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.Stay Connected
My Profile
I 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
Twitter List
Legislative Tracking Tools
Monthly Archives: February 2010
Hot U.S. Attorney Action in Drug Misbranding, Device Sales and Supplement Frauds
There were a spate of announcements last week about actions taken by U.S. attorneys – one that involves a guilty plea for misbranding a drug; one person getting a 51 month sentence for selling unapproved medical devices and one guilty … Continue reading
Posted in Uncategorized
Comments Off on Hot U.S. Attorney Action in Drug Misbranding, Device Sales and Supplement Frauds
Social Media Tools and Strategy – A Webinar Coming Up
I was at a talk not long ago where two questions were posed by the speaker to the audience. First was – how many people have cell phones? Naturally everyone in the room raised their hand. The second question was … Continue reading
Posted in New and Social Media, Tutorial
2 Comments
A Few Pharma Companies Speak to FDA Social Media Docket
On January 29th new documents appeared in the FDA's docket that has been devised to collect commentary after the November 12-13 Part 15 meeting on social media and the Internet and medical product marketing. Up to this point, both in … Continue reading
Posted in FDA Policy, New and Social Media
3 Comments
Weekly Roundup – 02/05/10
All of Washington is braced for the onslaught of a snow storm that the weather service has termed "paralyzing" – obviously unaware of the fact that Congress is in a state of paralysis most of the time. Here is a … Continue reading
Posted in Uncategorized
Comments Off on Weekly Roundup – 02/05/10
FDA Should Begin a Collaborative Wiki to Innovate More Quickly
The FDA is now undertaking a glacially paced effort at examining the regulation of social media and the Internet. And slowly the agency has been increasingly using social media and emerging media tools to get word out, particularly during recalls, … Continue reading
Posted in FDA Policy, New and Social Media
2 Comments