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
Counterfeit Drugs and the FDA
Last week, Randall W. Lutter, Associate Commissioner for Policy and Planning at the FDA testified before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources Committee on Government Reform in the House. This, by the way, is the same … Continue reading
Posted in Current Affairs, FDA Policy
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Weekly Roundup – 7/14/06
Have a good weekend everyone! Warnings to Consumers on Erectile Dysfunction Remedies Sold On Internet – The FDA issued both a press release and a MedWatch alert warning consumers on products purchased on the Internet promising to address E.D. According … Continue reading
Posted in Weekly Roundup
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Down the Road – Incentivizing and Implementing Adaptive Trial Design
On July 10, 2006, Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at FDA delivered a speech before the 2006 Conference on Adaptive Trial Design that was very interesting for those contemplating the future of clinical trials design. … Continue reading
Posted in Clinical Trials
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Blame Canada! Where Will Drug Importation Lead?
According to media reports, the Senate voted in favor of a policy that is in direct conflict with FDA policy – to allow the importation of drugs through Canada. It was latched onto a Homeland Security bill that was before … Continue reading
Posted in Current Affairs
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A Win for the FDA and for 3 Companies – Gilead, BMS and Merck
Over the past several weeks, there have been several goals scored that have made headlines. Nearly all of them have involved the World Cup. Another occurred in medicine. This week The New York Times reports that the FDA will approve … Continue reading
Posted in FDA Image, FDA Policy, Pharma Industry Image
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