Module 2: Physicians' Expectations of Industry and Sales Personnel

Release date: March 30, 2004
Renewal date: January 30, 2007
Expiration date: January 30, 2009

Module 2: Physicians' Expectations of Industry and Sales Personnel
Produced by American Medical Association, 2003.

This module introduces the role of the industry representative and FDA regulations governing industry/physician relations.

Accreditation/designation statements
Disclosure information

To receive a certificate of credit for this module, you must explore the entire module and successfully complete the test at the end of the module.

This module includes three topics:

Topic 1: The Role of an Industry Representative
A look at the role of industry representatives, including a description of the job, training, accountability, and compensation.

Topic 2: FDA Requirements
An introduction to the role of the FDA in governing interactions between industry representatives and physicians.

Topic 3: Physician Responsibility
Highlights the FDA guideline that addresses physicians' responsibility to report product-related safety and promotional issues.

Accreditation/Designation Statements

The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The American Medical Association designates this activity for a maximum of 1.0 AMA PRA Category 1 Credit ^TM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Disclosure of Conflict of Interest:

There are not relevant financial relationships to disclose. The following information is provided about the authors:

Author:
Janet Lucy Rose, PA, MBA

Janet Lucy Rose, PA, MBA served as the Director of the FDA's Center of Drug Evaluation and Research's (CDER) Division of Drug Marketing, Advertising and Communication (DDMAC). This division is responsible for regulating prescription drug advertising and promotion in the United States, both to healthcare providers and consumers. Additionally, she served as the Director of CDER's Office of Training and Communications. Ms. Rose was also associated with Mead Johnson Pharmaceuticals, a division of Bristol-Myers Squibb Pharmaceuticals, where she served as industry sales representative, regional sales trainer, and District Sales Manager. Ms. Rose has a degree in biology, an MBA, and was board-certified as a Physician Assistant after graduating from Wake Forest University's Physician Assistant Program.

Ms. Rose works as a consultant to numerous pharmaceutical, biologics, advertising, and public relations firms. Additionally, she worked several years for the FDA. None of these relationships represent a conflict of interest in this context, as the content is factual only (not editorial or opinion), not related to any specific company (companies), does not mention any drugs, and Ms. Rose does not stand to gain anything from any company based on the content herein.

Reviewers for this module included AMA staff and Kenneth V. Iserson, MD, MBA, Director, Arizona Bioethics Program, University of Arizona.

In collaboration with the Working Group for the Communication of Ethical Guidelines on Gifts to Physicians from Industry and its Educational Advisory Committee chaired by R. Van Harrison, PhD, University of Michigan School of Medicine.

Project Manager: Beverley D. Rowley, PhD, Medical Education and Research Associates, Inc., Tempe, Arizona.

Off-Label Usage:

The content of this CME publication does not contain discussion of off-label uses.

Module 2: Physicians' Expectations of Industry and Sales Personnel

Topic 1: The role of an industry representative

Topic 2: FDA Requirements

Topic 3: Physician Responsibility

Module 2: References