FDA News Digest April 28, 2003 ______________________________________________________________ Drug-Releasing Stent Helps Keep Opened Arteries from Reclogging FDA has approved the first stent for use in angioplasty procedures to reduce the rate of reblockage of blood vessels that occurs with existing stents. The stent, left permanently in the artery to keep it open, slowly releases a drug to prevent the buildup of new tissue that can reclog the artery. About 800,000 angioplasty procedures are performed yearly in the United States, and in as many as 30 percent of cases, arteries become clogged again. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00896.html ______________________________________________________________ Permanent Implant Treats Gastroesophageal Reflux Disease FDA has approved Enteryx, a permanently implanted device that treats symptoms of gastroesophageal reflux disease (GERD), a condition in which some of the stomach's contents flows up into the esophagus, causing heartburn or pain in the chest or back of the throat. The device prevents the reflux of stomach acid into the throat. More than 60 million Americans have GERD, and about 25 million have symptoms daily. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01216.html ______________________________________________________________ First Treatment Approved for Rare Metabolic Disorder FDA has approved Fabrazyme, the first treatment for Fabry disease, a serious genetic metabolic disorder. Through an enzyme deficiency, the disease causes certain fats to accumulate in the blood vessels over many years. The result is significant pain, disability, and shortened life span. Fabrazyme treats the disorder by replacing the deficient enzyme, which reduces fat accumulation. FDA approved the treatment under a program that allows accelerated approval of therapies for patients with serious diseases. As one condition of approval, Fabrazyme's manufacturer must conduct additional studies to verify the product's clinical benefits and long-term safety. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00897.html ______________________________________________________________ FDA Commends Industry Group Action to Report Counterfeit Drugs A move by the drug industry's largest trade group to help identify and remove counterfeit drugs from the U.S. market has drawn praise from FDA. The action by the Pharmaceutical Research and Manufacturers of America obligates member companies to notify FDA within five working days if they believe one of their products has been counterfeited. This will allow FDA to take swift enforcement actions if necessary. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00894.html ______________________________________________________________ FDA Plans to Withdraw Older Proposals That Are No Longer Priorities FDA plans to withdraw 84 old proposed actions and rules, some more than 25 years old, that were never finalized and are no longer considered public health priorities. In some cases the issues have become outdated; in others, the agency has enacted alternatives. FDA is asking for public comments on the plan. Press release: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00893.html Questions and answers about the plan: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00893qanda.html Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/02n-0434-NI000001.pdf ______________________________________________________________ Report Affirms Progress Made in Ensuring Safe Food Supply A National Academy of Sciences report affirms progress FDA has made in reducing and preventing foodborne illness. The report attributes some of this progress to FDA's adoption of the Hazard Analysis and Critical Control Point system, which focuses on identifying and preventing hazards before they contaminate food. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01217.html ______________________________________________________________ Peter Pitts Appointed to Head FDA's External Relations FDA Commissioner Mark B. McClellan, M.D., has chosen Peter Pitts as FDA's associate commissioner for external relations. Pitts brings wide experience in marketing and communications to the position, in which he will oversee policy and program direction for FDA's liaisons with external audiences. Pitts has held managerial posts at several magazines and newspapers, and he is the author of the book "Become Strategic or Die." http://www.fda.gov/bbs/topics/NEWS/2003/NEW00892.html ______________________________________________________________ RECALLS The following products have been recalled for the reasons shown. Go to the linked page for more information: Harris Teeter HT Traders Pesto alla genovese (undeclared pine nuts) http://www.fda.gov/oc/po/firmrecalls/hteeter04_03.html Pacific Seafood Co. Pacific Fresh Seafood Mix (undeclared egg whites and wheat flour) http://www.fda.gov/oc/po/firmrecalls/pacificseafood04_03.html J.V. Trading Glendale Ltd. Chili Sauce (undeclared peanuts) http://www.fda.gov/oc/po/firmrecalls/jvtrading204_03.html Kusha Inc. Royal Spanish Rice Pilaf and Royal Chicken Rice Pilaf (incomplete ingredient statement for seasoning packet) http://www.fda.gov/oc/po/firmrecalls/kusha04_03.html ______________________________________________________________ PUBLIC MEETINGS May 7 Public Meeting, Satellite Broadcast to Discuss Bioterrorism Act FDA will sponsor a public meeting May 7 to discuss two sections of the Bioterrorism Act of 2002 regarding establishment and maintenance of records for foods and administrative detention of foods. The meeting will be broadcast by satellite to locations across the country, including sites in California, Florida, Massachusetts, and Ohio. http://www.fda.gov/CDRH/OHIP/DCM/html/cfsan_bio_2_event_page.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 the FDA News Digest. Our next posting will be May 5. 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
