Guidelines for Off-label Communications

Off-label information distribution by pharmaceutical companies to physicians is legal and in common practice, though 'off-label confusion' might be the better term. This article reviews several court cases relating to false claims associated with off-label communications and suggests seven steps to safely for marketing a pharmaceutical product for an unapproved indication.

Guidelines for Off-label Communications

Off-label information distribution by pharmaceutical companies to physicians is legal and in common practice, though 'off-label confusion' might be the better term. This article reviews several court cases relating to false claims associated with off-label communications and suggests seven steps to safely for marketing a pharmaceutical product for an unapproved indication.

Integrating Compliance into Commercial Practices

Pharmaceutical sales and marketing people often have an uneasy relationship with their compliance colleagues. In these days of OIG anti-kickback regulations and PhRMA guidelines for marketing to physicians, it behooves marketing professionals to work more cooperatively with compliance officials. In this article, two compliance officials from different pharmaceutical companies discuss ways in which commercial and compliance personnel can work together toward common goals.

Pharma’s Confidence Crisis: A Call for a New Marketing Paradigm?

It is said by many that pharma is an industry in crisis. It faces weakening pipelines, spiraling costs and political adversity. It is plagued by pricing pressures on every front, increasingly competitive markets, patent challenges and public distrust. What is the root cause of its many other challenges? This article examines the crisis and discusses strategies for overcoming it with case examples.

Managing Privacy Risks in Your Commercial Practices

Even though the privacy regulations under HIPAA (the Health Insurance Portability and Accountability Act of 1996) do not directly apply to pharmaceutical companies, HIPAA may have heightened health privacy sensitivities among consumers and health professionals. Learn what practical advice two attorneys at pharmaceutical companies have for their colleagues wishing to manage privacy risks.

The FTC-Lilly Consent Decree: What it Means for PHARMA Vendors and Partners

The 2002 settlement between ELi Lilly and the FTC regarding 'unauthorized disclosure of sensitive personal information collected from consumers' has an impact beyond Lilly. It also affects its agents who collect personally identifiable information from consumers in 'connection with the advertising, marketing, offering for sale, or sale of any pharmaceutical product…' Such agents could include interactive agencies that build and maintain Web sites, direct marketing agencies, fulfillment centers, market researchers, etc. If you are a pharmaceutical service provider, read this commentary to learn what you need to do to be compliant with privacy and security standards demanded by your pharma clients.

PhRMA Code Succeeding — So Far

This article summarizes the views of Scott Willoughby, Senior Manager of Ernst & Young and former Assistant General Counsel to the Pharmaceutical Research and Manufacturers of American (PhRMA) with regard to the current state of compliance with the PhRMA Code on Interactions with Healthcare Professionals and how it is impacting sales effectiveness.

OpEd: Risky Business

Product managers may take more risks than necessary and there may be few regulations that define a bright line between allowed and not allowed activities.

Developing Win-Win Key Opinion Leader Relationships

This article features results from research by Cutting Edge Information, a pharmaceutical business intelligence firm in Durham, North Carolina. Cutting Edge studied winning practices in thought leader management and has worked closely with more than a dozen KOL management executives from industry leaders, such as Pfizer, AstraZeneca and GlaxoSmithKline.

Putting the Customer Back in Customer Relationship Management

This article features the thoughts of Derek Evans, Vice President, Global Solutions Marketing at Dendrite International, on how to put the customer back in Customer Relationship Management. In addition to reinforcing the problems of too many reps, limited physician access, and physician dissatisfaction with the reps' level of knowledge, Evans emphasized the compound effect of excessive focus on high prescribers and the restrictions of formularies and government regulations.
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