California’s “Comprehensive Compliance Program” Law

California Recently Enacted Legislation Mandating “Comprehensive Compliance Programs” Requires that every pharma company adopt a “Comprehensive Compliance Program” (“CCP”) that is consistent with the OIG’s April 2003 Compliance Program Guidance, and with PhRMA’s July 2002 Code on Interactions with Healthcare Professionals. Requires CCP establish a “specific annual dollar limit” on incentives and “gifts, promotional materials, or items or activities” provided to an individual healthcare professional. Requires companies to conform their compliance programs to changes in OIG Guidance or the PhRMA Code within 6 months of any changes.

SB 1765- Declaration Requirement Companies must make a “written declaration of compliance” annually Must declare compliance with SB 1765 and company’s “Comprehensive Compliance Program” Declaration publicly posted, and available through toll-free number

- Drug samples for free distribution to patients Several “Exemptions” If given to providers in a manner that conforms to OIG Guidance and PhRMA Code, the following are exempt from the “dollar limits”: - Drug samples for free distribution to patients - Financial support for CME forums - Financial support for health education scholarships - Payments for legitimate consulting, or other professional services, if “fair market value”

Legislative Analysis Includes Specifics Compliance programs should have the 7 elements noted by OIG 1. Implement written policies/procedures 2. Designate compliance officer and committee 3. Implement regular, effective training and education 4. Maintain open communication between employees and compliance office 5. Conduct audits to monitor compliance 6. Enforce standards through publicized disciplinary guidelines 7. Investigate and respond to noncompliance and misconduct