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.
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Category Archives: Drug Safety
Who Ya Gonna Call?
Today Mashable carried an article entitled “Twitter’s Surprising Reaction to Meningitis Outbreak” that reported that as the meningitis outbreak associated with a contaminated steroid product unfolds, users of Twitter were more often searching for CDC than FDA. The fact that … Continue reading
Posted in Drug Safety, FDA, FDA Image 1 Comment
Is the Critical Path Initiative in Critical Condition? Is the Advancing Regulatory Science Initiative Replacing the Critical Path?
Does anyone remember the FDA's Critical Path Initiative (CPI)? Anyone? Does the FDA even remember the CPI? The CPI was launched six years ago in 2004 as the "FDA's national strategy for transforming the way that FDA-regulated products are … Continue reading
Posted in Drug Safety, FDA Policy, Science Comments Off on Is the Critical Path Initiative in Critical Condition? Is the Advancing Regulatory Science Initiative Replacing the Critical Path?
Change Coming to Pharmacovigilance
Just about every conversation about the use of digital and social media with pharmaceutical companies starts at the same point – NO. Even if there is a willingness, Med-Reg intimidates and shuts down the effort in most cases, causing the … Continue reading
Posted in Drug Safety 2 Comments
How Risk Averse Have We Become?
Something I've written about before is the swing of the pendulum from the 1990s to the 2000s in terms of public priorities for the FDA. What is the balancing act between risk and benefit when it comes to both … Continue reading
Posted in Drug Safety, FDA Policy, Food 2 Comments
FDA to Post Quarterly Report of Potential Safety Issues
There are few better ways to bury news than to send out a release on Friday afternoon. The FDA announced this past Friday afternoon that it would begin to post potential safety issues on the Internet. There are those who … Continue reading
Posted in Drug Safety, FDA Policy 2 Comments