FDA News Digest October 4, 2004 _______________________________________________ IN THIS WEEK'S ISSUE -- Vioxx Voluntarily Withdrawn by Manufacturer; FDA Issues Advisory -- Educational Program to Address Hormone Therapy, Menopause Questions -- FDA, European Agencies Announce Two Plans to Share Information -- Wisconsin Company Violates Court Order to Stop Making Drug Claims -- Recalls/Market Withdrawals -- Recent Speeches -- Public Meetings ____________________________________________________________ Vioxx Voluntarily Withdrawn by Manufacturer; FDA Issues Advisory Following post-marketing studies that showed an increased risk of heart attacks and strokes in those using the pain and anti-inflammation drug Vioxx, the drug's manufacturer has voluntarily withdrawn the product from the market. At the same time, FDA has issued a public health advisory advising patients to check with their doctors about alternatives to Vioxx. http://www.fda.gov/bbs/topics/news/2004/NEW01122.html Educational Program to Address Hormone Therapy, Menopause Questions FDA is implementing a nationwide campaign to address questions about the benefits and risks of hormone therapy for menopausal symptoms. The campaign will distribute educational materials to help women make informed decisions when considering hormone therapy. http://www.fda.gov/bbs/topics/news/2004/NEW01121.html FDA, European Agencies Announce Two Plans to Share Information FDA and the European Union have released an implementation plan that outlines how the two groups will exchange information related to medicinal products for human use as part of an cooperative agreement signed in 2003. Also available is a description of a pilot program between FDA and the European Medicines Agency that provides for "parallel scientific advice," an exchange of views between the two agencies during the development stage of new medicinal products such as human drugs and biologics. FDA-EU information-sharing plan: http://www.fda.gov/oia/arrangements0904.html FDA-EMA parallel scientific advice plan: http://www.fda.gov/oia/pilotprogram0904.html Wisconsin Company Violates Court Order to Stop Making Drug Claims FDA has informed Wisconsin-based Hillestad Pharmaceuticals that the company has violated a court order prohibiting drug claims in promoting its dietary supplements. In a letter to Hillestad, FDA instructed the company to stop making the illegal claims or it could face further action, including a possible contempt proceeding. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01316.html ____________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reason shown. Go to the linked page for more information. Certain Baskin-Robbins brand ice cream distributed in five Western states (undeclared eggs) http://www.fda.gov/oc/po/firmrecalls/baskin09_04.html Chef's Review Nonfat Dry Milk; 5 lb. size (possible Salmonella contamination) http://www.fda.gov/oc/po/firmrecalls/smartfinal09_04.html Seneca Foods Corp. sliced beets (packaged under 28 different labels); 15 oz. size (possible contamination due to underprocessing) http://www.fda.gov/oc/po/firmrecalls/seneca09_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 To access the RSS feed of FDA recalls information, go to http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml ______________________________________________________________ RECENT SPEECHES FDA Acting Commissioner Lester M. Crawford, D.V.M., before the U.S. Vatican Mission's Conference on "Feeding a Hungry World: The Moral Imperative of Biotechnology" (Sept. 24) http://www.fda.gov/oc/speeches/2004/vatican0924.html ______________________________________________________________ PUBLIC MEETINGS Oct. 13 -- Measuring the Effectiveness of the Nation's Food Service and Retail Food Protection System; Gaithersburg, Md. http://www.fda.gov/cdrh/ocer/dcm/html/baseline_event_page.html Oct. 13-14 -- Animal Models and Correlates of Protection for Plague Vaccines; Gaithersburg, Md. http://www.fda.gov/cber/meetings/plague101304.htm Oct. 19 -- Preparation for International Conference on Harmonization Meetings in Yokohama, Japan http://www.fda.gov/ohrms/dockets/98fr/oc04242.pdf Nov. 18 -- Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions http://www.fda.gov/OHRMS/DOCKETS/98fr/04-21676.htm For a list of 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 October 11. 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
