FDA News Digest February 10, 2003 __________________________________________________________________ Counterterrorism, Patient Safety Among FY 2004 FDA Funding Proposals The White House's fiscal year 2004 budget request for FDA totals $1.7 billion, which includes funding for programs in counterterrorism, patient safety, generic drug review, and evaluation of drugs for children. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01195.html __________________________________________________________________ FDA Recommends Extra Safety Measures for Some Donated Blood FDA has issued recommendations for the blood industry that describe additional inspection measures as a precaution while the agency investigates reports of certain blood products containing small white particles. Testing done so far by the Centers for Disease Control and Prevention has found no evidence that the particles are infectious agents. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01199.html __________________________________________________________________ Drug Approved to Help Increase Survival After Nerve Gas Exposure FDA has approved pyridostigmine bromide to help increase survival after exposure to Soman nerve gas. The product was approved for combat use by U.S. military personnel and is the first drug approved under a recent FDA rule that allows animal data to be used to gauge a drug's effectiveness when it cannot ethically be tested in humans. http://www.fda.gov/bbs/topics/NEWS/2003/NEW00870.html __________________________________________________________________ Contamination Prompts Injunction Filing Against Maryland Company After an FDA inspection found that food at facilities run by a Maryland company was held under unsanitary conditions and contaminated with rodent and insect material, the federal government filed for an injunction to prevent the company from processing food until the violations are corrected. The company, SCT Corporation, had repeatedly ignored FDA's earlier warnings to correct the problems. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01198.html __________________________________________________________________ FDA Investigates Improper Disposal of Bioengineered Pigs FDA has determined that pigs involved in bioengineering studies at the University of Illinois may not have been properly disposed of and may have entered the food supply. Based on current information, the agency says the incident poses no public health risk. But if improper disposal is confirmed, it would represent a significant breach of FDA requirements for the studies and would warrant strong action against those responsible. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01197.html __________________________________________________________________ Honey Containing Unapproved Additive Is Seized from Texas Company At FDA's request, U.S. marshals seized imported honey from Texas-based Hoyt's Honey Farm Inc., after the agency determined that the honey contained the unapproved additive chloramphenicol, an antibiotic drug used to treat life-threatening infections. The seizure is the third such action FDA has taken against different honey companies in the last six months. http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01196.html __________________________________________________________________ RECALLS The following product has been recalled for the reason shown. Go to the linked page for more information: Summit Import Inc. Sweetened Coconut (undeclared sulfites): http://www.fda.gov/oc/po/firmrecalls/summit02_03.html __________________________________________________________________ PUBLIC MEETINGS 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 February 18. To leave this list at any time, send an e-mail to LISTSERV@LIST.NIH.GOV In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
