About the Author
My 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.
Monthly Archives: April 2018
Weekly Roundup 4.27.18
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
Posted in Weekly Roundup
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Weekly Roundup 4.20.2018
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
Posted in Weekly Roundup
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Perspective on Pharma Support for Patient Advocacy Organizations
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
Posted in Pharma Industry Image, Politics
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Weekly Roundup 4.13.18
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
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FDA Enforcement Lags, Focus on Promotion of Unapproved Drugs
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
Posted in FDA Policy
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