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: Risk Management
Personalized Risk Communication
Everyone has heard of the concept of personalized medicine – the idea that medicine can be steered to individuals who will be the most likely to benefit from it based on a number of factors, primarily genetic. Personalized medicine involves … Continue reading
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REMS – A Paper Tiger?
MedGuides are pieces of paper that are shoved into a bag with your prescription to warn a patient about possible side effects. I take some prescriptions myself that come with MedGuides. I never have read one all the way through, … Continue reading
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Breakthrough in Pain Relief – Kind of….
No, it isn't a scientific breakthrough – it is a regulatory breakthrough. Yesterday the FDA approved a new opioid based pain relief medication indicated for use with patients in with cancer who experience breakthrough pain who have developed a level … Continue reading
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Obama Administration Shifts Agency Gears on Safety – What Does it Mean for Food and What Does it Mean for Drugs
There have been a lot of changes at the FDA in the past few weeks – changes in personnel and changes in approach. Today the New York Times reports that Dr. Joshua Sharfstein, who has taken the reigns as Acting … Continue reading
Posted in Food, Risk Management
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FDA to Get More Specific on REMS and Painkillers
Yesterday, the FDA announced that it has sent letters to the manufacturers of both generic and brand name opioid based products that they may be required to have a Risk Evaluation Mitigation Strategy (REMS), which the agency now has the … Continue reading
Posted in FDA Policy, Risk Management
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