About the AuthorMy 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.
My ProfileI 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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Legislative Tracking Tools
Monthly Archives: April 2009
Sebelius in – Now Give Us Hamburg Stat! The Swine Flu Outbreak Waits for No Senate.
Time is racing against politics which is racing against time. Yesterday the Senate finally confirmed the appointment of Kathleen Sebelius as HHS Secretary and she resigned her post as governor of Kansas. Given the unfolding events from last week … Continue reading
Posted in Current Affairs 1 Comment
Are Increased Foreign Inspections of Plants the Answer to Better Risk Management?
This week, Senators Kennedy and Grassley announced that they were reviving a legislative proposal from the last Congress that would increase the ability of the FDA to conduct foreign inspections of manufacturing facilities for drugs and devices where components are … Continue reading
Posted in Proposed Legislation 2 Comments
This is Not a Drill – What the Mexican Swine Flu Outbreak Means for Public Health and the Pharma Industry
For many years now, public health officials have been watching with worry for signs that the Avian flu virus might leap from birds to humans and become transmissible in a way that brings the onset of a flu pandemic not … Continue reading
Posted in Crisis Communications, Current Affairs Comments Off on This is Not a Drill – What the Mexican Swine Flu Outbreak Means for Public Health and the Pharma Industry
Weekly Roundup 4/24/09
I have not had a case of blog-fade, I am merely incredibly busy of late, which has made posting a challenge. Many mornings lately have involved 4:30 AM wakeups. You know how it is. There is comfort in unusually beautiful … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 4/24/09