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
Category Archives: Legislation
This is Your State – This is Your State on Drugs
In years gone by, I have taken occasion to write a posting with this title to take a look at the policy activity that is going on at the state level that impacts medicines. It has been a few years … Continue reading
Posted in Legislation Comments Off on This is Your State – This is Your State on Drugs
Legislative Proposals in the 114th Congress
Every so often, EyeonFDA has an update for you on legislation that is proposed in the Congress that would impact the medical product marketplace if passed. The new Congress has just two months old and while the last Congress was … Continue reading
Posted in Legislation Comments Off on Legislative Proposals in the 114th Congress
Is There a Doctor in the House? The Medical Background of Congress
Congress oversees a great deal that has to do with health care. You may have heard a little about that little piece of legislation that was passed called the Affordable Care Act (a/k/a Obamacare), comprehensively reforming our system of healthcare … Continue reading
Posted in Legislation Comments Off on Is There a Doctor in the House? The Medical Background of Congress
Election Impact – The New Class
Around elections, I have usually tried to provide some insight into where candidates stood on health care related issues, particularly affecting the development and marketing of medical products. I wasn’t able to do that through this election cycle, but now … Continue reading
Posted in Current Affairs, Legislation 1 Comment
Now What? Post-Election and FDA
We are finally post-election. The sense of relief that one can watch or listen to broadcast television or radio without seeing campaign ads is still being felt nationwide. Facebook sidebars are free of political jabber and de-friending over politics has … Continue reading
Posted in FDA Policy, Legislation, Politics Comments Off on Now What? Post-Election and FDA