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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Monthly Archives: January 2020
Sorting it Out – FDA AdComm Review for 2019
Has FDA been holding enough AdComms? There have been a large number of drugs approved in the past year, but there has not been a corresponding increase in the number of advisory committees staged by FDA. Late in 2019, I … Continue reading
Posted in Advisory Committee Prepapartion, Approval Announcements Comments Off on Sorting it Out – FDA AdComm Review for 2019
An Overview of FDA OPDP Enforcement for 2019
It is time to look back at enforcement for the 2019 year. It is still possible that FDA could post another letter, as there is a lag time between the time a letter is sent and the time it is … Continue reading
Posted in Warning Letters Tagged FDA Enforcement, OPDP, Warning Letters Comments Off on An Overview of FDA OPDP Enforcement for 2019
The Growing Profile and Influence of ICER
The year began with a prediction from Senator Mitt Romney to pharmaceutical executives that “change is coming”. There have been high profile hearings on the topic in the Congress and legislation that moved in both the Senate and the House … Continue reading
Posted in Pharma Industry Image, Pricing and Value Tagged ICER, Pharma, pharmaceutical pricing Comments Off on The Growing Profile and Influence of ICER
What They Said – A Look at Press Releases Issued by FDA in 2019
It is time to look at the forest rather than the trees. It has been a regular custom to occasionally look back and see what FDA has been saying, and how frequently the agency has been saying it and what … Continue reading
Posted in FDA Image, News Tagged FDA Press Releases Comments Off on What They Said – A Look at Press Releases Issued by FDA in 2019
2020 Vision – Notable FDA Actions During 2019
Happy New Year! It is 2020 – the year of clear vision. Let’s look back for a bit as we plunge forward. FDA is a giant agency where a lot happens. Narrowing down the actions of significance is therefore a … Continue reading
Posted in FDA Image, FDA Policy Tagged FDA 2019, FDA Approvals, FDA CBD, FDA Enforcement Comments Off on 2020 Vision – Notable FDA Actions During 2019