About the AuthorMy 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.
My ProfileI 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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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: July 2006
As has been long awaited and discussed herein, many elderly are reaching the Medicare Part Donut-hole as evidenced by articles in both the Sunday New York Times and the Washington Post. Both papers profile and document the surprise and fear … Continue reading
Well, as the sun sets on our week, it is time for the Weekly Roundup. So much has happened, my head is practically spinning. I don’t know about the rest of you, but for me it has been a long … Continue reading
The Bush Administration has been in office five years. There has been a confirmed commissioner in the office of the FDA for only 18 months out of that time. The Senate Committee on Health, Education, Labor and Pensions has scheduled … Continue reading
One of the touted aspects of the not-yet-introduced Kennedy Enzi bill aimed at FDA reform is the provision that would allow the FDA to monitor and fine drug companies for failure to meet up with post-marketing commitments. QDIS reported on … Continue reading
Anyone who has been reading headlines has seen concerns raised by those on the Hill and among some consumer groups about the financial ties that exist between those who serve on Advisory Committees. The issue was raised a few years … Continue reading