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.Stay Connected
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I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Monthly Archives: February 2009
Weekly Roundup – 2/13/09
So sad the last day of vacation. Above is a picture from my bedroom window one morning this week. Still, it was a lovely week of long drives in the mountains, hiking with the pups, good meals, including a killer … Continue reading
Posted in Weekly Roundup
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Government About to Enter Web 2.0 and YouTube
While the pharmaceutical industry for the most part hand wrings over the regulatory and messaging hurdles that hobble their entry into social and digital media, the federal government is having no such reservations. According to an article entitled "Feds … Continue reading
Posted in New and Social Media
1 Comment
Two More Pharmas Jump on the YouTube Bandwagon
While many companies are held back from participation in digital media by powerful and substantial fears of regulatory repercussions, two more companies have decided to join the ranks of Abbott, GSK, J&J and SanofiPasteur by developing a YouTube presence. MedReg … Continue reading
Posted in New and Social Media
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FDA to Get More Specific on REMS and Painkillers
Yesterday, the FDA announced that it has sent letters to the manufacturers of both generic and brand name opioid based products that they may be required to have a Risk Evaluation Mitigation Strategy (REMS), which the agency now has the … Continue reading
Posted in FDA Policy, Risk Management
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Weekly Roundup – 2/6/09
It has been a frigid week here in Washington, causing everything to move slowly – like stimulus legislation. Some new legislation regarding FDA and the pharma industry has been introduced and is now in the right hand column of the … Continue reading
Posted in Weekly Roundup
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