FDA News Digest for May 7, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

May 7, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- New Consumer Health Page, E-newsletter Debut

    -- FDA Warns of Counterfeit Medicines from Internet Sellers

    -- Drug Manufacturers Urged to Test Glycerin for Contamination

    -- Agencies Conclude Human Risk 'Very Low' from Melamine in Food

    -- Investigation Uncovers Chicken Feed Link to Tainted Gluten

    -- 'FDA Patient Safety News' Video Available Online, as Podcast

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

 

New Consumer Health Page, E-newsletter Debut

Offer ‘Comprehensive and Timely’ Information

 

As part of its efforts to make crucial health information easily available to consumers, FDA has launched two new online features:

 

Web page -- Called "Consumer Health Information for You and Your Family," the page presents important public health developments in easy-to-read language. It also links to other government health information and online Spanish-language publications. 

View the new page: http://www.fda.gov/consumer/

 

E-newsletter -- "FDA Consumer Health Information" replaces the agency's print publication, FDA Consumer. Published monthly free of charge, it includes the latest health news, safety warnings and product approvals.

Subscribe to the new e-newsletter: http://www.fda.gov/consumer/consumerenews.html

 

 

FDA Warns of Counterfeit Medicines from Internet Sellers

Following receipt of information showing that 24 Web sites may be involved in distributing counterfeit prescription drugs, FDA is warning consumers of the potential dangers of buying medicines online. The agency, for example, learned that three consumers obtained counterfeit versions of the weight-loss drug Xenical from two different Web sites. Some of these counterfeit drugs were composed of only starch and talc.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01623.html

-- Photos of counterfeit Xenical: http://www.fda.gov/bbs/topics/news/photos/xenical.html

-- More information on buying medicines online: http://www.fda.gov/buyonline/

 

Drug Manufacturers Urged to Test Glycerin for Contamination

FDA is warning pharmaceutical companies and others involved in making medications to be vigilant in assuring that glycerin -- a sweetener used in liquid drug products -- is not contaminated with diethylene glycol (DEG). Used in antifreeze and as a solvent, DEG poisoning can cause serious injury and death. Several incidents over the past several years illustrate the dangers of DEG poisoning. Most recently, in September 2006, DEG-contaminated cough syrup in Panama caused dozens of hospitalizations and 40 deaths.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01628.html 

 

Agencies Conclude Human Risk 'Very Low' from Melamine in Food

FDA and the U.S. Department of Agriculture have concluded that the risk is "very low" to humans from eating meat from hogs and chickens fed melamine-contaminated animal feed. In a worst-case scenario, the agencies determined that potential exposure to melamine would be about 2,500 times lower than the dose considered safe.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01629.html

 

Investigation Uncovers Chicken Feed Link to Tainted Gluten

FDA and the U.S. Department of Agriculture have learned that pet food byproducts made with contaminated wheat gluten have been used in chicken feed on several Indiana farms. Officials discovered the link as part of a continuing investigation into imported rice protein concentrate and wheat gluten found to be contaminated with the chemical melamine and melamine-related compounds.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01621.html

 

'FDA Patient Safety News' Video Available Online, as Podcast

FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

-- To view video or text version: http://www.fda.gov/psn

-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm

 

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

Pet Food Recall:

 

›  FDA has a special page that lists the latest information on brands of pet foods being recalled. 

http://www.fda.gov/oc/opacom/hottopics/petfood.html

 

Food Recalls:

 

›  Archer Farms Four Cheese Risotto, 6 oz. size; labeled "Best If Used By 16JUL2008AA"

    Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/aulcorp05_07.html

›  Galliker's Acidophilus Plus Reduced Milk, half-gallon size; only products with code date of May 13, 2007, are affected

    Reason for recall: may contain under-processed milk, which is potentially unsafe

http://www.fda.gov/oc/po/firmrecalls/galliker05_07.html

›  Galliker's Healthy Chekd Calcium Enriched Fat Free Milk, half-gallon size; only products with code date of May 14, 2007, are affected

    Reason for recall: overfortified with vitamin A

http://www.fda.gov/oc/po/firmrecalls/galliker205_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

 

May 2 -- FDA Deputy Commissioner Janet Woodcock, M.D., appeared before the House Committee on Energy and Commerce

    Subject: "Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States"

http://www.fda.gov/ola/2007/policy05022007.html

 

May 1 -- FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Committee on Oversight and Government Reform

    Subject: "FDA Overview"

http://www.fda.gov/ola/2007/overview050107.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

 

May 9-10 -- Oncologic Drugs Advisory Committee

    Under discussion: two pending new drug applications

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-6171.htm

 

May 16-17 -- Vaccines and Related Biological Products Advisory Committee

    Under discussion: evaluation of two vaccines

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-7090.htm

 

June 12-13 -- Public hearing to obtain feedback on FDA's Medication Guide program

    Location: Washington, D.C.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01606.html

 

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

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

 

QUESTION OF THE WEEK 

 

How can I participate in FDA's process for making its rules?

In general, any citizen can submit comments on rules FDA proposes. The agency announces rules in the Federal Register and usually accepts comments for 60 days. The Federal Register is available in many libraries or by going to the link below. FDA invites consumers to participate in the rulemaking process. For more information about submitting comments, see the link below or call the FDA Dockets Management Branch at (301) 827-6860.

-- More on submitting comments to FDA: http://www.fda.gov/opacom/backgrounders/voice.html

-- FDA Federal Register page: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm

 

 

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