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: May 2006
The Dangers of a Recess Appointment for Dr. von Eschenbach
Related to yesterday’s posting, because of the unorthodox way in which Plan B was handled, Acting Commissioner Andrew C. von Eschenbach faces the prospect of not ever being confirmed (though he actually had nothing to do with the issue). There … Continue reading
Posted in FDA Image Comments Off on The Dangers of a Recess Appointment for Dr. von Eschenbach
Good Time to Move on Plan B
Last week, former Acting Commissioner and former Commissioner Lester B. Crawford admitted in a deposition that he acted to pre-empt FDA staff from approving the OTC switch of Plan B, according to a report in the Baltimore Sun. What he … Continue reading
Posted in FDA Policy, OTC Switches Comments Off on Good Time to Move on Plan B
With an eye towards remembering those who have demonstrated the courage of their convictions, have a safe and pleasant Memorial Day.
Posted in Uncategorized Comments Off on Memorial Day
Weekly Roundup – 5-26-06
After a two-week hiatus, Weekly Roundup is back. Bad Legislative Action – An amendment to a House appropriations bill that would have provided for greater FDA authority over drug safety in post-marketing studies was stripped from the legislation. Expect hearings … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 5-26-06
Vitamins, Canada and a Lesson for NIH
With proposals before Congress (see Legislative section to the right) to allow the FDA additional power to regulate the industry of vitamins and supplements, there have been recent developments of note. Last week, the National Institutes of Health held a … Continue reading
Posted in DSHEA, Vitamins and Supplements Comments Off on Vitamins, Canada and a Lesson for NIH