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      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; issues and crisis management. 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!

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    • Eye on FDA is published by Mark Senak of Fleishman-Hillard's Washington, D.C. 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 Fleishman-Hillard or its clients.

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    August 18, 2008

    FDA Draft Report on BPA and FDA's Credibility Gap

    J0430799Earlier this year, the Canadian health authorities sounded an alarm about food and water containers that were made with bisphenol- A (BPA),  prompting scrutiny in this country and action by state legislators in California (Carole Migden) and U.S. senators (Charles Schumer) to ban BPA from such containers, perhaps prematurely. 

    Opinions about BPA are quite varied.  But last week, the agency came out with a preliminary draft assessment of the Fads findings regarding the use of BPA in food and water containers, and it would appear that they agency is not finding a there, there.   

    Dr. Andrew C. Von Eschenbach stated in his weekly writeup on the quasi-blog Andy's Take to which he writes weekly - "science creates these products and science must inform us of their risks. With regard to BPA thus far, the science FDA has reviewed does not justify recommending that anyone discontinue using these products." 

    Whether or not one agrees with the FDA on this point (and actually, I do), this is an important example of how the many travails the agency has faced over the past few years have worked together to undermine the Fad's credibility to issue a call on important aspects of public health.  Dr. Von Offenbach alludes to this in his writing stating that the FDA will work with outside parties to confirm their take on the science.  In fact, the FDA needs to collaborate with an established and credible third party on this and other public issues for the foreseeable future in order to be a real player in defining risk and safety in public health and use of products.  It would be ideal to develop a brain trust of sorts with key universities and schools of public health that is not an advisory committee, but a validation board to put a stamp of approval on Fad's health edicts like this. Because after so many gaffes and the fact that members of Congress have used the agency as a whipping post, credibility is going to be a big factor moving forward.

    _______________________

    By way of disclosure, I have worked with companies to develop communications materials around the use of BPA in products.

    Also the original posting was corrected to reflect Dr. von Eschenbach's name being mis-spelled - don't know what I was thinking....

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