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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Legislative Tracking Tools
Category Archives: OTC Switches
Adverse Events Reporting on OTCs and Supplements
As reported earlier this week, S.3546 – the Dietary and Supplement and Nonprescription Drug Consumer Act was passed by the Senate on December 6. Subsequently, on December 9, the House passed the Bill by a 2-1 majority. A few minutes … Continue reading
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Plan B Available OTC
Plan B will become available this week without a prescription, New York Newsday reports. It is about time. There are also reports that criticism has been voiced over the fact that the manufacturer has achieved exclusivity for a three year … Continue reading
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The Cold War
Recently Congressman Henry Waxman (D-CA) has been involved in correspondence with Acting Commissioner Andrew C. von Eschenbach. He wrote on August 23, September 22 and now again on October 23. It seems to be a monthly thing. His concern is … Continue reading
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A Study of Statins
There is perhaps no better candidate in the pipeline for an RX to OTC switch than for statins. Statins lower cholesterol dramatically and therefore one can intuit – they would lower the rate of heart disease in this country if … Continue reading
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FDA, the Commissioner and Plan B
Apparently now it is being reported by the Minneapolis Star Tribune and Associated Press that Dr. Lester Crawford is stating that there was no attempt to disallow Plan B’s switch from RX to OTC, but rather that he delayed the … Continue reading
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