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
Category Archives: Legislation
Let the Sunshine – Part 2 – Why is it Important?
As noted yesterday, the Physician Payment Sunshine Act is now law, but so far, the deadline for Health and Human Services to provide guidance to medical product manufacturers on what exactly to report and how exactly to report it has … Continue reading
Posted in Legislation, Pharma Industry Image 1 Comment
Let the Sunshine Part 1 – The Case of the Missing Guidelines
It may have escaped the notice of some that The Physician Payment Sunshine Act – legislation proposed that would bring greater transparency to the relationship between medical product manufacturers and medical providers – became law when the Patient Protection and … Continue reading
Posted in Legislation Comments Off on Let the Sunshine Part 1 – The Case of the Missing Guidelines
Bills, Bills, Bills – An Update on Legislative Proposals
It has been a while since providing an update on legislative proposals introduced in Congress that would impact the FDA, medical products and food industries. With Congress out on recess, it seemed like a good time to catch up on … Continue reading
Posted in Legislation, Proposed Legislation Comments Off on Bills, Bills, Bills – An Update on Legislative Proposals
FDA Funding – When the Audience Changes, the Message Must Change
On March 11, Dr. Margaret Hamburg presented testimony before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies regarding funding for the FDA. Her remarks did a capable job of outlining what the FDA does and … Continue reading
Posted in FDA Image, Finance, Legislation 1 Comment
House Appropriations Proposes Specific Cuts for the Continuing Resolution
Yesterday morning I posted about impending budget cuts to FDA for the next fiscal year and posed the question whether or not less money might equate to less enforcement. Ironically, a short time later, the House Appropriations Committee released a … Continue reading
Posted in Legislation, Proposed Legislation 2 Comments