FDA News Digest May 27, 2003 ______________________________________________________________ BSE NEWS FDA Investigating Case of Cow Found with BSE in Canada FDA is working closely with Canadian and other U.S. officials to learn more about a case of bovine spongiform encephalopathy (BSE, or "mad cow disease") reported in a cow in a remote area of Alberta, Canada. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00908.html Canada Reports BSE Cow May Have Been Used for Pet Food The Canadian government reports that a cow that tested positive for BSE may have been used to make dog food, some of which was reportedly shipped to the United States. FDA stresses that there is no scientific evidence that dogs can contract BSE or transmit the disease to humans. The dog food company, The Pet Pantry International, is taking steps to retrieve product that may have been distributed. http://www.fda.gov/bbs/topics/NEWS/2003/NEW0910.html _____________________________________________________________ FDA Advises Consumers Not to Use Imported Viagra FDA is responding to irregularities in its handling of a large number of small import shipment of unapproved Viagra, apparently from Belize. Through a series of procedural irregularities, unapproved foreign versions of the erectile dysfunction drug that FDA examined upon importation were released to individuals who ordered them. FDA is notifying these persons by letter that the agency cannot vouch for the quality, safety, or effectiveness of these unapproved products. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01222.html _____________________________________________________________ First Drug Approved for Sterilizing Male Dogs FDA has approved Neutersol Injectable Solution, the first product for chemical sterilization of male puppies. The drug is an alternative to surgical castration and may help control burgeoning dog populations. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01221.html ______________________________________________________________ FDA Commissioner Applauds Bill Authorizing Animal Drug User Fees FDA Commissioner Mark B. McClellan, M.D., has issued a statement praising the U.S. Senate for passing the Animal Drug User Fee Act of 2003. Like existing legislation that authorizes FDA to collect fees for reviewing human drugs and medical devices, the new bill will provide fees to help FDA enhance its review process for animal drugs and make these products available more quickly. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01225.html ______________________________________________________________ Report, Online Database Show Status of Postmarketing Studies FDA is taking two measures to inform the public about the status of manufacturers' commitments to carry out further clinical studies following approval of certain drugs and biological products. One is publication of a Federal Register report on postmarketing studies, which FDA requires for all products that receive accelerated approval. The other is an online searchable database with postmarketing study commitments made since Jan. 1, 1991. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01223.html ______________________________________________________________ RECALLS The following products are being recalled for the reasons shown. Go to the linked page for more information: Lipitor (three lots of the cholesterol-lowering drug are counterfeit) http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01224.html Fresh Express 10 Oz. Hearts of Romaine (possible Listeria contamination) http://www.fda.gov/oc/po/firmrecalls/freshexpress05_03.html Wegmans Brand Graham Crackers (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/wegmans05_03.html Asian Boy Brand Sweet Lotus Candy (undeclared sulfites) http://www.fda.gov/oc/po/firmrecalls/sweetlotus05_03.html ______________________________________________________________ PUBLIC MEETINGS Video of May 7 Bioterrorism Act Meeting Available Online A video recording of a May 7 FDA public meeting and satellite broadcast that discussed two provisions of the Bioterrorism Act of 2002 is available on FDA's website. The two-hour recording is available in English, Spanish, or French. FDA held the meeting to help explain proposed regulations regarding the administrative detention of food that may pose a risk to public health and records maintenance among food companies. http://www.cfsan.fda.gov/%7Ecomm/vltbtac2.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 June 2. 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
