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
My Profile
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: Legislation
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
New Drug Proposed for FDA Regulation of Cosmetics
Recently there have been a number of new laws proposed or enacted aimed at giving the FDA more authority over both food and drugs. However, another area (often overlooked) of regulatory authority is cosmetics. This week, however, cosmetics takes on … Continue reading
Posted in Legislation
1 Comment
Health Care Reform and Its Impact on FDA and Pharma
Last week, the excruciatingly long and unpredictable path of health care reform passed another milestone when President Obama held a summit at Blair House among leaders in Congress to try to forge out a bipartisan approach to a bill that would … Continue reading
Posted in FDA Policy, Legislation
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Why Healthcare Reform is Struggling – A Failure to Communicate
Back in the 1990s when I was working as Policy Director at AIDS Project Los Angeles, I was having trouble getting an appointment with a particular Congressman to discuss proposed cuts to the Housing Opportunities for People with AIDS (HOPWA) … Continue reading
Posted in Legislation
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FDA Related Proposed Legislation in Congress
Since the 111th Congress has gotten underway, there have been a host of new and recycled bills that have been proposed. This probably only reprsents the tip of the iceberg of the types of reforms that are aimed at … Continue reading
Posted in Legislation
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