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
Monthly Archives: May 2009
It is always a good idea to review the content of Warning and untitled letters to learn from the lessons being taught be DDMAC with respect to communications that promote the marketing of pharmaceutical, biotech and device products. However, I … Continue reading
Days and days of torrential and sporadic rains have taken their toll. With all the wet, the weeds in the garden prosper while my unplanted daisies languish in their little plastic cups waiting and yearning for the wide expanse of … Continue reading
On May 5 I participated in a Webcast that laid out considerations for businesses in pandemic communications planning. The attendance and coverage were great. But it occurred to me afterword that many of the things I was outlining were steps … Continue reading
This is not a joke -at least they didn't intend it to be. You can decide. On May 5, the FDA issued a Warning Letter to General Mills because of the promotional claims on a box of Cheerios. Here … Continue reading
Just what is comparative effectiveness research (CER)? It seems that as many opinions exist as there are people to express them. This past month, there has been a good deal written about comparative effectiveness, particularly as President Obama included $.1 … Continue reading