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.
Posts by Date
My Favorite Dogs
Monthly Archives: February 2007
As anyone can see who visits the actual Eye on FDA site, there is a great deal of legislation that is being considered by Congress for passage. Some of it involves fundamental changes to the way that the FDA does, … Continue reading
Recently I have submitted posts regarding the executive order issued by Texas governor Rick Perry that mandated HPV vaccine Gardasil for teenage girls and on the Merck decision to pull back its lobbying program related to the same. The New … Continue reading
The focus this week is on safety, safety, safety. In addition to the drug actions taken below, there were safety warnings on baby food due to a possible botulism connection and one on peanut butter due to salmonella. FDA Proposes … Continue reading
As we have all heard by now, Merck has decided to cease its lobbying efforts to promote its position that its HPV vaccine Gardasil should be mandatory for children. The HPV vaccine program has been fraught with controversy. First, while … Continue reading
I always enjoy taking a tour and looking at what the states are doing during their respective legislative sessions that would impact the pharmaceutical industry. I visited the sites of several state legislatures – states I regard as healthcare bellwether … Continue reading