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
If a Tree Falls in the Forest….
If a tree falls in the forest, and almost no one notices, did the tree almost not fall? Pharmaceutical Executive noticed, but I didn’t notice anyone else notice. I’m talking about the long-proposed user fee program for the FDA’s Division … Continue reading
Posted in DTC Advertising, FDA Policy, Marketing
2 Comments
New DTC Oversight Powers Given FDA – Show Me the Money!
I was fascinated to read the RPM Report analysis of the new system that will emerge when the new FDA bill is signed into law. A new user fee program for review of DTC ads will exist that allows the … Continue reading
Posted in DTC Advertising, FDA Policy, Legislation, Marketing
1 Comment
What a Ban on DTC Means for Public Relations
There have been several proposals before Congress which, in one way or another, have the potential to impact the amount of direct-to-consumer advertising (DTC) allowed. Some would give the FDA authority to restrict such advertising. Others have called for it … Continue reading
Posted in DTC Advertising, Proposed Legislation
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The News on the News
Since there was so little activity this week given the holiday and the Ford funeral, there is no Weekly Roundup today. But I took the opportunity to do something I’ve wanted to do for a long time. Longtime readers will … Continue reading
Posted in DTC Advertising
1 Comment
PDUFA Fees to Raise Money for Ad Reviews
And now, for a commercial break. At the precipice of the Congressional turnover, the FDA has reached a tentative agreement regarding the review by the agency of television commercials. According to the Wall Street Journal last week, pharmaceutical companies would … Continue reading
Posted in DTC Advertising, PDUFA
2 Comments