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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Category Archives: DTC Advertising
MAD Doctors! FDA Deputizes Docs to do DDMAC Ad Reviews!
"Paging Dr. Draper! Paging Dr. Draper! We have an ad in the examination room that requires your attention, STAT!" The PA system goes quiet. In the waiting room, patients shuffle their feet nervously, waiting, waiting, waiting…. Dr. Draper enters the … Continue reading
Posted in DTC Advertising, FDA Policy, Warning Letters 3 Comments
FDLI Conference – Part 2 – Janet Woodcock Speech
At the opening of the 20th Food and Drug Law Institute Conference Annual Advertising and Promotion Conference, CDER's Dr. Janet Woodcock stood in for Dr. Margaret Hamburg who was said to have had a scheduling conflict due to a meeting … Continue reading
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Should FTC Oversee Online Communications?
As is well known, FDA's DDMAC has stubbornly refused to deliver any guidance for industry and for advertisers on what is and is not acceptable in communications on the Internet. Instead, the agency has repeatedly stated that it is not … Continue reading
Posted in DTC Advertising Comments Off on Should FTC Oversee Online Communications?
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