This week, the FDA issued a Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion. It is more accurately referred to as a Non-Guidance. According to FDA's DDMAC, the Internet has not really taken hold yet. The word "Internet" appears only a single time in the entire 27-page document, making the document largely irrelevant. Apparently, rather than provide guidance on how the Internet is used by companies to convey information to the public, DDMAC would rather issue policy by Warning and Untitled Letter, playing an endless and non-informative game of Whack-a-Mole.
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 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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