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
GINA is Here…
President Bush this week signed into law the Genetic Information Nondiscrimination Act (GINA) which is the "first and only" legislative effort at the federal level that will provide protections against discrimination based on an individual’s genetic information in health insurance … Continue reading
Posted in Legislation
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Congress, Safety, Heparin and Hearing on the Hill
Reuters video regarding yesterday’s hearing:
Posted in Legislation
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Stupak and Dingell “Concerned” May Spell Additional Reforms
On Friday, April 11, the House Committee on Energy and Commerce issued a release entitled "After Review of ENHANCE Trial Documents, Dingell, Stupak Express "Serious Concerns"" after writing to the CEOs of Merck and Schering Plough to ask for additional … Continue reading
Posted in Current Affairs, Legislation
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New DTC Oversight Powers Given FDA – Show Me the Money!
I was fascinated to read the RPM Report analysis of the new system that will emerge when the new FDA bill is signed into law. A new user fee program for review of DTC ads will exist that allows the … Continue reading
Posted in DTC Advertising, FDA Policy, Legislation, Marketing
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This is Your State – This is Your State on Drugs – An Intermittent Series
I’m a bit late on this update, which came out late last month, but the National Conference of State Legislatures has released another overview of what states are doing in legislation so far this year in healthcare. Here are a … Continue reading
Posted in Legislation
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