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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Tag Archives: Pharma
Big Decisions – Reviewing FDA Advisory Committee Outcomes Since 2020
In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms – When the Going Gets Tough – noting, among other things that there had not only been fewer meetings but also that it appeared that the … Continue reading
Posted in Advisory Committee Prepapartion Tagged AdCom, AdComm, AdComms, Drug Approvals, Pharma Comments Off on Big Decisions – Reviewing FDA Advisory Committee Outcomes Since 2020
Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge
As the year began, no one really thought that within a few months, the systems upon which we rely on for just about everything would be so severely disrupted and tested by the presence of something we cannot even see … Continue reading
Posted in Approval Announcements, FDA Policy Tagged Drug Approvals, FDA, Pharma Comments Off on Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge
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
Enforcement Updates: OPDP Issues First Letter of the Year
In recent years, FDA’s Office of Prescription Drug Promotion (OPDP) has been diminished in the volume of its enforcement expressed through the issuance of Warning and Untitled Letters. OPDP now sends out only a handful of letters each year when … Continue reading
Posted in Warning Letters Tagged FDA, OPDP, Pharma 2 Comments
Sorting it Out – FDA AdComm Review for 2018
In 2017, the Advisory Committees voted to recommend approval 71.4 percent of the time; in 2018 it was 66.6 percent. Continue reading
Posted in Advisory Committee Prepapartion Tagged AdComms, Drug Approvals, FDA, Pharma 1 Comment