BASIC LIBRARY OF KEY DOCUMENTS FOR HEALTHCARE COMMUNICATION PROFESSIONALS
This section of the Resource Center provides links to the most critical documents that every healthcare communication professional should be familiar with. These are all publicly available documents from regulatory bodies, federal agencies, or trade or professional organizations.
To access the resources in this library just scroll down, or click any item below:
FDA Regulations (Prescription Drug Advertising)
[Note: sometimes referred to as 21 CFR, Part 202]
View the Regulations Click here to view the Regulations
PhRMA Code (Pharmaceutical Research and Manufacturers of America’s Principles on Interactions with Healthcare Professionals)
PhRMA represents research-based pharmaceutical and biotechnology companies. Guidelines for interacting with healthcare professionals are addressed in the PhRMA Code, which was updated and enhanced as of 7/1/08 and takes effect on 1/1/09.
View the Code Click here to see a copy of the PhRMA Code on Interactions with Healthcare Professionals
Analogous to the PhRMA Code for the Pharmaceutical industry is the AdvaMed Code for the Medical Devices industry:
AdvaMed Code (Advanced Medical Technology Association’s Code of Ethics on Interaction with Health Care Professionals)
AdvaMed’s member companies produce nearly 90% of the healthcare technology purchased annually in the US, and more than 50% around the world; this technology includes medical devices, diagnostic products, and health information systems. Guidelines for interacting with healthcare professionals are addressed in the AdvaMed Code, which also includes Frequently Asked Questions about the Code.
View the Code Click here to access AdvaMed’s Code of Ethics on Interaction with Health Care Professionals
OIG Compliance Guidelines (Office of the Inspector General of HHS – “OIG Compliance Program Guidance for Pharmaceutical Manufacturers”)
In May, 2003, the OIG of the Department of Health and Human Services published in the Federal Register its guidelines stating the fundamental principles of compliance programs for pharmaceutical manufacturers. These Guidelines also detail the specific elements that pharmaceutical manufacturers should consider when developing and implementing an effective compliance program. The purpose of the Compliance Program Guidance is to encourage the use of internal controls to efficiently monitor adherence to applicable statutes, regulations, and program requirements, in order to prevent and reduce fraud and abuse in federal healthcare programs, such as Medicare and Medicaid.
View the Guidelines Click here to view the Guidelines
Sample Corporate Integrity Agreements (CIAs) from the OIG
Corporate Integrity Agreements (CIAs) are detailed and restrictive agreements, typically lasting 4-5 years, imposed by the OIG when serious misconduct (e.g., fraudulent action) is discovered. This may happen, for instance through an audit or a whistleblower’s reporting. The following are links to recent CIAs for six pharmaceutical companies:
View the Bristol-Myers Squibb CIA Click here to view this CIA
View the Merck CIA Click here to view this CIA
View the Jazz Pharmaceuticals CIA Click here to view this CIA
View the InterMune CIA Click here to view this CIA
View the Serono CIA Click here to view this CIA
View the Purdue CIA Click here to view this CIA
All CIAs Click here for the complete list of Corporate Integrity Agreements on the OIG Web site
ACCME (Accreditation Council for Continuing Medical Education)
ACCME’s stated mission is identifying, developing, and promoting standards, which apply to all CME providers, for quality continuing medical education (CME) utilized by physicians. The following are links to three sets of ACCME policies and standards applying to all CME providers.
View the Standards Click here to see a copy of the ACCME Accreditation Policies for CME Providers
View the Standards Click here to see a copy of the ACCME Standards for Commercial Support
View the Standards Click here to see a copy of the ACCME Essential Areas and Their Elements
AMA Guidelines
The American Medical Association is the country’s largest physician group, advocating on issues vital to the nation’s health. The following are links to three sets of AMA policies and standards applying to physicians:
View the Standards Click here to go to the AMA’s Ethical guidelines for gifts to physicians from industry
View the Standards Click here to go to the AMA’s Guidelines for Corporate Relationships
View the Standards Click here to go to the AMA’s Ethical opinions and guidelines