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: August 2006
Plan B Approved!!!
A hearty congratulations to Dr. Andrew C. von Eschenbach for doing the right thing and moving Plan B from prescription to over-the-counter today when the FDA issued official notice of the Plan B Approval. The delay of the Plan B … Continue reading
Posted in Uncategorized 1 Comment
Consumer Confidence in Scientific Studies – Studying the Impact of Studies
An interesting article appeared this week in Yahoo Health News speculating on the confidence that patients and consumers might be losing in the claims associated with treatments and goods. The article cites a few high profile drug reversals, such as … Continue reading
Posted in Uncategorized Comments Off on Consumer Confidence in Scientific Studies – Studying the Impact of Studies
Well folks, it is summer and things are moving kind of slow in DC. My commute, which in any other season is about 40 minutes to go 6 miles now takes only 15 minutes. But the fact that news is … Continue reading
Posted in Miscellaney Comments Off on Hodgepodge
Risk Benefit and DSHEA
The FDA has issued a statement regarding the decision by the Tenth Circuit Court of Appeals reversing a lower court decision on the FDA actions to ban ephedra from sale in the United States. You will recall that after a … Continue reading
Posted in Vitamins and Supplements Comments Off on Risk Benefit and DSHEA
D Day for Plan B?
Barr Labs announced last week that it had re-filed its application with the FDA to move Plan B contraceptives from RX to OTC. Also last week, some in conservative ranks began to call upon the White House to withdraw the … Continue reading
Posted in FDA Image Comments Off on D Day for Plan B?