM
AND CERTIFICATION OF COMPLIANCE
Arbor Pharmaceuticals is committed to ethically conducting its business. This commitment is unwavering and evident in everything we do.
Compliance with Applicable Laws
All Arbor employees must comply with all applicable laws and regulations including those related to the commercialization of pharmaceutical products. In addition to legal requirements, Arbor adheres to industry standards and best practices including the Compliance Program Guidance for Pharmaceutical Manufacturers, developed by the USDHHS Office of Inspector General and the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals ("PhRMA Code").
Written Policies and Standards
Arbor has implemented written policies, procedures and standards regarding compliance. These policies reaffirm Arbor's commitment to compliance and address the company's sales and marketing practices as well as specific areas of fraud and abuse such as the reporting of pricing and rebate information to federal health care programs.
Compliance Officer and Committee
Arbor has appointed a Chief Compliance Officer as well as a Compliance Committee. These entities are charged with the oversight, implementation and management of its compliance program. The Compliance Officer reports to the Chief Executive Officer and the management team as necessary. The Compliance Officer and the Compliance Committee periodically review the compliance program to respond to changes in applicable laws and regulations and best practices in the industry.
Education and Training
Arbor provides regular education and training programs to its employees. This includes training for those employees who interact with healthcare practitioners to ensure adherence to the PhRMA Code, anti-kickback laws and regulations governing the commercialization of pharmaceutical products.
Reporting and Investigation
Arbor's employees are encouraged to promptly report any violations of the compliance program to his/her manager or the company's Compliance Officer. In addition, the company has established a hotline for employees to anonymously and confidentially report suspected misconduct. The hotline number is 855-249-5706. All reported violations will be investigated by the Compliance Officer or his designee and the company will promptly respond to any violations of the compliance program. Arbor does not tolerate any retaliation against employees who provide good faith reports of suspected misconduct or participate in any investigation.
Arbor monitors its compliance via periodic audits. These audits ensure that the company's compliance program is comprehensive and that it has been appropriately implemented and followed.
Trustworthy Employees and Contractors
Arbor only hires honest employees and contractors. Arbor will not hire anyone who is excluded from participation in federal health care programs. Accordingly, all employees must submit to drug screenings and background investigations.
If violations of the compliance program occur, Arbor will take appropriate corrective and/or disciplinary action. The punishment will fit the crime and could include termination or reporting the incident to the relevant authorities.
Arbor has established an aggregate spending limit of $1,500 per health care professional. Fees associated with services received from health care professionals are excluded from this amount and these fees are based on the fair market value of the services provided. Product samples that are intended for free distribution to patients, items of nominal value (less than $10) or financial support for educational purposes are exempt from this limit.
Certification of Compliance
To the best of our knowledge, as of January 1, 2019 Arbor Pharmaceuticals, LLC is in material compliance with its Comprehensive Compliance Program and the requirements of the California Health & Safety Code §§ 119400-119402. It is Arbor’s expectation that all employees and contractors comply with its CCP and all policies that support this program. Arbor is committed to assessing ongoing compliance with the CCP, which is designed to prevent, detect and address potential or actual instances of non-compliance. This certification is based upon reviews performed in 2018. To obtain a copy of Arbor’s Compliance Program and written Certification of Compliance, please contact us at (866) 516-4950.