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 the medium, but the message that is the focus of their regulatory efforts and if you are doing something online that you could not do in print or broadcast, then you are tripping a regulatory wire. This stance, however, ignores the fact that the Internet presents a wealth of possibilities that are not addressed by print or broadcast, leaving industry and advertisers to guess as to the agency's intentions and resulting in policy being set reactively by warning letters rather than by proactive guidance.
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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