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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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    « Tracking Approvable Letters | Main | Weekly Roundup - 10/13/06 »

    October 12, 2006

    Should the FDA Drop Food from its Mandate?

    J0262733_2 All of the food woes of the past few weeks raise some serious questions which have been before considered, but merit re-visitation.  First we had the spinach e-coli outbreak, the carrot juice botulism, the lettuce recall and a ground beef e-coli recall.   During his tenure as acting commissioner, Dr. Lester Crawford made food security a priority as expressed through many statements and speeches on the matter.

    As it stands now, responsibility for food safety is shared between the Food and Drug Administration and the United Stated Department of Agriculture.  If you go to the store and buy venison, for example, that is under the jurisdiction of the FDA.  If you go to the store and buy beef, that is under the jurisdiction of the USDA.  The USDA inspects most meat and poultry.  The FDA has no similar ability to inspect produce.  Make sense?

    Further, neither agency has jurisdiction over setting a national policy on security and inspections for all food.  That is why, after the e coli breakout of spinach, there seemed to be so much confusion and even delay.

    After 2001, when our national obsession with all forms of security logically entered a pitched phase, Homeland Security expressed a desire to re-visit the idea of a single food agency, an idea long favored by Democrats such as Richard Durbin (D-IL) and by many consumer groups.  According to a Reuters article from 2001, Secretary Ridge stated "We need to consider this in light of homeland security, whether or not we want to have multiple organizations basically tasked with the same responsibility, or if we couldn't enhance our security, improve our efficiency and maybe save a few bucks and put them someplace else for enhanced security if we merged functions."  President Bush had expressed interest, according to this article, in streamlining the responsibilities. 

    But now, according to an Associated Press story carried in the Lexington-Herald Leader the Bush Administration again disfavors a single agency, as recently expressed by Richard Raymond, undersecretary of Agriculture and in charge of food safety.  He said a single agency "isn't necessary".  I guess we are just supposed to be satisfied with his word on that, there was no explanation given.   (This, by the way, is what Candidate Bush used to refer to as a flip-flop.)  One hopes that it is not opposed simply because Democrats have been a proponent of a single agency. 

    In the meantime, the FDA is being inundated with potentially huge new mandates related to drug safety.  The recent IOM report, the CBO report favoring comparative clinical trials, legislation to extend authority over Phase IV clinical trials, more staff to review direct-to-consumer advertising lead to an important question.  If the FDA has a long way to go to make the regulation of safety in drugs, and has no real system for catching the food problems early on, why not give food over to USDA and concentrate on the drug side?  What rationale or national interest is at stake in keeping food jurisdiction separate between two agencies with different rules.  Shouldn't someone else be steering the ship on food safety, while the FDA manages drugs?  Come on Richard Raymond, explain your point of view. 

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