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: July 2006
Clouds on the Horizon, Part 3
Every so often, I think it is a good idea to take stock of the current environment and assess the opportunities and challenges that lie ahead for both the FDA and for industry. Right now, there are a LOT of … Continue reading
Posted in Current Affairs, FDA Image, Pharma Industry Image
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Weekly Roundup 7-7-06
Unusual Warning Letter Posting – The FDA took the unusual step of posting a Warning Letter not on the Warning Letter Page, but on its home page relating to a manufacturer of flu vaccine. Vigilence over the flu vaccine manufacturing … Continue reading
Posted in Weekly Roundup
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Canadian DTC in the US
Yesterday, I heard something I never heard before. While listening to my commercial radio station as I was driving into work, I heard an advertisement for, not one drug, but any prescription drug. The commercial was for home delivery of … Continue reading
Posted in Drug Importation, Marketing
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Doing More in Defense of DTC Advertising
I think Direct-to-Consumer (DTC) ads are great. I do believe that they educate consumers and allow for greater choice and understanding. My legs aren’t restless, though I’m sure for those who have restless legs, it is a relief to know … Continue reading
Posted in Marketing, Pharma Industry Image
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Warning Letter Summary for Second Quarter 2006
As noted last week, there has been a great deal of concern expressed over the Bush Administration’s lax approach to the FDA’s mission. In my mind, one marker of that has been the lack of leadership at the FDA, either … Continue reading
Posted in Warning Letters
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