Who am I? My name is Mark Senak. I’m a lawyer and I work in the Washington D.C. office of the international communications firm FleishmanHillard. For the past several years, I have been consulting with pharmaceutical, biologic and device companies that are engaged in the process of bringing new medical products to market. I offer both a breadth and depth of thought and experience when it comes to the approval and marketing of pharmaceutical drugs, particularly as related to their regulation by the FDA. I have done a good deal of crisis and issues management work. My public affairs experience began when I served for many years in HIV advocacy.
I have written and spoken in various publications and venues on the impact of the regulatory environment on the marketing of medical products. I have also worked a great deal in counseling clients on issues and crises management. That has come in handy in working with clients as they prepare to sponsor a new medical treatment before the FDA – because it is all about managing the various issues that a candidate treatment faces in the areas of safety and efficacy.
Why This Blog? There are two sectors that have changed dramatically over the past decade – one is health care and the other is communications. Sometimes the changes are obvious – sometimes they are more subtle. Given FDA has jurisdiction over both new treatments and the speech to talk about them, a blog about the nexus between the two seems like a good idea.
What Will You Find on This Blog? First off, you will find resources – convenient links to the FDA website so that you don’t have to go digging through that huge space to find what you are looking for. You can find here. Second, you will get my views on the latest trends I perceive how I believe that regulatory or legislative action might impact the market place, and what kinds of communications are helpful or harmful to the best interests of bringing new drugs to the market place. You will also find good, honest and direct advice if you are a medical product innovator. Everyone else will find good honest analyses. Lastly, I want to be a resource. If you have a question, ask it. If you want something discussed here, let me know. If you have suggestions for improvements, I want to hear them.
What you will NOT find here. While I work for an agency, you will not find their thoughts here. There is a link here to the agency’s Web site, in case you are interested. But the thoughts and analyses expressed here are mine, which the agency is kindly letting me to post in this venue. But the point of view expressed here is my own and not those of my firm. My postings are not screened or approved.