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: July 2009
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
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
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
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
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