About the AuthorMy 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.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Fixing the FDA
First, from USA Today – an article by Julie Schmit entitled "FDA is Failing to Meet Its Food Safety Inspection Goals" – a headline that kind of says it all. According to the article, the FDA failed to meet its inspection goals in 17 of 39 states and in 5 states had no inspections at all during the 2007-2008 time period, which sadly, is an improvement over the track record of the previous year. It should be noted that the inspection process at the state level was a key factor in the great and seemingly never ending peanut recall. Still, the FDA's performance with the subsequent pistachio recall, where the agency acted before people got sick rather than after, signals improved performance. Nevertheless, one senses a growing lack of confidence among policy makers who believe that something needs to be done. Does that take the form of increased inspections or breaking the agency in two? I think neither are the solution, but time will tell.
The other variable that may come to influence the outcome is with the hearings that go on today to confirm Margaret Hamburg as FDA Commissioner, which is the subject of the second newspaper article, this time from the New York Times' Gardiner Harris entitled "Obama's Choice for FDA Doesn't Shy Away from Difficult Situations" – which seems a statement of the obvious given the fact that she is willing to head the FDA right now. The story relates her background as someone able to turn dire situations around, including the situation at Riker's Island – a prison in New York – where she was able to address the burgeoning TB epidemic in the jail by setting up a "top-notch" TB clinic in the prison in 3 months.
Prior to that time, I used to do wills and non-criminal legal work for the inmates of the Riker's Island HIV ward. Let me tell you, it was difficult to think that you were in anything that could be called "hospital ward" when you entered that facility. Cockroaches on my jacket shoulder would sometimes appear. The deputy warden insisted that condoms could not be distributed because sexual activity was not condoned. The doctors smoked in the ward. There was a lot of filth and odors that accompanied it. And to top it off, of course, you were locked inside of it. I may be a critic of the FDA and think there is some dead wood that needs to be cut away at the top, but the FDA is nothing compared to what the Riker's Island hospital prison ward was like. The article also notes that she was successful in pushing for reform on one of the most common sense HIV prevention efforts – needle exchange, which despite its obvious benefits, political opposition was widespread. If she could successfully take on those kinds of challenges, I have a lot of faith in her prospects in FDA reform.
I just wish she'd get to FDA sooner rather than later……