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: April 2018
Another busy week that did not permit me time to get to some of the postings I have been working on between Roundups, but next week look for some. There has certainly been a lot going on and a lot … Continue reading
In some recent postings, it has been noted that the FDA Commissioner has made liberal use of the vehicle of “Commissioner Statements”. Last month, there were 9 – on average 2 a week. Then suddenly this month, the entire first … Continue reading
Last week Kaiser Health News (KHN) released a database called “Pre$cription for Power” that tracked pharmaceutical company donations made to patient advocacy groups, with an extensive accompanying article. The database is an important collection of information and serves to enhance transparency … Continue reading
For those of superstition, it is the first of two Friday the 13ths for this year. For the rest of us, we are assessing our bad luck with regard to the fact that if you live in the mid-Atlantic it … Continue reading
It goes without saying that enforcement by FDA’s Office of Prescription Drug Promotion (OPDP) as identified through regulatory action letters (warning or untitled) over the past few years is a mere shadow of its former self. Enforcement was once robust, … Continue reading