About the Author
My 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.Stay Connected
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I 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: April 2009
DDMAC Mis-steps Badly and “Sows Confusion”
Last week, the New York Times carried an article "FDA Rules on Ads Sow Confusion as Applied to the Web" that addresses the call by the agency to issue 14 letters regarding 45 brands based on the lack of risk … Continue reading
Posted in DTC Advertising, FDA Policy
4 Comments
Perspectives on DTC Perspectives
Yesterday I had the good fortune to participate on a panel staged at the National DTC Perspectives Conference held here in Washington. The conference was impressive not only because of the size and scope of the turnout – hundreds … Continue reading
Posted in DTC Advertising, FDA Policy
2 Comments
FDA Staffing Provides Insight into Future Changes Affecting DTC
This week it was announced that a senior fellow from the office of Senator Edward Kennedy would be heading back to FDA as a senior counselor to Dr. Joshua Sharfstein where it is reported that the FDA Office of Legislative … Continue reading
Posted in DTC Advertising, FDA Policy
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A Conversation Around the Legal Questions About the FDA’s 14 Untitled Letters on Paid Search Ads
The issuance of the 14 untitled letters by the FDA a week ago Friday has been very troubling on a number of circumstances. The agency accompanied the action that the letters were sent as part of "routine monitoring" which, unfortunately, … Continue reading
Posted in FDA Policy
1 Comment
Weekly Roundup – 4/10/09
The cherry blossoms are done, but for some reason, the tourists are still sticking around Washington. The Administration continues to fill jobs, though frankly not at a fast enough rate, with the Secretary of HHS still unconfirmed as is the … Continue reading
Posted in Weekly Roundup
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