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: April 2006
As part of a new feature, I’ve designated Friday’s as mop-up time – a review of what happened during the week with handy links to the sources. GAO Issues Review of FDA on Safety – Unless you had been living … Continue reading
Well, there was good news and there was bad news. A few years back, a story in USA Today revealed that a large number of FDA Advisory Committee members had financial ties to the industry. It was, if I recall, … Continue reading
Yesterday there was an article carried in the Washington Post stating that, according to an FTC report, brand name drug companies are increasingly prone to reaching deals with generic companies to delay their entry onto the market. In essence, a … Continue reading
There has recently been a lot of hullabaloo about the fact that a large number of psychiatrists associated with writing the guidelines contained in the DSM manual have had past connections to drug companies according to recent reports. I am … Continue reading
Last week, the FDA issued a statement to the effect that marijuana has no medical value. Unfortunately, the FDA’s credibility on scientific decisions that have political issues associated with them has been wantonly squandered by agency’s inaction on the RX-OTC … Continue reading