Relypsa’s Compliance Program

Relypsa is committed to integrity and doing what’s right. The Relypsa Compliance Program (“RCP”) is briefly described below. This Compliance Program is dynamic and is regularly reviewed and modified, as needed, to meet ever-changing compliance needs.

  1. Leadership
    The U.S. Healthcare Compliance Officer has responsibility for oversight of Relypsa’s U.S. Compliance Program. This includes oversight of the development and operation of the RCP. The U.S. Healthcare Compliance Officer has been vested with authority relating to U.S. compliance within the organization and shall exercise independent judgment concerning these matters.
  2. Code of Conduct
    Relypsa, a Vifor Pharma Group Company, has a Code of Conduct. All employees receive training on the Code and will receive training on an annual basis.
  3. Annual Spending Limit
    Relypsa has established guidelines and expectations regarding appropriate interactions with healthcare professionals. It is Relypsa’s policy to comply with the Pharmaceutical Research and Manufacturers of American (“PhRMA”) Code on Interactions with Healthcare Professionals (dated July 1, 2002), which includes limits on gifts, meals, and other activities with healthcare professionals. Accordingly, Relypsa has implemented policies and procedures to ensure that the annual dollar amount on gifts, promotional materials, or items for activities provided to individual medical or healthcare professionals practicing in the State of California does not exceed $1,500. This limit excludes financial support for continuing medical education, financial support for health education scholarships, and payments made at fair market value for legitimate professional services provided by healthcare professionals as permitted by the applicable rules.
  4. Education and Training
    All employees and new employees receive effective and timely compliance training annually. Relypsa will review and update its training programs periodically, as needed.
  5. Lines of Communication
    Relypsa maintains an open door policy for reporting and addressing compliance questions or concerns, including an anonymous hotline and anonymous reporting website.
    Hotline: 1-844-290-0608 (U.S.)
  6. Auditing, Monitoring, and Corrective Action
    Relypsa engages in auditing and monitoring activities and programs that are designed to identify potential areas of concern, mitigate compliance risks, and prevent recurrence of noncompliance. The U.S. Healthcare Compliance Officer also oversees the implementation and completion of corrective actions to address noncompliance.