FDA News Digest July 28, 2003 _______________________________________________ FDA Approves Enbrel to Treat Ankylosing Spondylitis FDA has approved a new indication for etanercept (trade name Enbrel) to treat patients with active ankylosing spondylitis (AS), a chronic inflammatory disease affecting primarily the lower back and joints. Etanercept, a genetically engineered protein, had already been licensed to treat rheumatoid arthritis, juvenile rheumatoid arthritis, and psoriatic arthritis. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01240.html _______________________________________________ Thompson, McClellan Commend Senate for Passing Pediatric Research Equity Act In a joint statement, HHS Secretary Tommy G. Thompson and FDA Commissioner Mark B. McClellan, M.D., commended the Senate's passage of the Pediatric Research Equity Act of 2003. The legislation is another step toward closing the gaps that have existed in guaranteeing proper testing of pharmaceutical products for children, they said. http://www.hhs.gov/news/press/2003pres/20030724.html _______________________________________________ N.Y. Man Convicted of Selling Phony Cancer Cure Over the Internet Jason Vale, president of Christian Brothers Contracting Corp. of Queens, N.Y., was convicted of three counts of criminal contempt for violating a court order not to sell Laetrile as a cure for cancer. Vale had been using the Internet to market the fake cancer cure, also known as amygdalin and "Vitamin B-17." http://www.fda.gov/bbs/topics/NEWS/2003/NEW00927.html ____________________________________________________________ New FDA Website Highlights Agency Initiatives A new area on the FDA website highlights Commissioner Mark McClellan's five major initiatives for the agency, providing information about the public health issues that the initiatives are intended to address, along with strategies, desired outcomes and accomplishments to date. The site also includes other relevant materials, such as text of the Commissioner's speeches and congressional testimony, as well as information about FDA's organization and senior management. http://www.fda.gov/oc/mcclellan/ ____________________________________________________________ Ensuring the Safety and Security of the Nation's Food Supply On July 23, 2003, the Food and Drug Administration (FDA) submitted to HHS Secretary Tommy G. Thompson a progress report entitled "Ensuring the Safety and Security of the Nation's Food Supply," which summarizes the leadership demonstrated at FDA in combating the terrorist threat to foods. HHS press release: http://www.hhs.gov/news/press/2003pres/20030723.html More information: http://www.fda.gov/oc/initiatives/foodsecurity ____________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information. J.V. Trading Glendale Ltd. Lukai Sweetened Jujube (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/jvtrading07_03.html Gusto Food, Inc. Mr. No. 1 Brand Bamboo Shoot Sliced (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/gusto07_03.html Mazur Meat Market Potato Salad (possible Listeria monocytogenes contamination) (New York State press release) http://www.fda.gov/oc/po/firmrecalls/mazur07_03.html Global Commodities, Inc. Dried Green Raisins (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/global07_03.html Kadouri International Foods, Inc. Pakistani Green Raisins (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/kadouri07_03.html Lisy Corporation Ground Cumin (potential Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/lisy07_03.html _______________________________________________ RECENT TESTIMONY FDA Commissioner Mark B. McClellan, M.D., before the Joint House Subcommittee on Commerce, Trade and Consumer Protection and the Subcommittee on Oversight and Investigations. Topic: "Ephedrine Alkaloid-Containing Dietary Supplements" (July 24) http://www.fda.gov/ola/2003/Ephedra0724.html FDA Commissioner Mark B. McClellan, M.D., before the Senate Committee on Health, Education, Labor, and Pensions. Topic: "FDA's Role in Counterterrorism Activities" (July 24) http://www.fda.gov/ola/2003/FederalBiodefenseReadiness0724.html FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., before the Senate Special Committee on Aging. Topic: "FDA's Regulation of Prescription Drug Promotion" (July 22) http://www.fda.gov/ola/2003/AdvertisingofPrescriptionDrugs0722.html ______________________________________________ Thanks for subscribing to the FDA News Digest. Our next posting will be August 4. 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
