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: April 2008
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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Weekly Roundup – 04/11/08
Well, Congress is back and writing enough letters to the stakeholders in the pharmaceutical industry to keep the Post Office in the black for many months! The cherry blossoms have peaked and we have settled into several days of gloomy … Continue reading
Posted in Weekly Roundup
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A Signal for the Future on Intellectual Property?
Congressman Henry Waxman (D-CA), through the House Committee on Oversight and Reform, sent a letter to Susan C. Schwab, the U.S. Trade Representative yesterday that urged her to focus on access to medicines for those treatments that were life-saving weighing … Continue reading
Posted in Intellectual Property
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Warning Letter Summary – First Quarter 2008
For some time, I have been writing about the lack of enforcement coming out of FDA in general and the Division of Drug Marketing and Advertising and Communications (DDMAC). Well, DDMAC has hit a new low. In looking at warning … Continue reading
Posted in Warning Letters
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More DTC Reforms
Yesterday I noted that there were letters flowing down from the Hill to manufacturers regarding some specific examples of Direct-to-Consumer (DTC) ads that were of interest to various members for various reasons. Today, the Los Angeles Times carries a report … Continue reading
Posted in DTC Advertising
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