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: February 2008
Warning! Warning! Warning! (Yawn)
Pursuant to the posting earlier this week which noted the rate of drug safety alerts out of the FDA, there also this week was a story published at CNNMoney.com that raises the very valid question whether or not patients and … Continue reading
Posted in Drug Safety, FDA Policy
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FDA Strategy When Under Attack – Drift
In recent weeks, policymakers have turned up the heat on the FDA. First, Congressman Bart Stupak (D-MI) sent Dr. Andrew C. von Eschenbach a Valentine by demanding his resignation on February 14. Less than a week later, Congresswoman Rosa DeLauro … Continue reading
Posted in FDA Image
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FDA MedWatch Alerts – Up or Down?
The Health Section of today’s Washington Post runs a story called "Why All the Drug Alerts? Step-Up Signals FDA Bid for Renewed Trust" which focuses on the uptick in FDA safety alerts about drugs. The uptick that the Post notes … Continue reading
Posted in FDA Image
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Is Pharmacogenomics a Realistic Possibility?
Late last month, the National Health Policy Forum published a background paper called Pharmacogenomics: A Primer for Policymakers written by Leslie Tucker. It is a really excellent overview of the state of the state on pharmacogenomics and as the title … Continue reading
Posted in FDA Policy
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Weekly Roundup – 2/22-08
Inside the Beltway it is cold, foggy and icy. Hopefully where you are, it is warm and pleasant. This week I posted on the listing of approvable letters for 2007. This proved an immensely popular posting, I am happy to … Continue reading
Posted in Weekly Roundup
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