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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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    « This is Your State - This is Your State on Drugs - An Intermittent Series | Main | PDUFA IV »

    September 13, 2007

    Receipe for Reform - Is Food the Next Frontier?

    J0422441An Associated Press story today entitled "Government Never Improved Produce Inspections After Deadly E-Coli Outbreak"  discusses the current state of food inspections, particularly leafy greens.  According to the article:

    "AP's review of data obtained through the federal Freedom of Information Act found that federal officials inspect companies growing and processing salad greens an average of just once every 3.9 years. Some proposals in Congress would require such inspections at least four times a year."

    This month, hopefully, Congress will step up to the plate and finalize some FDA reforms aimed at the pharmaceutical and biotechnology industries with the goal of improving safety.  With that piece of business off their collective plate, one has to wonder whether or not the next target will be the food industry.  Beyond e-coli, there have been a number of food-related issues this year that call into question not only home-grown greens, but the importation of foods such as fish and feed for animals.  This puts the range of reform-minded individuals everything from inspection practices to bio-terror and safety issues. 

    How do we stop tainted products being processed at home at the same time we ensure that adulterated products do not enter our food chain from beyond our shores, as happened this year?

    My guess is that with some of the heat off the pharmaceutical industry given PDUFA reforms, food reforms may be the next thing Congress cooks up.  That should keep the new "food czar" David Acheson at FDA in the public eye for the coming year. 

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