Pharma Marketing Network

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.

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.

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.

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.

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.

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.

Gain a perspective on issues surrounding the utilization of anonymous patient-level data. Learn strategies for gaining acceptance from upper management, accurately predicting the value of each new Rx, ramifications of HIPAA, identifying and understanding physician prescribing habits and much more!

Publication Planning 2003:cUtilizing Scientifically Accurate, Commercially Relevant Strategies for Optimal Drug Acceptance and Exposure.

The Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum has been established as a direct result of the heightened need for corporate compliance programs, increased government scrutiny and new regulations being imposed upon the pharmaceutical industry.

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.