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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Monthly Archives: February 2011
Weekly Roundup – 2/25/11
I can scarcely believe that the first two months of the year are over. Time is rushing by. Layer on top of that how quickly the world has changed in just the last 8 weeks. What will the next 8 … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 2/25/11
House Energy and Commerce to Re-Open Heparin Contamination Issue After House Votes to Cut FDA Funding
The U.S. House of Representatives Energy and Commerce Committee announced today that it was re-opening examination of the heparin contamination issue. A letter was sent by the Chair of the Committee, Rep. Fred Upton (R-MI) as well as other members to … Continue reading
Posted in Uncategorized 2 Comments
Government Shutdown? What Would it Mean?
Everyone is abuzz about what it would mean if there was a government shut down due to the current budget impasse caused by passage of cuts to the current fiscal year expenditures by the U.S. House of Representatives. For the … Continue reading
Posted in Uncategorized 4 Comments
Weekly Roundup 2/18/11
Inside the Beltway this week, as with much of the country, there was a tremendous thaw and we saw temperatures in the 70s. I saw my first daffodils sticking their little green necks above ground. But Washington is fickle. When … Continue reading
Posted in Uncategorized 1 Comment
Proposed Health Care, FDA and Pharma-Related Legislation Out of the 112th Congress
Before the re-design of the blog, off to the right I had a lengthy list of proposed legislation in the 111th Congress with links to the actual legislation. This includes laws aimed at health care access, at the FDA itself, … Continue reading
Posted in Proposed Legislation 1 Comment