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.
Monthly Archives: March 2006
Another Resource
Recently I introduced you to Kip Piper’s excellent blog to learn about Medicare and Medicaid issues. This week I want to steer you back here. To the column at the left, I have indicated "Resources by Me". These are two … Continue reading
Posted in Useful Resources
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One Consequence of FDA Senate Hearings
There was lots of news of appointments at the FDA yesterday. In addition to the fact that Dr. Andrew C. von Eschenbach was formally nominated as Commissioner, David W. Boyer was appointed by Dr. von Eschenbach as the new head … Continue reading
Posted in Pharma Industry Image
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The RX to OTC Switch Environment
There are fewer drugs available for switching from prescription to over-the counter status than there have been in years gone by. Several years ago I was involved providing counsel on the largest switch of a drug from prescription (RX) to … Continue reading
Posted in OTC Switches
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A New Commissioner for the FDA?
Word has it that Acting FDA Commissioner Andrew C. von Eschenbach, M.D. (appointed in September 2005) is about to drop the acting part of his title and assume full leadership of the agency. He has little shoes to fill. The … Continue reading
Posted in FDA Policy
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Does the Return of Tysabri Signal a New Direction?
On February 28th, 2005, Biogen Idec and Elan announced the market suspension of Tysabri, a treatment for multiple sclerosis. The voluntary action was taken, per the Dear Healthcare Professional letter issued by the companies, out of reports that two patients … Continue reading
Posted in FDA Policy, Risk Management
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