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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Legislative Tracking Tools
Category Archives: Food
Health Claims and Food – GAO Issues a Report – FDA Needs to Clarify
Last week, the General Accounting Office issued a report entitled “FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims” where – well, the title sort of gives away the gist of the thing, doesn’t it. FDA does need to … Continue reading
Posted in Food, Uncategorized
2 Comments
Food Safety Modernization Act – Passed but Not Funded – A Conversation with Congressman Jack Kingston of the House Appropriations Committee
Many were surprised when at the end of the 111th Congress, the Food Safety Modernization Act was passed and in early January, President Obama signed it into law. FDA Commissioner Margaret Hamburg was a key proponent of the bill, and … Continue reading
Posted in Food, Legislation
8 Comments
The Food Administration – The Drug Administration – Legislation Introduced for a Single Agency
Right now, the regulatory jurisdiction for the Food and Drug Administration is huge, overseeing by most estimates approximately one-fourth of the U.S. economy. And in recent months it has expanded into regulating the marketing of tobacco products. Presumably in the … Continue reading
Posted in Food, Uncategorized
1 Comment
The Senate Weighing in on FDA Decisions Says No to GE Salmon
There has never been a shyness on the part of members of Congress from weighing in when it comes to FDA examination of a scientific issue. That is unfortunate. Food Safety News reports (along with The Hill) that eleven U.S. Senators … Continue reading
Posted in FDA Policy, Food
Comments Off on The Senate Weighing in on FDA Decisions Says No to GE Salmon
A Serial on Cereal – The FDA and the FTC
In May of last year, the Food and Drug Administration sent a Warning Letter to General Mills about a box of Cheerios. The problem? The FDA read the Cheerios box and didn't like what they saw when it came … Continue reading
Posted in Food, Regulatory Communications
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