FDA News Digest for October 20, 2003

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FDA News Digest

October 20, 2003

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First Drug Approved for Moderate-to-Severe Alzheimer's Disease

FDA has approved Namenda (memantine), to treat moderate-to-severe

Alzheimer's disease. Previous Alzheimer's therapies have been intended for

treating less severely affected patients. The drug helps treat Alzheimer's

in some patients, but there is no evidence that it affects the underlying

cause of the disease. About 4.5 million Americans have Alzheimer's disease,

a degenerative condition that affects memory, judgment, and the ability to

reason.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00961.html

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Electronic Registration System Debuts to Boost Security in Food Supply

To help bolster the safety and security of America's food supply, FDA has

unveiled a new online system that food facilities can use to register with

the agency. This system will help with quick identification of food

processors involved in any deliberate or accidental food contamination. All

foreign and domestic food facilities must register with FDA by Dec. 12 as

part of the provisions of the Public Health Security and Bioterrorism

Preparedness and Response Act of 2002.

Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00960.html

More information: http://www.fda.gov/oc/bioterrorism/furls/

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Proposal Aims to Ensure Safety, Effectiveness of Unapproved Medicines

FDA is proposing steps to ensure the safety and effectiveness of certain

unapproved, but widely marketed, medicines. These drugs were developed and

marketed before modern standards for drug approval were established. These

drugs have continued to be prescribed by some health professionals because

some people believe they are safe and effective for certain uses. Some of

these drugs, however, have been shown to be ineffective and even dangerous.

FDA is proposing that adequate scientific data be developed for all these

drugs.

Press Release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00962.html

Draft Compliance Policy Guide: http://www.fda.gov/cder/guidance/5704dft.pdf

Questions and Answers: http://www.fda.gov/cder/compliance/CPG_QandA.htm

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Joint Agency Health Initiative to Focus on Older Hispanic Americans

FDA and the Administration on Aging are collaborating on a program to

communicate important health information to older Hispanic Americans and

their families. The two agencies will cultivate and expand partnerships with

national Hispanic organizations, Hispanic media, and other private

organizations. The population of Hispanics over age 65 is projected to reach

13 million by 2050.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00959.html

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Rumors of Flu Vaccine Recall are False, say FDA and CDC

Rumors that a contaminated lot of influenza vaccine has been recalled are

false, according to FDA and the U.S. Centers for Disease Control and

Prevention. No contamination of any flu vaccine has occurred anywhere in

the United States and FDA has not recalled any flu vaccine, the agencies

say.

http://www.fda.gov/cber/flu/flurclstmt.htm

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RECALL

The following product is being recalled for the reason shown. Go to the

linked page for more information.

Ashe County Mexican-Style Quesco Fresco cheese (possible Listeria

monocytogenes contamination)

http://www.fda.gov/oc/po/firmrecalls/ashecounty10_03.html

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PUBLIC MEETINGS

Oct. 23 -- Public Meeting on Obesity; Bethesda, Md.

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

Oct. 23-24 -- Workshop on Counterterrorism Products Regulated by the FDA

Center for Biologics Evaluation and Research; Bethesda, Md.

http://www.fda.gov/cber/meetings/cntrtrrsm102303.htm

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

to

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

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