Regulatory Guidelines
ACCME Standards for Integrity and Independence
Initially developed in 1992, the ACCME Standards has established a framework for ensuring that CME developed with financial grant support from commercial interests is delivered without bias. Updates to the Criteria in 2006, provide us with rules for evaluating and certifying medical education activities. In addition to the Standards, the ACCME produces guidelines and policies with which accredited providers must comply.
ACCME Standards for Integrity and Independence
PhRMA Code on Interactions with Healthcare Professionals
The Pharmaceutical Research and Manufacturers Association (PhRMA) developed a voluntary code of ethics that provides pharmaceutical and biotech employees with guidelines for interacting with healthcare providers.
PhRMA Code on Interactions with Healthcare Professionals
FDA Final Guidance on Industry-Supported Scientific and Educational Activities
In 1997, the FDA released a guidance document that distinguished the differences and separation of two distinct those activities managed by pharmaceutical and biotech companies and CME and other activities, supported by companies, that are otherwise independent from the promotional influence of the supporting company.
FDA Final Guidance on Industry-Supported Scientific and Educational Activities
OIG Compliance Program Guidance for Pharmaceutical Manufacturers and Exclusion List
The federal Office of Inspector General (OIG) of the Department of Health and Human Services issued a 2003 document requiring pharmaceutical organizations to fully separate their sales and promotional activities from their education activities. Certified CME is a subset of the educational activities addressed in the guidance, but the OIG clearly states that these activities should be “independent from promotional influence.”
OIG Compliance Program Guidance for Pharmaceutical Manufacturers