ACCME Standards for Commercial Support
Initially developed in 1992, the ACCME Standards set forth a framework for ensuring that CME developed with financial grant support from “commercial interests” is certified and delivered without bias. Updates to the Standards in 2004, as well as Board and policy changes between 2006 and 2008, provide Global and other accredited providers a basic “rulebook” 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 Commercial Support
OIG Compliance Program Guidance for Pharmaceutical Manufacturers and Exclusion List
The federal Office of Inspector General 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
The OIG also maintains a searchable database of excluded individuals and entities.
OIG Excluded Individuals and Entities
US Senate Finance Committee Staff Report
In 2007, the U.S. Senate Finance Committee issued a staff report regarding pharmaceutical company education grants for CME. While the report authors demonstrated a lack of understanding regarding certified CME in several areas, the report accurately noted that CME quality had improved in recent years but still needed to improve further. Based on data received from pharmaceutical companies and the ACCME, the report cited apparent flaws with enforcement of standards and guidelines by the ACCME. The ACCME has since responded to several criticisms in the staff report.
US Senate Finance Committee Staff Report
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 appropriate behavior when meeting with physicians and others.
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 types of activities: 1) those activities manage by, or on behalf of, pharmaceutical and biotech companies, and 2) 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
