Balancing Global Corporate Messaging with Local Concerns: Lessons from the Trenches
April 25, 2016
As all of our work becomes increasingly global, it is interesting to note the significant social, cultural, language and other differences that make message development and communications training for different countries more challenging than ever. This is particularly true when the messages on a product or issue have to be consistent across a global organization, but at the same time, resonate with – and not offend — audiences in specific regions.
Executive Speaking Success: Tips for Health Care Leaders
April 11, 2016
What can health care leaders do to make an impact and be remembered? They need to reach what I’m calling the new C-Suite. No, not that C-Suite located on the top floor filled with a company’s most important C-level executives, the CEO, COO, CFO… No, this C-Suite outlines the elements you need to master to achieve executive speaking success.
Off-Label Promotion: The Transition from Volume to Value
March 16, 2016
Last week, FDA and Amarin Corporation reached a negotiated settlement of a legal case concerning off-label promotion for use of a drug for an unapproved indication. The negotiation established parameters for how Amarin and the FDA will operationalize the Court’s finding that the FDA cannot stop a company from providing truthful and non-misleading information about unapproved new indications of a drug. What the Court decision and the negotiated settlement mean for the future of off-label new use promotion beyond Amarin will become clear over time. What this case prompts for me is perhaps the bigger question – and that is, how should FDA and life science companies consider the larger set of data issues that sit at the heart of our healthcare system’s transition from volume to value?
Why the Amarin Settlement Will Have Little Impact on Pharma Marketing in the U.S.
March 11, 2016
Following the results of the Amarin legal judgment, there has been speculation that the ability to promote unapproved, “off-label” claims for prescription drugs will dramatically change. Yet, there are specific reasons why the Amarin First Amendment legal case succeeded and hundreds, if not thousands, of other cases have failed. While the Amarin judgment has set a precedent, it should not have a dramatic change on promotional claim requirements in pharma marketing – meaning that companies do not have First Amendment protection for statements that are untruthful and misleading. It’s not expected that the FDA will diminish the criteria needed to support substantial evidence of efficacy. Instead they will continue to vigorously protect public health and the communication of accurate, science-based information.