About This Monograph
Prior to 2012, FDLI published the FDLI Monograph Series, which consisted of six monographs annually. We now publish 4 to 6 Primers each year.
Life sciences companies continue to feel the pressure of stepped-up enforcement, often with regard to alleged behavior of their sales representatives. There is an exponential increase in attention being devoted to sales force issues from the Department of Justice, U.S. Attorneys, National Association of Attorneys General (NAAG), state prosecutors, state and federal regulators, investigative journalists, plaintiffs' counsel and advocacy groups.
The pharmaceutical, medical device and biotechnology industries are particularly vulnerable through their sales representatives due to the boundless laws and regulations that affect the promotion, sale and distribution of product. Sales representatives need to comply with state aggregate spend disclosure laws, sampling restrictions, licensing requirements for detailers and lobbyists, individual medical facility registration requirements, and limitations on interactions with healthcare practitioners. The life sciences sales representative is vulnerable to attack because of his or her direct interaction with medical practitioners and an alleged industry history of suspect promotional practices by some. This charged environment creates a perfect storm for casting the field force as scapegoats in lawsuits. Companies should be cognizant of employment issues stemming from a diverse field force, as well as liability and risk associated with discrimination and whistleblower suits. All these restrictions work in conjunction with state anti-kickback, consumer fraud, and false claims issues, as well as restrictions on promotional and off-label communications.
This monograph focuses on the importance of training and monitoring sales representatives, including behavior in interactions with healthcare practitioners. It also details best employment practices, and what to expect if litigation looms. It is designed to assist legal and compliance officers, managers and supervisors of life sciences company sales forces, and human resources professionals in dealing with the training and behavior of sales representatives to avoid exposing the company to prosecution, enforcement actions, penalties and/or civil lawsuits.
After reading this Monograph, you will be better able to:
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- Understand the myriad restrictions impacting field personnel and potential exposure for litigation;
- Manage issues related to the employment of sales representatives who work almost exclusively off-site; and
- Create a compliance program, code of conduct, and policies and procedures to ensure compliance, reduce risk and maximize effectiveness of sales representatives.