FDA News Digest for November 14, 2005

[FDA News Digest]

Title: Message

FDA News Digest

November 14, 2005

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IN THIS WEEK'S ISSUE

 

--  FDA Warns Sellers of 'Alternative Hormone Therapies'

--  First Oral Drug Approved to Treat Chronic Iron Overload

--  New Labeling Warns of Higher Estrogen in Ortho Evra Patch

--  FDA, EU Extend Confidentiality Arrangements Five More Years

--  Latest 'Patient Safety News' Video Available Online

--  FDA's Goodman Elected to Institute of Medicine

--  Recalls/Safety Alerts

--  Recent Speeches

--  Upcoming Public Meetings

--  Question of the Week

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FDA Warns Sellers of  'Alternative Hormone Therapies'

 

FDA has taken action against companies marketing unapproved "alternative hormone therapies." The agency considers these products unapproved drugs that have not been shown to be safe and effective for their touted benefits of treating or preventing diseases such as cancer, heart disease and osteoporosis.

http://www.fda.gov/bbs/topics/news/2005/NEW01260.html

 

First Oral Drug Approved to Treat Chronic Iron Overload

 

FDA has approved Exjade, a drug that treats chronic iron overload due to multiple blood transfusions. Exjade is the first oral drug approved for iron overload, which can damage the heart and the liver. Previous treatments required daily infusions lasting eight to 12 hours.

http://www.fda.gov/bbs/topics/news/2005/NEW01258.html

 

New Labeling Warns of Higher Estrogen in Ortho Evra Patch

 

The maker of the Ortho Evra contraceptive skin patch has revised the product's labeling to warn that the patch exposes women to higher levels of estrogen than most birth control pills. FDA urges women considering this product to consult with their doctors about balancing the patch's potential risks with its benefits. Ortho Evra, the first skin patch approved for birth control, is applied weekly to release estrogen and progestin through the skin into the bloodstream.

http://www.fda.gov/bbs/topics/news/2005/NEW01262.html

 

FDA, EU Extend Confidentiality Arrangements Five More Years

 

Calling its confidentiality arrangements with the European Commission and the European Medicines Agency a "positive experience," FDA has renewed arrangements with the two groups for another five years. The arrangements allow the three agencies to share information as part of their regulatory processes. This includes scientific advice, inspection reports, and post-marketing surveillance.

http://www.fda.gov/bbs/topics/news/2005/NEW01257.html

 

Latest 'Patient Safety News' Video Available Online

 

FDA has posted the November edition of "Patient Safety News," a 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. Among topics covered is the recently strengthened risk management program for Accutane.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm

 

FDA's Goodman Elected to Institute of Medicine

 

The Institute of Medicine of the National Academies has conferred membership on Jesse Goodman, M.D., director of FDA's Center for Biologics Evaluation and Research. The honor is among the highest in the United States for contributions to the advancement of medical sciences, health care, and public health.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01261.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

 

Recall:

 

Worthington Choplets Vegetable and Grain Protein Patties; 1 lb. 4 oz. size

Reason for recall: undeclared egg and milk

http://www.fda.gov/oc/po/firmrecalls/worthington11_05.html (revised posting with additional distribution states)

 

Safety Alert:

 

FDA has notified health care providers about the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose, and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone- (GDH-PQQ) based glucose monitoring systems.

http://www.fda.gov/medwatch/safety/2005/safety05.htm#maltose

 

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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RECENT SPEECHES

Nov. 9 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the Pharmaceutical Compliance Congress.

Subject: "Improving the Pathway for Medical Innovation"
http://www.fda.gov/oc/speeches/2005/compliance1109.html

To view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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UPCOMING PUBLIC MEETINGS

 

Nov. 14 -- Prescription Drug User Fee Act (PDUFA) Public Meeting

Under discussion: stakeholder views as FDA prepares to work on amended authorizing legislation for PDUFA

Location: Bethesda, Md.

-- Press release: http://www.fda.gov/bbs/topics/news/2005/NEW01259.html

-- Meeting information: http://www.fda.gov/oc/meetings/pdufa111405.html

-- PDUFA White Paper: http://www.fda.gov/oc/pdufa/PDUFAWhitePaper.pdf

 

Nov. 14-15 -- Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science

Under discussion: topics that include pharmacogenetics of warfarin and the critical path biomarker-surrogate endpoint project.

Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12539dd11141505.html

 

Nov. 16 -- Cardiovascular and Renal Drugs Advisory Committee

Under discussion: a proposed drug to treat rejection in heart transplant patients

Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cder12533d111605.html

 

Nov. 16-17 -- Vaccines and Related Biological Products Advisory Committee

Under discussion: use of Madin-Darby canine kidney cells for manufacture of inactivated influenza vaccines

Location: Bethesda, Md.

http://www.fda.gov/oc/advisory/accalendar/2005/cber12391dd11161705.html

 

Nov. 17 -- Third Annual CDRH/CBER Medical Device User Fee and Modernization Act (MDUFMA) Stakeholder Meeting, a public gathering to obtain information from stakeholders on MDUFMA-related issues.

Location:  Gaithersburg, Md

http://www.fda.gov/cdrh/meetings/111705.html

 

Dec. 7-8 -- Hearing to obtain public input on the agency's current risk communications and outreach strategies, which include patient information sheets, press releases, public health advisories, and other tools.

Location: Washington, D.C.

http://www.fda.gov/bbs/topics/answers/2005/ans01367.html

 

Dec. 15 -- Joint FDA/USDA meeting to discuss a consistent regulatory approach concerning the jurisdiction over certain products containing meat or poultry.

Location: Rosemont, Ill.

http://www.fda.gov/bbs/topics/news/2005/NEW01255.html

 

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

 

What are "cosmeceuticals"?

 

While the Food, Drug, and Cosmetic Act does not recognize the term "cosmeceutical," the cosmetic industry has begun to use this word to refer to cosmetic products that have drug-like benefits.

 

The Food, Drug, and Cosmetic Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body. While drugs are subject to an intensive review and approval process by FDA, cosmetics are not approved by FDA prior to sale. However, if a product has drug properties, it must be approved as a drug.

 

For more on cosmetics, see http://www.cfsan.fda.gov/~dms/cos-toc.html.

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