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.
Category Archives: DTC Advertising
Health for Sale – What Would DDMAC Do?
Last week I was fortunate enough to catch a segment of the PBS News Hour that featured a new exhibit at the Philadelphia Art Museum called “Health for Sale“. The exhibit is comprised of the direct-to-consumer (DTC) of yesteryear – … Continue reading
Posted in DTC Advertising, Miscellaney, Uncategorized
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MAD Doctors! FDA Deputizes Docs to do DDMAC Ad Reviews!
"Paging Dr. Draper! Paging Dr. Draper! We have an ad in the examination room that requires your attention, STAT!" The PA system goes quiet. In the waiting room, patients shuffle their feet nervously, waiting, waiting, waiting…. Dr. Draper enters the … Continue reading
Posted in DTC Advertising, FDA Policy, Warning Letters
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FDLI Conference – Part 2 – Janet Woodcock Speech
At the opening of the 20th Food and Drug Law Institute Conference Annual Advertising and Promotion Conference, CDER's Dr. Janet Woodcock stood in for Dr. Margaret Hamburg who was said to have had a scheduling conflict due to a meeting … Continue reading
Posted in DTC Advertising, FDA Policy
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Should FTC Oversee Online Communications?
As is well known, FDA's DDMAC has stubbornly refused to deliver any guidance for industry and for advertisers on what is and is not acceptable in communications on the Internet. Instead, the agency has repeatedly stated that it is not … Continue reading
Posted in DTC Advertising
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DDMAC Mis-steps Badly and “Sows Confusion”
Last week, the New York Times carried an article "FDA Rules on Ads Sow Confusion as Applied to the Web" that addresses the call by the agency to issue 14 letters regarding 45 brands based on the lack of risk … Continue reading
Posted in DTC Advertising, FDA Policy
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