About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Category Archives: Regulatory Communications
Promotion of Investigational Compound – Historical Overview
Communications regarding medicines in development – often referred to as “investigational compounds” can be particularly challenging. On the one hand, there are data milestones and advancements for the product through the regulatory cycle about which there is great interest. On … Continue reading
Posted in FDA Policy, Regulatory Communications, Warning Letters
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A Serial on Cereal – The FDA and the FTC
In May of last year, the Food and Drug Administration sent a Warning Letter to General Mills about a box of Cheerios. The problem? The FDA read the Cheerios box and didn't like what they saw when it came … Continue reading
Posted in Food, Regulatory Communications
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A Bitter Pill to Swallow – The Perils in Off Label Promotion
On September 29, the US. Attorney's Office for the Northern District of California announced that a former CEO of InterMune was convicted of wire fraud for the "creation and dissemination of false and misleading information about the efficacy of InterMune's … Continue reading
Posted in Regulatory Communications
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Social Media and Pharmaceutical Marketing
On several occasions in the past, I have posted here on the need for pharmaceutical companies to embrace new and social media, along with several suggestions for doing so. One of the perceived barriers to the involvement of pharmaceutical companies, … Continue reading
Posted in Marketing, Regulatory Communications, Social Media, Useful Resources
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Anatomy of a Consent Decree
Following yesterday’s posting about catching up, another thing that happened last week is that a Consent Decree was issued by the FDA. The company involved was Shelhigh, Inc., which produces implantable devices. First of all, what is a Consent Decree? … Continue reading