FDA News Digest November 10, 2003 ________________________________________________ FDA Continues Campaign Against Importing of Unapproved Foreign Drugs FDA is continuing its aggressive campaign to ensure that unapproved and potentially risky foreign prescription drugs are not imported and sold in the United States, as evidenced by several recent actions. In one, FDA informed CanaRx that its business of supplying imported prescription drugs to the city of Springfield, Mass., is illegal. In another action, FDA informed Illinois officials that their plans to import foreign drugs will create potential hazards for patients. And in a related matter, a federal district judge found that foreign drug importer Rx Depot "violates the law," an action that FDA says "sends a clear signal that those who would put profit before safety will not be allowed to threaten the public health." Press release on CanaRx: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00973.html FDA letter to Illinois officials: http://www.fda.gov/oc/opacom/hottopics/importdrugs/kamath.html FDA statement on Rx Depot decision: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00974.html _____________________________________________________________ Congressional Passage of Animal Drug User Fee Act Praised FDA Commissioner Mark B. McClellan, M.D., has released a statement commending several members of both houses of Congress for their leadership in the recent passage of the Animal Drug User Fee Act of 2003. When enacted, this bill will allow FDA to collect user fees to help speed FDA review of animal drugs, shortening the time for introduction of new therapies to treat pets and food-producing animals. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00975.html _____________________________________________________________ FDA, CDC Set New Rules to Help Prevent Transmission of Monkeypox New rules, established jointly by FDA and the Centers for Disease Control and Prevention, aim to prevent transmission of the rare viral disease monkeypox by restricting the domestic sale and possession of African rodents, North American prairie dogs, and certain other animals shown to communicate the disease. Occurring primarily in the rain forests of central and west Africa, monkeypox was first reported in the United States this year. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00970.html _____________________________________________________________ FDA Guidance Stresses Importance of Genetic Differences in Drug Development FDA has issued guidance that encourages drug and biologic developers to conduct tests during drug development that take into account small genetic differences in patients. These differences help explain if a patient will respond to a drug positively, will not respond at all, or will experience a side effect. FDA says the promise of this emerging field, known as pharmacogenomics, is its potential to provide an individualized therapy by predicting which patients have a greater chance of benefit or risk. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00969.html _____________________________________________________________ FDA Fines Eye Doctor $1.1 Million for Clinical Study Violations Louisiana-based ophthalmologist Leon C. LaHaye and the eye care center he owns have agreed to pay the federal government a total of $1.1 million in civil penalties for violating federal laws in clinical studies of a laser system to treat nearsightedness. Violations alleged in the case include use of an unapproved laser on patients before beginning a study and treating more subjects than allowed under an FDA-approved study plan. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00972.html _____________________________________________________________ Seven Universities Awarded Women's Health Research Contracts FDA's Office of Women's Health has awarded contracts to seven universities to conduct clinical research on women's health issues. Under one of the contracts, the University of Arizona will study whether pregnancy changes the activity of the antidepressant sertraline. Under another contract, Boston University will examine blood glucose monitoring for diabetes, comparing fingertip-drawn blood samples with those taken from other locations on the body. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00971.html ______________________________________________________________ RECALL The following product is being recalled for the reason shown. Go to the linked page for more information. River Valley Foods Sugar-Free Golden Pound Cake (undeclared milk) http://www.fda.gov/oc/po/firmrecalls/rivervalley11_03.html ______________________________________________________________ PUBLIC MEETINGS Nov. 12 -- FDA Public Workshop on Clinical Trial Endpoints in Colorectal Cancer; Washington, D.C. http://www.fda.gov/cder/drug/cancer_endpoints/colonAnnouncement.pdf Nov. 20 -- FDA Workshop: Exploring the Link Between Food Labeling and Weight Management; Bethesda, Md. https://secure.z-techcorp.com/cmt/meetings/meeting_detail.cfm?meeting_id=26 For a list of upcoming FDA meetings, seminars, and other public events, go to http://www.fda.gov/opacom/hpmeetings.html. _______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be November 17. To leave this list at any time, send an e-mail to LISTSERV@xxxxxxxxxxxx In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
