About the Author
My 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.
Tag Archives: Pharma
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
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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
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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
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
HHS Proposes Pricing in DTC
In May the Administration released a plan called “America’s Patients First” , a blueprint to lower drug prices and reduce out-of-pocket costs. One of the items contained in that blueprint was to have the manufacturers of medicines include the list … Continue reading
Posted in DTC Advertising, FDA Policy
Tagged DTC, FDA, Pharma, pricing
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