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. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
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 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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Legislative Tracking Tools
Monthly Archives: October 2011
Weekly Roundup – 10-28-11
Snow is predicted for the weekend in the Northeast and there is a prediction for rain mixed with snow in our area. We haven’t even had the frost on the pumpkin yet! The leaves haven’t fallen off the trees! Madness! … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 10-28-11
Let the Sunshine Part 3 – Taking it on the Road: Transparency Outside the U.S.
The past two days have been focused on The Physician Payment Sunshine provisions of the Patient Protection Affordable Care Act in the U.S. which will require the reporting of financial relationships between medical product manufacturers and medical providers by 2013. … Continue reading
Posted in Pharma Industry Image, Podcast Comments Off on Let the Sunshine Part 3 – Taking it on the Road: Transparency Outside the U.S.
Let the Sunshine – Part 2 – Why is it Important?
As noted yesterday, the Physician Payment Sunshine Act is now law, but so far, the deadline for Health and Human Services to provide guidance to medical product manufacturers on what exactly to report and how exactly to report it has … Continue reading
Posted in Legislation, Pharma Industry Image 1 Comment
Let the Sunshine Part 1 – The Case of the Missing Guidelines
It may have escaped the notice of some that The Physician Payment Sunshine Act – legislation proposed that would bring greater transparency to the relationship between medical product manufacturers and medical providers – became law when the Patient Protection and … Continue reading
Posted in Legislation Comments Off on Let the Sunshine Part 1 – The Case of the Missing Guidelines
Weekly Roundup – 10/21/11
Autumn is definitely here now. I can tell because I am discovering sweaters I forgot I had and my lawn looks like that of Boo Radley’s and I can just about see Scout stepping across in her ham costume – … Continue reading
Posted in Weekly Roundup 1 Comment