U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jan 2008 14:34:48 -0600 (CST)
Subject: MedSun Update

Medical Product Safety Network

You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).

The content on the Homepage has been updated to reflect February's Newsletter items.  This information can be viewed by clicking here. 

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Jan 2008 10:37:16 -0600 (CST)
Subject: Drug Information Update- Clarification of Recent FDA Initiatives Affecting OTC Drugs

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

FDA recently announced implementation of two statutory amendments affecting over-the-counter (OTC) drug products.

Because there has been some confusion expressed by stakeholders over these two actions, FDA is issuing this clarification.

The following table clarifies the type of OTC drug products affected by each statutory provision and answers specific questions about each of the requirements.

 

	Toll-Free Number Interim Final Rule	Draft Labeling Guidance
To which OTC drug products does this initiative apply?	OTC products marketed pursuant to applications approved under section 505 of the FDCA	OTC drug products marketed without an approved application
What must be on the drug product’s label?	Unless the packaging includes a toll-free number through which consumers can report complaints to the manufacturer or distributor, the drug facts label must contain a statement including FDA’s toll-free MedWatch telephone number in the content and format specified in 21 CFR 201.66(c)(5)(vii).	The domestic address or phone number at which the manufacturer or other “responsible person” may receive a report of a serious adverse event associated with the use of a drug product.
What is the legislative origin of this initiative?	Best Pharmaceuticals for Children Act of 2001 & Food and Drug Administration Amendments Act of 2007 (FDAAA)	Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (DSNDCPA)
What is the effective date of these requirements?	The toll-free number interim final rule became effective January 1, 2008	The DSNDCPA requirements became effective December 22, 2007
Will FDA exercise enforcement discretion regarding these requirements?	FDA will exercise enforcement discretion regarding the requirements of the toll-free number interim final rule until January 1, 2009.	FDA will exercise enforcement discretion regarding the labeling requirements of the DSNCDPA until January 1, 2009.

For more information, please visit: http://www.fda.gov/cder/Offices/OTC/OTC_clarification.htm

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 25 Jan 2008 14:17:39 -0600 (CST)
Subject: Drug Information Update- Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

On January 14, 2008, Merck/Schering Plough Pharmaceuticals issued a Press Release reporting preliminary results from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. This trial was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin (ezetimibe plus simvastatin) or simvastatin alone.  Merck/Schering Plough Pharmaceuticals, the company that conducted the trial, stated that there was no significant difference between Vytorin and simvastatin in the amount of atherosclerotic plaque in the inner walls of the carotid (neck) arteries despite greater lowering of LDL-cholesterol (bad cholesterol) with Vytorin compared to simvastatin.  FDA has not received a final study report and at this time it is not clear why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to patients treated with simvastatin alone.

This early communication is in keeping with FDA’s commitment to inform the public about ongoing postmarketing drug issues.  Once Merck/Schering Plough Pharmaceuticals completes the analysis of the unblinded data from ENHANCE, it will submit a final study report to FDA. Once FDA receives the final study report, FDA estimates it will take approximately 6 months to fully evaluate the data. After reviewing the data from the ENHANCE study, and considering all other available information about the link between LDL lowering and reduction of cardiovascular events, FDA will determine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted.

For more information, please visit: http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 17 Jan 2008 10:25:15 -0600 (CST)
Subject: Drug Information Update

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

The U.S. Food and Drug Administration today issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.

There are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness.

The announcement does not include the FDA's final recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. The agency's review of data for 2-to-11-year-olds is continuing. The FDA is committed to making a timely and comprehensive review of the safety of OTC cough and cold medicines in children. The agency plans to issue its recommendations on use of the products in children ages 2 to 11 years to the public as soon as the review is complete.

Today's statement is based on the FDA's review of data and discussion at a joint meeting of the Nonprescription Drugs and Pediatric Advisory Committees on Oct. 18 and 19, 2007.

Pending completion of the FDA's ongoing review, parents and caregivers that choose to use OTC cough and cold medicines to children ages 2 to 11 years should:

• Follow the dosing directions on the label of any OTC medication,
• Understand that these drugs will NOT cure or shorten the duration of the common cold,
• Check the "Drug Facts" label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients, and
• Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs.

The FDA recommends that anyone with questions contact a physician, pharmacist or other health care professional to discuss how to treat a child with a cough or cold.

For more information and the full list of the FDA's recommendations, visit:

Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children
http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm

Questions and Answers for Consumers
http://www.fda.gov/consumer/updates/coughcold011708.html

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 14 Jan 2008 16:18:03 -0600 (CST)
Subject: Dietary Supplements & Food Labeling Newsletter January 2008 (#15)

* * * U.S. Food and Drug Administration * * *
* * Center for Food Safety and Applied Nutrition * *
* Dietary Supplement/Food Labeling Electronic Newsletter *

WHAT IS "FDA-DSFL"?

FDA-DSFL is an electronic newsletter from the Food and Drug Administration's Office of Nutrition, Labeling, and Dietary Supplements (ONLDS), in the Center for Food Safety and Applied Nutrition (CFSAN). Its purpose is to give interested parties access to key information and updates on dietary supplements, food labeling and nutrition issues.

+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

January 14, 2008

Availability of Downloadable/Printable Posters
for Nutrition Information of Raw Fruits, Vegetables, and Fish

The Food and Drug Administration's Center for Food Safety and Applied Nutrition has posted on its website downloadable and printable posters of nutrition information for the 20 most frequently consumed raw fruits and vegetables consumed in the United States. The website also includes a poster that lists nutrition information for fish which has been cooked by moist or dry heat with no added ingredients.

FDA is providing these posters to encourage retail stores that sell raw fruits, vegetables, and fish to participate in the voluntary point-of-purchase nutrition information program (21 CFR 101.42 through 101.45). Retail store operators can download the posters and print them for display to consumers in proximity to the relevant foods in the stores and for dissemination to consumers.

FDA encourages consumers to use the posters to help plan a healthy diet and learn about the important nutrients contained in fruits, vegetables and fish. Federal dietary guidelines recommend two cups of fruit and 2 1/2 cups of vegetable per day for a recommended 2,000 calorie intake, with higher or lower amounts depending on the calorie level. In addition to protein, fish contributes polyunsaturated and monounsaturated fats to the diet.

Raw Fruits, Vegetables, and Fish Posters

Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Final Rule; Correction Federal Register, August 17, 2006

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 9 Jan 2008 15:21:57 -0600 (CST)
Subject: Drug Information Update- FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals.

The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use) are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer's disease, stroke, and various forms of cancer.

FDA is concerned that the claims for safety, effectiveness, and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

For more information, please visit:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html

http://www.fda.gov/cder/pharmcomp/default.htm

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U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 3 Jan 2008 11:03:30 -0600 (CST)
Subject: Drug Information Update- Toll Free Number for Reporting Adverse Events on Labeling for Human Drug Products

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

The Food and Drug Administration (FDA) is issuing an interim final rule to codify the provisions of the proposed rule entitled ‘‘Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products’’ (69 FR 21778, April 22, 2004) that, under the Food and Drug Administration Amendments Act of 2007 (FDAAA), became effective by operation of law on January 1, 2008. This interim final rule requires the addition of a statement on the labeling of certain human drug products for which an application is approved under the Federal Food, Drug, and Cosmetic Act.  The added statement includes a tollfree number and advises that the number is to be used only for reporting side effects and is not intended for medical advice.  As mandated by FDAAA, this interim final rule does not apply to over-the-counter drug products approved as new drugs under the act if the product packaging includes a manufacturer’s or distributor’s toll-free number for reporting complaints.

To read the interim final rule, please visit:

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-25426.htm

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