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: Social Media
A “Long Shot” at Getting FDA Off the Dime on Social Media
Last month, Politico reported on the communications aspects of the 21st Century Cures Act (the Act) – also known as H.R. 6 – the sweeping legislation that addresses a range of issues related to medical research and access to medicines. … Continue reading
Posted in Current Affairs, Social Media
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FDA Enforcement of Digital Communications – An Update
In 2013, I published a white paper called “FDA Communications Oversight in a Digital Era” that drew upon the data base I had put together of OPDP Warning and Untitled Letters (referred to collectively as “regulatory action letters”). The object … Continue reading
Posted in Social Media
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Live Streaming – Game Changer for AdComms and Beyond?
This week there was a lot of talk about last week and the meeting of the American Society of Clinical Oncology annual meeting ASCO 15, which was the 51st annual meeting of the society held May 29 – June 2 … Continue reading
Posted in Advisory Committee Prepapartion, New and Social Media, Social Media
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The Regulation of Search
Where are we when it comes to the regulation of search and digital media by FDA? After issuing some guidance documents, we know a little more about FDA’s approach to digital and social media, but there are still many outstanding … Continue reading
Posted in Social Media
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Pharma Twitter Followers on the Rise
As a highly regulated industry, the pharmaceutical sector was very slow to embrace social media and given the very slow and highly restrictive guidance put out by FDA on that topic, branded participation – particularly on Twitter – is going … Continue reading
Posted in Social Media
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