FDA News Digest July 19, 2004 ________________________________________________ IN THIS WEEK'S ISSUE -- New FDA Program Aims to Improve Reviews of Cancer Products -- FDA Approves New Use of Drug to Treat Common Form of Skin Cancer -- FDA Proposes to Enhance Drug Approval Information for Companies -- Rx Drugs from Bogus Canadian Web Site Found to Be Fake, Substandard -- N.J. Judge Orders Injunction for Three Unapproved Drugs, Refunds for Buyers -- 57 Cases of Illness May be Linked to Food at Sheetz Gas Stations in 3 States -- Landa Named Deputy Director of Regulatory Affairs in FDA Food Center -- Latest FDA Consumer Magazine Available Online -- Recalls/Market Withdrawals -- Recent Speeches -- Congressional Testimony -- Public Meetings ______________________________________________________________ New FDA Program Aims to Improve Reviews of Cancer Products FDA has created a program to strengthen the way it reviews products to diagnose, treat and prevent cancer. The program creates an Office of Oncology Drug Products, consolidating three offices responsible for reviewing cancer drugs and biologicals. Among anticipated benefits of the new office will be improvements in the consistency of review and policy toward oncology drugs. Press release: http://www.fda.gov/bbs/topics/news/2004/NEW01091.html Questions and answers: http://www.fda.gov/oc/initiatives/oncology/questions.html FDA Approves New Use of Drug to Treat Common Form of Skin Cancer FDA has approved Aldara topical cream to treat superficial basal cell carcinoma (sBCC), a common form of skin cancer. This cancer is typically treated by surgical removal. The cream should be used for sBCC only when surgery is medically less appropriate. Aldara was previously approved for treating actinic keratosis and external genital warts. http://www.fda.gov/bbs/topics/news/2004/NEW01088.html FDA Proposes to Enhance Drug Approval Information for Companies FDA is proposing to change its new and generic drug review process by replacing the agency's current "approvable" or "not approvable" letter system with a new type of letter that gives companies specific information about what they need to do before their drugs can be approved. The agency is making the proposal as part of its efforts to implement performance goals referred to in 2002 drug user fee legislation. http://www.fda.gov/bbs/topics/news/2004/NEW01092.html Rx Drugs from Bogus Canadian Website Found to Be Fake, Substandard An FDA analysis of three commonly prescribed drugs bought from a Website advertised as Canadian showed the drugs were fake, substandard, and potentially dangerous. The products bought were so-called "generic" versions of Viagra, Lipitor, and Ambien, none of which has an FDA-approved generic version. The findings reinforce FDA's strong concerns about buying prescription drugs from unknown sources. http://www.fda.gov/bbs/topics/news/2004/NEW01087.html N.J. Judge Orders Injunction Against 3 Unapproved Drugs, Refunds for Buyers A New Jersey District Court judge has found that three products sold by Lane Labs-USA Inc. as treatments for cancer and HIV are unapproved drugs. The judge issued a permanent injunction against the products -- Benefin, MGN-3, and SkinAnswer -- and ordered refunds for all buyers of the products since Sept. 22, 1999. http://www.fda.gov/bbs/topics/news/2004/NEW01086.html 57 Cases of Illness May be Linked to Food at Sheetz Gas Stations in 3 States FDA is warning consumers that 57 cases of Salmonella-related illness may be associated with food bought between July 2 and 9at deli counters at Sheetz gas stations in Pennsylvania, Maryland, and West Virginia. FDA is working with other federal and state officials to determine the scope of the problem. http://www.fda.gov/bbs/topics/news/2004/NEW01090.html Landa Named Deputy Director of Regulatory Affairs in FDA Food Center FDA has named Michael Landa, Esq., to be deputy director of regulatory affairs in the agency's Center for Food Safety and Applied Nutrition (CFSAN). He will oversee major health claim petitions, the agency's obesity initiative, and planning and execution of CFSAN's enforcement strategies. http://www.fda.gov/bbs/topics/news/2004/NEW01089.html ______________________________________________________________ Latest FDA Consumer Magazine Available Online The July-August 2004 issue of FDA Consumer has articles on the following topics: -- Diabetes -- Confronting the national epidemic of this disease, with focus on children and minorities. -- Prescription drug ads -- FDA is ensuring that these are easy to understand and don't mislead consumers. -- Drug interactions -- Drugs can interact with other drugs, dietary supplements, and even food and beverages. -- Generic drugs -- Some U.S. generics are less expensive than both Canadian brand-name and generic drugs. -- Dietary supplements -- FDA uses a science-based approach to protect consumers. -- Pets that scratch -- Itchy skin on pets is often a sign of allergies that can be treated. -- Homemade ice cream -- A few food safety tips can help prevent possible foodborne illness. Also included is a list of questions and answers about prescription drug advertising. The issue is online at http://www.fda.gov/fdac/404_toc.html Subscribe to FDA Consumer: http://www.fda.gov/fdac/orderform/fdap.html _________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked pages for more information. Carl Zeiss Ophthalmic System; Visulas 532s with Visulink 532U (mirror coating could tear and loosen) http://www.fda.gov/cdrh/recalls/recall-060304.html Grist Mill Co. Fruit & Nut Trail Mix Granola Bars and Muesli Cereals; sold under various brand names (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/gristmill07_04.html For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Institute of Food Technologists (July 13) http://www.fda.gov/oc/speeches/2004/ift0713.html FDA Acting Commissioner Lester M. Crawford, D.V.M., before the World Obesity Congress & Expo (July 12) http://www.fda.gov/oc/speeches/2004/worldobesity0712.html To view an archive of speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm ______________________________________________________________ CONGRESSIONAL TESTIMONY FDA Associate Commissioner for Policy and Planning William K. Hubbard, before the Senate Committee on the Judiciary; subject: importation of prescription drugs (July 14) http://www.fda.gov/ola/2004/importeddrugs0714.html To view an archive of Congressional testimony by FDA officials, go to http://www.fda.gov/ola/listing.html ______________________________________________________________ PUBLIC MEETINGS July 20-23 -- National Health Information Infrastructure 2004: Cornerstones for Electronic Healthcare; Washington, D.C. http://www.hsrnet.net/nhii/welcome.htm July 28-29 -- Research Strategies, Study Designs and Statistical Approaches to Biomarkers Validation for Cancer Diagnosis and Detection; Gaithersburg,Md. http://www3.cancer.gov/prevention/biomarkers2004/index.html 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 July 26. 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