FDA News Digest March 15, 2004 ______________________________________________________________
THIS WEEK'S NEWS -- FDA Proposes Action Plan to Confront Nation's Obesity Problem -- HHS Cracking Down on Distributors of Steroid-Like 'Andro' Products -- Proposal Issued on Developing Drugs for Smallpox Vaccine Side Effects -- FDA Approves New Type of Drug for Hyperparathyroidism -- FDA Lauds Senate for Passing Consumer Protection, Animal Drug Bill -- Recalls/Market Withdrawals -- Latest FDA Consumer Magazine Now Available Online -- Recent FDA Testimony -- Public Meetings ______________________________________________________________ FDA Proposes Action Plan to Confront Nation's Obesity Problem To help tackle what FDA is calling the "nation's obesity epidemic," the agency has released the final report of its Obesity Working Group. The report, called "Calories Count," proposes measures that include: enhancing the food label to display calorie count better; encouraging restaurants to provide nutritional information; stepping up enforcement actions concerning food label accuracy; revising agency guidance for developing obesity drugs; and working cooperatively with other organizations on obesity research. Press release: http://www.fda.gov/bbs/topics/news/2004/hhs_031204.html More obesity information: http://www.fda.gov/oc/initiatives/obesity/ HHS Cracking Down on Distributors of Steroid-Like 'Andro' Products As part of a crackdown by the Department of Health and Human Services on the steroid-like "andro" (androstenedione), FDA is asking 23 companies to stop distributing andro-containing products sold as dietary supplements. Andro products have been promoted to enhance athletic performance, but FDA says the products are a potential health risk. FDA could take further action if companies fail to stop distributing andro products. http://www.fda.gov/bbs/topics/news/2004/hhs_031104.html Proposal Issued on Developing Drugs for Smallpox Vaccine Side Effects FDA has issued draft guidance for developing drugs that can treat the side effects of the smallpox vaccination. Though the current smallpox vaccine can protect most people against the disease, the vaccine can potentially cause serious complications in certain people. The need for drugs to combat side effects is important because the potential of smallpox being used as a terrorism weapon has raised the possibility of large-scale vaccination in an emergency. http://www.fda.gov/bbs/topics/news/2004/NEW01033.html FDA Approves New Type of Drug for Hyperparathyroidism FDA has approved Sensipar (cinacalcet), a drug to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, and hypercalcemia in patients with parathyroid cancer. Use of Sensipar lowers serum levels of parathyroid hormone, which is associated in target patients with altered metabolism of calcium and phosphorus, bone pain, fractures, and an increased risk of cardiovascular death. http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01282.html FDA Lauds Senate for Passing Consumer Protection, Animal Drug Bill FDA has commended the Senate's passage of S741, a bill that contains the proposed Food Allergen Labeling and Consumer Protection Act of 2003 and the Minor Use and Minor Species Animal Health Act. The food allergen act would provide improved food labeling information to millions of consumers who suffer from food allergies. The minor species act is intended to increase the availability of new therapies for animals, including zoo animals and pets for which treatments are not available. http://www.fda.gov/bbs/topics/news/2004/NEW01034.html ______________________________________________________________ RECALLS/MARKET WITHDRAWALS The following product is being recalled for the reason shown. Go to the linked page for more information. Adco USA uneviscerated fish (possible contamination with Clostridium botulinum spores) http://www.fda.gov/oc/po/firmrecalls/adco03_04.html For a listing of recalls, market withdrawals, and safety alerts from the last 60 days, go to http://www.fda.gov/opacom/7alerts.html ______________________________________________________________ Latest FDA Consumer Magazine Now Available Online The March-April 2004 issue of FDA Consumer has articles on the following topics: -- Joint replacement -- Hip and knee replacements are helping people of all ages live pain-free, active lives. -- Chronic pain -- A look at the physical and emotional impact of pain that doesn't go away. -- Food security -- FDA and U.S. Customs and Border Protection are helping ensure the safety of America's food imports. -- Science meets beauty -- FDA evaluates cosmetic treatments, such as products designed to restore youthful appearance. -- Safe food additives -- FDA has a list of familiar food ingredients "generally recognized as safe." -- Over-the-counter pain relievers -- FDA reminds consumers that it is important to follow directions carefully. -- 2003-04 flu season -- The early onset of flu cases underscored the value of vaccination. -- Ephedra -- Dietary supplements with this ingredient present unreasonable risks of illness or injury, FDA says. -- Crackdown on illegal products -- How FDA is protecting consumers from dangerous drugs and dietary supplements. The issue is online at http://www.fda.gov/fdac/204_toc.html. Subscribe to FDA Consumer: http://www.fda.gov/fdac/orderform/fdap.html ______________________________________________________________ RECENT FDA TESTIMONY FDA Commissioner Mark B. McClellan, M.D., before the Senate Committee on Commerce, Science and Transportation; on the cost of prescription drugs and issues related to proposals to legalize importation of prescription drugs into the U.S. (March 11) http://www.fda.gov/ola/2004/drugcost0311.html To view the text of past FDA testimony, go to http://www.fda.gov/ola/listing.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 22. To leave this list at any time, send an e-mail to [EMAIL PROTECTED] In the body of the message, write SIGNOFF FDA-NEWSDIGEST-L
