Business Implications of Pending Pharma Sales & Marketing Regulations, July 24, 2008

Numerous states have imposed regulations challenging US pharmaceutical sales and marketing. These regulations, and many more newly proposed, encompass physician spend limitations, data restrictions, pharmaceutical detailing/marketing controls, and more. While some regulations have existed in Europe for years, they are new for the U.S. and have a wide variety of associated compliance, business and cost implications. They create a new market landscape that poses risks and opportunities, particularly meaningful as the industry continues to evaluate changes in the traditional field sales model.

This panel brought together five key stakeholders – pharmaceutical manufacturers, service and advisory organizations, and a physician – to discuss these passed and pending legislations and their implications for the healthcare industry.  Panelists included:

     • Thomas Abbott (President, i3 Pharma Informatics)
     • Bill Buzzeo (VP/GM Compliance Solutions, Cegedim Dendrite)
     • Dave Carver (Senior Director, Sales Operations, Schering-Plough)
     • Justin Dillon (Associate Director, Federal & State Reporting, Merck)
     • Naomi Grobstein, MD (Family Health Center of Montclair)

Susan Dorfman (VP Global Marketing, Skila) and Mark Hurwich (VP Professional Services, marketRx) moderated.

Based on audience feedback the panel narrowed its focus to three topics: Revised PhRMA Marketing Code proposed in July 2008 and its influence on pharma sales and marketing practices; privacy and data mining of physician prescription data, and pharma sampling practices.  The discussions on all three topics were engaged and extensive, with both audience and panelists challenging and supporting often opposing viewpoints.  The dynamic nature of the discussions underscored both the variety of viewpoints that exist on each of these topics, and also the interest in the audience in exploring the real implications behind the impending challenging regulatory changes for the pharmaceutical industry.         

1) Both panelist and audience were keenly interested in discussing the newly Revised PhRMA Marketing Code for Responsible Interactions with Healthcare Professionals (proposed by PhRMA in July 2008) and what it would mean for the pharma industry.  The Code, which will take effect in January 2009, provides firm guidance on such interactions including the use of promotional materials; grants and consulting arrangements; meals and entertainment; continuing medical education; clinical practice guidelines; and sales and marketing training for company representatives.  Some panellists asserted that the revised code would not cause substantial change in pharma companies' current practices, but in fact may result in a more effective allocation of resources to sales and marketing – hence the pharmaceutical companies may agree to the changes voluntarily.  Yet, others were skeptical whether pharmaceutical companies would simply find "other ways" to market their products

2) Privacy and Data Mining
Should pharma companies be allowed to see physicians' longitudinal prescription data?
At the core of the discussion was a fundamental philosophical dilemma between the importance of allowing freedom of information access versus the potential for pharma companies to exert undue influence on physicians' prescription decisions – with no one right answer, the discussion was illuminating for everyone.

3) Sampling
While sampling practices often are beneficial to companies' sales, samples are also often misused, underutilized, or even wasted.  Panelists agreed that, as a general rule, it is in the interests of pharmaceutical companies and society at large when samples are used for the purpose of trial of new medicines by patients, and not as an inducement or substitute to a drug prescription.

The meeting was sponsored by Cegedim Dendrite, and took place at its facility in Bedminster, NJ.