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.
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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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: April 2011
The FDA is going to study the Internet. In the Federal Register tomorrow, the agency is publishing a notice seeking comment on the “Examination of Online Direct-to-Consumer Prescription Drug Promotion“. Here is an excerpt: “Pharmaceutical products are launched and marketed … Continue reading
Every so often I write about a topic that has nothing to do with healthcare, FDA or regulatory matters. This is one of those times. Many years ago while I was in law school, I met a man who became … Continue reading
Commuting in DC without school and without Congress is dreamy. Everything is blooming, except things in my yard. My neighbor’s lilacs are in bloom, mine aren’t. My neighbor’s wisteria is blooming, mine isn’t. Some of my neighbors still have daffodils … Continue reading
A few months ago in early February, a Congressman attended a meeting of the House Ways and Means Committee. At a little after 2PM, he cast a vote on an issue before the committee. Just shy of a half hour … Continue reading