This week's News Digest draft

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

March 26, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- Tougher Procedures Proposed for Serving on Advisory Committees

    -- Investigation of 2006 Spinach Outbreak Yields Important Information

    -- User Fee Proposal Aims to Strengthen Drug Review and Safety

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

»  New Postings on FDA.gov

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NEWS

 

Tougher Procedures Proposed for Serving on Advisory Committees

FDA has drafted guidelines containing a more stringent approach for considering potential conflicts of interest in members of its advisory committees. The guidelines aim to simplify the process for screening committee members and provide more consistency in the consideration of who is eligible to serve. Advisory committees provide FDA with independent advice on issues related to the products the agency regulates. FDA will accept comments on the proposal for 60 days.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01591.html

 

Investigation of 2006 Spinach Outbreak Yields Important Information

FDA and California have jointly issued a report on an investigation into the causes of last year's outbreak of E. coli O157:H7 linked to bagged spinach. Though investigators uncovered the environmental risk factors and the areas most likely involved in the outbreak, they were unable to determine definitively the contamination origin. FDA says the probe yielded "valuable information" to help reduce the likelihood of similar outbreaks. Three deaths and 205 confirmed illnesses resulted from the outbreak.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01593.html

 

User Fee Proposal Aims to Strengthen Drug Review and Safety

FDA has submitted to Congress its final proposal for reauthorizing the Prescription Drug User Fee Act. The act provides for collection of user fees, paid by brand drug and biotechnology companies, that are added to appropriated funds to support review of new human drugs. Goals contained in the proposal include enhancing premarket review of drugs and creating a modern postmarket safety system that follows products across their full life cycle.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01592.html

 

To view an archive of past FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html.   

 

To access the RSS feed of FDA news releases, go to

http://www.fda.gov/bbs/topics/news/rssPress.xml.

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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RECALLS/SAFETY ALERTS

Food Recalls:

 

Five different brands of Jermuk brand of mineral water

    Reason for recall: possible contamination with arsenic, a toxic substance and known cause of cancer

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01594.html

(Note: FDA is reissuing its earlier warning not to drink these products) 

 

Various lots of FiberChoice Plus Multivitamins fiber supplement

    Reason for recall: undeclared fish component

http://www.fda.gov/oc/po/firmrecalls/fiberchoice03_07.html

 

Various types of Frango Cheggs chocolate and chocolate-covered egg-shaped candies

    Reason for recall: undeclared egg and milk

http://www.fda.gov/oc/po/firmrecalls/harrylondon03_07.html

 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated

products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.

 

To access the RSS feed of FDA recalls information, go to

http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml

[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]

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CONGRESSIONAL TESTIMONY

 

March 22 -- FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Oversight and Investigations.

    Subject: the future of FDA's drug safety program

http://www.fda.gov/ola/2007/drugsafety032207.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

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UPCOMING PUBLIC MEETINGS

 

March 29 -- Anesthetic and Life Support Drugs Advisory Committee

    Under discussion: findings of nervous system degeneration in juvenile animals exposed to anesthetic drugs and relevance to pediatric patients

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-1991.htm

 

March 29 -- Food Defense Workshop

    Under discussion: regulations authorized by the Bioterrorism Act of 2002 and other subjects related to FDA-regulated food facilities

    Location: Dallas

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-19886.htm

 

April 10-11 -- Food Labeling Workshop (jointly sponsored by FDA and the University of Arkansas)

    Under discussion: FDA food labeling regulations, especially as they relate to small businesses and startups

    Location: Fayetteville, Ark.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-1570.htm

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

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QUESTION OF THE WEEK

 

How does FDA regulate infant formulas?

FDA ensures the safety and nutritional quality of infant formulas by requiring that companies follow specific manufacturing procedures. A law -- known as the Infant Formula Act -- was passed in 1980 giving FDA special authority to create and enforce standards for commercial infant formulas. Manufacturers must analyze each batch of formula to check nutrient levels and product safety. They then must test samples to make sure the product remains in good condition while it is on the market shelf. Infant formulas also must have codes on their containers to identify each batch, and manufacturers must keep very detailed records of production and analysis.

 

For more on infant formulas, see http://www.cfsan.fda.gov/~dms/inf-toc.html.

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NEW POSTINGS ON FDA.GOV

 

FDA has recently posted:

 

» A Web page that explains how FDA played an important

role in accelerating the availability of an artificial pancreas

to help maintain blood glucose levels within the normal range.

http://www.fda.gov/oc/initiatives/criticalpath/pancreas.html

 

» A Web page summarizing safety-related labeling changes

that FDA approved for drug products during February 2007.

http://www.fda.gov/medwatch/SAFETY/2007/feb07_quickview.htm

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