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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Monthly Archives: July 2009
Should FTC Oversee Online Communications?
As is well known, FDA's DDMAC has stubbornly refused to deliver any guidance for industry and for advertisers on what is and is not acceptable in communications on the Internet. Instead, the agency has repeatedly stated that it is not … Continue reading
Posted in DTC Advertising Comments Off on Should FTC Oversee Online Communications?
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
A Warning Letter Story
Normally here at Eye on FDA, warning and untitled letters are reviewed quarterly. Sometimes, however, one stands out as somewhat extraordinary. So it happens with a warning letter DDMAC issued last week regarding a DVD. The DVD features an interview with … Continue reading
Posted in FDA Policy 2 Comments
Why Healthcare Reform is Struggling – A Failure to Communicate
Back in the 1990s when I was working as Policy Director at AIDS Project Los Angeles, I was having trouble getting an appointment with a particular Congressman to discuss proposed cuts to the Housing Opportunities for People with AIDS (HOPWA) … Continue reading
Posted in Legislation Comments Off on Why Healthcare Reform is Struggling – A Failure to Communicate
Breakthrough in Pain Relief – Kind of….
No, it isn't a scientific breakthrough – it is a regulatory breakthrough. Yesterday the FDA approved a new opioid based pain relief medication indicated for use with patients in with cancer who experience breakthrough pain who have developed a level … Continue reading
Posted in Risk Management Comments Off on Breakthrough in Pain Relief – Kind of….