Category Archives: DTC Advertising

MAD Doctors! FDA Deputizes Docs to do DDMAC Ad Reviews!

Posted on May 12, 2010 by Mark Senak

 "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 | 3 Comments

FDLI Conference – Part 2 – Janet Woodcock Speech

Posted on September 21, 2009 by Mark Senak

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 →

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Should FTC Oversee Online Communications?

Posted on July 30, 2009 by Mark Senak

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 →

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DDMAC Mis-steps Badly and “Sows Confusion”

Posted on April 20, 2009 by Mark Senak

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 | 4 Comments

Perspectives on DTC Perspectives

Posted on April 16, 2009 by Mark Senak

Yesterday I had the good fortune to participate on a panel staged at the National DTC Perspectives Conference held here in Washington.   The conference was impressive not only because of the size and scope of the turnout – hundreds … Continue reading →

Posted in DTC Advertising, FDA Policy | 2 Comments