FDA News Digest for February 6, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

February 6, 2006

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IN THIS WEEK'S ISSUE

»  News

    --  Drug Safety, Pandemic Flu, Bioterrorism Highlight FY'07 FDA Budget Request

    --  New Lab Test Can Detect Avian (Bird) Flu Infections in Humans

    --  FDA Approves Novel Treatment for Chronic Chest Pain

    --  Vaccine OK'd to Prevent Rotavirus Gastroenteritis in Infants

    --  New Drug Treats Chronic 'Idiopathic' Constipation in Adults

    --  'Widespread Deficiencies' Prompt Shutdown of Human Tissue Company

    --  Boston Scientific Pledges 'Aggressive Timeline' to Correct Problems 

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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Drug Safety, Pandemic Flu, Bioterrorism Highlight FY'07 FDA Budget Request

FDA has requested from Congress a fiscal year 2007 budget totaling $1.95 billion, a 3.8 percent increase over last fiscal year. Specific areas highlighted for funding include pandemic flu preparation, bioterrorism defenses, safety programs for medicines and human tissue transplants, and FDA's "critical path" plan to bolster personalized medicine. Included in the budget is $402 million in industry user fees that the agency plans to collect for oversight of human and animal drugs, medical devices, and other product categories. 

http://www.fda.gov/bbs/topics/news/2006/NEW01310.html

 

New Lab Test Can Detect Avian (Bird) Flu Infections in Humans

FDA has approved a lab test to diagnose H5 strains of avian (bird) flu virus in humans. The test can give preliminary results on suspected samples in four hours, compared to as long as three days with previous technology. The Centers for Disease Control and Prevention developed the test to help prepare for a possible avian flu pandemic. FDA, which acted quickly to approve the test, calls pandemic flu preparation "a top priority for our nation."

http://www.hhs.gov/news/press/2006pres/20060203.html

 

FDA Approves Novel Treatment for Chronic Chest Pain

FDA has approved Ranexa (ranolazine), the first new drug approved for treating chronic chest pain (angina) in over ten years. Because Ranexa affects electrical conduction in the heart, it should only be used by patients who have not responded to other angina treatments, such as long-acting nitrates, calcium channel blockers, or beta blockers. According to the American Heart Association, about 6.8 million Americans are diagnosed with angina yearly.

http://www.fda.gov/bbs/topics/news/2006/NEW01306.html

 

Vaccine OK'd to Prevent Rotavirus Gastroenteritis in Infants

RotaTeq, an oral vaccine that can help protect infants against rotavirus gastroenteritis, has received FDA approval. Rotavirus is a viral infection that can cause diarrhea, vomiting, fever, and dehydration. It is the leading cause of severe diarrhea worldwide in infants and children, causing about 55,000 hospitalizations annually in the United States alone.

http://www.fda.gov/bbs/topics/news/2006/NEW01307.html

 

New Drug Treats Chronic 'Idiopathic' Constipation in Adults

FDA has approved Amitiza (lubiprostone), a new type of prescription drug for treating chronic "idiopathic" constipation in adults. (Idiopathic refers to a condition where the cause is unknown.) Chronic idiopathic constipation is one of the most common disorders in this country, affecting women more often than men and those over 65 more frequently than younger people.

http://www.fda.gov/bbs/topics/news/2006/NEW01305.html

 

'Widespread Deficiencies' Prompt Shutdown of Human Tissue Company

Following inspections that revealed what FDA calls "serious and widespread deficiencies," the agency has ordered New Jersey-based Biomedical Tissue Services (BTS) Ltd. to stop its human tissue manufacturing operations. Among other problems, FDA uncovered serious violations of regulations governing tissue donor screening and record keeping. The agency says BTS "would present a danger to public health" if allowed to stay in operation because its products could increase the risk of transmitting diseases.

http://www.fda.gov/bbs/topics/news/2006/NEW01309.html

 

Boston Scientific Pledges 'Aggressive Timeline' to Correct Problems

After meeting with FDA Feb. 3 to discuss a Jan. 26 FDA warning letter, officials from medical device maker Boston Scientific Corp. acknowledged deficiencies in the company's quality and device-reporting systems. The company confirmed its commitment to an "aggressive timeline" for resolving the problems, according to an FDA statement.

http://www.fda.gov/bbs/topics/news/2006/NEW01308.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

 

Device Recalls:

 

Various liquid-filled teethers distributed by The First Years

    Reason for recall: possible bacterial contamination

http://www.fda.gov/oc/po/firmrecalls/firstyears01_06.html

 

Flextome Cutting Balloon Device Monorail Delivery System (used to open blocked blood vessels)

    Reason for recall: potential for malfunction

http://www.fda.gov/cdrh/recalls/recall-120705.html 

 

All models of Baxter Healthcare Corp.'s Colleague Volumetric Infusion Pumps (used to give patients controlled amounts of medicines or fluids)

    Reason for recall: potential for several types of malfunction

http://www.fda.gov/cdrh/recalls/recall-121305.html

 

Animal Feed Recall:

 

One lot of _expression_ lamb feed; 50-lb. size

    Reason for recall: may contain potentially harmful levels of the drug monensin sodium

http://www.fda.gov/oc/po/firmrecalls/suther02_06.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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UPCOMING PUBLIC MEETINGS

 

Feb. 8-9 -- FDA Anti-Counterfeit Drug Initiative Public Workshop and Vendor Display

    Under discussion: adoption of radio-frequency identification in the U.S. medicine supply chain to combat counterfeit products

    Location: Bethesda, Md.

http://www.fda.gov/rfidmeeting.html

 

Feb. 8-9 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

    Under discussion: industry and FDA perspectives on proper conduct of FDA-regulated clinical trials

    Location: Houston, Texas

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-18871.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

Does freezing affect the level of nutrients contained in foods?

Freezing does not reduce the amount of nutrients. And for meat and poultry products, there is little change in protein value during freezing.

For more on freezing foods, see http://www.cfsan.fda.gov/~dms/a2z-f.html#freezing.

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