Tag Archives: off-label

Social Media Questions Pharma Companies Should Be Asking

For pharma companies, entering the social media scene is not as simple as just creating a Facebook page or learning how to tweet in 140 characters or less. Social media poses a regulatory and litigation maze that must be carefully navigated. Here, Mathew dos Santos and Lori Leskin provide some insight into the most pressing questions companies are, […]
Posted in E-Media, FDA, Guest Blog, multimedia, Patient Communication, Regulatory, social media | Also tagged , | Leave a comment

What Does ‘Off Label’ Mean in 2014?

by Tom Norton Years ago, while sitting in an Rx company lunch room, I was listening to one of the company’s top sales reps discuss the commercial progress a recently launched prescription was making. The rep said that the product was selling “OK” under its FDA approved, indicated therapeutic area. However, he quietly said, “It’s […]
Posted in Biotech, FDA, Guest Blog, healthcare, Legal, Market Access, Marketing, pricing, Regulatory, Strategy | Also tagged , | 1 Comment

Confessions of a Compliance Director

In anticipation of CBI’s (a PharmExec sibling company) 11th Annual Pharma Compliance Congress happening later this month, PharmExec spoke with a compliance director at a mid-sized pharma ($5 billion in annual sales) about life under a CIA, and the potential trigger issues for 2014. In an effort to promote candor and avoid overly circumspect responses, […]
Posted in compliance, Corporate Responsibility, E-Media, Emerging Markets, FDA, healthcare, Legal, Marketing, Medical Education, pricing, Regulatory, Sales, social media, Strategy | Also tagged , , , , , , , , , , , , , | Leave a comment

Tom Abrams: Caronia Won't Stop Off-Label Enforcement

The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
Posted in Advertising, Agency Insight, E-Media, FDA, leadership, Legal, Marketing, Regulatory, social media | Also tagged , , , , , , | 1 Comment

Temple 'Horrified' by Caronia Decision

If people can promote drugs for uses that lack supporting evidence, it would turn back the clock to the pre-1962 world of medicine where there wasn’t any research or data on what medicines worked and what was harmful, says Robert Temple, deputy director for clinical science at FDA’s Center for Drug Evaluation and Research (CDER).
Posted in compliance, FDA, Marketing, Sales | Also tagged , , , , | 2 Comments
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