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.Stay Connected
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I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Monthly Archives: September 2009
The Swine Flu Vaccine is Approved – If You Build it Will They Come?
Yesterday the Food and Drug Administration announced the approval of flu vaccines for the H1N1 flu virus, popularly known as Swine Flu, being manufactured by four separate firms. The amount of time between the initial outbreaks of H1N1 this Spring, … Continue reading
Posted in Approval Announcements
2 Comments
Irony of Ironies – FDA Opens Up a Pharma-Based Twitter Feed
For some time, the pharmaceutical industry has been wondering around the social media space with a blindfold on. With no guidance, and no indication of any position whatsoever, FDAs DDMAC has let each medical products take their chances in the … Continue reading
Posted in FDA Policy, New and Social Media
5 Comments
Early Communications Means Early Warning, Early Prep
On Friday, I had the opportunity to provide some thoughts to Matthew Perrone of the Associated Press in relation to an article he was writing about the recent "early communication" from the FDA regardin GlaxoSmithKline's Over-the-Counter weight loss product alli. … Continue reading
Posted in Crisis Communications, FDA Policy
Comments Off on Early Communications Means Early Warning, Early Prep
Google Wave 3 – How Will Google Wave Communications Be Regulated – If At All?
According to Mashable, Google Wave will be released to a limited number of people on September 30, 2009. Many people are excited about this. I am one of them. For background on my thoughts on Google Wave and the medical … Continue reading
Posted in New and Social Media
2 Comments
FDA’s Reportable Food Registry
For months now, there have been growing signs of the determination of the Obama Administration to engage the FDA as never before in the prevention of risk – on food, drugs and devices. The latest iteration of this came today … Continue reading
Posted in Food
2 Comments