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.
Posts by Date
Legislative Tracking Tools
Monthly Archives: March 2006
FDA Summing up 2005
It is Friday, and true to my developing tradition, I am going to softball it by delivering just a short and sweet message. But yesterday, FDA actually delivered a lengthy one by issuing a press release today summing up the … Continue reading
Posted in FDA Image Comments Off on FDA Summing up 2005
A Comment on Public Comment
During FDA Advisory Committee meetings, there is an Open Public Comment period that is scheduled to permit concerned members of the public to comment on the issues before the advisory committee. Those who sign up are asked, in the interests … Continue reading
Posted in Advisory Committee Prepapartion Comments Off on A Comment on Public Comment
If this Little Piggy Goes to Market – Will the Consumer Stay Home?
A big story yesterday was centered on scientists making a genetically engineered pig that when eaten, rather than producing Omega-6 into your system, brought the sought after Omega-3. Getting the benefits of salmon while eating pork chops! It’s a … Continue reading
Posted in Food Comments Off on If this Little Piggy Goes to Market – Will the Consumer Stay Home?
States Take Aim at Marketing Costs
Recall my recent posting of March 21, 2006 regarding the President’s call for more transparency in health care. Some states aren’t waiting for an answer to that call, they are moving on their own. Last month, Julie Appleby reported in … Continue reading
Posted in Marketing, Proposed Legislation Comments Off on States Take Aim at Marketing Costs
This is Your State… This is Your State on Drugs
When state legislatures tire of waiting for federal action, they often begin to take the initiative themselves. For example, consider that while legislation has been introduced into Congress to affect the FDA Office of Drug Safety, there is legislation being … Continue reading
Posted in Proposed Legislation, Useful Resources Comments Off on This is Your State… This is Your State on Drugs