FDA News Digest May 24, 2004 ________________________________________________
THIS WEEK'S NEWS -- Rule Aims to Prevent Disease Transmission Through Tissue Transplants -- Drug Shows Small Survival Improvement for Advanced Prostate Cancer -- Vidaza Approved for Treating MDS, a Rare Bone Marrow Disease -- Expedited Review to Help Provide HIV/AIDS Drugs to Developing Countries -- Illness Associated With Certain Basil and Mesculin/Spring Mix Salads -- FDA Will Review Outside Activities of FDA Employees -- Latest FDA Consumer Magazine Now Available Online -- Recalls/Market Withdrawals -- Congressional Testimony ______________________________________________________________ Rule Aims to Prevent Disease Transmission Through Tissue Transplants FDA has finalized a rule to establish eligibility criteria for donors of human cells, tissues, and cellular and tissue-based products to help prevent transmission of communicable disease through transplants of these products. The new rule expands on an existing regulation that previously applied only to certain tissues and diseases. http://www.fda.gov/bbs/topics/news/2004/NEW01070.html Drug Shows Small Survival Improvement for Advanced Prostate Cancer FDA has approved Taxotere (docetaxel), an injected drug to be used with the steroid prednisone to treat patients with advanced prostate cancer that has spread. It is the first approved drug to show an improvement in survival for patients who have not responded to hormone therapy. Clinical trials showed a survival advantage of about 2.5 months. http://www.fda.gov/bbs/topics/news/2004/NEW01068.html Vidaza Approved for Treating MDS, a Rare Bone Marrow Disease FDA has approved Vidaza (azacitidine) to treat myelodysplastic syndrome (MDS), a set of disorders in which bone marrow does not function normally and not enough normal blood cells are made. About 7,000 to 12,000 new MDS cases are diagnosed yearly in the United States. http://www.fda.gov/bbs/topics/news/2004/NEW01069.html Expedited Review to Help Provide HIV/AIDS Drugs to Developing Countries A new expedited review process aims to ensure that the United States is providing safe and effective HIV/AIDS drugs to developing countries as part of the Emergency Plan for AIDS Relief. Under the program, lifesaving drugs will be offered at lower prices to millions of people in Africa and the Caribbean. News release: http://www.hhs.gov/news/press/2004pres/20040516.html More information: http://www.fda.gov/oc/initiatives/hiv/default.htm Illness Associated With Certain Basil and Mesculin/Spring Mix Salads FDA is warning consumers about two outbreaks of the foodborne illness cyclosporiasis associated with raw basil and mesculin/spring mix salad served in Texas and Illinois. FDA is working with federal, state, and other health authorities to determine the cause and scope of the outbreak. http://www.fda.gov/bbs/topics/news/2004/NEW01071.html FDA Will Review Outside Activities of FDA Employees Following recent questions about possible conflicts of interest involving agencies of the Department of Health and Human Services, FDA is conducting a comprehensive review of all current outside activity requests from all FDA employees. The review will result in a final agency policy on reviewing and approving outside activities. http://www.fda.gov/bbs/topics/news/2004/NEW01067.html ______________________________________________________________ Latest FDA Consumer Magazine Now Available Online The May-June 2004 issue of FDA Consumer has articles on the following topics: -- Colorectal cancer -- FDA has approved two new drugs for advanced disease. -- Mercury in fish -- FDA, EPA issue joint advisory for reducing exposure. -- Obesity -- The Department of Health and Human Services tackles this growing problem. -- Rx drug safety -- About 6 million Americans abused prescription medicines in 2002. -- "Andro" products -- FDA has concerns about the safety of androstenedione. -- "Mad cow disease" -- Agencies work to protect public health and livestock. -- Counterfeit drugs -- FDA's strategies for dealing with this problem. -- Summer safety -- Tips on handling eight warm-weather hazards. -- Acrylamide -- An FDA action plan for dealing with this substance in foods. -- FDA science -- 2004 Forum spotlighted agency research, collaborations The issue is online at http://www.fda.gov/fdac/304_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. Medtronic Quick-Set Plus Infusion Sets (possible problems with insulin flow) http://www.fda.gov/oc/po/firmrecalls/medtronic05_04.html Paramount Farms Whole Natural Raw Almonds (possible Salmonella contamination) Alert notice: http://www.fda.gov/bbs/topics/news/2004/NEW01072.html Recall notice: http://www.fda.gov/oc/po/firmrecalls/paramount05_04.html Essensia Cookies (undeclared nuts in some packages) http://www.fda.gov/oc/po/firmrecalls/essensia05_04.html Queso Duro Viejo/Hard Cheese (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/riogrande05_04.html Popeye Cafe Parisian Complete Salad Kit (undeclared walnuts and pecans) http://www.fda.gov/oc/po/firmrecalls/riverranch05_04.html For a listing 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 ______________________________________________________________ CONGRESSIONAL TESTIMONY FDA Associate Commissioner for Regulatory Affairs John M. Taylor, before the Senate Committee on Health, Education, Labor and Pensions; subject: imported drugs (May 20) http://www.fda.gov/ola/2004/importeddrugs0520.html FDA Office of In Vitro Diagnostic Device Evaluation and Safety Director Steven Gutman, M.D., before the House Subcommittee on Criminal Justice, Drug Policy and Human Resources; subject: FDA's role in regulating medical devices (May 18) http://www.fda.gov/ola/2004/adaltis0518.html FDA Office of Cell Tissue and Gene Therapies Senior Investigator Emanuel F. Petricoin, before the House Investigation and Oversight Subcommittee; subject: ethics (May 18) http://www.fda.gov/ola/2004/petricoin0518.html Statement for the Record on Ethical Standards (May 18) http://www.fda.gov/ola/2004/ethics0518.html ______________________________________________________________ Thanks for subscribing to FDA News Digest. Our next posting will be June 1. 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