Introduction On June 1, FDA issued a draft guidance, Evaluation and Reporting of Age, Race and Ethnicity Data in Medical Device Clinical Studies, which provides recommendations for the evaluation and reporting of age, race, and ethnicity data in medical device clinical studies.  This draft guidance has important implications for trial…

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Jun 15

Truth & Consequences: Pricing, Patient Access and What’s Next for Today’s BioPharm

Today’s exciting medical innovations should be shining moments for biopharma. Instead, companies are increasingly being tarnished by a... View Webinar

Today’s exciting medical innovations should be shining moments for biopharma. Instead, companies are increasingly being tarnished by a backlash over prices. Increased scrutiny means the old way of justifying a therapy’s price is obsolete. Influential stakeholders are demanding collaboration and transparency to maximize patient access.

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“60 Minutes” stories are morality plays. Good vs. Evil. The hero is the correspondent, who brings the story to climax with what Mike Wallace called, the “best question. One they don’t know is coming and I already have the answer.” They call that moment, the “Gotcha.”

When executives are deciding whether to accept interviews with shows like “60 Minutes,” they need to understand the gestalt of these shows – and learn how to survive and even excel on them.

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May 18

Preparing Early for a Successful FDA Advisory Committee or Device Panel Meeting

Good data alone are no longer enough to win approval. In today’s environment, it is critical to prepare a clear, credible and engaging... View Webinar

Good data alone are no longer enough to win approval. In today’s environment, it is critical to prepare a clear, credible and engaging presentation and to start the preparation process early.

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May 16

Panel Meeting Strategies: A Critical Look at the New Draft Guidance

We will: understand the panel process, detail recent draft guidance impacts panel preparation, assess opportunities to enhance the likelihood of... View Webinar

We will: understand the panel process, detail recent draft guidance impacts panel preparation, assess opportunities to enhance the likelihood of success before you submit your PMA, and understand success panel preparation steps.

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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.

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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?

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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.

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