FDA News Digest February 23, 2004 ______________________________________________________________ THIS WEEK'S NEWS -- FDA Commissioner to be Nominated for Medicare/Medicaid Position -- Report Highlights Steps Being Taken to Fight Counterfeit Drug Threat -- W. Va. Business Warned About Offering Illegal Foreign Drugs -- Recalls/Market Withdrawals -- Public Meetings ______________________________________________________________ FDA Commissioner to be Nominated for Medicare/Medicaid Position President Bush has announced his intention to nominate FDA Commissioner Mark B. McClellan, M.D., to be administrator of the Centers for Medicare and Medicaid Services (CMS) in the Department of Health and Human Services. If confirmed for the position by the Senate, McClellan would be joining CMS on the heels of new legislation aimed at lowering prescription drug costs for seniors. Among other duties, he would be overseeing a new drug discount program with financial assistance for low-income beneficiaries. McClellan has served as FDA commissioner since late 2002. Lester M. Crawford, D.V.M., Ph.D., will become the agency's acting commissioner. http://www.whitehouse.gov/news/releases/2004/02/20040220.html Report Highlights Steps Being Taken to Fight Counterfeit Drug Threat An FDA task force has released a final report highlighting steps the agency sees as necessary to protect consumers from the growing threat of counterfeit drugs. These include improving security in product packaging and distribution, enhancing regulatory oversight, increasing penalties, improving vigilance, and increasing international cooperation. Press release: http://www.hhs.gov/news/press/2004pres/20040218.html Task force report: http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html More information on counterfeit drugs : http://www.fda.gov/oc/initiatives/counterfeit/ W. Va. Business Warned About Offering Illegal Foreign Drugs FDA has sent a letter to West Virginia-based Discount Prescriptions from Canada Inc., warning the company that its business of helping customers import illegal prescription drugs from Canada violates federal law. The agency says statements on the company's Web site mislead consumers into believing that drugs imported from Canada are as safe as domestically dispensed drugs. http://www.fda.gov/bbs/topics/NEWS/2004/NEW01025.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following products are being recalled for the reasons shown. Go to the linked page for more information. Trader José's Fresh Guacamole and Señor Felix's Guacamole in 16-ounce cups (possible Listeria contamination) http://www.fda.gov/oc/po/firmrecalls/freshfood02_04.html Toysmith Jelly Pops (undeclared egg and peanut) http://www.fda.gov/oc/po/firmrecalls/toysmith02_04.html Ile de France Brie Soft Ripened Cheese in 4.5 oz. tins (potential contamination with Clostridium botulinum) http://www.fda.gov/oc/po/firmrecalls/schratter02_04.html Duragesic fentanyl transdermal system (possible seal breach) http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#duragesic For a listing of recalls and market withdrawals from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ PUBLIC MEETINGS March 17 -- FDA/Drug Information Association Workshop: "Combating Counterfeit Drugs"; Washington, D.C. http://www.diahome.org/Content/Events/04027.pdf 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 March 1. 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
