Who am I? My name is Mark Senak. I’m a lawyer and I work at the international communications firm Fleishman-Hillard in Washington D.C. 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 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 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. If you want to find more out about me, check out my bio.
Why This Blog? The regulatory environment has been in a huge state of flux, as has the pharmaceutical industry. On the regulatory side, the FDA has been without a leader for more of the past five years than not. Several incidents – the Vioxx withdrawal, the flu vaccine fiasco and a documented loss of faith among its own employees, have led many to lose faith in the agency. To counter that, the agency is necessarily going to have to ensure that it appears to be vigilant and on the job, protecting the public safety. On the pharmaceutical side, treatments being developed today for use tomorrow are increasingly complex in nature and scope and sophistication. The impact of these new treatments has been dramatic, yet the image of the industry is at an all time low, hovering nervously just above the oil and tobacco industries in public approval ratings. The industry needs to think and think hard about how the changing regulatory environment is going to change the way the industry communicates to its most important constituencies – regulators, treaters and patients. I have a lot of thoughts and analyses about what is going on. I wanted a place to express them.
What Will I 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.