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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Legislative Tracking Tools
Monthly Archives: December 2008
DTC in the Crosshairs of Congressman Waxman
Reuters carried a report yesterday confirming not only that a moratorium on Direct-to-Consumer (DTC) advertising is likely to be introduced in the next Congress, but is going to be broached by Congressman Henry Waxman, the new Chair of the House … Continue reading
Posted in DTC Advertising 1 Comment
FDA Approval Track Record Since Advent of Complete Response Letters
It has been four months since FDA's CDER began issuing Complete Response Letters in place of Approvable or non-approval letters. Looking back to August to get an idea of where we are in terms of the approval of new molecular … Continue reading
Posted in Approvable Letters, FDA Policy 1 Comment
Weekly Roundup – 12/05/08
Are you ready? The scaffolding at the Capitol building is nearly complete. The changes are poised to happen. If you haven't already, catch up on my perspective on the changes on the EyeonFDA YouTube channel with videos of my 3-part … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup – 12/05/08
The Tom Daschle Appointment for HHS – What’s Inside?
Former Senate leader Tom Daschle has been tapped by President-Elect Barack Obama as the new Secretary of Health and Human Services. Here is some of the legislation Senator Dashcle either sponsored or co-sponsored related to FDA and to the pharmaceutical … Continue reading
Posted in Current Affairs Comments Off on The Tom Daschle Appointment for HHS – What’s Inside?
The Changing Policy and Communications Environment and Implications for Pharma Marketing, Part 3
Here is the last of the 3-part series about the impact of expected upcoming changes in the policy environment and the tremendous migration in the communications environment and how this affects the marketing of pharmaceutical products. In this last installment, … Continue reading
Posted in Useful Resources Comments Off on The Changing Policy and Communications Environment and Implications for Pharma Marketing, Part 3