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.
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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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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The news that Dr. Gottlieb was leaving his post as Commissioner of FDA took everyone by surprise. Perhaps another surprise to many was the skill and judgment he brought to the job when initially he faced many critics due to … Continue reading
This week the Senate Finance Committee held the second in what will be four hearings on the price of pharmaceutical drugs – Drug Pricing in America: A Prescription for Change. The first hearing, on January 29, listened to a panel … Continue reading
As hearings on Capitol Hill these past two months (and in the months to come) have examined the issue of pharmaceutical pricing to inform potential legislation as well as to garner attention, FDA has been addressing the issue in the … Continue reading
In 2017, the Advisory Committees voted to recommend approval 71.4 percent of the time; in 2018 it was 66.6 percent. Continue reading
Periodically it is a good idea to take the pulse of what FDA is saying. This is not by looking at each press release individually, though of course that is important, but rather to look at the aggregate of what … Continue reading