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: Proposed Legislation
One of the considerable elements re-shaping the marketing of pharmaceuticals in the United States has been the outlooks and activities and probable future legislation under advisement by members of Congress. While the various actions at the federal level have dominated … Continue reading
Twice with in the past week, the New York Times has carried an article referencing the desire among some to split the Food and Drug Administration into two parts, one that oversees food and one that oversees drugs. On … Continue reading
As we all wait anxiously for Congress to do its job and actually produce legislation for signature, and as many FDA employees see their jobs hanging in the balance while awaiting PDUFA IV, some may wonder what it is all … Continue reading
This year, Senators Charles Grassley (R-Iowa) and Max Baucus (D-Mont) have been on more of a tear than usual regarding the FDA. A lot of their focus this year has been on post-marketing surveillance of drugs and devices. They are … Continue reading
There have been several proposals before Congress which, in one way or another, have the potential to impact the amount of direct-to-consumer advertising (DTC) allowed. Some would give the FDA authority to restrict such advertising. Others have called for it … Continue reading