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.
Category Archives: Generic Drugs
FDA’s Contribution to the Pricing Issue – Generic Activism
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
Posted in Generic Drugs
Tagged FDA, generics, pharmaceutical pricing
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FDA and The Scarlet Letter
FDA apparently intends to implement today an idea that has been kicking around for a while to begin publishing the names of companies that have had letters of complaint lodged against them asserting that they are taking actions to block … Continue reading
Posted in FDA Policy, Generic Drugs
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FDA’s Generic Drugs – FDA Tracker Status Update
A month ago I was able to sit down with FDA's Deputy Commissioner Dr. Joshua Sharfstein to discuss the FDA's new effort at transparency and accountability called FDA Tracker, resulting in a podcast on the subject. FDA Tracker is a … Continue reading
Posted in FDA Policy, Generic Drugs
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FTC Report on Generic Drug Deals
No doubt the latest report from the Federal Trade Commission (FTC) Bureau of Competition is going to set the hair of several congresspeople on fire and will perhaps result in a hearing on the matter. The subject of the report … Continue reading
Posted in Generic Drugs, Industry Image
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The Critical Path of the Critical Path
Yesterday the FDA issued a news release that was entitled the "Critical Path Opportunities for Generic Drugs" that raises more than a few interesting points. First, it has been a long time since we’ve heard much about the FDA’s Critical … Continue reading
Posted in Generic Drugs
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